Hamburg, for whom this will be her first official trip to the country, will make appearances in Delhi, Kochi and Mumbai during the visit. Between February 10 and 18, she expects to meet with government leaders involved in the regulation of medical and food products exported to the United States.
The commissioner’s main priority is to reduce the sanitation and testing issues that have led to recent bans on Indian manufacturing plants, Hamburg told Bloomberg, and she will meet with GN Singh of the Central Drugs Standard Control Organisation, India’s drugs controller general.
“We need to expand our overseas inspections to respond to the increasing role of India in the generic-drug products that are coming into this country,” Hamburg revealed to the news wire.
According to the FDA’s official line: “The cooperation of United States 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.”
But, tellingly, it added: “Commissioner Hamburg will… 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.”
“We’ll talk about our expectations and standards in regard to safety, quality, etc.,” Hamburg told Bloomberg.
Poor track record
Generic drug makers Ranbaxy Laboratories and Wockhardt have been banned from selling medicines in the US from Indian plants due to quality concerns. A fourth Ranbaxy facility was prohibited last month from sending products to the US after FDA inspectors found drugs were re-tested to gain favourable results after initial analyses failed.
“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,” said Hamburg.
“I look forward to enhancing our existing relationship and identifying additional opportunities for collaboration.”
Also on Hamburg’s itinerary is a tour of a spice firm and a visit to a seafood processing plant. A report in October found that India, which exports more spices to the US than any other country, has a poor track record for spice contamination, with around 9% of shipments found to be contaminated with salmonella.
Currently, India is the second-largest provider of finished drug products and the eighth-largest exporter of food products to the America.