The Union government on Friday banned 14 fixed-dose combination (FDC) medicines after they were found to lack therapeutic relevance.
Fixed-dose combinations (FDCs) are medicines that combine more than one drug in a single pill, and are also referred to as “cocktail” medicines.
According to the notification, the Expert Committee recommended that “there is no therapeutic justification for this FDC and the FDC may involve risk to human beings”.
The notification also said that “in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution” of these FDCs.
The long-pending move has been taken on the basis of the recommendations of the Expert Committee and the Drugs Technical Advisory Board.
“…the central government is satisfied that it is necessary and expedient in the public interest to regulate by way of prohibition the manufacture for sale, sale and distribution for human use of the said drug in the country,” notification said.
On April 20, News18 reported that the health regulatory agency has been asked to filter out cocktail drugs from the Indian market and a ban is likely to be announced soon.
The idea behind these medicines is to ease compliance for those required to take multiple medicines as part of long-term treatment or when the combination is proven to have a clear benefit over single-compound drugs.
But these drugs have been under the scanner because a lax regulatory framework allowed several unscientific combinations to flood the market. There are also fears that this may increase drug resistance in people.
In 2016, the ministry started a drive to filter out irrational drug combinations from the Indian pharmaceutical industry by banning around 350 FDCs, which impacted over 2,700 branded drugs. Apart from banning cocktail medicines, the DCGI may also focus on banning codeine-based medicines in a phased manner.