CDSCO State Drug Alert: 132 Drug Batches Including Telmisartan, Azithromycin Fail Quality Tests

Written By :  Susmita Roy
Published On 2026-07-24 17:20 GMT   |   Update On 2026-07-24 17:20 GMT

New Delhi: In another major drug quality surveillance exercise, 132 batches of drugs, cosmetics and Ayurvedic products have been declared Not of Standard Quality (NSQ) by State Drug Testing Laboratories across India for June 2026, highlighting continued monitoring of medicines circulating in the domestic market.

The list includes products tested by laboratories in Tamil Nadu, Gujarat, Punjab, Telangana, Kerala, Rajasthan, Goa, Delhi, Jammu & Kashmir, Maharashtra, Odisha and several other states.

The NSQ list covers a wide spectrum of pharmaceutical formulations, including tablets, capsules, oral suspensions, syrups, injections, eye drops, creams, ointments, lotions, powders for injection, oral rehydration salts (ORS), veterinary injections, cosmetics and Ayurvedic formulations, reflecting extensive post-marketing quality surveillance across multiple therapeutic categories.

Among the products that failed quality testing were Permethrin Medicated Soap manufactured by Vimson Derma; Magnesium Sulphate Injection IP by Hindustan Medicines Pvt. Ltd.; Ranitidine Oral Solution IP by Revive Formulation India Pvt. Ltd. and Smayan Healthcare Pvt. Ltd.; multiple batches of Telmisartan Tablets IP manufactured by Super Formulations Pvt. Ltd., Merion Care Pvt. Ltd., Regent Ajanta Biotech, Aristo Pharmaceuticals Pvt. Ltd., Kerala State Drugs and Pharmaceuticals Ltd., Alteus Remedies Pvt. Ltd. and Relief Biotech Pvt. Ltd.; Azithromycin Oral Suspension IP by Zeta Formulation Pvt. Ltd. and Livin Formulations; Gentamicin Injection IP by Zazen Pharma Pvt. Ltd.; Pantoprazole Gastro-resistant Tablets IP by Aristo Pharmaceuticals, Jackson Laboratories, Middle Mist Pharmaceuticals and others.

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

Apart from pharmaceuticals, the June 2026 alert also includes Neeta Mehandi Cone manufactured by Yutika Natural Pvt. Ltd., Rajasthan; Shubham Kumkum manufactured by Shubham Enterprises, Solapur, Maharashtra; Kumkum Pinjar manufactured by M.V. Vaze Consumer Products, Osmanabad (Tuljapur), Maharashtra; and Ayurvedic products including Triphala Churna and Hingwasht Churna, both manufactured by Inducare Pharma Pvt. Ltd., Pune, Maharashtra. These products were declared Not of Standard Quality (NSQ) due to microbial contamination, pH deviations, excessive ash content, fineness defects, and other quality deficiencies.

The list also includes several commonly prescribed medicines such as Amlodipine & Atenolol Tablets IP manufactured by Mankind Pharma, Amoxycillin & Potassium Clavulanate Tablets IP manufactured by Alkem Health Science, A Unit of Alkem Laboratories, Rabeprazole Gastro resistant Tablets IP 20 m manufactured by Lupin, Phenazone & Lidocaine Hydrochloride Ear Drops -5ml manufactured by Pure & Cure Healthcare, and others.

The quality defects reported by the State laboratories were diverse and included dissolution failures, assay/content deficiencies, pH deviations, sterility failures, bacterial endotoxin contamination, microbial contamination, particulate matter, identification failures, description defects, disintegration failures, hardness and physical instability, related substance failures, weight variation, net content deficiencies, enzyme activity failure, storage non-compliance, labeling violations, discoloration, rough tablet surfaces, mottling defects, and misbranding. Several products were also found to contain incorrect or insufficient quantities of active pharmaceutical ingredients, while some failed pharmacopoeial specifications for identity and quality.

Notably, three batches of Aceclofenac and Paracetamol tablets and one batch of Paracetamol Paediatric Oral Suspension were reported as misbranded under the provisions of the Drugs and Cosmetics Act due to labeling and regulatory non-compliance in addition to quality defects.

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