Prohibition of 16 FDCs

REGD. No. D. L.-33004/99 CG-DL-E-19062026-273649 EXTRAORDINARY PART II—Section 3—Sub-section (ii) PUBLISHED BY AUTHORITY No. 2962] | NEW DELHI, MONDAY, JUNE 15, 2026/JYAISTHA 25, 1948 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 11th June, 2026 S.O. 3068(E).— whereas, the Central Government is satisfied that the use of the drug fixed dose combination of Acetyl Salicylic Acid + Ethoheptazine is likely to involve risk to human beings when safer alternatives to the said drug are available; And whereas, it was decided to examine this fixed dose combination by an Expert Committee and the report may be placed before the Drugs Technical Advisory Board; And whereas, the matter was examined by an Expert Committee in the year 2021 and the said Committee reported that the available data and peer reviewed scientific evidences do not support the rationality of this fixed dose combination and considered it as irrational; And whereas, the Drugs Technical Advisory Board examined the report of the Expert Committee and in-principle agreed to the recommendation of the Expert Committee and recommended that the Sub-Committee of Drugs Technical Advisory Board shall examine all irrational fixed dose combinations including this fixed dose combination in detail; 2 | THE GAZETTE OF INDIA : EXTRAORDINARY | [PART II—SEC. 3(ii)] And whereas, the said Sub-Committee had also given opportunity to the manufacturers or stakeholders of the said fixed dose combination for presenting the precise data with respect to the fixed dose combination through public notices; And whereas, the said Sub-Committee, after examining the fixed dose combination, submitted its report dated the 28th December, 2024 with respect to the said fixed dose combination which, inter alia stated that in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this fixed dose combination as there is no therapeutic justification for the fixed dose combination of these ingredients; And whereas, the said report of the said Sub-Committee was considered by the Drugs Technical Advisory Board and it agreed with the said recommendation of the said Sub-Committee; And whereas, on the basis of the recommendations of the Drugs Technical Advisory Board, the Central Government being satisfied that it is necessary and expedient in public interest to prohibit the manufacture, sale or distribution of the said drug for human use 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, being satisfied that it is necessary and expedient in the public interest so to do, hereby prohibits the manufacture, sale or distribution of the fixed dose combination of Acetyl Salicylic Acid + Ethoheptazine for human use, with immediate effect. [F. No. X.11035/53/2014-DFQC(Pt.- III)] HARSH MANGLA, Jt. Secy. 3 | THE GAZETTE OF INDIA : EXTRAORDINARY | [PART II—SEC. 3(ii)] And whereas, the said Sub-Committee had also given opportunity to the manufacturers or stakeholders of the said fixed dose combination for presenting the precise data with respect to the fixed dose combination through public notices; And whereas, the said Sub-Committee, after examining the fixed dose combination, submitted its report dated the 28th December, 2024 with respect to the said fixed dose combination which, inter alia stated that in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this fixed dose combination as there is no therapeutic justification for the fixed dose combination of these ingredients; And whereas, the said report of the said Sub-Committee was considered by the Drugs Technical Advisory Board and it agreed with the said recommendation of the said Sub-Committee; And whereas, on the basis of the recommendations of the Drugs Technical Advisory Board, the Central Government being satisfied that it is necessary and expedient in public interest to prohibit the manufacture, sale or distribution of the said drug for human use 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, being satisfied that it is necessary and expedient in the public interest so to do, hereby prohibits the manufacture, sale or distribution of the fixed dose combination of Acetyl Salicylic Acid + Ethoheptazine for human use, with immediate effect. [F. No. X.11035/53/2014-DFQC(Pt.- III)] HARSH MANGLA, Jt. Secy. 4 | THE GAZETTE OF INDIA : EXTRAORDINARY | [PART II—SEC. 3(ii)] NOTIFICATION New Delhi, the 11th June, 2026 S.O. 3069(E).— whereas, the Central Government is satisfied that the use of the drug fixed dose combination of Aloe vera + Jojoba oil + Wheat germ oil + Tea tree oil is likely to involve risk to human beings when safer alternatives to the said drug are available; And whereas, it was decided to examine this fixed dose combination by an Expert Committee and the report may be placed before the Drugs Technical Advisory Board; And whereas, the matter was examined by an Expert Committee in the year 2021 and the said Committee reported that the available data and peer reviewed scientific evidences do not support the rationality of this fixed dose combination and considered it as irrational; And whereas, the Drugs Technical Advisory Board examined the report of the Expert Committee and in-principle agreed to the recommendation of the Expert Committee and recommended that the Sub- Committee of Drugs Technical Advisory Board shall examine all irrational fixed dose combinations including this fixed dose combination in detail; And whereas, the said Sub-Committee had also given opportunity to the manufacturers or stakeholders of the said fixed dose combination for presenting the precise data with respect to the fixed dose combination through public notices; And whereas, the said Sub-Committee, after examining the fixed dose combination, submitted its report dated the 28th December, 2024 with respect to the said fixed dose combination which, inter alia stated that in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this