Calcium and 48 other tablets fail to meet CDSCO’s quality standards

In its September report, the Central Drugs Standard Control Organisation (CDSCO) identified 49 drugs that failed quality tests, including commonly prescribed antibiotics, supplements, and pain relievers. The commonly used calcium supplement Shelcal 500 and antacid Pan D are among the four drugs flagged as spurious by the CDSCO.

The Central Drugs Standard Control Organisation (CDSCO), in its September quality control report has identified 49 pharmaceutical products that failed to meet quality standards out of nearly 3,000 samples tested, reflecting a failure rate of about 1.5%. This monthly evaluation, part of CDSCO’s routine surveillance, seeks to ensure the safety and efficacy of medicines on the Indian market.

The drugs flagged as Not of Standard Quality (NSQ) included popular medications like Metronidazole tablets from Hindustan Antibiotics, Domperidone tablets by Rainbow Life Sciences, and Oxytocin injections by Pushkar Pharma. Other substandard products identified were Metformin tablets from Swiss Biotech Parentarels, Calcium with Vitamin D3 tablets from Life Max Cancer Laboratories, PAN 40 by Alkem Labs, and Paracetamol tablets from Karnataka Antibiotics & Pharmaceuticals Ltd., raising concerns about commonly used medicines.

Additionally, the CDSCO labeled four drugs as “spurious” or counterfeit, including Shelcal 500 (a calcium supplement), Pan D (an antacid), Urimax-D (for enlarged prostate treatment), and Deca-Durabolin 25 (for osteoporosis). These drugs were marked as counterfeit as the listed manufacturers confirmed they had not produced them.

However, the failure of a drug sample of any specific batch to meet the quality standards does not mean that all drugs being sold by that name are sub-standard. ‘Only that specific batch is considered not of standard quality’, according to an official source.

The CDSCO Chief, Dr. Rajeev Singh Raghuvanshi noted that while only a small percentage of drugs failed, the findings demonstrate the need for continual regulatory oversight. He said, “Vigilant action and monitoring of drugs by CDSCO drastically bring down the percentage of less efficacious drugs.”

CDSCO performs monthly drug sampling to evaluate quality standards and releases NSQ reports publicly. By recalling substandard drugs batch-by-batch, it strives to minimize harmful products and improve safety & transparency in India’s pharmaceutical sector.