USFDA to Speed up Plant Inspections
Mumbai: The US Food and Drug Administration is considering alternative approaches for inspections of manufacturing sites, acting upon requests from several companies, including Indian drug makers, to address the issue.
The move has been triggered by the shortage of drugs — most of them supplied by Indian generic drug companies — that the US faces during the Covid-19 pandemic. The Indian Pharmaceutical Alliance has asked the FDA last month to find a solution for inspecting the manufacturing plants of its members.
“During Covid-19, the US Food and Drug Administration will continue to utilise and implement additional alternative inspection tools and approaches while postponing domestic and foreign routine surveillance inspections. This will continue as local, national and international conditions warrant, with the exception of certain mission-critical inspections,” the US regulator said in a statement dated May 11.
Sudarshan Jain, secretary-general of the IPA, said the organisation would not like to comment on the matter because certain communication between regulators and companies needs to be private for the sake of national interest.
Life sciences and biotech website Fiercepharma reported on Thursday that the IPA had asked for “virtual reviews of facilities that are new, are slated to produce a new class of drugs or have completed a corrective action plan following a previous inspection failure.”
Lockdown in India
The lockdown in India and other countries has created logistical issues that have hampered exports and led to drug shortages. Sun Pharmaceuticals, Lupin, Dr Reddy’s Laboratories and Aurobindo Pharma are among those that supply critical care drugs to the US. India’s pharma exports to the US are estimated at $20 billion.
The FDA typically sends investigators to inspect a drug company’s manufacturing facilities to ensure they comply with US laws and regulations. In the past month, several Indian companies received FDA approvals for plants after waiting for several months. Lupin and Dr Reddy’s got approvals for large manufacturing facilities in Pithampur and Srikakulam last month.
The FDA also temporarily lifted a warning letter for Mumbai-based IPCA in March. The company makes hydroxychloroquine, the drug that is being tested in the US and other parts of the world for Covid-19.
The US regulator, while suspending foreign inspections, had said that it will use measures such as physical examinations 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 in advance of or in lieu of inspections.