Sanofi recalls batches of Combiflam after regulator alert

DCGI had issued an alert twice, saying drug was sub-standard, as its disintegration in the blood stream was delayed

As the Drugs Controller General of India (DCGI) found Sanofi’s popular painkiller drug, Combiflam, to be of sub-standard quality twice in the past three months, the company has recalled the affected batches.

DCGI had issued an alert in February and in April. It said the drug was not of standard quality, with delayed disintegration time of the molecule in the blood stream.

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.

“Some batches of 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. 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,” said a Sanofi spokesperson.

According to IMS Health, a global information and technology services company, Combiflam had annual sales (April 2015 to April 2016) of Rs 162.7 crore. It is the leading brand of its molecule (ibuprofen+paracetamol). Cipla’s Ibugesic Plus is the second brand in this category, with annual sale of Rs 62.2 crore.

The other drug which DCGI found in April to be of substandard quality was Macleod Pharma’s Orcerin. The molecule’s name is Diacerin and is used to treat joint pain and arthritis. The regulator found ‘related substances’ in the tablets it tested. Macleod Pharma did not respond to e-mailed queries from this newspaper.

IMS Health says Orcerin had annual sale of Rs 4.6 crore. It is the top brand in this molecule. Glenmark’s Dycerin is the second one, with annual sale of Rs 3.6 crore.
NOT UP TO THE MARK

• Drug regulator issued alerts for Combiflam twice – in Febraury and in April
   
• The disintegration test — which measures the time it takes for the tablet to completely disintegrate in the blood stream did not give satisfactory results
   
• Sanofi says there is no impact on the safety and efficacy of the product
   
• Combiflam had annual sales of Rs 162.7 crore and is a leading brand for its molecule
  

 

Another major drug found to be of substandard quality in April was Macleod Pharma’s Orcerin