Paracetamol, Antacid, Pan D among 53 drugs to fail regulator's quality test

Over 50 medicines, including those for diabetes, hypertension, vitamins, calcium D3 supplements, bacterial infections, and acid reflux, have failed quality tests conducted by India’s drug regulator.

The Central Drugs Standard Control Organisation (CDSCO) issued a ‘Not of Standard Quality’ (NSQ) alert for August, highlighting that some of the top-selling medicines were produced by well-known pharmaceutical companies, including Alkem Laboratories, Hetero Drugs, Hindustan Antibiotics Limited (HAL), and Karnataka Antibiotics and Pharmaceuticals Ltd.

Among the medicines flagged as NSQ are paracetamol tablets (500 mg), the anti-diabetic drug Glimepiride, high blood pressure medication Telma H (Telmisartan 40 mg), acid reflux medication Pan D, and calcium supplements Shelcal C and D3. The list also includes the widely used antibiotic Metronidazole, manufactured by HAL, and Shelcal, distributed by Torrent Pharmaceuticals and produced by Pure & Cure Healthcare in Uttarakhand.

Alkem Health Science’s antibiotics, Clavam 625 and Pan D, were also identified as substandard by a Kolkata state-run laboratory. This lab found that Cepodem XP 50 dry suspension from Hyderabad-based Hetero, prescribed for severe bacterial infections in children, did not meet quality standards.

Further concerns were raised over paracetamol tablets from Karnataka Antibiotics & Pharmaceuticals Ltd. Additionally, Sun Pharma Laboratories Ltd.’s Ursocol 300, designed to dissolve certain gallstones, was flagged as spurious. Multiple batches of Telmisartan manufactured by Life Max Cancer Lab in Haridwar also failed quality tests.

CDSCO has released two lists of drugs that did not pass quality checks: one containing 48 popular drugs and the other detailing responses from the pharmaceutical companies whose products failed.

The manufacturers’ responses indicated that the actual manufacturers (as per the label claim) did not produce the flagged batches, suggesting that these may be spurious drugs. However, the final determination is subject to ongoing investigations. Companies such as Sun Pharma and Glenmark provided similar replies, asserting they had not manufactured the implicated medicines.

Sun Pharma’s three drugs—Pulmosil for erectile dysfunction, Pantocid for acid reflux, and Ursocol 300—were among those that failed the tests. Glenmark’s hypertension drug Telma H (Telmisartan) and Macleods Pharma’s Defcort 6 for arthritis treatment also did not meet quality standards. All three companies echoed that they had not produced these medicines.

The drug regulator issues NSQ alerts following random monthly sample checks carried out by state drug officials.