The Central Drugs Standard Control Organization (CDSCO), in its latest drug alert, pulled up five batches of medicines of three government-run pharmaceutical companies for failing quality control tests.
The Indian regulator has flagged Bengal Chemicals and Pharmaceuticals Ltd (BCPL), Orissa Drugs and Chemicals Ltd (ODCL) and Hindustan Antibiotics Ltd (HAL) for some of their batches failing to meet quality control norms.
The regulator flagged two batches of BCPL’s paracetamol tablets, which were manufactured at its Kanpur facility, as well as a batch of ODCL’s de-worming medicine albendazole, for failing to meet dissolution test.
The regulator also flagged HAL’s ciprofloxacin tablets for failing to meet dissolution test. The regulator also pulled up the company’s compound sodium lactate solution for injection, used to replace fluids and electrolytes in patients with low blood volume or low blood pressure, for failing to meet sterility test as well as for not meeting description criteria, as per the drug alert for October.
Dissolution test measures the rate at which the medicine releases its active pharmaceutical ingredients to treat the body.
According to a report by The Indian Express, BCPL and HAL have disputed the claim that the samples were sub-standard, with BCPL also planning to challenge CDSCO’s findings.
BCPL has said that re-tests of the samples showed that they passed the quality tests. However, the company has withdrawn a batch of around 1.94 lakh tablets of paracetamol, the report said.
The drug alert has also flagged a batch each of GlaxoSmithKline Pharmaceuticals’ Betnovate-C and Betnovate-N skin creams as being substandard.
However, a spokesperson for the company said that the batches were counterfeit, and even the regulator acknowledged that.
CDSCO has also pulled up a batch of Lupin Limited’s Lupizole antacid as being substandard. Lupizole, which has the generic name lansoprazole, is a proton pump inhibitor that is used to treat acidity.
Lupin’s reply to emailed queries sent by Mint is awaited.