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REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-16082024-256395
EXTRAORDINARY
PART II-Section 3-Sub-section (ii)
PUBLISHED BY AUTHORITY
No. 3107]
NEW DELHI, MONDAY, AUGUST 12, 2024/SHRAVANA 21, 1946
5098 GI/2024
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 12th August, 2024
S.O. 3266(E). Whereas, the Central Government is satisfied that the use of the drug Fixed Dose
Combination (hereinafter to be referred as FDC) of Naproxen IP 375mg + Esomeprazole Magnesium Trihydrate
IP 20mg hard gelatin Capsules or Tablets 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 whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended for
restriction under section 26A of Drugs and Cosmetics Act, 1940 for manufacture, sale and distribution of the FDC of
Naproxen IP 375mg + Esomeprazole Magnesium Trihydrate IP 20mg Capsule or Tablet subject to the following
conditions, namely:-
(i) Naproxen is in an enteric coated form.
(ii) The FDC is indicated in adults for the symptomatic treatment of osteoarthritis rheumatoid arthritis and ankylosing
spondylitis, in patients who are at risk for developing non-steroidal anti-inflammatory drug (NSAID)-associated
gastric and/or duodenal ulcers, to reduce the risk of developing gastric and duodenal ulcers and as per treatment
guidelines.
(iii) Demonstration of bioequivalence of the FDC with the internationally available innovator's FDC.
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 regulate by way of restriction of
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 restricts the manufacture, sale or distribution of the drug FDC of Naproxen IP 375mg
+ Esomeprazole Magnesium Trihydrate IP 20mg Capsule or Tablet shall be subject to the following conditions,
namely:-
(i) Naproxen shall be in an enteric coated form.
(ii) The FDC shall be indicated in adults for the symptomatic treatment of osteoarthritis rheumatoid arthritis and
ankylosing spondylitis, in patients who are at risk for developing non-steroidal anti-inflammatory drug (NSAID)-
associated gastric and/or duodenal ulcers, to reduce the risk of developing gastric and duodenal ulcers and as per
treatment guidelines.
(iii) Bioequivalence of this FDC shall be demonstrated with the internationally available innovator's FDC within one
year time.
2. This notification shall come into force on the date of its publication in the Official Gazette.
[F. No. X.11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
NOTIFICATION
New Delhi, the 12th August, 2024
S.O. 3267(E). Whereas, the Central Government is satisfied that the use of the drug Fixed Dose
Combination (hereinafter to be referred as FDC ) of Naproxen IP 250/500mg + Pantoprazole IP 20mg hard gelatin
Capsules or Tablets 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 whereas, the Drugs Technical Advisory Board also examined the said FDC and recommended for
restriction under section 26A of Drugs and Cosmetics Act, 1940 for manufacture, sale and distribution of the FDC of
Naproxen IP 250/500mg + Pantoprazole IP 20mg hard gelatin Capsules or Tablets subject to the following conditions,
namely:-
(i) Naproxen is in an enteric coated form.
(ii) The FDC is indicated in adults for the symptomatic treatment of osteoarthritis rheumatoid arthritis and ankylosing
spondylitis, in patients who are at risk for developing non-steroidal anti-inflammatory drug (NSAID)-associated
gastric and/or duodenal ulcers, to reduce the risk of developing gastric and duodenal ulcers and as per treatment
guidelines.
(iii) Bioequivalence of FDC is shown with Naproxen and Pantoprazole given separately as per standard package insert
for these within one year.
(iv) Efficacy and safety equivalence demonstrated with naproxen esomeprazole international innovator's FDC for the
indication, within one year.
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 regulate by way of restriction of
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 restricts the manufacture, sale or distribution of the drug FDC of Naproxen IP
250/500mg + Pantoprazole IP 20mg hard gelatin Capsules or Tablets shall be subject to the following conditions,
namely:-
(i) Naproxen shall be in an enteric coated form.
(ii) The FDC shall be indicated in adults for the symptomatic treatment of osteoarthritis rheumatoid arthritis and
ankylosing spondylitis, in patients who are at risk for developing non-steroidal anti-inflammatory drug (NSAID)-
associated gastric and/or duodenal ulcers, to reduce the risk of developing gastric and duodenal ulcers and as per
treatment guidelines.
(iii) Bioequivalence of FDC is shown with Naproxen and Pantoprazole given separately as per standard package insert
for these within one year.
(iv) Efficacy and safety equivalence demonstrated with Naproxen Esomeprazole international innovator's FDC for the
indication, within one year.
3. This notification shall come into force on the date of its publication in the Official Gazette.
[F. No. X.11035/53/2014-DFQC (Part-IV)]
RAJIV WADHAWAN, Advisor (Cost)
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.
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