NPPA clarifies on the definition of ‘manufacturer’ and ‘dealer’ for implementation of ceiling price of coronary stents

NPPA clarifies on the definition of ‘manufacturer’ and ‘dealer’ for implementation of ceiling price of coronary stents

August 8, 2017 Industry Specific 0

Further to the order dated 13th February, 2017 on ceiling price of Coronary Stents issued by the National Pharmaceutical Pricing Authority (“NPPA”) (reported in the trail mail), the NPPA has clarified on the definition of manufacturer and dealer under the Drug Price Control Order, 2013 (“DPCO”) by way of an addendum dated 3rd August, 2017.


The DPCO, in an earlier order dated13th February, 2017 had fixed the ceiling price of coronary stents. Accordingly, the NPPA had put a cap on the prices of bare metal stents (the basic category) at Rs. 7,260 and the more advanced stents at Rs. 29,600.

The NPPA had issued subsequently issued clarifications that hospitals are required to comply with the notified ceiling price of stents.

Current Scenario:

With a view to implement the earlier order dated 13th February, 2017, the NPPA has clarified the definition of ‘manufacturer’ by way of the addendum.

The Addendum has provided the following clarification:

  1.  ‘Manufacturer’ means any person who manufactures or imports or market drugs for distribution or sale in the country. Accordingly, any person who imports stents directly without having registration certificate (RC) in Form 41 issued underDrugsand Cosmetics Act, 1945 and Rules in its own name and does it under Form 10 license issued on the undertaking given in Form 9 by another person shall be construed as ‘distributor’.
  2. Trade marginin excessof 8%, if any involved in the transactions between such distributors and any other ‘person/institution/hospitals’ up to consumer/patient, will be liable to be deposited, jointly or severally, by the concerned along with interest payable from the date of transaction under the provisions of the DPCO read with the Essential Commodities Act, 1955. 

Source: National Pharmaceuticals Pricing Authority

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