48 Drug Batches Fail Quality Tests in CDSCO's March 2026 NSQ Alert

The flagged products cut across a wide range of categories including tablets, capsules, injections, syrups, oral solutions, topical preparations, and even medical devices and cosmetic products like mehandi cones, reflecting broad-based quality surveillance across the pharmaceutical and healthcare supply chain.

The NSQ list features widely used formulations such as Paracetamol Tablets IP 650 mg manufactured by Ipca Laboratories, Diclofenac Sodium Injection IP by Venus Bio Sciences; Rabeprazole and Domperidone Capsules by Prosperity Drugs and Spanker Biotech, Tacrolimus Capsules by Spen Formulations; Lactulose Solution IP by Unicure India; Pantoprazole Tablets by multiple manufacturers; and Amikacin Sulphate Injection IP by Oscar Remedies.

Other notable entries include Fentanyl Citrate Injection by Maan Pharmaceuticals, Liposomal Amphotericin B Injection by Gufic Biosciences, and Oral Rehydration Salts IP by Goa Antibiotics & Pharmaceuticals.

Medical devices like absorbent gauze and electrosurgical control pencils, along with multiple batches of mehandi cones, were also found non-compliant.

The reasons cited for NSQ classification were diverse and critical, including failure in dissolution tests affecting drug release, assay failures indicating incorrect active ingredient content, sterility and bacterial endotoxin failures in injectables, microbial contamination, particulate matter presence, pH deviations, and non-compliance with identification and description standards. Some products also failed specific impurity tests such as ethylene glycol contamination and total viable microbial count.

Drugs that fail to meet prescribed quality standards are termed Not of Standard Quality (NSQ). The definition of “standards of quality” is provided under Section 16 (1) (a) of the Drugs and Cosmetics Act, 1940, which requires that a drug complies with standards specified in the Second Schedule of the Act.