- Combiflam contains mixture of paracetamol and ibuprofen as API
- Regulator says some tablets failed disintegration test;i.e. took too long to break down within body
- Sanofi withdrawn tablets with batches carried expiry dates of May and June 2018
The popular over the counter painkiller Combiflam is being withdrawn by Sanofi for some batches in India following drugs regulator found the lots were substandard, said the local unit of French drug manufacturer Sanofi.
Combiflam failed disintegration test and were found to be “not of standard quality” , said the Central Drugs Standard Control Organisation (CDSCO) in notices posted on its website.
What is Disintegration tests ?
This is 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.
Combiflam is one of Sanofi’s blockbuster drug out of five biggest brands in India, according to annual report dated March 2015 published by Sanofi.
CDSCO notice indicates drugs that were manufactured in June 2015 and July 2015, and with expiry dates of May 2018 and June 2018 are of concern.
“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,” a Sanofi spokeswoman said in an email to news agency Reuters.
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Sanofi India’s shares were down 2 percent in early trade on Thursday. Company already taking action to counter the panic in market.