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New Delhi, June 2025 — The Central Drugs Standard Control Organisation (CDSCO), India’s apex drug regulatory body, has identified 58 batches of pharmaceutical products as Not of Standard Quality (NSQ) in its latest monthly alert for May 2025. The affected products include commonly prescribed medicines, injectables, oral suspensions, and combination formulations from various manufacturers across the country.
The CDSCO’s regulatory surveillance program routinely collects drug samples from sales and distribution points for analysis. The results, which are published monthly on the CDSCO portal, aim to inform stakeholders—including healthcare professionals, pharmacists, and the public—about batches that fail to meet established quality standards. The latest findings are based on tests conducted by Central and Regional Drug Testing Laboratories, including CDL Kolkata, RDTL Guwahati, RDTL Chandigarh, CDTL Mumbai, and CDTL Indore.
Among the drugs flagged for quality issues are several widely used products:
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CALXIA-500 (Calcium Carbonate + Vitamin D3) tablets by Gidsha Pharmaceuticals, which failed dissolution tests at CDL Kolkata.
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Ondansetron, Rabeprazole Sodium, Pantoprazole, Ciprofloxacin, and Betamethasone Sodium Phosphate injectables—failed tests related to particulate matter, clarity, pH, or assay.
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Sitagliptin & Metformin FDC (Sitajak-M) by Jackson Laboratories—failed assay test for Sitagliptin.
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Buprenorphine and Buprenorphine Hydrochloride Injections—flagged for spurious identification, particulate matter, and related substances.
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Fexofenadine (Fexodil 180 mg) and Pantoprazole tablets—flagged for dissolution failures.
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Dexamethasone Sodium Phosphate Injection (Dexona) by Zydus Healthcare Limited—reported as NSQ due to particulate matter, assay of dexamethasone phosphate, and description.
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Sporlac Tablets (Probiotics) by J.B. Chemicals & Pharmaceuticals Ltd.—failed the “Identification of Bacillus clausii” test.
Other quality issues identified include failures in sterility, microbial limits, uniformity of weight, assay content, and dissolution—all critical parameters under the Drugs and Cosmetics Act, 1940. The CDSCO defines NSQ drugs as those that fail to meet specified quality standards or specifications.
The regulatory body has reiterated its commitment to drug safety and compliance, urging stakeholders to review the list of NSQ batches and take appropriate action to prevent the use of substandard medicines in the market.
Disclaimer:
This news article is based on the official CDSCO alert and publicly available information. While every effort has been made to ensure accuracy, readers are advised to consult the official CDSCO portal for the most up-to-date and comprehensive list of Not of Standard Quality drug batches. The information provided here is for general awareness and should not be considered medical advice. Always consult a healthcare professional before making any changes to your medication.
