Central Drugs Standard Control Organisation (CDSCO) has directed its officials keep a strong vigil on the movement of Combiflam after batches of the drug was found substandard, according to Indian express report. The test was conducted on March 10. CDSCO has written a letter to its zonal, sub-zonal offices and state licensing authorities under the west zone- Chhattisgarh, Goa, Daman & Diu, Gujarat, Madhya Pradesh and Maharashtra in this regard. You are hereby requested to instruct your inspectorate staff under your jurisdiction to keep strong vigil on the movement of subject drug in your state, Deputy Drugs Controller (India), West Zone, CDSCO, K Bangarurajan said in the letter. If any movement of such drug is reported, necessary action may kindly be taken in the matter, and required information may be forwarded directly to this office at the earliest, he said.
It has been learned that it is not clear what necessary action has to be taken if any movement of this drug is observed, a senior official rom Goa’s state licensing authority was quoted as saying by IE. It has been learned that Combiflam batch number A151195 had failed CDSCO’s disintegration test on March 10. It was manufactured in October 2015. Notably, the test generally checks whether the time taken by the tablet to completely disintegrate in the blood stream is within the prescribed limit or not.
CDSCO has issued warning for 60 medicines, including Combiflam, which failed different quality tests in March. At present, India does not have any regulations in the legal framework that allow recall of substandard batches. According to report, Combiflam has an annual sales Rs 169.2 crore and possesses 50 per cent market share. It has been in India for more than 25 years, the report says.
The spokesperson of Sanofi India, which manufactures and sells Combiflam, told The Indian Express: “We have already addressed the issue of disintegration. We are working closely with CDSCO and have taken necessary action as required. Furthermore, we have not received any information or notification from CDSCO, as reported by you.” The company did not clarify whether the affected batches of Combiflam were withdrawn after the March 10 test results.
Last year drug major Sanofi had recalled four batches of its painkiller Combiflam in the country after CDSCO found the lots sub-standard, according to PTI report.