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Corporate Aug 30, 2013

Indian pharma cos should follow strict regulations, warns US FDA

Washington: 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, said.

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 per cent 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.


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