India

The Central Drugs Standard Control Organisation (CDSCO) is the primary national regulatory authority responsible for the approval and oversight of pharmaceuticals, medical devices, diagnostics, and related health products in India. The principal governing legislation includes the Drugs and Cosmetics Act, 1940 (and its Rules of 1945), significantly amended by the Medical Devices Rules, 2017 (revised in 2020 and subsequently) and the New Drugs and Clinical Trials Rules, 2019. Regulatory pathways vary by product category: pharmaceuticals follow a new drug application route reviewed by the Drug Controller General of India (DCGI), while medical devices and in vitro diagnostics are classified into four risk-based classes (A through D) with corresponding registration requirements ranging from self-certification for Class A to mandatory CDSCO approval for Class C and D products. Digital health products may fall under emerging software-as-a-medical-device (SaMD) guidance, though a comprehensive standalone regulatory framework is still evolving.

Key submission requirements include the appointment of an Indian Authorised Agent or local legal manufacturer for foreign applicants, and dossiers are generally expected to conform to the Common Technical Document (CTD) format for pharmaceuticals, with product-specific technical files required for medical devices. India has progressively accepted data from recognised foreign regulatory authorities (such as the US FDA, EMA, TGA, Health Canada, MHRA, and PMDA) to facilitate abridged or accelerated review pathways, reducing the need for fresh local clinical trials in certain cases. Notable recent reforms include the operationalisation of the Medical Device Rules, 2017 as the standalone regulatory framework replacing earlier Schedule M provisions, the introduction of a mandatory registration portal (SUGAM) for online submissions, enhanced post-market surveillance obligations, and India's ongoing harmonisation efforts with international standards bodies such as IMDRF and ICH, signalling a trajectory toward greater regulatory convergence.

Public procurement of health products in India operates across central and state government levels, creating a layered and sometimes complex landscape. At the central level, the Ministry of Health and Family Welfare (MoHFW) drives procurement through flagship programmes such as Ayushman Bharat, the National Health Mission (NHM), and the Pradhan Mantri Jan Aushadhi Pariyojana (PMJAP). The Central Medical Services Society (CMSS) serves as the central procurement agency for medicines, vaccines, and health commodities under centrally sponsored schemes, while HLL Lifecare Limited (HLL) is a key government-owned entity for health product supply. At the state level, State Medical Supply Corporations or State Health Societies conduct their own tenders and procurement, resulting in significant variation in timelines, pricing norms, and vendor qualification criteria across the 28 states and 8 Union Territories. Government procurement is predominantly governed by the General Financial Rules (GFR), 2017, and the Public Procurement Policy for Micro and Small Enterprises (MSEs), with price negotiations increasingly informed by the Drug Price Control Order (DPCO) administered by the National Pharmaceutical Pricing Authority (NPPA).

The private sector constitutes approximately 70-75% of total healthcare expenditure in India, making it a critical channel for health product market access alongside the public sector. Private procurement occurs through hospital group purchasing, retail pharmacy chains, and wholesale distributors, with pricing governed more freely by market dynamics, though essential medicines remain subject to NPPA ceiling prices. Donor-funded and multilateral procurement channels, including UNICEF Supply Division, the Global Fund, USAID-funded programmes (such as those managed through USAID India and global procurement mechanisms), and Gavi, the Vaccine Alliance, play a meaningful role particularly for HIV/AIDS, tuberculosis, malaria, and immunisation commodities, often leveraging India's domestic manufacturing base as a global supply source. India's 'Make in India' initiative and the Production Linked Incentive (PLI) schemes for pharmaceuticals and medical devices actively encourage domestic manufacturing through financial incentives and preferential procurement policies, with public tenders increasingly incorporating local content or domestic manufacturer preference criteria, which foreign market entrants must factor into their market access strategies.