The National Pharmaceutical Pricing Authority (NPPA) has issued Internal Guidelines for making representation to NPPA against price notifications. The proposed Guidelines will be applicable with prospective effect covering all pending cases at various levels in the office at present.
According to the new Internal Guidelines, all the applicants have to first comply with the price notification. In case of non-compliance, representations will not be entertained at all. Any manufacturer making a claim about a particular PTR/MRP should have necessarily reported the same price in the return submitted by them in Form V of Schedule II to the DPCO 2013, to the NPPA, and the onus of providing documentary evidence in this regard shall lie with the applicants.
The Internal Guidelines further state that only market-based data will be entertained, that is the data should be verifiable with the data base of IMS Health and/or Pharma Trac and Form V submitted by the manufacturers concerned, and no other data will be considered by the NPPA.
According to the Guidelines, no application will be entertained beyond a period of 15 days of the date of publication of the notification in the official Gazette. The case of applicant whose review petition on the same matter is pending with the government would be considered after final order/directions of the government.
The decision to come out with a new Internal Guidelines for making representation to NPPA against price notifications was taken by the NPPPA in its meeting held on 15.9.2014. The new Guidelines have been approved by the NPPA in supersession of Circular dated 24.9.2013 and 9.10.2013 issued vide F No-3/Misc/Adv/2013-NPPA for making representation to NPPA for price correction against price notifications issued under DPCO-2013 in order to bring in consistency, objectivity and transparency.