Indian Pharma Companies Should Follow Strict Regulations: U.S. 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 U.S. are of the highest quality, have safety built into them and are effective.

"We should not be seen singling out anyone. Absolutely not," the U.S. 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 singling (of Indian pharma companies) out on this," said Lal, strongly refuting all such news reports.

In its latest action against Indian drug makers, the U.S. 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.

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