Sanofi is recalling some batches of Combiflam as the Central Drugs Standard Control Organisation (CDSCO) found them to be not of standard quality. The batches manufactured in June 2015 and July 2015, carried expiry dates of May 2018 and June 2018 has failed disintegration tests.
Combiflam is a combination of paracetamol and ibuprofen, and is one of Sanofi's five biggest brands in India. The tablets had delayed disintegration time which means time taken for breakdown of a tablet in the human body was unnecessarily high.
DCGI had issued an alert in February and April. It said the drug was not of standard quality, with delayed disintegration time of the molecule in the blood stream.
Disintegration tests are 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, according to the US Food and Drug Administration.
The company does not expect the recall to affect the Combiflam sales as it is one of its largest brands in India. The tablet is made at Sanofi’s factory in Ankleshwar, Gujarat. DCGI had tested Combiflam in February and April at its regional laboratories in Kolkata and Chandigarh, respectively.
Nearly 102 medicines in the last five months have failed the tests and are under the category of spurious, substandard, adulterate, or misbranded medicines.
Some of the medicines that appear on the monthly alert list issued by the government includes Cipla’s CIP-ZOX, Macleods Pharmaceutical’s Orcerin, Indian Drugs and Pharmaceuticals Ltd’s Pantoprazole, Ipca Laboratories’ Zerodol-SP and Karnataka Anibiotics & Pharmaceutical Ltd’s Norfloxacin.