The Central Drugs Standard Control Organization (CDSCO) has issued a drug alert for 60 medicines, including the popular painkiller Combiflam and cold medicine D Cold Total.
These drugs are manufactured and sold by Sanofi India and Reckitt Benckiser Healthcare India and they failed different quality tests in March 2017.
Combiflam which is a combination of ibuprofen and paracetamol, is one of Sanofi’s leading brands with annual sales of Rs 169.2 core.The CDSCO has found it to be substandard three times.
CDSCO has found Cipla’s Oflox-100 DT an anti-biotic tablets, Theo Asthalin tablets which is used for respiratory problems, and Cadila’s Cadilose solution usually prescribed for constipation are also substandard.
Sanofi has said it will take “appropriate action” once it receives official notice from the drug regulator.
A company spokesperson told the Indian Express, “Certain batches of Combiflam manufactured in 2015 were deemed substandard because the tablets showed a delay in the disintegration time. Essentially, there are several pharmaceutical parameters that are routinely assessed, one of which is to check the breakdown of a tablet in the human body. The batch identified by the CDSCO in March 2017 was also manufactured in 2015.”