Steps to regulate the pricing and quality of medical devices

• Dual regulatory architecture: NPPA (under Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers) controls price; CDSCO (under MoHFW) controls quality, safety and performance.
• Statutory basis: Drugs (Prices Control) Order (DPCO), 2013 for pricing and Drugs and Cosmetics Act, 1940 + Medical Devices Rules, 2017 for quality.
• UPSC relevance: classic GS-II/III intersection — governance of an essential-goods market, consumer protection, Aatmanirbhar Bharat in healthcare.