NEW DELHI: Some batches of popular painkiller Combiflam is being withdrawn in India after the country’s drugs regulator found them substandard, said French drugmaker Sanofi.
Some batches of Combiflam were found to be “not of standard quality” as they failed disintegration tests, said the Central Drugs Standard Control Organisation in notices posted on its website.
Disintegration tests are used to test the time it takes for tablets and capsules to break down inside the body, and are used as a quality-assurance measure in pharmaceuticals. “It is a regular quality check exercise by the central laboratories. Some batches of Combiflam were found to be not of standard quality, that’s why the company was alerted to withdraw the batches,” drug Controller General of India Dr G.N. Singh said.
Combiflam is a combination of paracetamol and ibuprofen, and is one of Sanofi’s five biggest brands in India. The drug batches cited by the CDSCO were manufactured in June 2015 and July 2015, and carried expiry dates of May 2018 and June 2018.