Rationalizing Drug Cocktails: NPPA to conduct prescription audit of FDC drugs

The drug price regulator's decision comes amid an increase in applications by pharma companies for fixed-dose combination medicines or drug cocktails that it says could pose a health hazard.

FDCs are medicines that combine more than one drug in a single pill, thereby, easing medication for those who are supposed to take multiple drugs as part of long-term treatment.The drug watchdog has been expressing concern over the increased usage of the FDC drugs for quite some time and has once again noted that most of the retail price applications of new drugs mainly consist of FDCs of two or more drugs. 

In this light, NPPA has been calling for tighter controls on drug cocktails and their rationality by taking up the matter with the Union Health Ministry. The matter had already been highlighted to the Indian Council of Medical Research (ICMR) a couple of months ago., and NPPA had flagged the prospect of "profiteering" by pharma companies on approving Fixed Dose Combinations (FDCs) of two or more drugs that may also lead to "over-medication" as a potential hazard. "There seems to be a problem of irrational pack size wherein a consumer is forced to buy more than his/her need," it had noted.

Also Read: NPPA Calls For Tighter Control On FDC Drugs

Since October 2020, NPPA has been deliberating the trend of combined drugs which as per the Authority is not desirable in the public interest. In its latest meeting in January this year, NPPA decided to undertake a 'prescription audit'.

During the meeting, the members viewed that a 'prescription audit' might throw light on the prescription patterns of several drugs and their usage. The members also opined that the NPPA should undertake the audit as it could help in future decision-making. It noted;

"The Authority noted that most of the retail price applications of new drugs mainly consist of Fixed Dose Combinations (FDCs) of two or more drugs. It was discussed and felt that undertaking a 'prescription audit' may throw light on the prescription patterns of various drugs & their usage. The Authority was of the view that NPPA may undertake a 'prescription audit' as the findings can be of help for decision making."