New Delhi: Drug price watchdog National Pharmaceutical Pricing Authority (NPPA) has expressed concerns about drug cocktails, highlighting “over-medication” as a potential hazard while also flagging the prospect of “profiteering” by pharma companies.
The observations of the NPPA came during a meeting on 26 October — whose minutes are available on its website — as it took up applications to fix the prices of 34 new drugs, most of which were fixed-dose combination (FDC) medicines or drug cocktails.
According to the minutes, the NPPA “apprehended that fixation of retail price of these FDCs may lead to a higher price being fixed than the sum of the price of their individual components resulting in profiteering by the companies”.
It also “expressed concern that approval of these FDCs may compromise the rationale in the usage of the drugs and may lead to over-medication”. The authority subsequently said the trend must be highlighted before the country’s apex health research agency, the Indian Council of Medical Research (ICMR).
FDCs are medicines that combine more than one drug in a single pill. The idea is to ease compliance for those required to take multiple medicines as part of long-term treatment, or when the combination is proved to have a clear benefit over single-compound drugs.
They have been under the scanner because a lax regulatory framework allowed several unscientific combinations to flood the market, and there are also fears that they may increase drug resistance.
Since 2016, the Modi government has approved over 2,100 FDCs out of 6,600 reviewed for efficacy. Many FDCs have also been banned over the years amid questions about their efficacy.
What does NPPA say?
The meeting held earlier this week was chaired by NPPA chairperson Shubhra Singh. It was also attended by A.K. Pradhan, deputy drug controller (DDC) from the office of the Central Drugs Standard Control Organisation (CDSCO), which approves new drugs, including FDCs.
According to the minutes of the meeting, “the authority noted that the retail price applications of new drugs mainly consist of Fixed-Dose Combinations (FDCs) of two or more drugs”.
“Guidelines in the usage of these FDCs need to be looked into,” it said. The matter, it added, must be highlighted before the ICMR so it can look into the trend.