Drug watchdog again finds Combiflam substandard
The Drugs Controller General of India (DCGI) has again found Sanofi's popular painkiller drug, Combiflam, of 'sub-standard' quality, in its latest test last month. It had found the same defect in the medicine in February and April, too.
"We are working with the regulatory authorities to initiate recall of the batch concerned. Since consumption from this batch is not likely to cause any adverse health consequences, typically, it would qualify as a Class-3 recall," said a Sanofi India spokesperson.
As in the past two occasions, the DCGI said the drug tested in June was not of standard quality, with delayed disintegration time of the molecule in the blood stream. Sanofi had recalled three batches of Combiflam tablets (also a Class-3 one) after they were found substandard for the same reason in February and April.
"A probable reason for the increase in the disintegration time could be inappropriate storage conditions, which is under investigation," added the company spokesperson.
According to DCGI, a Class-3 recall is asked for in a situation where the use of, or exposure to, a defective product is not likely to cause any adverse health consequences.
Also Read: Sanofi Recalls Batches Of Combiflam After Regulator Alert
"These batches have passed other technical parameters... establishing that the labelled amount of drug in Combiflam is available for the required therapeutic action," said the spokesperson.
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. In June, it tested the tablets - manufactured in June 2015 and were going to expire by May 2018 - in Chandigarh only.
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 in this country. It is the leading brand of its molecule (ibuprofen plus paracetamol). Cipla's Ibugesic Plus is the second brand in this category, with annual sale of Rs 62.2 crore.
Sanofi says the consumption of Combiflam from this June batch is not likely to cause any adverse health consequences
In total, the drug regulator has issued alerts for Combiflam thrice – in Febraury, April and June
The disintegration test — which measures the time it takes for the tablet to completely disintegrate in the blood stream did not give satisfactory results
Combiflam had annual sales of Rs 162.7 crore and is a leading brand for its molecule