CDSCO Flags 46 Drug Batches Including Thyroxine, Amoxycillin-Clavulanate as NSQ in May 2026

New Delhi: Continuing its nationwide post-market surveillance and quality monitoring drive, the Central Drugs Standard Control Organisation (CDSCO) has flagged 46 batches of drugs, medical devices, pharmaceutical ingredients, and surgical products as Not of Standard Quality (NSQ) for May 2026, highlighting persistent quality concerns across multiple therapeutic categories and healthcare products.

The latest NSQ list includes a broad range of products such as antibiotics, anti-diabetic medicines, cardiovascular drugs, thyroid medicines, cough and cold preparations, injectables, nutritional supplements, surgical dressings, infusion sets, and active pharmaceutical ingredients.

The NSQ list features widely used formulations such as Iron Sucrose Injection USP manufactured by Marc Laboratories Ltd.; Amoxycillin and Potassium Clavulanate Tablets IP by Medreich Limited; Rosuvastatin Tablets IP 20 mg and Ondansetron Tablets IP by Wings Biotech LLP; Cefixime Dispersible Tablets IP by Blue Cross Laboratories Pvt. Ltd.; Teneligliptin and Metformin Hydrochloride Extended Release Tablets IP by Rivpra Formulation Pvt. Ltd.; Pregabalin Capsules IP 300 mg by Scout Lifescience Pvt. Ltd.; Amlodipine Tablets IP 5 mg by Super Formulations Pvt. Ltd. and Amlodipine Besylate Tablets IP by Apple Formulations Pvt. Ltd.; Thyroxine Sodium Tablets IP 50 mcg by Healthy Life Pharma Pvt. Ltd.; and Heparin Sodium Injection IP 5000 IU/ml by Nandani Medical Laboratories Pvt. Ltd.

Among the notable products declared NSQ were Ferric Carboxymaltose Injection 50 mg/ml manufactured by Maan Pharmaceuticals, which failed the bacterial endotoxin test; Triamcinolone Acetonide Injection IP manufactured by NDB Healthcare, which failed sterility testing, and Ceftriaxone Injection IP manufactured by Macleods Pharmaceuticals, which was found deficient in appearance, clarity of solution, and particulate matter parameters.

The list also includes several medical devices and surgical products such as Swabs Sterile, Cotton Bandage (Non-Sterile), Roller Bandage Cloth (Non-Sterile), Absorbent Cotton Wool IP, Gauze Bandage, and Infusion Sets.

The reasons for NSQ classification were varied and included critical failures in assay, indicating incorrect active ingredient content; dissolution, affecting drug release and therapeutic efficacy; sterility and bacterial endotoxin failures in injectable products; particulate matter, clarity of solution, and uniformity of weight defects; microbial contamination; related substances and impurity failures; deviations in pH and alkalinity; and failures in identification tests confirming the presence of the declared active ingredients. Several products also failed tests related to water content, absorbency, fluorescence, sulphated ash, and physical quality specifications.

Particularly noteworthy was an antibiotic capsule batch manufactured by Laborate Pharmaceuticals India Ltd., which was found not only to fail identification and assay requirements for Ampicillin but was also detected to contain 246.8 mg of Amoxycillin per capsule despite no label claim for Amoxycillin. The laboratory report stated that the product was deemed a misbranded drug under Section 17 of the Drugs and Cosmetics Act, 1940, making it one of the most serious quality violations reported in the May 2026 NSQ list.

Drugs and healthcare products that fail to meet prescribed quality standards are categorized as Not of Standard Quality (NSQ). Under Section 16(1)(a) of the Drugs and Cosmetics Act, 1940, a drug is required to comply with the standards specified under the Act and the relevant pharmacopoeial requirements. Failure to meet these standards can result in regulatory action, including product recalls, investigations, and legal proceedings against manufacturers where warranted.