Central Drug Regulatory Authority finds samples of Shelcal 500, Pan D spurious

New Delhi: The Central Drug Regulatory Authority has found samples of four drugs, including widely used calcium supplement Shelcal 500 and Pan D, as spurious, while samples of 49 drugs were listed as not of standard quality.

The samples of 49 drugs include paracetamol, Pan D, calcium and vitamin D3 supplements, Oxytocin, Metronidazole and fluconazole as "Not of Standard Quality" in its monthly drug alert report for September.

Some of the batches of drugs which have been listed as not of standard quality are by companies like Alkem Health Science, Aristo Pharmaceuticals, Camila Pharmaceuticals, Innova Captain, Hindustan Antibiotics and Ipca Laboratories.

Drug Controller General of India (DCGI) Rajeev Singh Raghuvanshi said the inspections are carried out periodically to bring down the percentage of less efficacious drugs.

"Vigilant action and monitoring of drugs by CDSCO (Central Drugs Standard Control Organisation) drastically brings down the percentage of less efficacious drugs," he said.

"Out of nearly 3,000 samples tested, 49 drugs were asked to be recalled as they were found less efficacious (NSQ). Only nearly 1.5 per cent of the total drugs sampled found to be less efficacious," Raghuvanshi said.

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, an official source said.

The Central Drug Regulatory Authority in its August report had listed samples of over 50 drugs, including widely used paracetamol, Pan D, calcium and vitamin D3 supplements and anti-diabetes pills as "Not of Standard Quality".