NSQ Drug Alert: 60 Batches Including Paracetamol, Cefixime, Telmisartan Fail CDSCO Quality Tests in February

New Delhi: In a fresh drug alert highlighting ongoing quality surveillance, 60 batches of drugs and medical devices have been declared Not of Standard Quality (NSQ) by laboratories operating under the Central Drugs Standard Control Organisation (CDSCO) during February2026.

The flagged products span a broad spectrum of dosage forms including injectables, tablets, capsules, syrups, suspensions, oral liquids, and medical devices, indicating extensive regulatory scrutiny across therapeutic categories and manufacturing segments.

The NSQ list includes commonly used formulations such as Ambroxol + Levosalbutamol + Guaiphenesin Syrup manufactured by Athens Life Sciences, Tranexamic Acid Injection I.P manufactured by Marc Laboratories, Rabeprazole and Domperidone Capsules manufactured by Laborate Pharmaceuticals, Rabeprazole Sodium Injection manufactured by Martin & Brown Bio-Sciences, Paracetamol Tablets IP 500 mg manufactured by Zenith Drugs, Cefixime Oral Suspension manufactured by Lark Laboratories (India) Ltd., and Telmisartan Tablets IP 40 mg manufactured by Signature Phytochemical Industries, Amikacin Sulphate Injection IP manufactured by Maan Pharmaceuticals and others.

The list further includes Pheniramine Maleate Injection manufactured by Sanofi India, Baclofen Tablets IP 10 mg manufactured by Intas Pharmaceuticals.

Additionally, medical devices such as the Silky Gold Foley Balloon Catheter (Siliconised) manufactured by Ribbel International and Single-use Hypodermic Needle manufactured by Hindustan Syringes & Medical Devices were flagged for failing the bacterial endotoxin test and sterility tests, respectively.

The reasons cited for NSQ classification varied widely. These included assay failures (active ingredient content outside permissible limits), dissolution failures affecting drug release, sterility failures in injectables, presence of particulate matter, pH deviations, microbial contamination, failure in bacterial endotoxin tests, and non-compliance in description or appearance-related parameters. In certain cases, products also failed tests for fungal contamination, total bacterial count, and specific impurities such as ethylene glycol.

Drugs that fail to meet prescribed quality standards are termed Not of Standard Quality (NSQ). The definition of “standards of quality” is provided under Section 16 (1) (a) of the Drugs and Cosmetics Act, 1940, which requires that a drug complies with standards specified in the Second Schedule of the Act.