Tough pill to swallow: Batches of Combiflam withdrawn for being 'sub-standard'

French drugmaker Sanofi on 12 May decided to revoke some batches of its painkiller Combiflam in India after a few batches were found to be "sub-standard" by the drug regulators in the country.

According to the India's Central Drugs Standard Control Organisation (CDSCO), some batches of the medicine had failed the disintegration tests, which means that the medicines were not of standard quality.

"As the drug regulators have categorised the said batches as sub-standard quality, we've recalled affected batches," the spokesperson of Sanofi India said.

The drugmaker company said that they "have already implemented suitable measures to address this concern."

Disintegration tests of medicines are a measure to test the time it takes for tablets and capsules to break down inside the body, and according to the US Food and Drug Administration these tests are used as a quality-assurance measure in pharmaceuticals.

"Some batches of Combiflam tablets were found to have a delayed disintegration time," ANI quoted the Sanofi India spokesperson as saying.

"There is a pharmaceutical parameter that requires the breakdown of a tablet in the human body to be assessed. Though disintegration time was delayed,doctors & patients can be assured that there is no impact on safety of product," the spokesperson said.