The USFDA is looking for ways to speed up plant inspections, health news, ET HealthWorld


Mumbai: The US Food and Drug Administration is considering alternative approaches to inspecting production sites acting on requests from several companies, including Indian drug manufacturers, to tackle the problem.

The move is triggered by the shortage of drugs – most supplied by Indian generic drug companies – that the United States faces over the course of Covid-19 pandemic. The Indian Pharmaceutical Alliance requested the FDA last month to find a solution to inspect its members’ manufacturing facilities.

“Under Covid-19, the US Food and Drug Administration will continue to use and implement additional alternative inspection tools and approaches while subjecting domestic and foreign routine surveillance inspections. This will continue, as local, national and international conditions justify, with the exception of certain mission-critical inspections, “the US regulator said in a statement dated May 11.

Sudarshan Jain, IPA secretary general, said the organization will not comment on the matter because certain communications between regulators and companies must be private for the sake of national interest.
Life sciences and biotech website Fiercepharma reported Thursday that the IPA had requested “virtual reviews of new facilities, is intended to produce a new class of drugs or has completed a corrective action plan following a previous inspection failure.”

The shutdown in India and other countries has created logistical problems that have hampered exports and led to drug shortages. Sun Pharmaceuticals, Lupine, Dr. Reddy’s Laboratories and Aurobindo Pharma are among those providing critical care medicines to the United States. India’s pharma exports to the US are estimated at $ 20 billion.

The FDA typically sends investigators to inspect a pharmaceutical company’s manufacturing facilities to ensure they comply with U.S. laws and regulations. In the last month, several Indian companies received FDA approval of plants after waiting for several months. Lupine and Dr. Reddy’s got approvals for major production plants in Pithampur and Srikakulam last month.

The FDA also temporarily lifted a warning letter for Mumbai-based IPCA in March. The company manufactures hydroxychloroquine, the drug being tested in the US and other parts of the world for Covid-19.

The US regulator, while suspending foreign inspections, had said it would use measures such as physical examination and / or product sampling at its borders, review a company’s compliance history, use information shared by other governments as part of mutual recognition and confidentiality agreements, and request records prior to or in lieu of inspections.


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