What happened (Government statement on regulating drug prices and improving access)

The Union Government, through a written Rajya Sabha reply by Minister of State for Chemicals and Fertilizers Anupriya Patel, set out how India regulates and controls prices of life-saving drugs and how it improves access to essential medicines at affordable rates. The Government described DPCO, 2013 as the core legal instrument for price regulation through the National Pharmaceutical Pricing Authority (NPPA), and then listed several schemes that make essential medicines cheaper or free in different care settings.

Background and earlier position: How drug prices are controlled under DPCO, 2013

India’s drug price regulation is described as operating under Drugs (Prices Control) Order, 2013 (DPCO, 2013) based on the National Pharmaceuticals Pricing Policy, 2012. Under the extant provisions of DPCO, 2013, NPPA performs multiple functions:

Ceiling prices for scheduled drugs: NPPA fixes ceiling prices of drugs included in Schedule-I of DPCO, 2013. Schedule-I is based on the National List of Essential Medicines, and the ceiling pricing is also tied to the retail price of new drugs as defined in para 2(1)(u) of DPCO, 2013.Annual revision method for scheduled drugs: Ceiling prices of scheduled drugs are revised every year based on the Wholesale Price Index (WPI).Limitation on price hikes for non-scheduled formulations: For non-scheduled formulations, manufacturers are required not to increase the maximum retail price (MRP) of such formulations by more than 10% of the MRP during the preceding 12 months.Extraordinary public interest pricing: NPPA fixes prices of drugs under Para 19 of DPCO, 2013 in cases of extraordinary circumstances and public interest.Action against overcharging: Instances of overcharging are dealt with as per the provisions of DPCO, 2013.

The Government also stated that details of prices fixed or revised by NPPA are available on NPPA’s website (www.nppa.gov.in).

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