Top Indian Pharma Firms Under US FDA Microscope For Manufacturing Lapses

Top Indian pharmaceutical companies have come under scrutiny from the US Food and Drug Administration for lapses in the manufacturing of exported drugs.

What Happened? Indian pharma companies, including giants like Sun Pharma, Cipla, and Lupin have been pulled up by the US drug regulator for failures in drug manufacturing practices, Bloomberg reported.

The report said that inspections by FDA officials had found unsanitary manufacturing conditions at some plants, poorly trained staff, shredding documentation and evidence of contaminated drugs being exported to the US, resulting in nine warning letters being issued to pharma companies in India since 2022.

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Lupin’s staff reportedly only investigated 48 breakdown notifications out of 1,759 between 2019 and March 2023 at one of its sites. Cipla had received over 3,000 complaints from the US related to a single drug made at one plant but had not taken steps to reduce those complaints, the FDA found. Meanwhile, two of Sun Pharma’s plants in India for failing to meet quality standards.

All three companies told the business publication that they were working on fixing these issues.

India, the world’s largest exporter of cheap generic drugs, has been trying to regulate manufacturing in the 4.12 lakh crore industry after a spate of overseas deaths linked to adulterated cough syrup supplied by smaller private firms.

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