fixed dose combination as there is no therapeutic justification for the fixed dose combination of these ingredients; And whereas, the said report of the said Sub-Committee was considered by the Drugs Technical Advisory Board and it agreed with the said recommendation of the said Sub-Committee; And whereas, on the basis of the recommendations of the Drugs Technical Advisory Board, the Central Government being satisfied that it is necessary and expedient in public interest to prohibit the manufacture, sale or distribution of the said drug for human use 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, being satisfied that it is necessary and expedient in the public interest so to do, hereby prohibits the manufacture, sale or distribution of the fixed dose combination of Aloe vera + Jojoba oil + Wheat germ oil + Tea tree oil for human use, with immediate effect. [F. No. X.11035/53/2014-DFQC(Pt.- III)] HARSH MANGLA, Jt. Secy. 6 | THE GAZETTE OF INDIA : EXTRAORDINARY | [PART II—SEC. 3(ii)] NOTIFICATION New Delhi, the 11th June, 2026 S.O. 3070(E). — whereas, the Central Government is satisfied that the use of the drug fixed dose combination of Amoxicillin + Serratiopeptidase + Lactobacillus Sporogenes is likely to involve risk to human beings when safer alternatives to the said drug are available; And whereas, after consultation with the Ministry of Health and Family Welfare, it was decided to examine this fixed dose combination by an Expert Committee and the report may be placed before the Drugs Technical Advisory Board; And whereas, the matter was examined by an Expert Committee in the year 2021 and the said Committee reported that the pharmacodynamically irrelevant, there is no sound clinical evidence of concurrent use of Amoxicillin and Serratiopeptidase. This combination is not as per standard therapeutic guidelines. The Committee also stated that available data and peer reviewed scientific evidences do not support the rationality of this fixed dose combination and considered it as irrational; And whereas, the Drugs Technical Advisory Board examined the report of the Expert Committee and in-principle agreed to the recommendation of the Expert Committee and recommended that the Sub- Committee of Drugs Technical Advisory Board shall examine all irrational fixed dose combinations including this fixed dose combination in detail; And whereas, the said Sub-Committee had also given opportunity to the manufacturers or stakeholders of the said fixed dose combination for presenting the precise data with respect to the fixed dose combination through public notices.; And whereas, the said Sub-Committee, after examining the fixed dose combination, submitted its report dated the 28th December, 2024 with respect to the said fixed dose combination which, inter alia stated that in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this fixed dose combination as there is no therapeutic justification for the fixed dose combination of these ingredients; And whereas, the said report of the said Sub-Committee was considered by the Drugs Technical Advisory Board and it agreed with the said recommendation of the said Sub-Committee; And whereas, on the basis of the recommendations of the Drugs Technical Advisory Board, the Central Government being satisfied that it is necessary and expedient in public interest to prohibit the manufacture, sale or distribution of the said drug for human use 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, being satisfied that it is necessary and expedient in the public interest so to do, hereby prohibits the manufacture, sale or distribution of the fixed dose combination of Amoxicillin + Serratiopeptidase + Lactobacillus Sporogenes for human use, with immediate effect. [F. No. X.11035/53/2014-DFQC(Pt.- III)] HARSH MANGLA, Jt. Secy. 7 | THE GAZETTE OF INDIA : EXTRAORDINARY | [PART II—SEC. 3(ii)] And whereas, the Drugs Technical Advisory Board examined the report of the Expert Committee and in-principle agreed to the recommendation of the Expert Committee and recommended that the Sub- Committee of Drugs Technical Advisory Board shall examine all irrational fixed dose combinations including this fixed dose combination in detail; And whereas, the said Sub-Committee had also given opportunity to the manufacturers or stakeholders of the said fixed dose combination for presenting the precise data with respect to the fixed dose combination through public notices.; And whereas, the said Sub-Committee, after examining the fixed dose combination, submitted its report dated the 28th December, 2024 with respect to the said fixed dose combination which, inter alia stated that in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this fixed dose combination as there is no therapeutic justification for the fixed dose combination of these ingredients; And whereas, the said report of the said Sub-Committee was considered by the Drugs Technical Advisory Board and it agreed with the said recommendation of the said Sub-Committee; And whereas, on the basis of the recommendations of the Drugs Technical Advisory Board, the Central Government being satisfied that it is necessary and expedient in public interest to prohibit the manufacture, sale or distribution of the said drug for human use 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, being satisfied that it is necessary and expedient in the public interest so to do, hereby prohibits the manufacture, sale or distribution of the fixed dose combination of Amoxicillin + Serratiopeptidase + Lactobacillus Sporogenes for human use, with immediate effect. [F. No. X.11035/53/2014-DFQC(Pt.- III)] HARSH MANGLA, Jt. Secy. NOTIFICATION New Delhi, the 11th June, 2026 S.O. 3071(E).