You are currently viewing CDSCO Finds 93 Medicines Samples Substandard, Key Antibiotics, Chronic Drugs Affected

CDSCO Finds 93 Medicines Samples Substandard, Key Antibiotics, Chronic Drugs Affected

New Delhi: Highlighting continuing concerns over drug quality in India’s pharmaceutical supply chain, the Central Drugs Standard Control Organisation (CDSCO) has flagged 93 drug samples as Not of Standard Quality (NSQ) in its December 2025 alert, based on test results submitted by various State Drug Testing Laboratories (SDTLs) across the country.

These findings are based on the testing of samples collected by state drug inspectors and analysed at SDTLs and Regional Drug Testing Laboratories (RDTLs) located in multiple states, including Kerala, Puducherry, Jammu & Kashmir, Himachal Pradesh, Maharashtra, Tamil Nadu, Telangana, West Bengal, Tripura, Punjab, Rajasthan, and others.

The December 2025 NSQ list covers a broad spectrum of pharmaceutical formulations, including tablets, syrups, suspensions, injections, creams, nasal solutions, dispersible tablets, and oral disintegrating tablets. Therapeutic categories involved range from antibiotics, antiallergics, antidiabetics, cardiovascular drugs, analgesics, respiratory medicines, gastrointestinal drugs, psychotropic medicines, dermatological products, and nutritional supplements, to disinfectants and medical products.

Several well-known formulations, such as Amoxycillin & Potassium Clavulanate Tablets IP(CLAVAM 625) manufactured by Alkem Health Science,Aceclofenac & Paracetamol Tablets manufactured by Hindustan Antibiotics, Telmisartan Tablets IP 40MG manufacterd by Hindustan Laboratories, Ceftriaxone & Sulbactam for Injection IP (Keftragard-1500) manufactured by Ipca Laboratories, Montelukast Sodium & Levocetirizine Hydrochloride Dispersible Tablets, (CIVIKAST-LC KID) manufactured by Theon Pharmaceuticals, Levocetirizine Tablets IP 5mg Levocet manufactured by Hetero Healthcare, and others.

Under the Drugs and Cosmetics Act, 1940, a drug is deemed “Not of Standard Quality” if it fails to meet the standards specified in the Second Schedule of the Act. Section 16(1)(a) defines the ‘standards of quality’ as compliance with those prescribed requirements.

As part of continuous regulatory surveillance, CDSCO and state authorities routinely pick samples of drugs, cosmetics, and medical devices from sales and distribution points for analysis. The list of NSQ drugs is updated and displayed monthly on the CDSCO portal, enabling transparency and timely corrective actions.

Leave a Reply