FDA: India needs more inspectors

pharmafile | February 25, 2014 | News story | Manufacturing and Production FDA, India, generics, hamburg 

The Food and Drug Administration is to put more inspectors on the ground in India, following a visit there by FDA commissioner of food and drugs Dr Margaret Hamburg.

The US regulator is to increase staff in the country from 12 to 19 as concerns grow over just how well made – and safely exported – medicines are in India.

Hamburg travelled there this month to oversee quality issues – a pressing issue for the regulator as India’s pharma industry supplies 40% of OTC and generic prescription drugs consumed in the US – and FDA investigators are directly targeting Indian drug plants such as Ranbaxy’s under new quality control measures.

A loose ‘statement of intent’ has been signed by the US and India for co-operation on issues such as inspections, but Hamburg has denied that India is being singled out for special treatment.

“If a company is manufacturing a product for sale within the US, they have to meet our regulatory standards and requirements,” she told reporters. “What’s happening in India is consistent with what happens in the US and throughout the world.”

Regulatory attention also confirms how significant a player India has become, Hamburg went on. “India stands out and is particularly important, considering the country is the third largest trade partner for the US, second largest supplier of OTC and prescription drugs and eighth largest supplier of food,” she said.

Hamburg also revealed that, during a roundtable meeting of female industry and academic leaders in Mumbai, organised by the Confederation of Indian Industry, the state of the country’s clinical trial system was discussed.

“Two themes emerged during our discussion,” she explained. “The importance of biomedical research in India, specifically clinical trial design and enrolment, and the importance of quality and the role these prominent leaders in the pharmaceutical and food production sectors can play in communicating why quality matters.”

Many Indians have been wary of the way trials have been conducted and how trial participants are chosen and informed, she said.

“Quality was a recurring theme during my visit to India,” Hamburg added. “I was delighted that the group appreciated how smart regulation can help shape, support and strengthen the product development and manufacturing processes that can help ensure continuous quality.”

In a separate development, the FDA has just been given by the US government $20 million to help assess generic drugs, which make up around 80% of all medicines in the US.

Adam Hill

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