Pan D, Paracetamol And High BP Drugs Among 53 Medicines to Fail Safety Checks | Full List

New Delhi: India’s drug regulator, the Central Drugs Standard Control Organisation (CDSCO), flagged over 50 medicines for failing quality tests in August. The alert highlighted that several top-selling drugs produced by renowned pharmaceutical companies are involved, raising concerns about their safety and efficacy.

Key Medicines Flagged as Not of Standard Quality (NSQ):

• Paracetamol Tablets (500 mg)
• Glimepiride (anti-diabetic drug)
• Telma H (Telmisartan 40 mg, hypertension medication)
• Pan D (acid reflux medication)
• Shelcal C and D3 (calcium supplements)
• Metronidazole (antibiotic, manufactured by Hindustan Antibiotics Limited)
• Shelcal (distributed by Torrent Pharmaceuticals, produced by Pure & Cure Healthcare, Uttarakhand)
• Clavam 625 (antibiotic, manufactured by Alkem Health Science)
• Cepodem XP 50 (dry suspension for severe bacterial infections in children, produced by Hetero)
• Ursocol 300 (gallstone dissolution medication, manufactured by Sun Pharma Laboratories)
• Telmisartan (multiple batches from Life Max Cancer Lab, Haridwar)
• Defcort 6 (arthritis treatment, manufactured by Macleods Pharma)

The CDSCO's alert said that the flagged medicines were produced by several prominent companies, including Alkem Laboratories, Hetero Drugs, Hindustan Antibiotics Limited (HAL), and Karnataka Antibiotics and Pharmaceuticals Ltd.

Concerns arose when a Kolkata state-run laboratory identified Clavam 625 and Pan D as substandard. Moreover, the lab found that Cepodem XP 50 did not meet quality standards. Paracetamol tablets from Karnataka Antibiotics & Pharmaceuticals Ltd. also raised alarms, and Sun Pharma’s Ursocol 300 was labelled spurious.

Responses from manufacturers suggested that the batches in question may not have been produced by the actual manufacturers listed, indicating potential spurious drugs in circulation. Companies such as Sun Pharma and Glenmark have stated they did not manufacture the implicated products.

The CDSCO issues NSQ alerts based on random monthly sample checks by state drug officials.

In August, the regulator banned over 156 fixed-dose drug combinations deemed "likely to involve risk to humans," adding to the scrutiny of drug quality in the country.

Since 2014, the CDSCO has prohibited 499 fixed-dose combinations (FDCs) that combine two or more known drugs in a single dosage form.