NPPA sends back over 200 FDC Applications

By: Rakesh Saini

India’s drug pricing watchdog National Pharmaceutical Pricing Authority (NPPA) has moved in to back the health ministry in its efforts to check “irrational” fixed dose combinations (FDCs) it will review afresh all new applications for price fixations of FDC and examine their safety and efficacy.NPPA has also brought under the lens third-party drug makers and pharma companies that outsource to them to check irrational FDCs and spurious drugs. FDCs are cocktail drugs that contain two or more therapeutic ingredients in one dose. Many popular cough syrups, painkillers and antibiotics are FDC brands. NPPA has sent back more than 200 FDC price fixation applications, instructing manufacturing and marketing companies to apply again with a declaration that their formulations are not “irrational.


All manufacturers/marketing companies (whose cases have been rejected by NPPA so far) are advised to apply afresh… along with documents/information required as per revised check list, stated an NPPA notification dated March 8. We are taking cognizance of the fact that no irrational FDCs should get a price fixed by us and get legitimised in an indirect manner,” said Singh. “NPPA is concerned only with the pricing part (of this issue), and we are not declaring these FDCs rational or irrational .


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