Over 50 medicines of Sun Pharma, Torrent Pharma, Alkem Labs, and other firms fail quality test

In quality tests conducted by the Central Drugs Standard Control Organisation (CDSCO), more than 50 medication drugs failed, including those used in treatments for diabetes, hypertension, and common bacterial infections.

In its recent ‘Not of Standard Quality’ (NSQ) alert for August, the drug regulator identified a number of top-selling drugs manufactured by major pharmaceutical companies such as Alkem Laboratories, Hetero Drugs, Hindustan Antibiotics Limited (HAL), and Karnataka Antibiotics and Pharmaceuticals Ltd.

Among the medicines, listed as NSQ, are widely used products, including paracetamol tablets (500 mg), anti-diabetic drug Glimepiride, hypertension medication Telma H (Telmisartan 40 mg), acid reflux treatment Pan D, and calcium supplements Shelcal C and D3.

Notably, the antibiotic Metronidazole, produced by HAL, was also included, alongside Shelcal, distributed by Torrent Pharmaceuticals and produced by Pure & Cure Healthcare in Uttarakhand. Further investigations revealed that such drugs from Alkem Health Science, specifically Clavam 625 and Pan D, did not meet quality standards, as confirmed by a Kolkata state-run laboratory.

The lab also found that Hetero’s Cepodem XP 50 dry suspension also failed to comply with regulatory requirements.

Moreover, Sun Pharma’s Ursocol 300 was flagged as spurious. Among the drugs affected are Sun Pharma’s Pulmosil (for erectile dysfunction), Pantocid (for acid reflux), and Ursocol 300, alongside Glenmark’s hypertension medication Telma H and Macleods Pharma’s Defcort 6, are used for arthritis treatment.

The CDSCO has released two lists detailing the 48 popular drugs that failed quality checks and the responses from the implicated pharmaceutical companies. The responses indicated that the actual manufacturers listed on the labels did not produce the flagged batches, suggesting the possibility of spurious drugs. Companies like Sun Pharma and Glenmark echoed similar sentiments, asserting they had no involvement in the production of the implicated medications.

This scrutiny follows a recent ban on over 156 fixed-dose drug combinations considered “likely to involve risk to humans,” including popular fever medications and pain relievers.

Since 2014, the CDSCO has prohibited a total of 499 fixed-dose combinations, underscoring ongoing concerns regarding drug safety and efficacy in the Indian pharmaceutical market.