The Central Drugs Standard Control Organization (CDSCO), India's drug regulator, has once again found the over the counter popular painkiller drugs Combiflam and cold medicine D Cold Total to be substandard as they have failed the disintegration test, last month. In all, 60 medicines have failed different quality tests last month, leading to a drug alert being issued by the drug regulator.
Drug was found to be substandard thrice
According to a media report, the drug had failed the disintegration test last year after CDSCO found it to be substandard thrice -- in February, April and June. The drug is being manufactured by Sanofi India. One of the Combiflam batch number A151195 manufactured in the month of October, failed to CDSCO test in 2015.
Tablets show delay in the disintegration time
“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. Once we receive the official notice, we will ascertain the finding and take appropriate action," report said, quoting Sanofi India spokesperson. Combiflam's annual sales stands at Rs 169 crore. Besides, CDSCO also found Cipla’s Theo Asthalin tablets and Oflox-100 DT and Cadila’s Cadilose solution to be substandard drugs. Annual sales of Theo Asthalin drug in India stands at is Rs 17.3 crore, and that of Oflox at Rs 20.7 crore. In case of Cadilose, the drug's annual sales is of Rs 5.8 crore.