CDSCO Flags 74 Drugs, Devices Samples as NSQ in December: Zerodol-SP, Defcort, Telmisartan, Amikacin Among Failed Products

Written By :  Susmita Roy
Published On 2026-01-22 13:48 GMT   |   Update On 2026-01-22 13:49 GMT
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New Delhi: As part of a nationwide quality surveillance drive, the Central Drugs Standard Control Organisation (CDSCO) has flagged 74 drugs, pharmaceutical formulations, medical devices, and allied healthcare products as Not of Standard Quality (NSQ) during routine testing conducted in December 2025.

The failures reported by central and regional drug testing laboratories across India, span critical therapeutic categories, including antibiotics, cardiovascular drugs, anti-diabetics, injectables, syrups, suspensions, APIs, excipients, medical devices, and even surgical bandages.

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The NSQ list includes commonly prescribed medicines such as Dexamethasone Sodium Phosphate Injection IP 4 mg/ml. DEXOHIN manufactured by Hindustan Medicines, Amikacin Injection IP 100 mg manufactured by Agron Remedies, Telmisartan Tablets IP manufactured by BENNET Pharmaceuticals, Vildagliptin and Metformin Tablets IP manufactured by Unicure India, Clopidogrel & Aspirin Tablets IP manufactured by Theon Pharmaceuticals and others.

The list further includes widely used medicines such as Aceclofenac 100 mg, Serratiopeptidase 15 mg & Paracetamol 325 mg Tablets Zerodol-SP manufactured by Ipca Laboratories, Deflazacort Tablets 6 mg (Defcort 6) manufactured by Macleods Pharmaceuticals, Progesterone Sustained Release Tablets 300 mg (OPTOGEST 300) SR manufactured by Synokem Pharmaceuticals, Primaquine Phosphate Tablets IP 2.5 mg manufactured by Jackson Laboratories, and others.

The reasons for declaring the products Not of Standard Quality (NSQ) were wide-ranging and multi-factorial. These included assay failures, where the active pharmaceutical ingredient was found outside permissible limits; dissolution failures in solid oral dosage forms; sterility test failures in injectables and infusions; and the presence of particulate matter.

Drugs that fail to meet the quality standards or specifications are known as Not of Standard Quality (NSQ) drugs. The term ‘standards of quality’ is defined under Section 16 (1) (a) of the Drugs and Cosmetics Act, 1940, as ‘standards of quality’, meaning that the drug complies with the standards set out in the Second Schedule of the said Act.

NOT OF STANDARD QUALITY (NSQ) ALERT FOR THE MONTH OF DECEMBER 2025

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