Indian Kanoon - Search engine for Indian Law

25. Before delving into the specifics of the matter, the Commission notes the regulatory landscape governing the sale and purchase prices of medicines, medical devices, and medical procedures in India.

26. The regulatory landscape for medicines in India is governed by the Drugs and Cosmetics Act, 1940, which governs the manufacture, sale, and distribution of drugs, cosmetics, and medical devices in the country and ensures that only drugs meeting safety and efficacy standards are approved and sold in the market. Under the 1940 Act, the primary regulatory body is the Central Drugs Standard Control Organization ('CDSCO'), working under the Ministry of Health and Family Welfare ('MoHFW'). Though largely, the CDSCO does not interfere with or regulate the prices of medicines, medical devices, medical procedures etc., certain medicines that satisfy the priority healthcare needs of the majority of the population are brought within price control regulations by the government, through the medium of a National List of Essential Medicines ('NLEM'), which is a dynamic list, and is revised from time to time by the MoHFW. The list forms part of the Drug Price Control Order ('DPCO'), 2013 which is an order issued by the Government of India under Section 3 of the Essential Commodities Act, 1955, to regulate and cap the prices of certain drugs and medical devices (through Medical Devices Rules, 2017), with a view to ensure their affordability. The implementation of DPCO 2013 is overseen by the NPPA. Prices of such drugs are merely monitored by the NPPA and an annual increase in the MRP of up to 10% is permitted for such drugs.

28.6 Prices of medical products cannot be regulated under the Act because it is settled that the Commission is not a price regulator. Prices of medical products are regulated under the DPCO, 2013 by NPPA.

28.7 There is no policy for capping/regulation of room rents by the Government. The prices of room rents may not be adjudicated by the Commission because it would be beyond the scope of the Act.