Full Text
REGD. No. D. L.-33004/99
The Gazette of India
EXTRAORDINARY
PART II—Section 3—Sub-section (ii)
PUBLISHED BY AUTHORITY
CG-DL-E-21082024-256531
No. 3125]
NEW DELHI, MONDAY, AUGUST 12, 2024/ SHRAVANA 21, 1946
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3285(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Amylase + Protease + Glucoamylase + Pectinase + Alpha Galactosidase + Lactase + Beta-Gluconase + Cellulase + Lipase + Bromelain + Xylanase + Hemicellulase + Malt diastase + Invertase + Papain is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Amylase + Protease + Glucoamylase + Pectinase + Alpha Galactosidase + Lactase + Beta-Gluconase + Cellulase + Lipase + Bromelain + Xylanase + Hemicellulase + Malt diastase + Invertase + Papain with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3286(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Antimony Potassium Tartrate + Dried Ferrous Sulphate is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Antimony Potassium Tartrate + Dried Ferrous Sulphate with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3287(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Benfotiamine + Silymarin + L-Ornithine L-aspartate + Sodium Selenite + Folic acid + Pyridoxine hydrochloride is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Benfotiamine + Silymarin + L-Ornithine L-aspartate + Sodium Selenite + Folic acid + Pyridoxine hydrochloride with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3288(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Bismuth Ammonium Citrate + Papain is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Bismuth Ammonium Citrate + Papain with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3289(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Cyproheptadine HCl + Thiamine HCl + Riboflavine + Pyridoxine HCl + Niacinamide is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Cyproheptadine HCl + Thiamine HCl + Riboflavine + Pyridoxine HCl + Niacinamide with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3290(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Cyproheptadine Hydrochloride + Tricholine Citrate + Thiamine Hydrochloride + Riboflavine + Pyridoxine Hydrochloride is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Cyproheptadine Hydrochloride + Tricholine Citrate + Thiamine Hydrochloride + Riboflavine + Pyridoxine Hydrochloride with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3291(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Rabeprazole Sodium (As enteric coated tablet) + Clidinium Bromide + Dicyclomine HCl + Chlordiazepoxide is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Rabeprazole Sodium (As enteric coated tablet) + Clidinium Bromide + Dicyclomine HCl + Chlordiazepoxide with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3292(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Fungal Diastase + Papain + Nux vomica Tincture + Cardamom Tincture + Casein Hydrolysed + Alcohol is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Fungal Diastase + Papain + Nux vomica Tincture + Cardamom Tincture + Casein Hydrolysed + Alcohol with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3293(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Mefenamic Acid + Paracetamol Injection is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Mefenamic Acid + Paracetamol Injection with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3294(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Omeprazole Magnesium + Dicyclomine HCl is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Omeprazole Omeprazole Magnesium + Dicyclomine HCl with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3295(E).— Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of S-adenosyl methionine + Metadoxine + Ursodeoxycholicacid BP + L-Methylfolate Calcium eq. to L-Methylfolate + Choline bitartratee + Silymarin + L-ornithine L-aspartate + Inositol + Taurine is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of S-adenosyl methionine + Metadoxine + Ursodeoxycholicacid BP + L-Methylfolate Calcium eq. to L-Methylfolate + Choline bitartratee + Silymarin + L-ornithine L-aspartate + Inositol + Taurine with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3296(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Silymarin + Thiamine Mononitrate + Riboflavin + Pyridoxine HCl + Niacinamide + Calcium pantothenate + Vitamin B12 is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Silymarin + Thiamine Mononitrate + Riboflavin+ Pyridoxine HCl + Niacinamide + Calcium pantothenate + Vitamin B12 with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3297(E).— Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Silymarin + Pyridoxine HCl + Cyanocobalamin + Niacinamide + Folic Acid is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Silymarin + Pyridoxine HCl + Cyanocobalamin + Niacinamide + Folic Acid with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3298(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Silymarin + Vitamin B6 + Vitamin B12 + Niacinamide + Folic acid + Tricholine Citrate is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Silymarin + Vitamin B6 + Vitamin B12 + Niacinamide + Folic acid + Tricholine Citrate with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3299(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Sodium Citrate + Citric Acid Monohydrate Flavored with Cardamom Oil, Caraway Oil, Cinnamon Oil, Clove Oil, Ginger Oil + Alcohol is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Sodium Citrate + Citric Acid Monohydrate Flavored with Cardamom Oil, Caraway Oil, Cinnamon Oil, Clove Oil, Ginger Oil + Alcohol with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3300(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Sucralfate + Acelofenac is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Sucralfate + Acelofenac