NPPA relaxes the requirement of linking price approval of new drugs to Integrated Pharmaceutical Database Management System
In a recent Office Memorandum dated December 19, 2017 the National Pharmaceutical Pricing Authority (“NPPA”) has announced that price approval of new drugs will not be linked to Integrated Pharmaceutical Database Management System (“IPDMS”). This announcement comes as a significant relief to pharmaceutical companies whose Form I applications for price fixation of new drug under Para 2(u) of DPCO, 2013 had been pending due to non-compliance to IPDMS or because of launch of new drug without prior approval (“WPA”).
Applications from non-IPDMS compliant pharmaceutical companies were kept pending in accordance with the decision of the government in its meeting held in February 2017, wherein it was specifically stipulated that applications for price fixation of new drugs would not be attended to, in case of failure of completion of IPDMS information.
Subsequently, in a letter dated November 23, 2017, the Department of Pharmaceuticals (“DoP”) had directed the NPPA that the issue of IPDMS or WPA is not to be considered for deciding the price approval of new drugs. Accordingly, the NPPA decided that price approval of new drugs shall need not be linked to IPDMS and any other conditions. However, the NPPA maintained that linking of new drugs approval with IPDMS was beneficial in speeding up the process of data submission and data bank updation.
The NPPA has clarified that the remaining applications of new drugs which are being examined, will be cleared within the time prescribed under DPCO 2013, provided that all the information as per NPPA’s office memorandum F.No. 19(78)/2014/Div.II/NPPA dated 07.02.2017 are complete.