India

The Central Drugs Standard Control Organisation (CDSCO) is India's primary national regulatory authority responsible for the approval and oversight of pharmaceuticals, medical devices, diagnostics, and related health products. The principal governing legislation is the Drugs and Cosmetics Act, 1940 (as amended), complemented by the Medical Devices Rules, 2017 for devices and diagnostics, and the New Drugs and Clinical Trials Rules, 2019 for pharmaceuticals. The approval process generally requires submission of a dossier to the Drugs Controller General of India (DCGI), followed by technical review by subject-matter expert committees. Products are classified by risk category, with higher-risk products requiring more rigorous review, clinical evidence, and, in some cases, local clinical trials or bridging studies. State-level licensing authorities work in parallel with CDSCO for manufacturing and distribution approvals.

India accepts dossiers broadly aligned with the Common Technical Document (CTD) format, and the country is a member of the International Council for Harmonisation (ICH), progressively aligning its submission standards with global norms. A local authorized agent or Indian subsidiary is mandatory for foreign manufacturers seeking registration. Recent reforms of significance include the mandatory registration of medical devices under the Medical Devices Rules, 2017, which brought devices under a formal regulatory framework after a phased implementation timeline. The government has also introduced the Medical Device (Amendment) Rules, 2020 and subsequent notifications to streamline classification and review processes. Digital health products, including Software as a Medical Device (SaMD), are increasingly being brought within the regulatory purview, and CDSCO has issued draft guidance on their classification. The Jan Aushadhi scheme and amendments to price control mechanisms under the Drugs Price Control Order (DPCO) further reflect India's active regulatory reform agenda.

Public procurement of health products in India operates through a multi-layered structure involving both central and state government agencies. At the national level, the Ministry of Health and Family Welfare (MoHFW) oversees procurement for centrally sponsored schemes, including the National Health Mission (NHM) and Ayushman Bharat. The Central Medical Services Society (CMSS) functions as the central procurement agency for essential medicines, vaccines, and medical devices supplied to public health programs. At the state level, State Medical Supply Corporations or equivalent agencies conduct independent tenders, resulting in significant variation in pricing, product specifications, and procurement timelines across India's 28 states and 8 union territories. The Government e-Marketplace (GeM) portal has been mandated for government procurement, increasing transparency and enabling small and medium enterprises to participate. The National Pharmaceutical Pricing Authority (NPPA) regulates the prices of essential medicines and certain medical devices listed under the National List of Essential Medicines (NLEM), which has a direct bearing on public tender price expectations.

The private sector constitutes a substantial portion of India's health market, with a large network of private hospitals, diagnostic chains, and retail pharmacies procuring independently through distributors and direct manufacturer agreements. Multinational and domestic companies typically engage with private channel partners and hospital procurement committees. India also receives support from multilateral and bilateral donor agencies: UNICEF, the Global Fund to Fight AIDS, Tuberculosis and Malaria, the Bill and Melinda Gates Foundation, and USAID are active in supporting commodity procurement and supply chain strengthening, particularly for HIV, tuberculosis, malaria, and immunization programs. Gavi, the Vaccine Alliance, supports vaccine procurement and health system strengthening. The government's 'Make in India' and 'Atmanirbhar Bharat' (self-reliant India) initiatives have introduced Production Linked Incentive (PLI) schemes for pharmaceuticals, medical devices, and bulk drugs, creating financial incentives for domestic manufacturing and, in certain public tenders, preference for locally manufactured products. Companies without domestic manufacturing presence may face pricing disadvantages in public procurement processes where local content is a scoring criterion.