Combiflam, a popular painkiller made by Sanofi, France has been withdrawn in batches after failing integration test. Indian Drugs Regulator has released statements about the drug not being up to the mark. The Central Drugs Standard Control Organisation (CDSCO) has pointed towards its low quality and standard.
Combliflam is composed of Ibuprofen and Paracetamol and is used widely for headaches and muscle pain. It is one of Sanofi’s five most popular brands in the country.
The disintegration test is conducted to determine the time needed for the medicine to dissolve inside the body. It is a standard procedure to analyze the quality of the drug in pharmaceuticals.
The batch of Combiflam that underwent the test had June and July 2015 as manufacturing dates and June and July 2018 as expiry dates as revealed by the CDSCO.
A representative from Sanofi released a statement addressing the issue. She said that although the drug took more time to disintegrate than normal, patients and doctors need not worry about its effect or quality. The drug is safe to use and will affect the same way as it is known to.
On Thursday, Sanofi India experienced a 2 percent fall in their shares.
After the withdrawal of Combiflam batches, the Indian drug regulator body has revealed 102 medicines that have failed tests in the last five months. They have been put under the radar for adulteration and quality issues. Some of these are popular drugs like Macleods Pharmaceutical’s Orcerin, Karnataka Anibiotics & Pharmaceutical Ltd’s Norfloxacin, Cipla’s CIP-ZOX, Ipca Laboratories’ Zerodol-SP.
All these drugs have been put on the alert list by the government, and GN Singh, a member of the DGCI said that the companies do recall the damaged batches but they do it carefully and discreetly so it does not hurt their brand image.
Ipca Laboratories’ Zerodol-SP medicine used to treat fever has failed the ‘Identification and Assay’ test, which puts its efficiency under question. Macleods Pharmaceutical’s Orcerin used to cure joint diseases has failed ‘related substance’ test that indicates the presence of impurities in the drug.
Sanofi’s withdrawal of the flawed Combiflam batch on Thursday has helped draw attention towards the quality issue of medicines in India.