State Drug Alert: CDSCO Flags 78 NSQ, Spurious, Misbranded Drug Samples in April Quality Checks

New Delhi: Reflecting continuing concerns over medicine quality and regulatory compliance in India's pharmaceutical market, the Central Drugs Standard Control Organisation (CDSCO) has flagged 78 drug, medical device, and cosmetic samples as Not of Standard Quality (NSQ), spurious, or misbranded in its April 2026 drug safety alert, based on reports submitted by State Drug Testing Laboratories across the country.

The latest alert includes a wide range of pharmaceutical products such as tablets, capsules, syrups, injections, oral suspensions, lotions, powders, and surgical products across multiple therapeutic categories including antibiotics, antihypertensives, antidiabetics, gastrointestinal medicines, respiratory formulations, painkillers, dermatology products, nutritional supplements, and steroid preparations.

Several widely used medicines failed critical quality parameters including dissolution, assay, sterility, microbial contamination, disintegration, identification, and labelling compliance. In some cases, drugs were reportedly found to contain “Nil” active pharmaceutical ingredient content, raising serious concerns over patient safety and therapeutic efficacy.

Among the prominently flagged products were Esomeprazole Tablets IP manufactured by Zoic Biotech Pvt. Ltd. and Adwin Pharma, which failed dissolution tests; Telmisartan Tablets manufactured by Helax Health Care Pvt. Ltd., Alembic Pharmaceuticals Ltd., and Bennet Pharmaceuticals Limited, which failed assay and dissolution standards; and Metoprolol Succinate prolonged-release tablets manufactured by Helax Health Care Pvt. Ltd., which reportedly failed IP standards and also showed discrepancies in product labelling.

Several antibiotic formulations also came under scrutiny. Cefixime Tablets manufactured by Alkem Health Science and Cefpodoxime Tablets manufactured by Aristo Pharmaceuticals and VADSP Pharmaceuticals were declared spurious or failed identification and assay tests. Amoxycillin and Potassium Clavulanate formulations manufactured by multiple companies, including Sun Pharmaceuticals, Alkem Health Science, Finecure Pharmaceuticals, and VADSP Pharmaceuticals, reportedly failed dissolution or assay parameters, while some batches allegedly did not contain the required amount of clavulanic acid.

A number of gastrointestinal medicines were also flagged. Pantoprazole and Rabeprazole formulations manufactured by Aristo Pharmaceuticals, Oaksun Lifesciences, Keylink Global Exim, and Inventia Healthcare reportedly failed identification, dissolution, or assay tests. One batch of Pantoprazole & Domperidone Capsules manufactured by Aristo Pharmaceuticals was declared spurious after reportedly failing identification and assay requirements.

The alert additionally identified several products as spurious or misbranded under the provisions of the Drugs and Cosmetics Act, 1940. R Zara-DSR Capsules manufactured by Samay Pharma India Pvt. Ltd. were declared spurious after assay contents of Rabeprazole Sodium and Domperidone were reportedly found “Nil”. Similarly, multiple products were flagged for incorrect or incomplete labelling declarations.

Apart from pharmaceutical formulations, the alert also covered cosmetic and surgical products. Activated Teeth Whitening Powder with Charcoal manufactured by Dentiglow and ALPC Wellness Rosemary Water for Hair reportedly failed microbial count standards. Mehandi cones manufactured by Pushp Henna Pvt. Ltd. and surgical absorbent gauze and rolled bandages manufactured by firms in Tamil Nadu and Haryana also failed quality parameters related to microbial load, dimensions, and labelling compliance.

Under the Drugs and Cosmetics Act, 1940, a product is categorised as “Not of Standard Quality” if it fails to comply with standards prescribed under the Indian Pharmacopoeia (IP) or other regulatory specifications. Such standards are mandatory to ensure the safety, quality, and effectiveness of medicines and healthcare products marketed in the country.