NEW DELHI: India's drug regulator flagged select batches of four drugs, including commonly used calcium supplement Shelcal 500 and antacid Pan D, as spurious on Friday.
In its latest monthly drug alert, the Central Drugs Standard Control Organisation (CDSCO) also listed 49 drugs and formulations, manufactured by 40 pharmaceutical companies, as Not of Standard Quality (NSQ). NSQ drugs are those that fail to meet the quality standards set by national and international authorities.
These 49 drugs were found to be of substandard quality out of the 3,000 drugs that were recalled batch-wise by the CDSCO.
The other two medicines flagged as spurious are Urimax-D, used to treat men with an enlarged prostate, and Deca-Durabolin 25 injection, prescribed for osteoporosis.
The CDSCO said,"The actual manufacturer (as per label claim) has informed that the impugned batch of the product has not been manufactured by them and that it is a spurious drug. The product is purported to be spurious; however, the same is subject to the outcome of investigation."
According to the Drugs Controller General of India (DCGI), Dr. Rajeev Singh Raghuvanshi, “Vigilant action and monitoring of drugs by CDSCO drastically bring down the percentage of less efficacious drugs. Out of nearly 3,000 samples tested, 49 drugs were recalled as they were found to be less efficacious (NSQ). Only around 1.5% of the total drugs sampled were found to be less efficacious.”
Among the 49 drugs identified as NSQ were popular medicines like Nimesulide and Paracetamol tablets by Innova Captab Limited, Pantoprazole Gastro-resistant tablets by Alkem Health, Cefpodoxime tablets by Aristo Pharmaceuticals Pvt. Ltd., Amoxicillin and Potassium Clavulanate tablets by Alkem Health, and Ciprofloxacin tablets by Cadila Pharmaceuticals Limited.
These medicines are commonly used to treat osteoarthritis, heartburn, and bacterial infections.
Last month, the CDSCO flagged over 50 drugs that failed quality tests. These included medicines for diabetes, hypertension, vitamins, calcium D3 supplements, bacterial infections, and acid reflux.
As part of continuous regulatory surveillance, drug samples are collected from sales and distribution points, analyzed, and the list of Not of Standard Quality (NSQ) drugs is displayed on the CDSCO portal on a monthly basis.
The purpose of displaying the NSQ list is to inform stakeholders about the substandard batches identified in the market.
