The Central Government has restricted the manufacture, sale, and distribution of two fixed dose combinations (FDCs) containing Naproxen and either Esomeprazole Magnesium Trihydrate or Pantoprazole. These notifications were issued on August 12, 2024.
The decision was taken after a thorough review by an expert committee and the Drugs Technical Advisory Board (DTAB). The FDCs were found to pose potential risks to human health, and safer alternatives are available.
However, the government has allowed the continued sale of these FDCs under certain conditions, including:
- Naproxen must be in enteric-coated form.
- The FDCs are indicated for the symptomatic treatment of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in patients at risk of NSAID-associated ulcers.
- Manufacturers must demonstrate bioequivalence of their FDCs within one year.
- Bioequivalence of FDC is shown with Naproxen and Pantoprazole given separately as per standard package insert for these within one year
- Efficacy and safety equivalence demonstrated with Naproxen Esomeprazole international innovator’s FDC for the indication, within one year
This decision aims to protect public health by ensuring that only safe and effective drugs are available in the market.