with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3301(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Sucralfate + Domperidone + Dimethicone is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Sucralfate + Domperidone + Dimethicone with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3302(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Sucralfate + Domperidone is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Sucralfate + Domperidone with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3303(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Tincture Ipecacuanha + Tincture Urgenia + Camphorated Opium Tincture + Aromatic Spirit of Ammonia + Chloroform + Alcohol is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Tincture Ipecacuanha + Tincture Urgenia + Camphorated Opium Tincture + Aromatic Spirit of Ammonia + Chloroform + Alcohol with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3304(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Ursodeoxycholic Acid + Metformin HCl is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Ursodeoxycholic Acid + Metformin HCl with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3305(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Weak Ginger tincture + Aromatic Spirit of Ammonia + Peppermint Spirit + Chloroform + Sodium Bicarbonate + Compound Cardamom + Alcohol is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Weak Ginger tincture + Aromatic Spirit of Ammonia + Peppermint Spirit +Chloroform +Sodium Bicarbonate +Compound Cardamom + Alcohol with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3306(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Sucralfate + Pantoprazole Sodium + Zinc Gluconate + Light Magnesium Carbonate is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Sucralfate + Pantoprazole Sodium + Zinc Gluconate + Light Magnesium Carbonate with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3307(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Aloe + Vitamin E Soap is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Aloe + Vitamin E Soap with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3308(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Povidone Iodine+ Metronidazole + Aloe is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Povidone Iodine + Metronidazole + Aloe with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3309(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Azelaic acid + Tea Tree Oil + Salicylic acid + Allantoin + Zinc oxide + Aloe vera + Jojoba oil + Vitamin E + Soap noodles is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Azelaic acid + Tea Tree Oil + Salicylic acid + Allantoin + Zinc oxide + Aloe vera + Jojoba oil + Vitamin E + Soap noodles with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3310(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Azithromycin + Adapalene is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Azithromycin + Adapalene with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3311(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Calamine + Aloes + Allantoin is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Calamine + Aloes + Allantoin with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3312(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Calamine + Diphenhydramine Hydrochloride + Aloe + Glycerine + Camphor is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Calamine + Diphenhydramine Hydrochloride + Aloe + Glycerine + Camphor with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3313(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Chlorphenesin + Zinc oxide + Starch is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Chlorphenesin + Zinc oxide + Starch with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3314(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Clindamycin Phosphate + Zinc acetate is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Clindamycin Phosphate + Zinc acetate with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3315(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Gamma Benzene Hexachloride + Benzocaine is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Gamma Benzene Hexachloride + Benzocaine with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3316(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Glucosamine hydrochloride + Diacerein + Menthol + Camphor + Capsaicin is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Glucosamine hydrochloride + Diacerein + Menthol + Camphor + Capsaicin with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3317(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Hydroxyquinone 2.0%w/w + Octyl Methoxycinnamate 5.0% w/w + Oxybenzone 30 % w/w is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Hydroxyquinone 2.0%w/w + Octyl Methoxycinnamate 5.0% w/w + Oxybenzone 30 % w/w with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3318(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Ketoconazole +Zinc Pyrithione +D-Panthenol +Tea Tree Oil +Aloes is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Ketoconazole +Zinc Pyrithione +D-Panthenol +Tea Tree Oil +Aloes with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3319(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Ketoconazole +Aloe vera+ Vitamin A Acetate is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Ketoconazole +Aloe vera+ Vitamin A Acetate with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3320(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Ketoconazole +Aloes + ZPTO is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Ketoconazole +Aloes + ZPTO with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3321(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Kojic Acid +Arbutin +Octinoxate +Vitamin E + Mulberry is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Kojic Acid +Arbutin +Octinoxate +Vitamin E + Mulberry