Highlighting that India’s copycat drug sector is still plagued by quality issues amid rising global concern over tainted drug supplies, U.S. health care watchdog FDA has sent warning letters to three major Indian drugmakers in the last two months.
According to the reports, three major Indian drugmakers – Cadila Healthcare, Glenmark Pharmaceuticals and Lupin are the latest local medicine makers to be reprimanded by the U.S. Food and Drug Administration. A plant with a warning letter is barred from introducing new products in the US, stymieing the company’s ability to grow revenue in the world’s top pharmaceutical market. The latest regulatory crackdown shows the U.S. regulator’s stance is hardening toward lapses in quality control even as it seeks cheaper drugs to contain health care costs. Indian pharmaceutical factories collectively produce about 40 per cent of the American generic drug supply. Earlier, the firms have been faulted by the FDA for everything from lax documentation to open toilet drains and malfunctioning equipment.
Earlier there were reports that Indian pharma firms received 34% of FDA warnings this year. Now, the FDA is struggling to contain the damage after carcinogenic chemicals were discovered in generic drugs to control blood pressure and stomach acid, prompting drug makers in India and elsewhere to recall the medicines.
Cadila Healthcare received a warning letter against its Moraiya facility in the western state of Gujarat, about three years after a previous warning letter against this plant was lifted. “The company will continue to take all necessary steps to ensure that the US FDA is fully satisfied with our remediation of the above facility. We are confident of responding to US FDA to address the observations within the statutory time permitted in the letter,” Cadila Healthcare, a unit of Zydus Cadila, said in its statement.
Glenmark pharma said that they’d received a similar warning letter from FDA for its manufacturing site in Baddi in Himachal Pradesh without elaborating on the reasons for this regulatory action. Lupin has been struggling with regulatory issues at its US FDA-approved plants for two years. To add to its woes, Lupin received another warning letter last month, this time for its API-manufacturing plant at Mandideep.
Source: Livemint, The Print.