— whereas, the Central Government is satisfied that the use of the drug fixed dose combination of Dicyclomine + Paracetamol + Clidinium Bromide + Chlordiazepoxide is likely to involve risk to human beings when safer alternatives to the said drug are available; And whereas, it was decided to examine this fixed dose combination by an Expert Committee and the report may be placed before the Drugs Technical Advisory Board; And whereas, the matter was examined by an Expert Committee in the year 2021 and the said committee reported that Dicyclomine has a potent anti-cholinergic activity (anti-spasmodic) and also has some smooth muscle relaxant property. Combining these with another anti-cholinergic agent like Clidinium does not seem to be justified. The committee also stated that the available data and peer reviewed scientific evidences do not support the rationality of this fixed dose combination and considered it as irrational; 8 | THE GAZETTE OF INDIA : EXTRAORDINARY | [PART II—SEC. 3(ii)] And whereas, the Drugs Technical Advisory Board examined the report of the Expert Committee and in-principle agreed to the recommendation of the Expert Committee and recommended that the Sub- Committee of Drugs Technical Advisory Board shall examine all irrational fixed dose combinations including this fixed dose combination in detail; And whereas, the said Sub-Committee had also given opportunity to the manufacturers or stakeholders of the said fixed dose combination for presenting the precise data with respect to the fixed dose combination through public notices.; And whereas, the said Sub-Committee after examining the fixed dose combination, submitted its report dated the 28th December, 2024 with respect to the said fixed dose combination which, inter alia stated that in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this fixed dose combination as there is no therapeutic justification for the fixed dose combination of these ingredients; And whereas, the said report of the said Sub-Committee was considered by the Drugs Technical Advisory Board and it agreed with the said recommendation of the said Sub-Committee; And whereas, on the basis of the recommendations of the Drugs Technical Advisory Board, the Central Government being satisfied that it is necessary and expedient in public interest to prohibit the manufacture, sale or distribution of the said drug for human use 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, being satisfied that it is necessary and expedient in the public interest so to do, hereby prohibits the manufacture, sale or distribution of the fixed dose combination of Dicyclomine + Paracetamol + Clidinium Bromide + Chlordiazepoxide for human use, with immediate effect. [F. No. X.11035/53/2014-DFQC(Pt.- III)] HARSH MANGLA, Jt. Secy. 9 | THE GAZETTE OF INDIA : EXTRAORDINARY | [PART II—SEC. 3(ii)] NOTIFICATION New Delhi, the 11th June, 2026 S.O. 3072(E).— whereas, the Central Government is satisfied that the use of the drug fixed dose combination of Amoxicillin + Serratiopeptidase is likely to involve risk to human beings when safer alternatives to the said drug are available; And whereas, it was decided to examine this fixed dose combination by an Expert Committee and the report may be placed before the Drugs Technical Advisory Board; And whereas, the matter was examined by an Expert Committee in the year 2021 and the said Committee reported that the pharmacodynamically irrelevant, there is no sound clinical evidence of concurrent use of Amoxicillin and Serratiopeptidase. This combination is not as per standard therapeutic guidelines. The Committee also stated that available data and peer reviewed scientific evidences do not support the rationality of this fixed dose combination and considered it as irrational; And whereas, the Drugs Technical Advisory Board examined the report of the Expert Committee and in-principle agreed to the recommendation of the Expert Committee and recommended that the Sub- Committee of Drugs Technical Advisory Board shall examine all irrational fixed dose combinations including this fixed dose combination in detail; And whereas, the said Sub-Committee had also given opportunity to the manufacturers or stakeholders of the said fixed dose combination for presenting the precise data with respect to the fixed dose combination through public notices; And whereas, the said Sub-Committee, after examining the fixed dose combination, submitted its report dated the 28th December, 2024 with respect to the said fixed dose combination which, inter alia stated that in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this fixed dose combination as there is no therapeutic justification for the fixed dose combination of these ingredients; And whereas, the said report of the said Sub-Committee was considered by the Drugs Technical Advisory Board and it agreed with the said recommendation of the said Sub-Committee; And whereas, on the basis of the recommendations of the Drugs Technical Advisory Board, the Central Government being satisfied that it is necessary and expedient in public interest to prohibit the manufacture, sale or distribution of the said drug for human use 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, being satisfied that it is necessary and expedient in the public interest so to do, hereby prohibits the manufacture, sale or distribution of the fixed dose combination of Amoxicillin + Serratiopeptidase for human use, with immediate effect. [F. No. X.11035/53/2014-DFQC(Pt.- III)] HARSH MANGLA, Jt. Secy. 10 | THE GAZETTE OF INDIA : EXTRAORDINARY | [PART II—SEC. 3(ii)] NOTIFICATION New Delhi, the 11th June, 2026 S.O. 3073(E).