The Central Drugs Standard Control Organization, which regulates the sale and distribution drugs in India, has reportedly found popular medication like Combiflam, a pain reliever, and D Cold Total, a cold medicine, to be substandard.
Comiflam is manufactured by Sanofi India while D Cold Total is made by Reckitt Benckiser Healthcare India.
The Indian Express reported that the CDSCO conducted tests last month and, in addition to the two drugs mentioned above, found Cipla’s Oflox-100 DT tablets and Theo Asthalin tablets, and Cadila’s Cadilose solution to be substandard.
Oflox-100 DT is an anti-biotic while Theo Asthalin is used for respiratory problems. Cadilose is usually prescribed for constipation.
Along with these drugs, the CDSCO issued an alert for 55 other drugs, all of which failed different tests in March 2017, the Express reported.
ACTION PLAN BY SANOFI
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.”
The Express pointed out that Sanofi had previously recalled three batches of Combiflam last year after they were found to be substandard.
Cadila Pharmaceuticals was the other company to respond to the report, telling Indian Express, it had not “received any communication on this development, hence it is not possible for us to comment on the same.”