US drug regulator heads for India to talk about quality

US drug regulator heads for India to talk about quality

drugsThe top US drug regulator is headed to India, which supplies an estimated 40 percent of the generic drugs sold in the US, to talk about quality issues after recent action against some Indian drug makers.

The US Food and Drug Administration announced Thursday that Commissioner Margaret A. Hamburg, will travel to India Feb 10-18 “to further strengthen cooperation between the FDA and its Indian regulatory counterparts”.

During her first official trip to India, intended “to highlight importance of ongoing collaboration on food and drug programmes”, Hamburg will meet Indian policy and government leaders involved in the regulation of medical and food products exported to the US.

Besides Delhi, she will also visit Cochin and Mumbai

“Indian regulators are important strategic partners to the FDA and regular engagement is essential,” the FDA said noting currently, India is the second largest provider of finished drug products and the eighth largest exporter of food products to the US.

“The FDA’s ongoing engagement with our regulatory counterparts in India is critical to our ability to effectively promote the health and safety of American and Indian consumers,” Hamburg said.

“I look forward to enhancing our existing relationship and identifying additional opportunities for collaboration.”

“The cooperation of US and Indian food and drug officials is wide-ranging, from sharing information on the conduct of clinical trials to jointly addressing product safety issues that may have an impact on both American and Indian consumers,” FDA said.

Hamburg will also meet with industry leaders in India to discuss the importance of maintaining high-quality standards in producing goods to ensure consumers have access to safe products, the drug regulator said.

Quality concerns have led to FDA bans on some manufacturing facilities of Ranbaxy, the Indian unit of Daiichi Sankyo Co., as well as curbs on a plant of Wockhardt in the past year.

Inspections of human drug facilities in India rose to 195 in 2012 from 11 in 2002, according to data from the FDA.

Ranbaxy’s Toansa plant in Punjab was banned Jan 23 from producing or distributing drug ingredients for the US market.

Two other Ranbaxy facilities in India that once supplied to the US – Dewas (Madhya Pradesh) and Paonta Sahib (Himachal Pradesh) — have been barred from making products for the US since 2008, and a third, Mohali (Punjab), was banned in September.

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