Home >Industry >Manufacturing >India wants its officials during FDA inspections at drug units

Hyderabad: Concerned over Indian drug makers frequently running into overseas regulatory problems, the government has requested the US health watchdog Food and Drug Administration (FDA) to allow its officials during inspections of domestic pharma units.

While Indian pharma exports continue to grow and may touch $16.5 billion this year, many Indian pharmaceutical companies have faced regulatory action by the FDA in the recent past for alleged violation of “good manufacturing practices" and other irregularities at the drug facilities in different parts of the country. In many cases, these companies have been barred from selling their drugs in the US and other countries, although Indian firms account for a significant share of generic drug market in those places.

“US FDA’s increased inspections and observations (under 483) also are troubling us. The ministry of commerce has taken up the issue seriously. The earlier practice was that whenever they are visiting any Indian site they used to inform us. Now, they started coming without any notice. P.V. Appaji, director-general of Pharmexcil, (Pharmaceuticals Export Promotion Council), under the ministry of commerce and industry also said that India pharma exports may touch $16.5 billion this year. “Cultural differences and body language may sometime widen the gap (during FDA inspection). We are requesting them (FDA) to allow Indian regulators also to be present during the inspections," Appaji said.

Indian pharma exports have come under tremendous pressure in the recent times owing to various import alerts issued by the US drug regulator on some of the major pharma companies. Describing India as a nation which is “particularly important" to US food and drug trade, FDA commissioner Margaret Hamburg had earlier said inspections are routine part of the regulatory process and what happens in India is consistent with what happens in the US and throughout world.

A number of other Indian drug makers, including Ranbaxy, Sun Pharma, IPCA Labs, Wockhardt and Dr Reddy’s Laboratories were also pulled up by the FDA for one or the other reason. The FDA imposed a ban on the import of medicines produced at Ranbaxy’s India-based factories into the US, the world’s biggest drug market. Later, certain drugs produced at its Dewas plant were barred from export to the entire European Union region for non-compliance to “good manufacturing practice norms".

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