with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3322(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Lornoxicam +capsaicin +menthol+ camphor is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Lornoxicam + capsaicin + menthol + camphor with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3323(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Lornoxicam + Thiocolchicoside +Oleum Lini +Menthol + Methyl salicylate is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Lornoxicam + Thiocolchicoside +Oleum Lini +Menthol + Methyl salicylate with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3324(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Menthol + Aloe vera Topical Spray is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Menthol + Aloe vera Topical Spray with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3325(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Menthol +Lignocaine HCl +Aloe vera gel +Clotrimazole +Diphenhydramine is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Menthol + Lignocaine HCl+Aloe vera gel + Clotrimazole + Diphenhydramine with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3326(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Miconazole nitrate + Gentamicin + Fluocinolone Acetonide +Zinc Sulphate is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Miconazole nitrate + Gentamicin + Fluocinolone Acetonide +Zinc Sulphate with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3327(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Miconazole +Tinidazole is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Miconazole +Tinidazole with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3328(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Minoxidil +Aminexil+ Alcohol is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Minoxidil +Aminexil + Alcohol with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3329(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Minoxidil +Azelaic acid + saw palmetto is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Minoxidil +Azelaic acid + saw palmetto with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3330(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Minoxidil +Aminexil is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Minoxidil +Aminexil with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3331 (E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Pine Bark extract+ Kojic acid +Sodium Ascorbyl Phosphate is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Pine Bark extract + Kojic acid + Sodium Ascorbyl Phosphate with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3332(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Povidone Iodine +Tinidazole +Zinc sulphate is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Povidone Iodine + Tinidazole + Zinc sulphate with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3333(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Povidone Iodine + Ornidazole + Dexpanthenol is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Povidone Iodine + Ornidazole + Dexpanthenol with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3334(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Salicyclic acid +Aloe vera+ Allantoin +D-Panthenol is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Salicyclic acid + Aloe vera + Allantoin + D-Panthenol with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3335(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Silver sulphadiazine +Chlorhexidine Gluconate solution +Allantoin + Aloe vera gel +Vitamin E acetate is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Silver sulphadiazine +Chlorhexidine Gluconate solution +Allantoin + Aloe vera gel +Vitamin E acetate with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3336(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Sodium salicylate + Zinc gluconate + Pyridoxine HCl is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Sodium salicylate + Zinc gluconate + Pyridoxine HCl with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3337(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Tetracycline + Colistin Sulphate is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Tetracycline + Colistin Sulphate with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3338(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Clomiphene +Ubidecarenone is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Clomiphene + Ubidecarenone with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3339(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Combikit of Clomiphene Citrate + Estradiol Valerate is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Combikit Clomiphene Citrate + Estradiol Valerate with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3340(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Flavoxate HCl +Ofloxacin is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Flavoxate HCl + Ofloxacin with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3341(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Clomiphene Citrate +N-Acetylcysteine is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Clomiphene Citrate + N-Acetylcysteine with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3342(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Evening Primerose Oil +Cod liver oil is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Evening Primerose Oil +Cod liver oil with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3343(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Sildenafil Citrate +Papaverine +L-Arginine is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Sildenafil Citrate +Papaverine +L-Arginine with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3344(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Tranexamic acid +Mefenamic acid + Vitamin K1 is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Tranexamic acid + Mefenamic acid + Vitamin K1 with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3345(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Divalproex Sodium +Oxcarbazepine is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Divalproex Sodium +Oxcarbazepine with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3346(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Divalproex Sodium + Levetiracitam is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Divalproex Sodium +Levetiracitam with immediate effect
