India’s apex drug regulator has flagged 37 batches of medicines for failing quality tests in November, including MacLeod Pharmaceuticals’ tuberculosis-treating drug Coxerin, anti-hypertension medication amlodipine, multiple batches of de-worming drug albendazole and various antacids.
In its drug safety alert for November, the Central Drugs Standard Control Organization (CDSCO) tested 1,158 samples and declared 37 samples as being ‘not of standard quality’.
A batch of MacLeod Pharmaceuticals’ Coxerin, which are cycloserine capsules, failed to meet the standards set for ‘condensation products and assay’ tests, which are used to measure the availability of the drugs as well as the body’s biological response to a drug.
A batch of Intas Pharmaceuticals’ acid-reflux combination capsule containing rabeprazole sodium and domperidon failed to meet the criteria set for dissolution test, which measures the rate at which a medicine dissolves in the body and determines how much of it will be available for patients.
One batch each of Karnataka Antibiotics & Pharmaceuticals Ltd (KAPL), Albro Pharmaceuticals and Elfin Drugs’ albendazole also failed dissolution tests.
A batch of Bengal Chemicals & Pharmaceuticals’ (BCPL) amlodipine has also failed the assay test, while one batch of its antibiotic metronidazole also couldn’t pass the dissolution test.
The Indian Express reported the development in its Tuesday edition. As per the report, a BCPL spokesperson said that the company started re-testing batches from its control samples, and the report will be ready within 4-5 days. The company is also waiting for the CDSCO’s report following which it will take necessary action, The Indian Express report said.