The Ministry of Health and Family Welfare (“MoHFW”) has implemented restriction on the manufacture, sale or distribution of the following Fixed Dose Combinations (“FDC”) which are likely to involve risk to human beings, subject to the following conditions:
1. FDC of Naproxen IP 375mg + Esomeprazole Magnesium Trihydrate IP 20mg Capsule or Tablet
• Naproxen is in an enteric coated form;
• 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;
• Bioequivalence of this FDC is demonstrated with the internationally available innovator’s FDC within one year time.
2. FDC of Naproxen IP 250/500mg + Pantoprazole IP 20mg hard gelatin Capsules or Tablets
• Naproxen is in an enteric coated form;
• 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;
• Bioequivalence of FDC is shown with Naproxen and Pantoprazole given separately as per standard package insert for these within a period of one year;
• Efficacy and safety equivalence is demonstrated with Naproxen Esomeprazole international innovator’s FDC for the indication, within a period of one year.
Background: It was believed by MoHFW that the use of the drugs Naproxen IP 375mg + Esomeprazole Magnesium Trihydrate IP 20mg Capsule or Tablet and Naproxen IP 250/500mg + Pantoprazole IP 20mg hard gelatin Capsules or Tablets are likely to involve risk to human beings and safer alternatives of the same are available. Accordingly, an Expert Committee was appointed to examine the matter and further, the matter was examined by the Drugs Technical Advisory
Board which recommended the restriction on manufacture, sale or distribution of the drug FDC of Naproxen IP 375mg + Esomeprazole Magnesium Trihydrate IP 20mg Capsule or Tablet and Naproxen IP 250/500mg + Pantoprazole IP 20mg hard gelatin Capsules or Tablets.
A Copy of the Notification is attached herewith for your ease of reference
Source: Ministry of Health and Family Welfare
