India

The Central Drugs Standard Control Organisation (CDSCO) is the primary national regulatory authority responsible for overseeing the approval and market authorisation of pharmaceuticals, medical devices, diagnostics, and digital health products in India. The principal governing legislation includes the Drugs and Cosmetics Act, 1940 (as amended), the Medical Devices Rules, 2017, and the New Drugs and Clinical Trials Rules, 2019. The approval process generally requires submission of a dossier to CDSCO, technical review by subject matter experts or notified bodies, and, where applicable, inspection of manufacturing facilities. The Drug Controller General of India (DCGI) serves as the apex authority for granting market authorisation, while State Licensing Authorities (SLAs) manage manufacturing and distribution licences at the subnational level. For medical devices, risk-based classification under Classes A through D determines the stringency of the review pathway.

Applicants must appoint a local Indian agent or authorised representative if they are a foreign manufacturer, and this representative assumes regulatory responsibility for the product within the country. India accepts dossiers broadly aligned with the Common Technical Document (CTD) format and increasingly references International Council for Harmonisation (ICH) guidelines, though CDSCO maintains specific local requirements for clinical data, particularly favouring data generated in Indian patient populations or bridging studies justifying waiver of local trials. Notable recent reforms include the phased mandatory registration of medical devices under the Medical Devices Rules, 2017, the introduction of the Central Drugs Testing Laboratory network for quality verification, and the establishment of a dedicated digital health regulatory sandbox under the National Digital Health Mission framework. India's adoption of the Harmonised System of Nomenclature for medical devices and its alignment with select ASEAN Medical Device Directive (AMDD) principles reflect ongoing efforts to modernise the regulatory architecture.

Public procurement of health products in India operates through a layered federal structure involving central government bodies, state governments, and autonomous procurement agencies. At the national level, the Ministry of Health and Family Welfare (MoHFW) coordinates procurement through schemes such as the National Health Mission (NHM) and Pradhan Mantri Swasthya Suraksha Yojana (PMSSY). The Central Medical Services Society (CMSS) functions as the central procurement and warehousing agency for medicines, diagnostics, and devices under centrally sponsored programmes. State governments operate their own procurement agencies, such as the Tamil Nadu Medical Services Corporation (TNMSC) and the Rajasthan Medical Services Corporation (RMSC), which conduct state-level tenders independently, resulting in significant variation in pricing, formulary composition, and supplier eligibility criteria across the country. Procurement is predominantly conducted through open competitive tendering governed by the General Financial Rules (GFR), 2017, and the Public Procurement Policy for Micro and Small Enterprises (MSEs) Order, 2012.

India's private healthcare sector represents a substantial and growing procurement channel, accounting for a majority of total health expenditure, and operates largely through distributor networks, group purchasing arrangements among hospital chains, and direct manufacturer agreements. Key donor-funded and multilateral procurement channels, including UNICEF Supply Division, the Global Fund to Fight AIDS, Tuberculosis and Malaria, the US Agency for International Development (USAID), and Gavi, the Vaccine Alliance, remain active in India primarily for communicable disease programmes, immunisation supply chains, and reproductive and child health initiatives, though India's transition to middle-income status has progressively shifted financing responsibility to domestic sources. A significant policy dimension is the Indian government's emphasis on local manufacturing preference, reinforced through the Make in India initiative, the Production Linked Incentive (PLI) scheme for pharmaceuticals and medical devices, and procurement preference norms that favour domestically manufactured goods in government tenders. The Atmanirbhar Bharat policy framework further encourages import substitution, and certain government tenders explicitly restrict or limit participation by foreign-manufactured products where domestically produced equivalents are deemed available.