— whereas, the Central Government is satisfied that the use of the drug fixed dose combination of Aloe Extract + Allantoin + Alphatocopherol Acetate + D-Penthenol + Vitamin A is likely to involve risk to human beings when safer alternatives to the said drug are available; And whereas, it was decided to examine this fixed dose combination by an Expert Committee and the report may be placed before the Drugs Technical Advisory Board; And whereas, the matter was examined by an Expert Committee in the year 2021 and the said Committee reported that the available data and peer reviewed scientific evidences do not support the rationality of this fixed dose combination and considered it as irrational; 11 | THE GAZETTE OF INDIA : EXTRAORDINARY | [PART II—SEC. 3(ii)] And whereas, the Drugs Technical Advisory Board examined the report of the Expert Committee and in-principle agreed to the recommendation of the Expert Committee and recommended that the Sub-Committee of Drugs Technical Advisory Board shall examine all irrational fixed dose combinations including this fixed dose combination in detail; And whereas, the said Sub-Committee had also given opportunity to the manufacturers or stakeholders of the said fixed dose combination for presenting the precise data with respect to the fixed dose combination through public notices; And whereas, the said Sub-Committee, after examining the fixed dose combination, submitted its report dated the 28th December, 2024 with respect to the said fixed dose combination which, inter alia stated that in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this fixed dose combination as there is no therapeutic justification for the fixed dose combination of these ingredients; And whereas, the said report of the said Sub-Committee was considered by the Drugs Technical Advisory Board examined and it agreed with the said recommendation of the said Sub-Committee; And whereas, on the basis of the recommendations of the Drugs Technical Advisory Board, the Central Government being satisfied that it is necessary and expedient in public interest to prohibit the manufacture, sale or distribution of the said drug for human use 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, being satisfied that it is necessary and expedient in the public interest so to do, hereby prohibits the manufacture sale or distribution of the fixed dose combination of Aloe Extract + Allantoin + Alphatocopherol Acetate + D-Penthenol + Vitamin A for human use, with immediate effect. [F. No. X.11035/53/2014-DFQC(Pt.- III)] HARSH MANGLA, Jt. Secy. 12 | THE GAZETTE OF INDIA : EXTRAORDINARY | [PART II—SEC. 3(ii)] NOTIFICATION New Delhi, the 11th June, 2026 S.O. 3074(E).— whereas, the Central Government is satisfied that the use of the drug fixed dose combination of Aloe Extract + Vitamin E + Dimethicone + Glycerine is likely to involve risk to human beings when safer alternatives to the said drug are available; And whereas, it was decided to examine this fixed dose combination by an Expert Committee and the report may be placed before the Drugs Technical Advisory Board; And whereas, the matter was examined by an Expert Committee in the year 2021 and the said Committee reported that the available data and peer reviewed scientific evidences do not support the rationality of this fixed dose combination and it considered this fixed dose combination as irrational; And whereas, the Drugs Technical Advisory Board examined the report of the Expert Committee and in-principle agreed to the recommendation of the Expert Committee and recommended that the Sub- Committee of Drugs Technical Advisory Board shall examine all irrational fixed dose combinations including this fixed dose combination in detail; And whereas, the said Sub-Committee had also given opportunity to the manufacturers or stakeholders of the said fixed dose combination for presenting the precise data with respect to the fixed dose combination through public notices; And whereas, the said Sub-Committee after examining this fixed dose combination, submitted its report dated the 28th December, 2024 with respect to the said fixed dose combination which, inter alia stated that in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this fixed dose combination as there is no therapeutic justification for the fixed dose combination of these ingredients; And whereas, the said report of the said Sub-Committee was considered by the Drugs Technical Advisory Board and it agreed with the said recommendation of the said Sub-Committee; And whereas, on the basis of the recommendations of the Drugs Technical Advisory Board, the Central Government being satisfied that it is necessary and expedient in public interest to prohibit the manufacture, sale or distribution of the said drug for human use 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, being satisfied that it is necessary and expedient in the public interest so to do, hereby prohibits the manufacture sale or distribution of the fixed dose combination of Aloe Extract + Vitamin E + Dimethicone + Glycerine for human use, with immediate effect. [F. No. X.11035/53/2014-DFQC(Pt.- III)] HARSH MANGLA, Jt. Secy. 13 | THE GAZETTE OF INDIA : EXTRAORDINARY | [PART II—SEC. 3(ii)] NOTIFICATION New Delhi, the 11th June, 2026 S.O. 3075(E).— whereas, the Central Government is satisfied that the use of the drug fixed dose combination of Aloe Vera + Jojoba Oil + Vitamin E is likely to involve risk to human beings when safer alternatives to the said drug are available; And whereas, it was decided to examine this fixed dose combination by an Expert Committee and the report may be placed before the Drugs Technical Advisory Board; And whereas, the matter was examined by an Expert Committee in the year 2021 and the said Committee reported that the available data and peer reviewed scientific evidences do not support the rationality of this fixed dose combination and it considered this fixed dose combination as irrational; 14 | THE GAZETTE OF INDIA : EXTRAORDINARY | [PART II—SEC. 3(ii)] And whereas, the Drugs Technical Advisory Board examined the report of the Expert Committee and in-principle agreed to the recommendation of the Expert Committee and recommended that the Sub- Committee