Sanofi withdraws 4 batches of painkiller Combiflam in India after it fails drug test

Drug major Sanofi is recalling four batches of its painkiller Combiflam in India after the country’s drugs regulator found the lots sub-standard. The company has taken the step after the Central Drugs Standard Control Organisation (CDSCO) found out that the batches of Combiflam were “not of standard quality” as they failed disintegretion tests. When contacted, a Sanofi India spokesperson said.

“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, the spokesperson added.

“However, as the drug regulator have categorised the said batches as sub-standard or not of ‘standard’ quality, we have recalled the affected batches and already implemented suitable measures to address this concern,” the spokesperson said.

This qualifies as a Class III recall wherein consumption of the product is not likely to cause adverse health consequences, the company further said in a regulatory filing.

“We have acted immediately and completed the recall for two batches, while the recall of the remaining two batches is ongoing,” it added.

The company has analysed the issue and appropriate remedial steps have been taken to ensure that the tablets disintegrate within the specified timelines, it said. Consequently, the company does not expect the recall to affect the Combiflam sales, the company said.

According to the company’s latest annual report, Combiflam, which is a combination of paracetamol and ibuprofen, is one of Sanofi’s five largest brands in India. Shares of Sanofi India today ended at Rs 4,330 a piece on the BSE, up 0.27 per cent from previous close.