Sun Pharma, Glenmark, Alkem Labs Under Scrutiny As CDSCO Flags 53 Drugs For Quality Failures

India's apex drug regulatory body, the Central Drugs Standard Control Organisation, has flagged 53 drug samples for failing to meet quality standards, according to an NDTV report. Pharmaceutical companies including Sun Pharma Laboratories Ltd., Glenmark Pharmaceuticals Ltd., and Alkem Health Science Ltd. are implicated in this quality lapse, NDTV said, quoting CDSCO’s August report.

Pantocid, Paracetamol tablets, and Calcium and Vitamin D tablets are among the widely-used medications that are part of the list.

Sun Pharma’s Pantocid tablets, used for acid reflux, the Pulmosil injection for high blood pressure, and Ursocol 300 tablets, were all declared adulterated in August. Glenmark's Telma H tablets, used to treat hypertension, were also flagged as adulterated.

Sun Pharma on Thursday said it notified the CDSCO that the batch in question was not produced by the company and is a "spurious drug".

The company said the nature of the product is subject to the outcome of investigation.

Additionally, Alkem's Clavam 625 antibiotic and amoxicillin with potassium clavulanate tablets raised quality concerns. Calcium and Vitamin D tablets (Shelcal), produced by Pure and Care Healthcare Pvt. Ltd., also failed the standard quality tests. Even widely consumed paracetamol tablets from Karnataka Antibiotics & Pharmaceuticals Ltd. did not meet quality benchmarks.

The CDSCO released two lists detailing the drugs that failed quality tests. The first includes 48 well-known drugs, while the second features five additional items, along with responses from the implicated pharmaceutical companies.

Several manufacturers have disputed the findings, claiming that the flagged batches are counterfeit and not produced by them, as per NDTV.

This incident follows an earlier ban by the Indian government on 156 fixed-dose combination drugs, which included commonly used antibiotics, painkillers, and multivitamins, due to safety concerns.