India raises concerns over US FDA inspection on domestic pharma firms

11 Feb 2014 Evaluate

Reacting strongly to US Food & Drug Administration (FDA) for imposing disproportionately strong penalties on Indian pharmaceutical companies, India has raised concerns over US FDA inspection on domestic pharma firms, adding that authority was not giving enough opportunity to Indian pharmaceutical companies to explain themselves before taking action against them for flouting quality norms. Commerce and Industry Minister Anand Sharma met US FDA Commissioner Margaret Hamburg and told that in some cases when clarifications were sought from pharmaceutical companies, the US FDA took strong action even before the clarifications could be given.

It is reported that both countries have agreed on plan that their regulators will inform each other before undertaking inspections, allowing host-country inspectors to join as observers. The regulators will also share information on any problem found in terms of lack of compliance with current good manufacturing practices, clinical practices and laboratory practices by manufactures and sponsors of medical products and cosmetics. The US FDA has also offered to help in the capacity development of Indian drug regulators, academics and industry so that there would be a better coordination between the two countries in the area. Presently, inspections are conducted by the regulators separately as countries do not have any data-sharing agreement.

The US market accounts for highest revenue for the Indian pharma industry as the country has the largest number of USFDA-approved plants for generics manufacturing. However, US FDA, an agency of the United States responsible for protecting and promoting public health through the regulation and supervision of drugs, has stepped up its efforts to ensure that only good quality medicines reach the American shores. Over one and half years, it has raised concerns over the quality of the drugs produced in India and imposed penalties on plants owned by large companies such as Ranbaxy, Wockhardt, RPG Life Sciences and Agila Specialities for flouting quality norms. The recent actions taken by the US FDA has hurt the reputation of the country’s drug industry, which is the largest supplier of low-cost generics in the world.

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India raises concerns over US FDA inspection on domestic pharma firms

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