The popular painkiller Combiflam is being withdrawn in batches in India after the country’s drugs regulator found the lots were substandard, said the local unit of French drugmaker Sanofi.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 (CDSCO) 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.
Combiflam is a combination of paracetamol and ibuprofen, and is one of Sanofi’s five biggest brands in India, according to the company’s latest available annual report dated March 2015.
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, according to the notices.
“In the case of Combiflam, though the disintegration time was delayed, doctors and patients can be assured that there is no impact on the safety and efficacy of the product,” a Sanofi spokeswoman said in an email.