National Pharmaceutical Pricing Authority

The National Pharmaceutical Pricing Authority (NPPA) is the Central Government body that regulates the prices of medicines and medical devices covered by the drug-price-control framework. It implements the Drugs (Prices Control) Order, 2013 (DPCO) under the Essential Commodities Act, 1955.

Coverage of medical devices

Medical devices notified as drugs under the Drugs and Cosmetics Act are treated as formulations for price regulation under the DPCO. Since 1 April 2020, all medical devices have come within this regulatory framework, although the intensity of control differs between scheduled and non-scheduled devices.

Price regulation mechanism

• For a scheduled medical device included in Schedule I of the DPCO, NPPA fixes a ceiling price that manufacturers and importers cannot exceed.
• For a non-scheduled medical device, NPPA does not ordinarily fix the initial price, but monitors its maximum retail price.
• Under Paragraph 20 of the DPCO, the maximum retail price of a non-scheduled device cannot be increased by more than 10 per cent during the preceding 12 months.
• Price intervention may also be undertaken in extraordinary circumstances when required in the public interest under the DPCO framework.

Monitoring and enforcement

NPPA obtains price and market data, monitors compliance and acts against overcharging. It can direct price reduction and recover the overcharged amount with interest, while also monitoring availability to prevent price control from disrupting supply.

• Its mandate concerns pricing and availability; quality, safety, licensing and clinical regulation remain with the competent drug-regulatory authorities.
• Price ceilings regulate the permissible maximum retail price, but do not themselves determine procurement prices or reimbursement policies.