of Drugs Technical Advisory Board shall examine all irrational fixed dose combinations including this fixed dose combination in detail; And whereas, the said Sub-Committee had also given opportunity to the manufacturers or stakeholders of the said fixed dose combination for presenting the precise data with respect to the fixed dose combination through public notices; And whereas, the said Sub-Committee after examining this fixed dose combination, submitted its report dated the 28th December, 2024 with respect to the said fixed dose combination which, inter alia stated that in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this fixed dose combination as there is no therapeutic justification for the fixed dose combination of these ingredients; And whereas, the said report of the said Sub-Committee was considered by the Drugs Technical Advisory Board and it agreed with the said recommendation of the said Sub-Committee; And whereas, on the basis of the recommendations of the Drugs Technical Advisory Board, the Central Government being satisfied that it is necessary and expedient in public interest to prohibit the manufacture, sale or distribution of the said drug for human use 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, being satisfied that it is necessary and expedient in the public interest so to do, hereby prohibits the manufacture, sale or distribution of the fixed dose combination of Aloe Vera + Jojoba Oil + Vitamin E for human use, with immediate effect. [F. No. X.11035/53/2014-DFQC(Pt.- III)] HARSH MANGLA, Jt. Secy. 15 | THE GAZETTE OF INDIA : EXTRAORDINARY | [PART II—SEC. 3(ii)] NOTIFICATION New Delhi, the 11th June, 2026 S.O. 3076(E).— whereas, the Central Government is satisfied that the use of the drug fixed dose combination of Aloe vera + Orange oil is likely to involve risk to human beings when safer alternatives to the said drug are available; And whereas, it was decided to examine this fixed dose combination by an Expert Committee and the report may be placed before the Drugs Technical Advisory Board; And whereas, the matter was examined by an Expert Committee in the year 2021 and the said Committee reported that the available data and peer reviewed scientific evidences do not support the rationality of this fixed dose combination and considered it as irrational; And whereas, the Drugs Technical Advisory Board examined the report of the Expert Committee and in-principle agreed to the recommendation of the Expert Committee and recommended that the Sub- Committee of Drugs Technical Advisory Board shall examine all irrational fixed dose combinations including this fixed dose combination in detail; And whereas, the said Sub-Committee had also given opportunity to the manufacturers or stakeholders of the said fixed dose combination for presenting the precise data with respect to the fixed dose combination through public notices; And whereas, the said Sub-Committee, after examining the fixed dose combination, submitted its report dated the 28th December, 2024 with respect to the said fixed dose combination which, inter alia stated that in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this fixed dose combination as there is no therapeutic justification for the fixed dose combination of these ingredients; And whereas, the said report of the said Sub-Committee was considered by the Drugs Technical Advisory Board and it agreed with the said recommendation of the said Sub-Committee; And whereas, on the basis of the recommendations of the Drugs Technical Advisory Board, the Central Government being satisfied that it is necessary and expedient in public interest to prohibit the manufacture, sale or distribution of the said drug for human use 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, being satisfied that it is necessary and expedient in the public interest so to do, hereby prohibits the manufacture, sale or distribution of the fixed dose combination of Aloe vera + Orange oil for human use, with immediate effect. [F. No. X.11035/53/2014-DFQC(Pt.- III)] HARSH MANGLA, Jt. Secy. 16 | THE GAZETTE OF INDIA : EXTRAORDINARY | [PART II—SEC. 3(ii)] NOTIFICATION New Delhi, the 11th June, 2026 S.O. 3077(E).— whereas, the Central Government is satisfied that the use of the drug fixed dose combination of Aloe vera + Vitamin E + Herbal is likely to involve risk to human beings when safer alternatives to the said drug are available; And whereas, it was decided to examine this fixed dose combination by an Expert Committee and the report may be placed before the Drugs Technical Advisory Board; And whereas, the matter was examined by an Expert Committee in the year 2021 and the said Committee reported that the available data and peer reviewed scientific evidences do not support the rationality of this fixed dose combination. Further, the Committee noted that the product is not defined as well as characterized and also considered this fixed dose combination as irrational; 17 | THE GAZETTE OF INDIA : EXTRAORDINARY | [PART II—SEC. 3(ii)] And whereas, the Drugs Technical Advisory Board examined the report of the Expert Committee and in-principle agreed to the recommendation of the Expert Committee and recommended that the Sub- Committee of Drugs Technical Advisory Board shall examine all irrational fixed dose combinations including this fixed dose combination in detail; And whereas, the said Sub-Committee had also given opportunity to the manufacturers or stakeholders of the said fixed dose combination for presenting the precise data with respect to the fixed dose combination through public notices; And whereas, the said Sub-Committee, after examining the fixed dose combination, submitted its report dated the 28th December, 2024 with respect to the said fixed dose combination which, inter alia stated that in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this fixed dose combination as there is no therapeutic justification for the fixed dose combination of these ingredients; And whereas, the said report of the said Sub-Committee was considered by the Drugs Technical Advisory Board and it agreed with the said recommendation of the said Sub-Committee; And whereas, on the basis of the recommendations of the Drugs Technical Advisory Board, the Central Government being satisfied that it is necessary and expedient in public interest to prohibit the manufacture, sale or distribution of the said drug for human use 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, being satisfied that it is necessary and expedient in the public interest so to do, hereby prohibits the manufacture, sale or distribution of the fixed dose combination of Aloe vera + Vitamin E + Herbal for human use, with immediate effect. [F. No. X.11035/53/2014-DFQC(Pt.