India says US FDA imposed disproportionate penalties

India has blamed the US Food and Drug Administration (FDA) for imposing disproportionately strong penalties on Indian pharmaceutical companies.

At a meeting with FDA Commissioner Margaret Hamburg on Monday, Commerce and Industry Minister Anand Sharma also charged the US regulator with not giving enough opportunity to Indian drug-makers to explain themselves before taking action against them for flouting quality norms, a Government official told Business Line . The two countries have now decided that their regulators will inform each other before undertaking inspections, allowing host-country inspectors to join as observers.

At a separate meeting, Minister of Health and Family Welfare Ghulam Nabi Azad raised the same issues with the US FDA Commissioner. The two signed a Statement of Intent on Cooperation in the Field of Medical Products.

The regulators will also share information on any lacuna found in terms of lack of compliance with current good manufacturing practices, clinical practices, or laboratory practices by manufactures and sponsors of medical products and cosmetics.

At present the countries do not have any data-sharing agreement and inspections are conducted by the regulators separately. The FDA has offered help in the capacity development of Indian drug regulators, industry and academics so that there is better coordination between the two countries in the area.

The US regulator imposed penalties on plants owned by large companies such as Ranbaxy, Wockhardt, RPG Life Sciences and Agila Specialities over the past one-and-a-half years for flouting quality norms. This has hurt the reputation of the country’s drug industry, which is the largest supplier of low-cost generics in the world.

“The Commerce Minister told the FDA Commissioner that the environment had got vitiated following the recent FDA audit inspections. The industry has complained that even in cases where clarifications were sought, action was taken by the agency before the company could explain its stand. In some cases, disproportionate penalties have been imposed,” a Commerce Ministry official told Business Line .

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