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3347(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Ergotamine tartrate +Caffeine + Paracetamol +Prochlorperazine maleate is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Ergotamine tartrate + Caffeine + Paracetamol + Prochlorperazine maleate with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3348(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Piracetam + Ginkgo biloba extracts + Vinpocetin is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Piracetam + Ginkgo biloba extracts + Vinpocetin with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3349 (E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Ginkgo biloba + methylcobalamin is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Ginkgo biloba + methylcobalamin with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3350(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Ginkgo biloba + methylcobalamin + Alpha lipoic acid +Pyridoxine HCl is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Ginkgo biloba + methylcobalamin + Alpha lipoic acid + Pyridoxine HCl with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3351(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Ginseng Extract +Dried extract of Ginkgo Biloba is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Ginseng Extract + Dried extract of Ginkgo Biloba with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3352(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Meclizine HCl+ Paracetamol + Caffeine is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Meclizine HCl+ Paracetamol + Caffeine with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3353(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Nicergoline + Vinpocetine is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Nicergoline + Vinpocetine with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3354(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Gamma Linolenic Acid + Methylcobalamin is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Gamma Linolenic Acid + Methylcobalamin with immediate effect
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3355(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Beclomethasone Dipropionate + Neomycin Sulphate + Clotrimazole + Lignocaine HCl is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Beclomethasone Dipropionate + Neomycin Sulphate + Clotrimazole + Lignocaine HCl with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3356(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Boric acid+ Phenylephrine HCl + Naphazoline Nitrate + Menthol + Camphor is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Boric acid+ Phenylephrine HCl + Naphazoline Nitrate + Menthol + Camphor with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3357(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Naphazoline HCl + Chlorpheniramine Maleate + Zinc Sulphate + Hydroxy Propyl Methyl Cellulose is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Naphazoline HCl + Chlorpheniramine Maleate + Zinc Sulphate + Hydroxy Propyl Methyl Cellulose with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3358(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Chlorpheniramine Maleate + Naphazoline HCl + Zinc Sulphate + Sodium Chloride + Hydroxy Propyl Methyl Cellulose is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Chlorpheniramine Maleate + Naphazoline HCl + Zinc Sulphate + Sodium Chloride + Hydroxy Propyl Methyl Cellulose with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3359(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Chlorpheniramine Maleate + Naphazoline HCl + Hydroxy Propyl Methyl Cellulose is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Chlorpheniramine Maleate + Naphazoline HCl + Hydroxy Propyl Methyl Cellulose with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3360(E).— Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Chlorpheniramine Maleate + Sodium Chloride + Boric Acid + Tetrahydrozoline HCl is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Chlorpheniramine Maleate + Sodium Chloride + Boric Acid + Tetrahydrozoline HCl with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3361(E).— Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Chlorpheniramine Maleate + Phenylephrine HCl + Antipyrine is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Chlorpheniramine Maleate + Phenylephrine HCl + Antipyrine with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3362(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Ketorolac Tromethamine + Chlorpheniramine Maleate + Phenylephrine HCl + Hydroxy Propyl Methyl Cellulose is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Ketorolac Tromethamine + Chlorpheniramine Maleate + Phenylephrine HCl + Hydroxy Propyl Methyl Cellulose with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3363(E).— Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Ketorolac Tromethamine + Flurometholone is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Ketorolac Tromethamine + Flurometholone with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3364(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Naphazoline HCl + Zinc Sulphate + Boric Acid + Sodium Chloride+ Chlorpheniramine Maleate is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Naphazoline HCl + Zinc Sulphate + Boric Acid + Sodium Chloride+ Chlorpheniramine Maleate with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3365(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Boric Acid + Borax + Menthol + Camphor is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Boric Acid + Borax + Menthol + Camphor with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3366(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Chlorpheniramine Maleate +Boric Acid + Sodium Chloride + Zinc Sulphate is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Chlorpheniramine Maleate +Boric Acid + Sodium Chloride + Zinc Sulphate with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3367(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Chlorpheniramine Maleate +Boric Acid is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Chlorpheniramine Maleate +Boric Acid with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3368(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Naphazoline HCl + Chlorpheniramine Maleate + Methyl Cellulose is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Naphazoline HCl + Chlorpheniramine Maleate + Methyl Cellulose with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3369(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Naphazoline HCl + Hydroxy Methyl Cellulose + Boric Acid + Menthol + Camphor is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Naphazoline HCl + Hydroxy Methyl Cellulose + Boric Acid + Menthol + Camphor with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3370(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Naphazoline HCl + Boric Acid+Menthol+Camphor +Methyl Cellulose + Chlorpheniramine Maleate + Zinc Sulphate + Sodium Chloride is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Naphazoline HCl + Boric Acid+Menthol+Camphor +Methyl Cellulose + Chlorpheniramine Maleate + Zinc Sulphate + Sodium Chloride with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3371(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Naphazoline HCl + Phenylephrine HCl+ HPMC + Chlorpheniramine Maleate + Menthol+ Camphor is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Naphazoline HCl + Phenylephrine HCl+ HPMC + Chlorpheniramine Maleate + Menthol+ Camphor with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3372(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Chlorpheniramine Maleate + Boric Acid + Sodium Chloride + Zinc Sulphate + Menthol + Camphor is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Chlorpheniramine Maleate + Boric Acid + Sodium Chloride + Zinc Sulphate + Menthol + Camphor with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3373(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Chlorpheniramine Maleate + Boric Acid +Zinc Sulphate is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Naphazoline HCl + Hydroxy Propyl Methyl Cellulose + Chlorpheniramine Maleate + Boric Acid +Zinc Sulphate with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3374(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Naphazoline HCl + Azelastine HCl+ Sodium Carboxy Methyl Cellulose + Menthol + Camphor + Stabilized Oxychlorocomplex is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Naphazoline HCl + Azelastine HCl+ Sodium Carboxy Methyl Cellulose + Menthol + Camphor + Stabilized Oxychlorocomplex with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3375(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Naphazoline HCl + Sodium Carboxy Methyl Cellulose + Menthol + Camphor + Stabilized Oxychlorocomplex is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Naphazoline HCl + Sodium Carboxy Methyl Cellulose + Menthol + Camphor + Stabilized Oxychlorocomplex with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3376(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Naphazoline Nitrate + Chlorpheniramine Maleate + Phenylephrine HCl + Hydroxy Methyl Cellulose + Boric Acid+ Menthol+ Camphor is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Naphazoline Nitrate + Chlorpheniramine Maleate + Phenylephrine HCl + Hydroxy Methyl Cellulose + Boric Acid+ Menthol+ Camphor with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3377(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Naphazoline Nitrate + Chlorpheniramine Maleate + Zinc Sulphate + Boric Acid + Sodium Chloride is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Naphazoline Nitrate + Chlorpheniramine Maleate + Zinc Sulphate + Boric Acid + Sodium Chloride with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3378(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Norfloxacin + Tinidazole (with Betacyclodextrin) Eye ointment is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Norfloxacin + Tinidazole (with Betacyclodextrin) Eye ointment with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3379(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Ofloxacin + Beclomethasone Dipropionate + Lignocaine HCl is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Ofloxacin + Beclomethasone Dipropionate + Lignocaine HCl with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3380(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Naphazoline HCl + Chlorpheniramine Maleate + Phenylephrine HCl + Menthol + Camphor is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Naphazoline HCl + Chlorpheniramine Maleate + Phenylephrine HCl+ Menthol+ Camphor with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3381(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Phenylephrine HCl + Naphazoline HCl +Menthol+ Camphor + Hydroxy Propyl Methyl Cellulose is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Phenylephrine HCl + Naphazoline HCl +Menthol+ Camphor + Hydroxy Propyl Methyl Cellulose with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3382(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Phenylephrine HCl + Naphazoline HCl + Menthol + Camphor