Indian pharma welcomes US FDA commissioner's stance

The Indian pharmaceutical industry has welcomed the comments of US Food and Drug Administration (USFDA) Commissioner Margaret A Hamburg in her exclusive interview to Business Today.

Among her responses, Hamburg had said the FDA staff would be working with Indian companies  to identify problems and take necessary steps to self-correct. Kiran Mazumdar-Shaw, Chairman and Managing Director of Biocon said: "I think this is exactly the kind of approach we should be taking. Engaging with the USFDA was long overdue to understand where our shortcomings lie." Equally important, she said, was to know what the expectations of the USFDA were.

Daara B. Patel, Secretary-General, Indian Drug Manufacturer's Association (IDMA) agreed. "That is exactly what we have been seeking," he said.

On Hamburg's comment that the FDA was "planning multi-year capacity building workshops for industry and regulators with the Indian Drug Controller General's Office and the Indian Pharmaceutical Alliance," Mazumdar-Shaw said this was very important as "we certainly need capacity building in the regulatory system". Approving of Hamburg's assertion that quality would be one of the highest priorities for the FDA in 2014, she said, "I certainly believe quality has to be a focus." She also added: "It is very important we work with them, make sure that we engage with them and correct the perception that quality is an issue with India... I am sure it is possible for all Indian companies to come up to the expectations of the USFDA very easily."

Y K Hamied, Cipla's Non-Executive Chairman, said the FDA Commissioner comments were quite welcome. "I am personally happy. It is good that she is taking Indians into confidence... we should work as a team and should work together."

Similarly Ajay Piramal, Chairman, Piramal Enterprises, says: "We have to raise our standards on quality not just for markets abroad but also within India and it is therefore important that there is focus on quality... The last couple of years we have had some issues in Indian industry on quality and therefore it has to be a focus."  

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