New Delhi: After an order form the central drug regulator, namely, Central Drugs Standard Control Organisation- CDSCO as requiring the withdrawal of the 4 batches of popular painkiller- Combiflam from market, the Drug Major- Sanofi is set to recall the said 4 batches. The Drug regulator found such four batches as of lots sub- standard.
As such, it is notable here that the Central Drugs Standard Control Organisation earlier found the said four batches of the drug were “not of standard quality” as they failed disintegration tests. And on the said results by the drug regulator, the company is required to take its batches back and withdraw the same from the market too.
While commenting on the same, the company- Sanofi India’s spokesperson told the media agencies that “some batches of the 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.”
Moreover, the said spokesperson also found stated that, in this case of the Combiflam, though the disintegration time was delayed, but still the doctors and patients can be assured that there is no impact on the safe and efficacy of the product.
Besides such clarification, the company’s spokesperson also told that as the drug regulator in the country when declared the batches of the drug as of sub- standard or not of ‘standard quality’, the company has decided to recall the affected batches “and already implemented suitable measures for addressing this concern”.
Moreover, notably, the present recall of the drug is qualified to be a Class III recall, which means, though the drug is recalled from market, but its consumption is not having any adverse effect on health of the consumers, and this is confirmed by the company.
Also, company assured that as “we have acted immediately” there are two batches of the drug which have been recalled completely, “while the recall of the remaining two batches is ongoing.” The said brand, Combiflam which is a combination of paracetamol and ibuprofen is one of the largest brands of the company in India.
