US FDA Uncovers Failures in India Pharma Factories

US FDA Uncovers Failures in India Pharma Factories
Photo: 06.06.2023 305

US inspectors have in recent months uncovered wide-ranging lapses at factories run by some of India’s biggest pharmaceutical firms, reported Bloomberg.

India as the world’s top supplier of cheap medicine faces increased scrutiny after a spate of deadly manufacturing incidents. Dozens of drugmakers were issued notices and warning letters by the US Food and Drug Administration, which is increasing visits to Indian factories after the lifting of Covid-19 restrictions last year.

Inspectors detailed unsanitary conditions in manufacturing plants and poorly trained staff; shredded paperwork and under-investigated customer complaints; and evidence of exporting contaminated drugs to the US.

After a number of recent scandals linked to smaller, privately-held Indian companies, including the deaths of dozens of children in Gambia and Uzbekistan from adulterated cough syrup, and supplying contaminated chemotherapy drugs to the US,  there are renewed calls for for more rigorous oversight and a rethinking of supply chains across the world. At the same time, Indian Prime Minister Narendra Modi has positioned the country as an alternative to China for high-quality manufacturing.

During an FDA review of theGlobal Pharma Healthcare plant in southern India, inspectors found sterility problems. Global Pharma previously recalled eye drops and ointment exported to the US. This month, the Centers for Disease Control and Prevention linked the products to 81 drug-resistant bacterial infections, four deaths and 14 cases of vision loss. 

In an inspection of the Lupine plant, one of India's top five pharma manufacturers, inspectors found that the site’s staff only investigated 48 breakdown notifications out of 1,759 between January 2019 and March 2023. 

Cipla Ltd., a storied Mumbai-based drugmaker that pioneered the sale of cheap HIV drugs across Africa, received more than 3,000 US patient complaints since 2020 for an unidentified product made at its factory in central India, the FDA found.

At the plant of the country's largest drug maker, Sun Pharmaceuticals Industries in Halol in western India, auditors discovered water leaks and equipment used to manufacture drugs that weren’t adequately cleaned and maintained. After the inspection, Sun Pharma later recalled batches of several drugs, including a hormonal birth control as well as testosterone cypionate injections. The company said it would hire independent manufacturing auditors and temporarily halt shipments to the US.

On June 4, Indian authorities also announced that the country is poised to strengthen the quality of its medical products and improve market access by joining the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S). Joining PIC/S will enable India to adopt global standards and pave the way for enhanced cooperation and regulatory practices among countries.

Source: Bloomberg

pharmaceutical markets  India 

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