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Drug firms move ministry over FDC ban, seek time to sell stock
Mint Mumbai
|July 27, 2023
The Indian Drugs Manufacturers Association has presented its case to the top drug regulator, urging a re-evaluation of the ban on 14 fixed dose combination drugs (FDC), besides granting a grace period for liquidating existing inventory.
FDC drugs, which contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio, were recently baned by Drug Controller General of India (DCGI).
In its representation to the Union health ministry and the DCGI, IDMA said the 14 FDCs have been in use and consumed safely for at least 25 years without any reported adverse consequences.
Seeking to avoid wastage, the drug makers association is advocating for a year’s extension from the government to deplete the current drug stocks available in the market.
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