- III)] HARSH MANGLA, Jt. Secy. 18 | THE GAZETTE OF INDIA : EXTRAORDINARY | [PART II—SEC. 3(ii)] NOTIFICATION New Delhi, the 11th June, 2026 S.O. 3078(E).— whereas, the Central Government is satisfied that the use of the drug fixed dose combination of Dicyclomine + Paracetamol + Clidinium Bromide is likely to involve risk to human beings when safer alternatives to the said drug are available; And whereas, it was decided to examine this fixed dose combination by an Expert Committee and the report may be placed before the Drugs Technical Advisory Board; And whereas, the matter was examined by an Expert Committee in the year 2021 and the said committee reported that Dicyclomine has a potent anti-cholinergic activity (anti-spasmodic) and also has some smooth muscle relaxant property. Combining these with another anti-cholinergic agent like Clidinium does not seem to be justified. The said committee also stated that the available data and peer reviewed scientific evidences do not support the rationality of this fixed dose combination and considered this fixed dose combination as irrational; And whereas, the Drugs Technical Advisory Board examined the report of the Expert Committee and in-principle agreed to the recommendation of the Expert Committee and recommended that the Sub- Committee of Drugs Technical Advisory Board shall examine all irrational fixed dose combinations including this fixed dose combination in detail; And whereas, the said Sub-Committee had also given opportunity to the manufacturers or stakeholders of the said fixed dose combination for presenting the precise data with respect to the fixed dose combination through public notices.; And whereas, the said Sub-Committee after examining this fixed dose combination, submitted its report dated the 28th December, 2024 with respect to the said fixed dose combination which, inter alia stated that in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this fixed dose combination as there is no therapeutic justification for the fixed dose combination of these ingredients; And whereas, the said report of the said Sub-Committee was considered by the Drugs Technical Advisory Board it agreed with the said recommendation of the said Sub-Committee; And whereas, on the basis of the recommendations of the Drugs Technical Advisory Board, the Central Government being satisfied that it is necessary and expedient in public interest to prohibit the manufacture, sale or distribution of the said drug for human use 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, being satisfied that it is necessary and expedient in the public interest so to do, hereby prohibits the manufacture, sale or distribution of the fixed dose combination of Dicyclomine + Paracetamol + Clidinium Bromide for human use, with immediate effect. [F. No. X.11035/53/2014-DFQC(Pt.- III)] HARSH MANGLA, Jt. Secy. 19 | THE GAZETTE OF INDIA : EXTRAORDINARY | [PART II—SEC. 3(ii)] NOTIFICATION New Delhi, the 11th June, 2026 S.O. 3079(E).— whereas, the Central Government is satisfied that the use of the drug fixed dose combination of Paracetamol + Lignocaine is likely to involve risk to human beings when safer alternatives to the said drug are available; And whereas, it was decided to examine this fixed dose combination by an Expert Committee and the report may be placed before the Drugs Technical Advisory Board; 20 | THE GAZETTE OF INDIA : EXTRAORDINARY | [PART II—SEC. 3(ii)] And whereas, the matter was examined by an Expert Committee in the year 2021 and the said Committee reported that the available data and peer reviewed scientific evidences do not support the rationality of this fixed dose combination and it considered this fixed dose combination as irrational; And whereas, the Drugs Technical Advisory Board examined the report of the Expert Committee and in-principle agreed to the recommendation of the Expert Committee and recommended that the Sub- Committee of Drugs Technical Advisory Board shall examine all irrational fixed dose combinations including this fixed dose combination in detail; And whereas, the said Sub-Committee had also given opportunity to the manufacturers or stakeholders of the said fixed dose combination for presenting the precise data with respect to the fixed dose combination through public notices; And whereas, the said Sub-Committee, after examining the fixed dose combination, submitted its report dated the 28th December, 2024 with respect to the said fixed dose combination which inter alia stated that in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this fixed dose combination as there is no therapeutic justification for the fixed dose combination of these ingredients; and there is a possibility of risk with the fixed dose combination; And whereas, the said report of the said Sub-Committee was considered by the Drugs Technical Advisory Board and it agreed with the said recommendation of the said Sub-Committee; And whereas, on the basis of the recommendations of the Drugs Technical Advisory Board, the Central Government being satisfied that it is necessary and expedient in public interest to prohibit the manufacture, sale or distribution of the said drug for human use 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, being satisfied that it is necessary and expedient in the public interest so to do, hereby prohibits the manufacture sale or distribution of the fixed dose combination of Paracetamol + Lignocaine for human use, with immediate effect. [F. No. X.11035/53/2014-DFQC(Pt.