The medicines in question failed the disintegration criteria, according to drug safety alerts posted on the website of Central Drugs and Standards Control Authority (CDSCO).
Global healthcare leader Sanofi is recalling four batches of its popular painkiller Combiflam in India after the country’s drugs regulator found the lots were of poor quality.
Sanofi India decided to to recall some batches of Combiflam tablets after the Central Drugs Standard Control Organisation (CDSCO) discovered that some batches of Combiflam tablets had delayed disintegration time which means time taken for breakdown of a tablet in the human body was unnecessarily high.
However, Sanofi assured doctors and patients that there is no impact on the safety and efficacy of the product and consumption of the product is not likely to cause adverse health consequences.
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.
Combiflam is a combination of paracetamol and ibuprofen, and is one of Sanofi’s five biggest brands in India, according to the company’s latest available annual report dated March 2015.
The drug batches cited by the CDSCO were manufactured in June 2015 and July 2015, and carried expiry dates of May 2018 and June 2018, according to the notices.
“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. Sanofi India’s shares were down 2 percent in early trade on Thursday.