Steps to regulate the pricing and quality of medical devices

The National Pharmaceutical Pricing Authority (NPPA) under the Department of Pharmaceuticals (DoP) fixes ceiling prices of medicines included in the National List of Essential Medicines (NLEM) issued by the Ministry of Health and Family Welfare and incorporated in Schedule-I to the Drugs (Prices Control) Order, 2013 (DPCO, 2013). All manufacturers, marketers and importers of scheduled medicines are required to sell their products within such ceiling price (plus applicable Goods and Service Tax).

Four medical devices, namely, Bare Metal Stents, Drug Eluting Stents (DES) including metallic DES and Bioresorbable Vascular Scaffold (BVS)/Biodegradable stents, Intra Uterine Devices (IUDs) and condoms are included in Schedule-I to DPCO, 2013 and ceiling prices have been notified for these four devices. In addition to these four (04) scheduled medical devices, NPPA, in public interest, fixed and notified the ceiling prices for Orthopedic Knee Implants for knee replacement system in August 2017 and capped the trade margin of covid essential medical devices i.e. oxygen concentrators, pulse oximeter, blood pressure monitoring machine, nebuliser, digital thermometer and glucometer in June/July, 2021.

This information was given by Union Minister of State for Chemicals and Fertilizers, Smt. Anupriya Patel, in a written reply in the Rajya Sabha today.(UPDATED ON 3RD FEB 2026)