New Delhi: India’s drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has identified over 53 medicines as ‘Not of Standard Quality’ (NSQ) after conducting quality tests in August. The flagged medications include widely used treatments for diabetes, hypertension, and bacterial infections, produced by notable pharmaceutical companies such as Alkem Laboratories, Hetero Drugs, and Hindustan Antibiotics Limited.
Among the prominent drugs listed as NSQ are paracetamol tablets (500 mg), the anti-diabetic medication Glimepiride, the hypertension drug Telma H (Telmisartan 40 mg), acid reflux treatment Pan D, and calcium supplements Shelcal C and D3. The antibiotic Metronidazole and the dry suspension Cepodem XP 50, commonly prescribed for severe bacterial infections in children, were also found to be substandard.
Particular concerns have been raised about paracetamol from Karnataka Antibiotics & Pharmaceuticals Ltd. and Sun Pharma’s Ursocol 300, which is intended for dissolving gallstones and has been flagged as spurious. Additionally, multiple batches of Telmisartan manufactured by Life Max Cancer Lab did not meet quality standards.
The CDSCO has released two comprehensive lists detailing the affected drugs, along with responses from manufacturers. Many companies, including Sun Pharma and Glenmark, have denied responsibility for the flagged batches, asserting that the substandard products were not produced by them and suggesting the possibility of counterfeit goods.
The CDSCO routinely conducts random monthly sample checks, issuing NSQ alerts based on the findings. In August, the regulator also imposed a ban on over 156 fixed-dose drug combinations deemed hazardous, which included commonly used medications for cold and pain relief. Since 2014, a total of 499 such combinations have been prohibited to safeguard public health.
A drug-testing laboratory in Kolkata recently reported that antibiotics like Clavam 625 and Pan D were found to be spurious. The same lab flagged Cepodem XP 50 Dry Suspension, highlighting concerns about quality in pediatric medications.
CDSCO has categorized the flagged drugs into two lists—one containing 48 drugs that failed quality tests and another with 5 drugs in the NSQ Alert category, along with the respective responses from the manufacturers involved.