is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Phenylephrine HCl + Naphazoline HCl + Menthol + Camphor with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3383(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Sulphacetamide Sodium + Zinc Sulphate + Chlorpheniramine Maleate + Boric acid + Sodium Chloride is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Sulphacetamide Sodium + Zinc Sulphate + Chlorpheniramine Maleate + Boric acid + Sodium Chloride with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3384 (E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Zinc Sulphate + Boric acid + Naphazoline HCl + Sodium Chloride + Phenyl Ethyl Alcohol is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Zinc Sulphate + Boric acid + Naphazoline HCl + Sodium Chloride + Phenyl Ethyl Alcohol with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3385(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Cetirizine HCl + Paracetamol + Phenylephrine HCl is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Cetirizine HCl + Paracetamol + Phenylephrine HCl with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3386(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Cetirizine HCl + Phenylephrine HCl is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Cetirizine HCl + Phenylephrine HCl with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3387(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Levocetirizine + Phenylephrine HCl is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Levocetirizine + Phenylephrine HCl with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3388(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Levocetirizine + Phenylephrine HCl + Paracetamol is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Levocetirizine + Phenylephrine HCl + Paracetamol with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3389(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Phenylephrine HCl + Paracetamol + Levocetirizine HCl + Menthol is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Phenylephrine HCl + Paracetamol + Levocetirizine HCl + Menthol with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3390(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Levocetirizine HCl + Ambroxol HCl + Paracetamol is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Levocetirizine HCl + Ambroxol HCl + Paracetamol with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3391(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Levocetirizine HCl + Ambroxol HCl + Phenylephrine HCl is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Levocetirizine HCl + Ambroxol HCl + Phenylephrine HCl with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3392(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Diethylcarbamazine Citrate + Chlorpheniramine maleate is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Diethylcarbamazine Citrate + Chlorpheniramine maleate with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3393(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Diethylcarbamazine Citrate + Levocetirizine HCl is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Diethylcarbamazine Citrate + Levocetirizine HCl with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3394(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Ambroxol HCl + Phenylephrine HCl + Guaiphenesin is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Ambroxol HCl + Phenylephrine HCl + Guaiphenesin with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3395(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Bromhexine HCl + Phenylephrine HCl is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Bromhexine HCl + Phenylephrine HCl with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3396(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Etofylline + Theophylline anhydrous eq. to Theophylline hydrate + Ambroxol HCl is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Etofylline + Theophylline anhydrous eq. to Theophylline hydrate + Ambroxol HCl with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3397(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Etofylline + Theophylline anhydrous eq. to Theophylline hydrate+ Montelukast is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Etofylline + Theophylline anhydrous eq. to Theophylline hydrate + Montelukast with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3398(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Ambroxol HCl + Terbutaline Sulphate + Ammonium Chloride + Guaiphenesin + Menthol is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Ambroxol HCl + Terbutaline Sulphate + Ammonium Chloride + Guaiphenesin + Menthol with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3399(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Ambroxol HCl + Salbutamol Sulphate + Ammonium Chloride + Guaiphenesin + Menthol is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Ambroxol HCl + Salbutamol Sulphate + Ammonium Chloride + Guaiphenesin + Menthol with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3400(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Cetirizine HCl + Terbutaline Sulphate + Ambroxol HCl + Guaiphenesin is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Cetirizine HCl + Terbutaline Sulphate + Ambroxol HCl + Guaiphenesin with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3401(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Dextromethorphan Hydrobromide + Chlorpheniramine Maleate + Ammonium Chloride + Sodium Citrate + Menthol is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Dextromethorphan Hydrobromide + Chlorpheniramine Maleate + Ammonium Chloride + Sodium Citrate + Menthol with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3402(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Salbutamol Sulphate + Bromhexine HCl + Guaiphenesin + Ammonium Chloride + Menthol is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Salbutamol