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India pharma cos should follow strict regulations: FDA

Washington, Aug 30, 2013 (PTI):

The Food and Drug Administration (FDA) is not singling out Indian pharma companies, but insists the regulations in this regard are strictly followed, a top American drug official has said.

He said this was to ensure products that come into the US are of the highest quality, have safety built into them and are effective..

"We should not be seen singling out anyone. Absolutely not," the US FDA India Office Director, Altaf A Lal, told PTI.


He was asked about the concerns of the Indian pharma companies in view of the notices reportedly being issued to some of them in the regard.

"I give you an example. Of the four firms where we found to have deficiencies two are India, one was American firm, and one was German firm.

"So there is no signalling (of Indian pharma companies) out on this," said Lal, strongly refuting all such news reports in this regard.

In its latest action against Indian drug makers, the US health regulator FDA had red- flagged "significant deviations" from good manufacturing practices by two Indian pharmaceutical companies: Hyderabad-based Posh Chemicals and Himachal Pradesh-based Sentiss Pharma (formerly Promed Exports).

Kashmir-born Dr Lal now heads the India operations of the FDA, which now has a team of 12 inspectors based in New Delhi and Mumbai. The team is soon to be expanded to 19 members.

Lal said Indian companies should welcome increased inspection. "Inspections are not designed to harm. Inspections are designed to help.

"If there is a deficiency in a firm and the firm knows or does not know and we point deficiency in the firm that is in the interest of the public health, that is in the interest of India’s health and global health," he said.

"Our mandate is to ensure that the medicines and medical products that come into the US are of the same quality, have same standards and have same safety standards as medicines that come out in the US.

"So this requires us to be more proactive, be more engaging. That was not the case 10 years ago,"  Lal said.

FDA has a special focus on India given that it ranks number two in pharmaceuticals trade with the US, and that 40 percent of the over the counter prescription drug comes from India, he said.

FDA mission is to make sure that the products that come into the United States are of the highest quality, have safety built into them and are effective, he said.

"India office of the agency allows it to work with the regulators to share, to listen, to learn. It allows us to build capacity when needed and requested.It allows us to work with the industry, to explain what are the system, what are the qualities that we prescribe," he added.


"The third piece is conducting inspections, conducting them when needed, when appropriate both in the pharmaceutics side and food side," Lal said.

He said he has been working on a strategy to engage with industry both on the food side and the drug side on preventive controls.

This, he said, is through a programme where "we identify partners in government and partners in industry through industry associations to joint focused resulted oriented meetings to understand and explain what the issues of importance are, how industry can resolve it".

"The system which we would be discussing in India are designed to help industry, not only in India, but across the globe. When we talk about India, these are not necessarily Indian firms,", he added.

"The last data I saw of the four firms having deficiencies two were Indian, one was a German firm in India and one was an American firm.

"I think, we should not portray necessarily as India problem, this is a manufacturing problem in firms that operate out of India,"  Lal added.

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