India's top drug regulator says he will do surprise inspections of foreign-owned plants

Drug Controller General of India (DCGI) G.N. Singh, has caught some flak over the fact that U.S. and European regulators--citing serious quality issues--have banned products from a number of Indian plants with which his office has found no faults. Now he says the DCGI will start surprise inspections, but the drug regulator made it clear that the process cuts both ways and that foreign companies can expect his people to show up for a visit.

"There has to be a level playing field," Singh told the Indian Express on Wednesday. "If foreign regulators can make surprise checks on Indian pharma companies, we can do the same for both domestic as well as foreign drugmakers."

The FDA actually gives facilities advance notice of its visits, but the number of Indian drugmakers that have gotten crosswise with the agency in recent years has become a concern in the country. Singh's announcement came after the FDA last week banned a Ranbaxy Laboratories active pharmaceutical ingredient (API) plant following a follow-up inspection earlier this month. FDA inspectors said they found evidence that workers were repeatedly retesting batches until achieving the analytic results that were needed and then overwriting the failed results in the plant's database. It is the fourth Ranbaxy plant in India to be put on import alert. The agency in September banned a key formulation facility and two others have been prohibited from shipping to the U.S. for years after problems at Ranbaxy were first uncovered.

The FDA last year also banned two Wockhardt plants and sent warning letters to a number of other Indian manufacturers. But it has also issued warning letters to Western drugmakers doing business in India and taken actions in the U.S. that have resulted in the temporary closures of many U.S.-based facilities, both U.S. and foreign owned.

India accounts for about 40% of U.S. generic drug products, and lax attitudes about manufacturing quality by some Indian drugmakers have meant that the FDA has paid closer attention to operations there. It has been beefing up its inspection staff there and even sent a Kashmir-born official to oversee its office in India. But India is not the only country singled out for special attention. The FDA is also adding in-country inspectors in China, which is one of the largest producers of APIs in the world, and also one where weak enforcement has resulted in issues for the U.S.

- read the Indian Express story