Hamburg set to wrap up India trip on tough note

Lapses in quality unacceptable, asserts US pharma regulator

Margaret Hamburg, commissioner of the US Food and Drug Administration (US FDA), seems to be wrapping up her India trip on a tough note. Hamburg, who met government as well as industry officials in New Delhi and Kochi through the week and visited the Taj Mahal too, has reiterated in her latest blog that “lapses in quality” are “unacceptable” and indicated that going forward the US regulatory agency will increase inspections of “foreign facilities”.  “In recent years, the FDA has identified significant lapses in quality by some companies operating in the US and around the world. As a result, American consumers have had to endure greater risk of illnesses, recalls, and warnings about the products many of them rely on each day. This is unacceptable,” Hamburg said in her latest blog, posted on Friday.

The blog, written after Hamburg’s visit to the Taj Mahal in Agra and titled ‘Quality: A Recurring Theme During My Visit to India’, emphasised stringent quality checks. In fact, Hamburg pointed out how quality played a crucial role even in building and maintenance of the mausoleum. “It was evident as I walked along with hundreds of other visitors in socked feet that those responsible for building the Taj and those that are preserving the centuries old structure are committed to extraordinary quality”.

Hamburg has also stressed that the new law for generic drugs in the US mandates the regulator to conduct more inspections of foreign facilities and stringent quality checks. “GDUFA (Generic Drug User Fee Act) also requires that we step up our number of foreign inspections and gives us the funding to do so,” she wrote. This would mean that there would be no relief for domestic pharmaceutical companies struggling with the US regulator’s heightened inspection activities and enforcements.

In her previous blog a few days ago, Hamburg had appreciated the existing trade synergy between the US and India. She had also said though many Indian companies understand good manufacturing and quality processes, unfortunately they had been overshadowed by recent lapses in quality at a handful of pharmaceutical firms. That blog was posted on the second day of Hamburg’s visit to India and a day after her meetings with health minister Ghulam Nabi Azad, commerce and industry minister Anand Sharma and Drug Controller General of India G N Singh in New Delhi.

The latest blog comes after Hamburg’s interaction with chief executives of leading pharmaceutical companies such as Ranbaxy, Wockhardt, Cadila Health, Mylan and Torrent Pharma on Tuesday.

While Hamburg is the first US FDA commissioner to come on an official visit to India, the long duration of her visit also holds significance given the trade relations between the two nations. Hamburg has also suggested that the US FDA will increase its presence in India.

Hamburg will be in Mumbai during the last two days of her visit.

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INDIAN CLINICAL RESEARCH POLICY RESTRICTIVE, SAY US PHARMA COMPANIES

American pharmaceutical companies and their advocacy groups on Saturday rued the allegedly restrictive Indian policies on clinical research, saying such policies were harming the companies. “Clinical research has become a highly politicised topic in India fuelled, at least in part, by a sensational press,” John J Lewis, from the Association of Clinical Research Organization told the US International Trade Commission (USITC). USITC, a quasi-judicial federal agency, conducted a hearing in connection with its investigation ‘Trade, Investment, and Industrial Policies in India: Effects on the US Economy’ as asked by lawmakers. Describing the current situation in India as “troubling”, Lewis said as a result not only the health of the people in India and the Indian economy were suffering, but US (and Indian) companies were unable to conduct life-saving biomedical research and global health was suffering. Noting that US companies were harmed by Indian policies on clinical research, Lewis said in reality they could relocate their research to more hospitable countries in Eastern Europe or China. (PTI)

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