The apex board under the Drug Controller General of India has decided to postpone the decision on banning cocktails of multi-vitamin and multi-mineral medicines, News18.com has learnt.
The members of the apex board have decided that the Kokate committee ? the main panel formed for suggesting a ban on cocktail or fixed-dose medicines (FDCs) ? will update the board on the latest developments.
The Drugs Technical Advisory Board (DTAB), which met on September 26 to take the final call on fixed-dose-combination (FDC) medicines, has agreed to ban the selected 14 FDCs, including several codeine-based cough syrups such as Tossex, Ascoril C and Phensydyl T.
However, the board postponed the decision on the evaluation of the report on fixed-dose combinations related to vitamins and minerals-based formulations which were considered irrational by the professor Kokate committee and where the show-cause notices were issued to the manufacturers for submitting replies to prove rationality.
According to the minutes of the meeting of DTAB, accessed by News18.com, it was apprised that “Prof Kokate Committee has submitted its report to the government from time to time and the last such report was submitted related to vitamins, minerals and micronutrient formulations along with other remaining FDCs”.
“The board (DTAB) deliberated on the report of the committee and opined that the Prof Kokate Committee may be requested to apprise the board about the report for further course of action.”
What are FDCs?
Fixed drug combinations (FDC) or cocktail medicines combine more than one drug in a single pill. The government wants to eliminate irrational drug combinations from the Indian retail market as they lead to over-medication.
Cocktail drugs have been under the scanner because a lax regulatory framework allowed several unscientific combinations to flood the market, and there are also fears that this may increase drug resistance in people.
What is the Kokate Committee?
In 2014, the Ministry of Health and Family Welfare formed a committee under the Chairmanship of Professor CK Kokate, former vice-chancellor, KLE University, Karnataka, for examining the safety and efficacy of FDCs. The report submitted by this committee forms the basis for cleaning the irrational cocktail drugs from the Indian market.
Based on the committee’s decision, the government started a drive in 2016 to filter out many of these FDCs from the Indian pharmaceutical industry by banning around 350 of them, impacting over 2,700 branded drugs.
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