India’s drug regulator, the Central Drugs Standard Control Organisation (CDSCO), recently flagged over 50 medicines, including popular drugs for diabetes, hypertension, acid reflux, and bacterial infections, as “Not of Standard Quality” (NSQ) in its August report. Among the flagged drugs were well-known brands such as Pan D, Glimepiride, and Telma H, produced by major pharmaceutical companies like Alkem Laboratories, Hetero Drugs, and Hindustan Antibiotics Limited. Some vitamin and calcium supplements, such as Shelcal C and D3, also failed quality tests.
The report identified issues with multiple batches of medicines, including antibiotics, painkillers, and gallstone treatments. Alkem Health Science’s Pan D and Clavam 625, along with Hetero’s Cepodem XP 50, prescribed for severe bacterial infections in children, were found substandard by a state-run laboratory in Kolkata. Similarly, Sun Pharma’s Ursocol 300, designed to dissolve gallstones, was flagged as spurious. In response, pharmaceutical companies, including Sun Pharma and Glenmark, claimed they did not manufacture the implicated batches, raising concerns about counterfeit drugs.
In addition to the NSQ alert, CDSCO also banned over 156 fixed-dose combinations (FDCs) in August, including common fever and pain relief medications like Cheston Cold and Foracet, due to potential risks to human health. Since 2014, the regulator has prohibited nearly 500 FDCs, following random sample checks by state drug officials to maintain drug safety standards across the country.
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