Sulphate + Bromhexine HCl + Guaiphenesin + Ammonium Chloride + Menthol with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3403(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Terbutaline Sulphate + Bromhexine HCl + Chlorpheniramine Maleate is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Terbutaline Sulphate + Bromhexine HCl + Chlorpheniramine Maleate with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3404(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Chlorpheniramine Maleate + P.G Sulphonate + Ammonium Chloride + Sodium Citrate + Menthol is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Chlorpheniramine Maleate + P.G Sulphonate + Ammonium Chloride + Sodium Citrate + Menthol with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3405(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Aminophylline + Ammonium Chloride + Sodium Citrate is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Aminophylline + Ammonium Chloride + Sodium Citrate with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3406(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Paracetamol + Chlorpheniramine Maleate + Phenyl Propanolamine is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Paracetamol + Chlorpheniramine Maleate + Phenyl Propanolamine with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3407(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Trithioparamethoxyphenyl Propene + Chlorpheniramine Maleate is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Trithioparamethoxyphenyl Propene + Chlorpheniramine Maleate with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3408(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Aceclofenac 50mg + Paracetamol 125mg oral liquid is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Aceclofenac 50mg + Paracetamol 125mg oral liquid with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3409(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Aceclofenac 50mg + Paracetamol 125mg tablet is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Aceclofenac 50mg + Paracetamol 125mg tablet with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3410(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Adenosine triphosphate diphosphate + Magnesium Orotate is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Adenosine triphosphate diphosphate + Magnesium Orotate with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3411(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Amoxicillin Trihydrate + Dicloxacillin Sodium + Lactobacillus is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Amoxicillin Trihydrate + Dicloxacillin Sodium + Lactobacillus with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3412(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Camylofin Dihydrochloride 25 mg + Paracetamol 300mg is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Camylofin Dihydrochloride 25 mg + Paracetamol 300mg with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3413(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Cefixime+ Acetyl Cysteine is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Cefixime + Acetyl Cysteine with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3414(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Cephalexin Monohydrate + Serratiopeptidase is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Cephalexin Monohydrate + Serratiopeptidase with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3415(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Cetyl Myristoleate + glucosamine Sulphate Potassium +Methyl Sulfonyl methane is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Cetyl Myristoleate + glucosamine Sulphate Potassium+ Methyl Sulfonyl methane with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3416(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Diacerin IP + Glucosamine Sulphate Potassium Chloride USP + MSM (Methylsulphonyl Methane) + Cetyl Myristoleate is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Diacerin IP + Glucosamine Sulphate Potassium Chloride USP + MSM (Methylsulphonyl Methane) + Cetyl Myristoleate with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3417(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Paracetamol+ Diclofenac Potassium + Caffeine Anhydrous is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Paracetamol + Diclofenac Potassium + Caffeine Anhydrous with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3418(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Diclofenac sodium + Thiocolchicoside Injection is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under section 26A is recommended”;
And whereas on the basis of the recommendations of the said Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country;
Now, therefore, in exercise of powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby prohibits the manufacture for sale, sale and distribution for human use of drug FDC of Diclofenac sodium + Thiocolchicoside Injection with immediate effect.
[F. No. X-11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 2nd August, 2024
S.O. 3419(E).—Whereas, the Central Government is satisfied that the use of the drug Fixed Dose Combination (hereinafter to be referred as FDC) of Doxycycline + Ornidazole + Bromelain + Lactobacillus Rhamnosus + Lactobacillus Reuteri RC is likely to involve risk to human beings whereas safer alternatives to the said drug are available;
And whereas, the matter was examined by an Expert Committee appointed by the Central Government and the said Expert Committee considered this FDC as irrational;
And whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended that “there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of Drugs and Cosmetics Act 1940. In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore,
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