National Pharmaceutical Pricing Authority (NPPA) was established through a Government of India Resolution dated 29th August, 1997 as an independent body of experts for price control of essential and life saving medicines. NPPA implements the National Pharmaceutical Pricing Policy 2012 and the Drugs (Prices Control) Orders issued by the Department of Pharmaceuticals (DoP).
NPPA provides ceiling price to all Drugs notified under Schedule-I of the DPCO, 2013 and monitors annual price increase for these and the non-scheduled drugs. It has so far given ceiling price to 856 scheduled formulations and 950 new drugs. By invoking powers under Para 19 of DPCO, 2013, it has regulated prices of 106 anti-diabetic and cardio vascular drugs, stents and knee implants in public interest.
In February 2019, NPPA Launched a Pilot for price regulation of 42 anti-cancer drugs as proof of concept for Trade Margin rationalization of non-scheduled drugs. So far, 517 brands have reported saving up to 90%, amounting to Rs. 980 cr. per annum. It is estimated that NPPA has effected a saving of almost Rs.12,500 crore to the consumers since its constitution.
Indian Pharma is today uniquely placed as the Pharmacy of the World. It is the foremost supplier of generics, vaccines and anti-retroviral among the developing countries. The Pharma sector is a buoyant $33 billion industry with a strong export component. It is, thus, important to strengthen the Indian Pharma and also to provide level playing field for foreign companies under ‘Make in India’.
At the same time, out of pocket expenses on medicines remains the single largest cause for families being dragged below the poverty threshold in India. The Government of India has placed Drugs under section 3 of the Essential Commodities Act 1955 to enable its regulation. The Government is committed to improve access to essential and life saving medicines as it impacts quality of public health as also the economic viability of vulnerable sections of the society.
NPPA strives to strike a balance between the interests of the consumers and the Pharma Industry as per the ambit of the DPCOs. For the first time, NPPA is expanding outside Delhi, through the Price Monitoring and Research Units (PMRUs) at State levels, for strengthening monitoring and public awareness. There is a proactive attempt to synergise with the office of the Drug Controller General of India, State Drug Controllers and NIPERs for integrated data collection, regulation and improved services to the people. NPPA also seeks to undertake concurrent Research and Studies to enable credible contribution to Policy development at the Department of Pharmaceuticals and NITI Aayog.
NPPA administers ‘Pharma Sahi Dam’ and ‘Pharma Jan Samadhan’ platforms for information on medicine prices and registering public grievances. The Integrated Public Database Management System (IPDMS) is being implemented for online information collection from Pharma manufacturers.
NPPA’s role as a Regulator is to work towards a Healthy Nation by making medicines accessible and affordable while creating an enabling environment for the Indian Pharmaceutical Industry to develop into a world leader. NPPA invites the cooperation of all stakeholders in this endeavour.