New Delhi: Drug price watchdog National Pharmaceutical Pricing Authority (NPPA) has decided to raise concerns on drug cocktails before the Ministry of Health and Family Welfare, two months after it called for flagging the issue to the Indian Council of Medical Research (ICMR).
Highlighting “over-medication” as a potential hazard while also noting the prospect of “profiteering” by pharma companies, NPPA had in October said that it received several applications to fix the prices of new drugs — which were fixed-dose combination (FDC) medicines or drug cocktails.
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.
In its latest meeting on 23 December, the authority again noted that most of the retail price applications of new drugs mainly consist of FDCs of two or more drugs.
“In this context, it was observed by the authority that rationality of their use is important as information asymmetry exists in this area leading to concerns of consumer affordability and over medication,” it said, adding that “this is not desirable in the overall public interest and welfare”.
According to the minutes of the meeting uploaded this week, it was noted by the authority that “a number of public grievances are on the irrational pack size wherein a consumer is forced to buy more than his/her need”.
“Thus, looking at the pervasive nature of the issue that may also impact the public health system, it was agreed that these issues may be raised with the Ministry of Health and Family Welfare, Government of India,” the minutes said.
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‘Trend must be highlighted’
In October, the NPPA had “expressed concern that approval of these FDCs may compromise the rationale in the usage of the drugs and may lead to over-medication”.
It subsequently said the trend must be highlighted before the country’s apex health research agency, the ICMR.
The NPPA had “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”.
FDCs under scanner
FDCs 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.
Since 2016, the Narendra 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.
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