- III)] HARSH MANGLA, Jt. Secy. 21 | THE GAZETTE OF INDIA : EXTRAORDINARY | [PART II—SEC. 3(ii)] NOTIFICATION New Delhi, the 11th June, 2026 S.O. 3080(E).— whereas, the Central Government is satisfied that the use of the drug fixed dose combination of Gliclazide + Chromium Picolinate is likely to involve risk to human beings when safer alternatives to the said drug are available; And whereas, it was decided to examine this fixed dose combination by an Expert Committee and the report may be placed before the Drugs Technical Advisory Board; And whereas, the matter was examined by an Expert Committee in the year 2021 and the said Committee reported that the national as well as international standard treatment guidelines for TYPE 2 DM do not recommend the use of Chromium picolinate. The said Committee also stated that available data and peer reviewed scientific evidences do not support the rationality of this fixed dose combination considered it as irrational; And whereas, the Drugs Technical Advisory Board examined the report of the Expert Committee and in-principle agreed to the recommendation of the Expert Committee and recommended that the Sub- Committee of Drugs Technical Advisory Board shall examine all irrational fixed dose combinations including this fixed dose combination in detail; And whereas, the said Sub-Committee had also given opportunity to the manufacturers or stakeholders of the said fixed dose combination for presenting the precise data with respect to the fixed dose combination through public notices; And whereas, the said Sub-Committee, after examining the fixed dose combination, submitted its report dated the 28th December, 2024 with respect to the said fixed dose combination which inter alia stated that in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this fixed dose combination as there is no therapeutic justification for the fixed dose combination of these ingredients; And whereas, the said report of the said Sub-Committee was considered by the Drugs Technical Advisory Board and it agreed with the said recommendation of the said Sub-Committee; And whereas, on the basis of the recommendations of the Drugs Technical Advisory Board, the Central Government being satisfied that it is necessary and expedient in public interest to prohibit the manufacture, sale or distribution of the said drug for human use 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, being satisfied that it is necessary and expedient in the public interest 22 | THE GAZETTE OF INDIA : EXTRAORDINARY | [PART II—SEC. 3(ii)] so to do, hereby prohibits the manufacture, sale or distribution of the fixed dose combination of Gliclazide + Chromium Picolinate for human use, with immediate effect. [F. No. X.11035/53/2014-DFQC(Pt.- III)] HARSH MANGLA, Jt. Secy. NOTIFICATION New Delhi, the 11th June, 2026 S.O. 3081(E).— whereas, the Central Government is satisfied that the use of the drug fixed dose combination of Amoxicillin + Cloxacillin + Lactic acid bacillus + Serratiopeptidase is likely to involve risk to human beings when safer alternatives to the said drug are available; And whereas, it was decided to examine this fixed dose combination by an Expert Committee and the report may be placed before the Drugs Technical Advisory Board; And whereas, the matter was examined by an Expert Committee in the year 2021 and the said Committee reported that the pharmacodynamically irrelevant, there is no sound clinical evidence of concurrent use of Amoxicillin and Serratiopeptidase. This combination is not as per standard therapeutic guidelines. The said Committee also stated that available data and peer reviewed scientific evidences do not support the rationality of this fixed dose combination and considered this fixed dose combination as irrational; And whereas, the Drugs Technical Advisory Board examined the report of the Expert Committee and in-principle agreed to the recommendation of the Expert Committee and recommended that the Sub- Committee of Drugs Technical Advisory Board shall examine all irrational fixed dose combinations including this fixed dose combination in detail; And whereas, the said Sub-Committee had also given opportunity to the manufacturers or stakeholders of the said fixed dose combination for presenting the precise data with respect to the fixed dose combination through public notices.; And whereas, the said Sub-Committee, after examining the fixed dose combination, submitted its report dated the 28th December, 2024 with respect to the said fixed dose combination which, inter alia stated that in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this fixed dose combination as there is no therapeutic justification for the fixed dose combination of these ingredients; And whereas, the said report of the said Sub-Committee was considered by the Drugs Technical Advisory Board and it agreed with the said recommendation of the said Sub-Committee; And whereas, on the basis of the recommendations of the Drugs Technical Advisory Board, the Central Government being satisfied that it is necessary and expedient in public interest to prohibit the manufacture, sale or distribution of the said drug for human use 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, being satisfied that it is necessary and expedient in the public interest so to do, hereby prohibits the manufacture, sale or distribution of the fixed dose combination of Amoxicillin + Cloxacillin + Lactic acid bacillus + Serratiopeptidase for human use, with immediate effect. [F. No. X.11035/53/2014-DFQC(Pt.