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FDA warning letters to Indian pharmaceutical companies double in 2019

Published on 20/01/20 at 12:35pm

Indian pharmaceutical firms received more than double the amount of warning letters in the first ten months of 2019 compared with 2018.

They received 19 out of the 41 warning letters issued by the FDA, which reversed a trend that saw Indian companies increasingly complying with appropriate standards in the last five years. Its warning letters had reduced from 2015 to 2018, before this reported increase in 2019.

A warning letter is issued when the FDA considers one or more products, practices or processes to be in violation of the Federal Food, Drug, and Cosmetic Act, its implementing regulations and other federal statutes.

This will impact about 18% of the total pipeline of large drug makers. This means it will affect about 180 abbreviated new drug applications which will delay new product launches.

Recent FDA observations are less severe and are largely targeting hygiene and the upkeep of facilities, and it is expected to be resolved faster than previous cases.

Commenting on the FDA audits, Indian company Sun Pharma’s Managing Director said: “Indian companies file large number of products, and as a part of their assurance to the US Congress the FDA they have said that they will try and conduct as many pre-approval inspections as necessary. If we continue to be the largest filer of the new ANDAs in the world, we will have a large number of inspections.”

Conor Kavanagh

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