What NPPA does under DPCO, 2013 (drug-price regulation in practice)
The National Pharmaceutical Pricing Authority (NPPA) regulates drug prices in India under the Drugs (Prices Control) Order, 2013 (DPCO, 2013). DPCO, 2013 was promulgated based on the principles of the National Pharmaceutical Pricing Policy (NPPP), 2012.
NPPA’s central task is to fix ceiling prices for drug formulations covered in Schedule-I to DPCO, 2013. NPPA also defines rules for new drugs and for non-scheduled formulations through limits on changes in maximum retail price (MRP).
What happened: NPPA’s price-fixation process and compliance framework
NPPA fixes ceiling prices for formulations specified in Schedule-I to DPCO, 2013 in accordance with DPCO, 2013. The ceiling-price fixation uses market data and the retail price of a new drug.
DPCO, 2013 defines a “new drug” under 2(1)(u) of DPCO, 2013. The rule applies to the applicant manufacturer and marketer. The applicant manufacturer and marketer are required to sell the new drug within the price notified by NPPA.