200 new FDC applications sent back by NPPA

The National Pharmaceutical Pricing Authority (NPPA) has joined hands with the Health Minsitry to check irrational Fixed dose combinations (FDCs). The pricing body while reviewing all new FDC applications for price fixation will also examine their safety and efficacy.

According to the Economic Times third party drug makers and pharma companies outsourcing to them are also going to be scrutinized by the pricing authority to control spurious drugs and irrational FDCs. Fixed Dose Composition drugs are drugs that are a mix of two or more therapeutic drugs; 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," said chairman Bhupendra Singh.

"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," he said.