The local unit of French drug maker Sanofi on Thursday decided to withdraw the painkiller Combiflam in batches from India after the country's drugs regulator found the lot was substandard.
"Some batches of Combiflam tablets were found to have a delayed disintegration time. There is a pharmaceutical parameter that requires the breakdown of a tablet in the human body to be assessed. 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," said Sanofi India spokesperson in a statement.
The statement further stated that as the drug regulators have categorized the said batches as sub-standard quality, they had recalled the affected batches, adding that they had already implemented suitable measures to address the concerns.
The Central Drugs Standard Control Organisation (CDSCO) said that some batches of the medicine had failed the disintegration tests and hence were not of the standard quality.
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, according to the U.S. Food and Drug Administration.
Combiflam, a combination of paracetamol and ibuprofen, is one of Sanofi's five biggest brands in India, according to the company's latest available annual report dated March 2015.
According to the CDSCO, the concerned drug batches were manufactured in June 2015 and July 2015, and carried the expiry dates of May 2018 and June 2018.