NSQ Alert: 42 Drug, Surgical Product Samples Fail CDSCO Quality Tests in September

New Delhi: In a fresh drug safety alert underscoring continued regulatory vigilance, a total of 42 samples of drugs and surgical products have been declared Not of Standard Quality (NSQ) by laboratories under the Central Drugs Standard Control Organisation (CDSCO) for September 2026.

The flagged products include tablets, capsules, injections, intravenous fluids, syrups, oral solutions, ear drops, rolled bandages and adhesive tape. The reported failures concern parameters including assay, dissolution, disintegration, sterility, bacterial endotoxins, particulate matter, pH and microbial limits.

The NSQ list features formulations such as Thyroxine Tablets IP 25 mcg manufactured by Jackson Laboratories; Atorvastatin Tablets IP 40 mg by Sarthak Biotech; Itraconazole Capsules 200 mg by Torque Pharmaceuticals; Lactulose Solution IP 10 gm/15 ml by Gnosis Pharmaceuticals; and Pantoprazole Gastro-resistant Tablets IP 40 mg by Nestor Pharmaceuticals.

The list further includes Bupivacaine Injection IP 0.5% by Shukra Pharmaceuticals; Bupivacaine Hydrochloride in Dextrose Injection USP by Medizia Biotech; Promethazine Injection IP by Himalaya Meditek; Ferric Carboxymaltose Injection 50 mg/ml by Maan Pharmaceuticals; and Adrenaline Bitartrate Injection IP by Amba Research Laboratories.

Of the 42 entries, 31 were reported by the Central Drugs Laboratory, Kolkata; five by the Regional Drugs Testing Laboratory, Guwahati; four by the Regional Drugs Testing Laboratory, Chandigarh; and one each by the Central Drugs Testing Laboratories in Mumbai and Hyderabad. The findings relate to the specific samples and batches identified in the list.

Drugs that fail to meet prescribed quality standards are termed Not of Standard Quality. Section 16(1)(a) of the Drugs and Cosmetics Act, 1940, provides that, in relation to a drug, “standard quality” means compliance with the standards set out in the Second Schedule of the Act.