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.

The list includes common drugs like Cefixime, Azithromycin and Lactic Acid Bacillus Tablets, paracetamol tablets, Albendazole Tablets, Methylcobalamin injection, Ceftriaxone injection, Methotrexate injection among other.

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.

Related Posts

  • Pharma
  • July 24, 2025
  • 241 views
Natco Pharma shares dip over 2% after Rs 2,000-crore stake buy in South Africa’s Adcock Ingram

Natco Pharma shares slipped 2.5% to Rs 1,009 apiece on the BSE in Thursday’s trade after the company announced its plan to acquire a 35.75% stake in South Africa-based Adcock…

  • Pharma
  • July 22, 2025
  • 310 views
DGFT Extends Deadline on Application for Export of Pharma Grade Sugar

The Directorate General of Foreign Trade ( DGFT ) has notified an extension in the deadline for submitting applications for the export of Pharma Grade Sugar. This was communicated through Trade Notice…

Leave a Reply

Your email address will not be published. Required fields are marked *

You Missed

Natco Pharma shares dip over 2% after Rs 2,000-crore stake buy in South Africa’s Adcock Ingram

Natco Pharma shares dip over 2% after Rs 2,000-crore stake buy in South Africa’s Adcock Ingram

10, 000 Km is just a Number for Intercontinental Tele Surgery by SSIMantra

10, 000 Km is just a Number for Intercontinental Tele Surgery by SSIMantra

DGFT Extends Deadline on Application for Export of Pharma Grade Sugar

DGFT Extends Deadline on Application for Export of Pharma Grade Sugar

Bihar Healthcare is poised to be embraced by Robotic Surgery Mantra

Bihar Healthcare is poised to be embraced by Robotic Surgery Mantra