Popular drugs, including Phensedyl, Corex, Saridon and Vicks Action 500, would not have even come under the banned list, if the government had accepted in full the recommendations of the Kokate committee, set up to look into the matter.
According to the Kokate Committee, which submitted the fixed-dose combination (FDC) drugs list to the health ministry in January, “the committee did not discuss the FDCs, which were already approved by DCGI and those licensed pre 21.9.1988.”
The committee has reviewed about 6,600 FDCs so far.
FDCs combine two or more drugs in a single pill. When multiple drugs from the same therapeutic group are clubbed together, it may lead to resistance, according to experts.
The committee also recommends corrections if any such FDCs has been included in the list. “In case the committee made any comment with respect to above inadvertently, it shall be treated as not-discussed.”
Several products, including popular cough syrups Phensedyl and Corex, which have been banned, were approved by the Drug Controller General of India (DCGI). Others such as Saridon and Vicks Action 500 are licensed prior to 21.9.1988.
The Kokate Committee report, a copy of which is available with HT, has been signed by a seven-member team, including chairpersonv CK Kokate.
“Our mandate was to screen FDCs and submit to the government. These were all recommendations. The final call was in DCGI’s hand considering patient safety,” CK Kokate told HT.
“Whatever combination we have included in the banned list is directly related to patient’s safety. Moreover, we have tried to give a free hand to the committee so that they can work efficiently and suggest us about several things,” said DCGI GN Singh.
“Anything which was earlier approved by DCGI and has now become obsolete according to the latest findings can be pruned off. But there are very few cases in the banned list, which were either approved by the DCGI or licensed before 1988,” said KL Sharma, joint secretary, health ministry.
Companies, including Abbott, maker of cough syrup Phensedyl, Pfizer, Macleods, P&G and Piramal did not respond to HT’s requests for comments, saying the matter is sub-judice.
According to government estimates, the ban on 350 FDCs , which impacts over 2,700 branded drugs, will lead to a loss of about `7,000 crore for the industry. The domestic pharma industry currently has a market size of `1 lakh crore.