CDSCO Flags 27 Drug Batches Including Paracetamol, Ibuprofen, Levetiracetam as Not of Standard Quality

New Delhi: In a fresh drug quality alert highlighting continued regulatory surveillance, 27 batches of drugs and one medical device have been declared Not of Standard Quality (NSQ) by laboratories functioning under the Central Drugs Standard Control Organisation (CDSCO) for June 2026.

The NSQ list spans a broad range of pharmaceutical products, including tablets, injections, syrups, oral suspensions, capsules, eye/ear drops, ointments, and a disposable syringe, indicating comprehensive quality monitoring across multiple dosage forms and therapeutic categories.

Among the products that failed quality testing were Etodolac Tablets IP manufactured by Pacific India; Adenosine Injection IP 6 mg/2 ml manufactured by Smayan Healthcare Pvt. Ltd. and Welcure Remedies (two batches); Simethicone Drops by Priya Life Science; Paracetamol Paediatric Oral Suspension IP by Skylink Pharma; Phenytoin Sodium Injection USP by Radiant Parenterals Ltd.; Escitalopram Oxalate & Clonazepam Tablets IP by Oxford Pharma; Cyproheptadine Hydrochloride & Tricholine Citrate Syrup by Glorius Pharmaceuticals; Albendazole Tablets IP 400 mg by Mancare Laboratories Pvt. Ltd.; Montelukast Tablets IP by Civron Pharmaceuticals; Levetiracetam Tablets IP 1000 mg by Astonea Labs Limited; Calcium & Vitamin D3 Tablets IP by Sunlife Sciences; Pantoprazole Gastro-resistant Tablets IP by Athens Life Sciences; Atorvastatin Tablets IP 20 mg by Hindustan Antibiotics Ltd.; Povidone-Iodine Ointment USP 5% w/w by Hindustan Laboratories Limited and others.

The NSQ list also features a Disposable Syringe for Single Use Only manufactured by Sterisafe Health Solutions, which was declared Not of Standard Quality after failing the sterility test.

The quality deficiencies identified were varied and significant, including dissolution failures affecting drug release, assay failures indicating incorrect active ingredient content, sterility failures, bacterial endotoxin contamination, microbial contamination, particulate matter, pH deviations, identification failures, related substance and impurity issues, description non-compliance, hardness and friability defects, alcohol content deviations, and inadequate enzymatic activity.

Notably, one batch of Adenosine Injection IP manufactured by Welcure Remedies was also declared spurious under Section 17B of the Drugs and Cosmetics Act, 1940, after failing multiple critical quality parameters including identification, sterility, particulate matter and assay.

Also Read: CDSCO Flags 46 Drug Batches Including Thyroxine, Amoxycillin-Clavulanate as NSQ in May 2026