The Central Drugs Standard Control Organisation (CDSCO) has released its monthly drug quality alert for May 2026, identifying 157 drug samples as Not of Standard Quality (NSQ) and 2 drug samples as Spurious following testing by Central and State Drug Testing Laboratories across the country. The findings underscore the importance of continuous post-marketing surveillance to ensure the quality, safety and efficacy of medicines available to patients.
According to the report, several commonly prescribed medicines including antibiotics, anti-diabetic drugs, cardiovascular medicines, cough syrups, gastrointestinal medicines, injections and medical devices failed quality parameters such as dissolution, assay, sterility, microbial contamination, particulate matter, related substances, identification and disintegration tests.
Among the notable products that failed quality testing were batches manufactured by well-known pharmaceutical companies including Sun Pharmaceutical Industries, Alkem Laboratories, Medreich Limited, Cipla Limited, Macleods Pharmaceuticals, Blue Cross Laboratories, Unicure India, Wings Biotech, Cadila Pharmaceuticals, Taj Pharma India, Helax Healthcare and several others.
Antibiotic Products Among Key Failures
Multiple batches of Amoxycillin and Potassium Clavulanate Tablets IP manufactured by Sun Pharma, Medreich and Alkem Health Science failed quality testing. The products were reported to have failed dissolution tests for Amoxycillin and assay tests for Clavulanic Acid.
A batch manufactured by Apex Formulation was found non-compliant with identification and content requirements and was classified as a spurious drug by the testing laboratory.
Injections Fail Sterility and Quality Parameters
Several injectable products were reported as NSQ, including :
• Ferric Carboxymaltose Injection manufactured by Maan Pharmaceuticals, which failed the bacterial endotoxin test.
• Triamcinolone Acetonide Injection manufactured by NDB Healthcare, which failed the sterility test.
• Heparin Sodium Injection manufactured by Nandani Medical Laboratories, which failed assay requirements.
• Ceftriaxone Injection manufactured by Macleods Pharmaceuticals, which failed appearance, clarity and particulate matter tests.
• Iron Sucrose Injection manufactured by Marc Laboratories, which failed pH and alkalinity requirements.
Diabetes and Cardiac Medicines Also Affected
Anti-diabetic medicines were prominently featured in the NSQ list. Batches manufactured by Taj Pharma India and Rivpra Formulation failed assay and dissolution requirements involving Glimepiride, Voglibose, Metformin and Teneligliptin.
Cardiovascular medicines including Telmisartan, Amlodipine and Rosuvastatin products also failed quality parameters such as dissolution, related substances and description tests.
Cough Syrups and Respiratory Medicines Fail Assay Tests
Several cough and cold preparations manufactured by Crest Lifesciences, Bionexy Pharma, Dhwanilife Care, ASPO Pharmaceuticals and others failed assay requirements for active ingredients such as Ambroxol, Dextromethorphan, Menthol, Phenylephrine and Guaiphenesin.
Medical Devices and Surgical Products Fail Standards
Apart from medicines, CDSCO also reported quality failures in medical and surgical products including,
Absorbent Cotton Wool
Gauze Bandage
Roller Bandage Cloth
Infusion Sets
Sterile Swabs
The products failed tests relating to sterility, absorbency, dimensions, water-soluble substances, fluorescence and other pharmacopeial standards.
Cosmetic Products Also Found Non-Compliant
The report includes cosmetic products such as sunscreen lotion, lipstick and facewash. A sunscreen product manufactured by Elegant Cosmed failed microbial examination requirements, while certain cosmetic products were declared misbranded.
Two Drug Samples Declared Spurious
CDSCO's May 2026 alert also identified two drug samples as spurious. One of these involved Amoxycillin and Potassium Clavulanate Tablets that failed identification and content testing and was subsequently classified as a spurious drug under the provisions of the Drugs and Cosmetics Act.
Regulatory Significance
The monthly NSQ and spurious drug alerts are part of CDSCO's nationwide surveillance programme aimed at monitoring the quality of medicines circulating in the Indian market. Healthcare professionals, pharmacists, distributors and healthcare institutions are advised to verify affected batch numbers and take necessary action wherever these products are found in stock.
The complete CDSCO report provides batch-wise details including product name, batch number, manufacturer, testing laboratory and specific reasons for failure, enabling regulatory authorities to initiate further investigation and corrective action where required.