- III)] HARSH MANGLA, Jt. Secy. 24 | THE GAZETTE OF INDIA : EXTRAORDINARY | [PART II—SEC. 3(ii)] NOTIFICATION New Delhi, the 11th June, 2026 S.O. 3082(E).— whereas, the Central Government is satisfied that the use of the drug fixed dose combination of Cefadroxyl + Probenecid is likely to involve risk to human beings when safer alternatives to the said drug are available; And whereas, it was decided to examine this fixed dose combination by an Expert Committee and the report may be placed before the Drugs Technical Advisory Board; And whereas, the matter was examined by an Expert Committee in the year 2021 and the said committee stated that there is no pharmacokinetic data to substantiate the addition of probenecid with Cefadroxyl in regards to dose titration. There is need for conducting pharmacokinetic study to determine the doses of probenecid and in present circumstances the committee did not recommend; And whereas, the Drugs Technical Advisory Board examined the report of the Expert Committee and in-principle agreed to the recommendation of the Expert Committee and recommended that the Sub- Committee of Drugs Technical Advisory Board shall examine all irrational fixed dose combinations including this fixed dose combination in detail; And whereas, the said Sub-Committee had also given opportunity to the manufacturers or stakeholders of the said fixed dose combination for presenting the precise data with respect to the fixed dose combination through public notices.; And whereas, the said Sub-Committee, after examining the fixed dose combination, submitted its report dated the 28th December, 2024 with respect to the said fixed dose combination which, inter alia stated that in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this 25 | THE GAZETTE OF INDIA : EXTRAORDINARY | [PART II—SEC. 3(ii)] fixed dose combination as there is no therapeutic justification for the fixed dose combination of these ingredients; And whereas, the said report of the said Sub-Committee was considered by the Drugs Technical Advisory Board and it agreed with the said recommendation of the said Sub-Committee; And whereas, on the basis of the recommendations of the Drugs Technical Advisory Board, the Central Government being satisfied that it is necessary and expedient in public interest to prohibit the manufacture, sale or distribution of the said drug for human use 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, being satisfied that it is necessary and expedient in the public interest so to do, hereby prohibits the manufacture, sale or distribution of the fixed dose combination of Cefadroxyl + Probenecid for human use, with immediate effect. [F. No. X.11035/53/2014-DFQC(Pt.- III)] HARSH MANGLA, Jt. Secy. 26 | THE GAZETTE OF INDIA : EXTRAORDINARY | [PART II—SEC. 3(ii)] NOTIFICATION New Delhi, the 11th June, 2026 S.O. 3083(E).— whereas, the Central Government is satisfied that the use of the drug fixed dose combination of Cefuroxime + Serratiopeptidase is likely to involve risk to human beings when safer alternatives to the said drug are available; And whereas, after consultation with the Ministry of Health and Family Welfare, it was decided to examine this fixed dose combination by an Expert Committee and the report may be placed before the Drugs Technical Advisory Board; And whereas, the matter was examined by an Expert Committee in the year 2021 and the said Committee reported that the pharmacodynamically irrelevant, there is no sound clinical evidence of concurrent use of Cefuroxime and Serratiopeptidase. This combination is not as per standard therapeutic guidelines. The Committee also stated that available data and peer reviewed scientific evidences do not support the rationality of this fixed dose combination and considered this fixed dose combination as irrational; And whereas, the Drugs Technical Advisory Board examined the report of the Expert Committee and in-principle agreed to the recommendation of the Expert Committee and recommended that the Sub- Committee of Drugs Technical Advisory Board shall examine all irrational fixed dose combinations including this fixed dose combination in detail; And whereas, the said Sub-Committee had also given opportunity to the manufacturers or stakeholders of the said fixed dose combination for presenting the precise data with respect to the fixed dose combination through public notices.; And whereas, the said Sub-Committee, after examining the fixed dose combination, submitted its report dated the 28th December, 2024 with respect to the said fixed dose combination which, inter alia stated that in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this fixed dose combination as there is no therapeutic justification for the fixed dose combination of these ingredients; And whereas, the said report of the said Sub-Committee was considered by the Drugs Technical Advisory Board examined and it agreed with the said recommendation of the said Sub-Committee; And whereas, on the basis of the recommendations of the Drugs Technical Advisory Board, the Central Government being satisfied that it is necessary and expedient in public interest to prohibit the manufacture, sale or distribution of the said drug for human use 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, being satisfied that it is necessary and expedient in the public interest so to do, hereby prohibits the manufacture, sale or distribution of the fixed dose combination of Cefuroxime + Serratiopeptidase for human use, with immediate effect. [F. No. X.11035/53/2014-DFQC(Pt.- III)] HARSH MANGLA, Jt. Secy. Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054. SARVESH KUMAR MARASTAVASH SRIVASTAVA Date: 2006.06.19 22:31:26 +05:30