FDA's Hamburg says India is a significant pharma partner

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Margaret Hamburg
Margaret Hamburg

FDA Commissioner Margaret Hamburg's recap of her trip to India to discuss drug and food safety boiled down to two mantra-like statements during her Friday press conference: India is an important US partner and, when we inspect facilities, we are doing our job, not picking a fight.

The commissioner visited India February 10 through 18 to strengthen cooperation between the two countries, against a backdrop that includes the US prohibition against items sourced from four Ranbaxy plants in India, as well as intellectual property disputes, among other items.

“The fact that we have increased our presence in India is true...India is a very significant and growing player in the US marketplace in respect to US pharmaceuticals and food,” she said during Friday's call, and noted that this reach means the regulator is “doing the appropriate inspections and compliance activities in all countries that are bringing products that we regulate into the United States for consumption.”

Prior to her trip, India's government said it was going to talk to Hamburg about what it felt was unfair regulatory treatment, a thread several reporters picked up on Friday, including a claim that India's drug controller general has reportedly said complying with US rules would mean shutting down the country's drug manufacturing base. Hamburg rebutted with responses that reinforced the need for exports to comply with US regulations and a reported willingness of Indian authorities to understand and comply with US export requirements.

The FDA walked away from her trip with a statement of intent that outlines mutual responsibilities, including information exchanges, sharing inspection visit intent so representatives from both country's agencies can attend, and regular (possibly quarterly) meetings between regulators to iron out issues and track progress.

“India is a significant player in the marketplace [and] really needs to be at the table,” Hamburg said, referring to international rules and regulatory meetings. She said sending reps to these conferences is essential “for discussion of increased harmonization, communication and collaboration amongst nations, because there really does increasingly need to be a global coalition of regulators.”

Hamburg also noted that India's visit is not unique and that she has “visited China and... other countries as well.” She said she expects travel will continue as the supply chain's international reach becomes even more extensive.

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