India

The Central Drugs Standard Control Organisation (CDSCO) is the primary national regulatory authority responsible for overseeing the approval and market authorisation of health products in India, including pharmaceuticals, medical devices, diagnostics, and increasingly, digital health solutions. The principal governing legislation includes the Drugs and Cosmetics Act 1940 and its associated Rules, substantially augmented by the Medical Devices Rules 2017 (amended in 2020) and the New Drugs and Clinical Trials Rules 2019. The Drugs Controller General of India (DCGI), who heads CDSCO, holds authority over product licensing, import permissions, and clinical trial approvals. Approval pathways vary by product category: pharmaceuticals follow a new drug application route with mandatory clinical data review, while medical devices are classified into four risk-based classes (A through D) with conformity assessment requirements escalating accordingly. In vitro diagnostics follow a parallel risk-based classification framework introduced under the Medical Devices Rules.

Key submission requirements include the adoption of the Common Technical Document (CTD) format for pharmaceutical dossiers, aligned with ICH guidelines, though India-specific annexures are often required. For medical devices, technical documentation must demonstrate conformity with applicable standards, and products already approved by recognised stringent regulatory authorities (such as the US FDA, EMA, TGA, or Health Canada) may benefit from an abbreviated review pathway. A mandatory local Authorised Agent or Indian Sponsor is required for all foreign manufacturers seeking market authorisation, and local address and legal entity registration are prerequisites for import licensing. Significant recent reforms include the consolidation of medical device regulation under a unified rules framework, the introduction of online application portals (the SUGAM portal for pharmaceuticals and the CDSCO online system for devices), mandatory unique device identification (UDI) requirements, and enhanced post-market surveillance obligations. India is also actively working toward greater harmonisation with international regulatory norms through participation in IMDRF and ICMRA forums.

Public procurement of health products in India operates through a multilayered structure spanning central and state government levels. At the national level, key agencies include the Central Medical Services Society (CMSS), which manages centralised procurement and distribution of medicines, vaccines, and medical devices for national health programmes under the Ministry of Health and Family Welfare. The Health Management and Education Corporation (HMC) and state-level procurement agencies such as Tamil Nadu Medical Services Corporation (TNMSC), Kerala Medical Services Corporation (KMSCL), and Rajasthan Medical Services Corporation (RMSC) manage procurement for their respective state health systems. The Government e-Marketplace (GeM) platform has become an increasingly important mandatory channel for public sector procurement across categories including diagnostics and medical equipment. National health programmes, including the Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (PM-JAY) scheme and National Health Mission (NHM), drive large-scale centralised tenders for essential medicines and health commodities, with price negotiations often conducted through the National Pharmaceutical Pricing Authority (NPPA), which also enforces price controls on essential medicines listed under the National List of Essential Medicines (NLEM).

The private sector constitutes a substantial portion of health product consumption in India, estimated at over 70% of total healthcare expenditure, and operates through distributor and stockist networks governed by trade margin frameworks. Multinational and domestic manufacturers engage private hospital chains, retail pharmacy networks, and institutional buyers directly, often outside formal tender mechanisms. Donor-funded procurement channels are also active: UNICEF, the Global Fund to Fight AIDS, Tuberculosis and Malaria, USAID, and Gavi, the Vaccine Alliance support commodity procurement for HIV, TB, malaria, and immunisation programmes, frequently channelled through government systems or specialised procurement agents such as UNOPS and IDA Foundation. India additionally enforces a strong local manufacturing preference policy: the Public Procurement (Preference to Make in India) Order 2017, extended to medical devices and pharmaceuticals, mandates preferential procurement of domestically manufactured products in government tenders, with defined local content thresholds. The Production Linked Incentive (PLI) scheme for pharmaceuticals and medical devices further incentivises domestic manufacturing capacity, reinforcing supply chain localisation objectives in public procurement.