CDSCO issues alert against 62 substandard drugs; Samples from Lupin, Jackson Laboratories flagged

CDSCO issues alert against 62 substandard drugs; Samples from Lupin, Jackson Laboratories flagged

The Central Drugs Standard Control Organisation (CDSCO) has flagged 62 drug samples as they failed the quality test. The alert was issued by the drug regulator for November 2023.

The drug regulator’s list, as seen by Financial Express.com, reveals that 1197 drug samples were tested, out of which 1133 samples were of standard quality. 62 samples were not of standard quality, one sample was spurious and one sample was misbranded.

According to the drug regulator, dissolution, disintegration and assay are some of the reason of drug test failure. Lupin, Jackson Laboratories, E.G. Pharmaceuticals, Konis Pharmaceuticals, Biozenta Lifesciences Pvt., Aristo Pharmaceuticals, and Cotec Healthcare are some of the companies whose drug failed the quality test.

The regulator also issued a revised drug Alert for May 2022 which Omeprazole (Delayed-Release) and Domperidone (Sustained Release) Capsules, manufactured by Dr. Reddy’s Laboratories. CDSCO maintains that the assay of Omeprazole and Domperidone is the reason of failure.

“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. Thus, the product is purported to be spurious, however, the same is subject to outcome of investigation,” it stated.

The drug combination belongs to a group of medicines called gastrointestinal agents used to treat heartburn, indigestion, epigastric pain, gastro-oesophageal reflux disease (GERD), peptic ulcers and Zollinger-Ellison syndrome.