State Drug Alert: Azithromycin, Cefixime Among 191 Drug Samples Flagged by CDSCO for Quality Failures in August

The alert covers a broad range of products, including antibiotics, antidiabetics, antihypertensives, analgesics, gastrointestinal medicines, injections, vitamin supplements, veterinary formulations, medicated soaps and absorbent cotton products.

Several widely used medicines failed tests for assay, dissolution, disintegration, identification, sterility, bacterial endotoxins, description or uniformity of weight. Some products were also reported as misbranded because of labelling discrepancies, while four entries in the state list expressly describe the tested samples as spurious.

Among the notable products flagged are azithromycin 500 mg tablets, batch 2408001232, manufactured by Alembic Pharmaceuticals Ltd., which failed identification and assay tests at the Assam state laboratory; cefixime tablets, batch 25460922, manufactured by Alkem Health Science, which failed dissolution and assay at the same laboratory; and Cycloxan cyclophosphamide 50 mg tablets, batch CWC1006, manufactured by Zydus Life Sciences Ltd., which failed dissolution and assay at the Ernakulam regional laboratory.

Other products listed include misoprostol 200 mcg tablets, batch 6132, manufactured by Healthy Life Pharma Pvt. Ltd., which failed assay; folic acid 0.4 mg tablets, batch F01TE055, manufactured by Unicure India Ltd., which failed description, dissolution and assay; and several batches of paracetamol and telmisartan tablets reported for dissolution, description or other quality parameters.

The Punjab laboratory found 80.34 mg of azithromycin per 5 ml in oral suspension batch AZS1401, manufactured by Unicure India Ltd., against the label claim of 100 mg per 5 ml. The Mumbai laboratory reported that metronidazole 400 mg batch IT6050 and 200 mg batch IT6151, both manufactured by Inducare Pharmaceutical and Research Foundation, contained 32.44% and 52.75% of their stated amounts, respectively. Both batches failed dissolution tests and were described as misbranded in the alert.

A number of other products were described as misbranded. These include rosuvastatin 5 mg tablets, batch IT04501, and domperidone 10 mg tablets, batch IT14501, manufactured by Inducare Pharmaceutical and Research Foundation, as well as itraconazole 200 mg capsules, batch B23225009, manufactured by Torque Pharmaceuticals Pvt. Ltd. The Mumbai laboratory also reported dissolution failures for these batches.

Under the Drugs and Cosmetics Act, 1940, a drug is considered Not of Standard Quality when it does not meet applicable prescribed standards. CDSCO publishes drug alerts based on reports from central and state testing laboratories as part of regulatory surveillance.