India’s regulatory ecosystem: more complex than it appears
Global life-sciences companies approaching India often underestimate the regulatory complexity. Unlike single-agency markets (FDA in the US, EMA in Europe), India operates a multi-layered system. The Central Drugs Standard Control Organisation (CDSCO) handles new drug approvals, clinical trial permissions, and import licensing at the national level. State drug controllers manage manufacturing licences and local market surveillance. The National Accreditation Board for Testing and Calibration Laboratories (NABL) governs laboratory accreditation. And the NGCMA oversees GLP compliance.
For medical devices, the regulatory framework is even more recent — the Medical Devices Rules 2017 (amended 2026) created a dedicated pathway that is still maturing. Global manufacturers accustomed to the EU MDR or FDA 510(k) processes will find familiar concepts but different execution requirements.
Import registration requirements
Foreign manufacturers must register with CDSCO through an authorised Indian agent. The agent bears legal responsibility for the products in India and must be a licensed entity. The import registration process requires: a Free Sale Certificate from the country of origin, product dossiers meeting Indian format requirements, stability data under Zone IV climatic conditions, and (for certain drug categories) bioequivalence or clinical trial data generated in an Indian population.
Clinical trial considerations
India’s clinical trial regulations have undergone significant reform. The New Drugs and Clinical Trials Rules 2019 established clearer timelines, defined compensation frameworks for trial-related injuries, and introduced risk-based categories for trial approval. For global companies, the key decision is whether Indian clinical trial data is required for registration — which depends on the product category, available international data, and the specific CDSCO division handling your application.
Local partner selection
The choice of Indian agent, distributor, or contract manufacturing partner is one of the most consequential decisions for market entry. Technical competence, regulatory track record, and operational capacity matter more than commercial relationships. We have seen market entry strategies fail not because of regulatory barriers, but because of poorly selected in-country partners.
LaborWissen provides India market entry advisory services that cover regulatory pathway mapping, partner due diligence, dossier strategy, and ongoing regulatory intelligence for global life-sciences companies entering or expanding in India.