Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Demand for sub-category of stent


Mains Paper 2: Governance | Issues relating to development & management of Social Sector/Services relating to Health, Education, Human Resources

From UPSC perspective, the following things are important:

Prelims level: NPPA

Mains level: Issues related to drug prices and overall pharma sector

Ensuring consideration of technical superiority

  1. Medical Technology Association of India (MTaI) has demanded that while subjecting them to price capping, the National Pharmaceutical Pricing Authority (NPPA) should create sub-categories for stents
  2. This is to ensure consideration of technical superiority of each category of stent


  1. The NPPA, in one of its most controversial decisions, had fixed the ceiling prices of coronary stents through its notification on February 13, 2017
  2. It was valid for one year


National Pharmaceutical Pricing Authority (NPPA)

  1. The National Pharmaceutical Pricing Authority (NPPA) is a government regulatory agency that controls the prices of pharmaceutical drugs in India
  2. It was formed on 29 August 1997
  3. The NPPA regularly publishes lists of medicines and their maximum ceiling prices
  4. The latest drug price control order (DPCO) was released in 2013 which has a list of 384 drugs
  5. Functions of NPPA are:
  • To implement and enforce the provisions of the Drugs (Prices Control) Order in accordance with the powers delegated to it
  • To deal with all legal matters arising out of the decisions of the Authority
  • To monitor the availability of drugs, identify shortages, if any, and to take remedial steps
  • To collect/ maintain data on production, exports and imports, market share of individual companies, profitability of companies etc, for bulk drugs and formulations

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