New Delhi: Sanofi has withdrawn some batches of its popular painkiller Combiflam after the Drugs Controller General of India (DCGI) found the drug to be of sub-standard quality.
According to a DCGI alert, the sub-standard quality Combiflam delayed disintegration time of the molecule in the blood stream.
The drug batches that were tested by the DCGI were manufactured in June 2015 and July 2016 and are due for expiry in May 2018 and June 2018. The tests were carried out in the months of February and April in Kolkata and Chandigarh respectively.
“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 a Sanofi spokesperson.
Combiflam, a combination of ibuprofen and paracetamol, is one of Sanofi’s leading brands with annual sales of Rs 162.7 core.
Another drug that has been detected with the same problem is Macleod Pharma’s Orcerin. Also being a top brand, it has annual sales up to Rs 4.6 crore.
