The Drug Controller General of India (DGCI) has asked the same panel that was constituted in 2014 to probe 6,600 fixed-dose combinations (FDCs) of which 350 have been banned last week, to further probe into 1,200 fixed-dose combiinations in the country for safety reasons.
According to a report in Hindustan Times, the DGCI has submitted the “B” list to the Kokate committee and 120 drugs in the list were of banned drugs altogether. “As per estimate, each FDC has at least 5 to 10 brands in the market, which means around 1,200 more drugs are likely to be banned,” the official at CDSCO told HT.
FDC drugs contain two or more active pharmaceutical ingredients in fixed proportions in a single pill and also contain codeine which poses severe damage to brain. The Kokate Committee has so far classified the 6,600 drugs into four categories — irrational, require further deliberations, rational and require additional data generation.
"Under the irrational category, there were 963 FDCs, out of which 350 have been announced, and the list has been dismantled. We have moved to the ‘require further deliberations’ category, where the final list is expected to come in six months,” said an official at the Central Drugs Standard Control Organisation (CDSCO), according to the Hindustan Times report.
“We are not against any product or brand. We are only siphoning off the irrational combinations,” said C.K. Kokate, chairman of the panel.