In a recent drug safety update, 60 batches of medicines and medical devices have been classified as Not of Standard Quality (NSQ) by laboratories under the Central Drugs Standard Control Organisation (CDSCO), underscoring continued regulatory vigilance.
The affected products cover a wide range of dosage forms such as injections, tablets, capsules, syrups, suspensions, oral liquids, and medical devices reflecting comprehensive monitoring across therapeutic segments and manufacturing units.
Among the drugs flagged are widely used formulations, including Ambroxol + Levosalbutamol + Guaiphenesin syrup from Athens Life Sciences; Tranexamic Acid injection by Marc Laboratories; Rabeprazole + Domperidone capsules from Laborate Pharmaceuticals; Rabeprazole Sodium injection by Martin & Brown Bio-Sciences; Paracetamol 500 mg tablets by Lark Laboratories (India) Phytochemical Industries; and Amikacin Sulphate injection by Maan Pharmaceuticals. Other products include Pheniramine Maleate injection by Sanofi India and Baclofen tablets by Intas Pharmaceuticals.
Certain medical devices were also found non-compliant, including a siliconised Foley balloon catheter by Ribbel International, which failed bacterial endotoxin testing, and single-use hypodermic needles from Hindustan Syringes & Medical Devices that did not meet sterility standards.
The reasons for NSQ classification varied across products. Common issues included incorrect levels of active ingredients (assay failures), poor dissolution impacting drug release, sterility concerns in injectables, particulate contamination, pH imbalance, microbial presence, and endotoxin test failures. Some samples also showed fungal contamination, high bacterial counts, or impurities such as ethylene glycol, along with deviations in appearance and description.
Under the Drugs and Cosmetics Act, 1940, a drug is labelled NSQ if it does not meet prescribed quality standards, as defined in Section 16 (1) (a), which mandates compliance with specifications listed in the Act’s Second Schedule.
