42 Drug Batches Including Paracetamol, Metformin Fail CDSCO Quality Tests in April

New Delhi: In a fresh drug safety alert underscoring continued regulatory surveillance, 42 batches of drugs, injections, syrups, tablets, medical devices, and allied healthcare products have been declared Not of Standard Quality (NSQ) by laboratories functioning under the Central Drugs Standard Control Organisation for April 2026.

The flagged products span multiple therapeutic categories including anti-infectives, anti-diabetic medicines, painkillers, gastrointestinal drugs, respiratory syrups, injectables, nutritional supplements, and intravenous fluids, indicating extensive nationwide quality monitoring across the pharmaceutical supply chain.

The NSQ list includes widely used formulations such as Itraconazole Capsules USP 100 mg manufactured by Bal Pharma; Pantoprazole and Domperidone Capsules by Asterisk Healthcare; Misoprostol Tablets IP by Akums Drugs & Pharmaceuticals; Diclofenac Sodium Injection IP by Venus Bio Sciences; Diazepam Injection IP by Systochem Laboratories; Iron Sucrose Injection USP by Martin & Brown Bio-Sciences and T. Walkers Pharmaceuticals; Metformin and Glimepiride Tablets by Merril Pharma; and multiple batches of Albendazole Tablets manufactured by Mancare Laboratories.

Medical and allied healthcare products including Infusion Sets manufactured by Romsons Group Pvt. Ltd. and Absorbent Cotton Wool IP by Jind Surgicals were also found to be non-compliant during testing.

The reasons cited for NSQ classification were wide-ranging and critical, including failures in dissolution tests affecting drug release, assay failures indicating incorrect active pharmaceutical ingredient content, sterility failures in injectables and infusion products, particulate matter contamination, pH deviations, identification test failures, clarity and description issues, and non-compliance with pharmacopoeial standards under IP, USP, and BP specifications.

The NSQ samples were reported by various government drug testing laboratories including CDL Kolkata, RDTL Guwahati, RDTL Chandigarh, CDTL Mumbai, CDTL Hyderabad, and CDTL Indore as part of routine post-marketing surveillance conducted by CDSCO.

Drugs and medical products that fail to meet prescribed quality standards are categorised as Not of Standard Quality (NSQ). The standards of quality are defined under Section 16(1)(a) of the Drugs and Cosmetics Act, 1940, which mandates compliance with specifications laid down under the Second Schedule of the Act and recognised pharmacopoeial standards.