India Entry for Healthcare & Pharma

Why India for healthcare & pharma?

India combines large-scale generic and API manufacturing, deep R&D and clinical-research capability, and a fast-growing domestic healthcare market — a rare combination for foreign pharma and med-tech companies weighing an India footprint.

Greenfield vs brownfield FDI — the key distinction

The route depends on whether you build new or invest into an existing company. Greenfield (a new project) is 100% under the automatic route. Brownfield (investing into an existing Indian pharma company) is permitted up to 100% but requires prior government approval beyond 74%, along with non-compete conditions. See FDI entry routes and the standard wholly owned subsidiary setup.

Product & establishment approvals (CDSCO)

• Drug manufacturing and import licences via the CDSCO and state licensing authorities
• New-drug approvals under the New Drugs and Clinical Trials Rules
• Medical-device registration and licensing under the Medical Devices Rules
• Clinical-trial approvals for phase I–IV studies

Manufacturing standards

Facilities must meet Schedule M (India GMP) and, for regulated exports, WHO-GMP or the target market’s equivalent (US-FDA, EU-GMP, PIC/S). Build the quality system into the site design — retrofitting is expensive.

Location & clusters

Hyderabad’s Genome Valley (Telangana), Gujarat (Ahmedabad–Vadodara belt) and Telangana more broadly are India’s leading pharma bases, with established supplier ecosystems and regulatory experience. See best locations for foreign companies and the state hubs for Telangana and Gujarat.

Pricing controls

Scheduled drugs are subject to price control under the Drug Price Control Order (DPCO), administered by the National Pharmaceutical Pricing Authority (NPPA). Factor scheduled-formulation exposure into the business model at the product-portfolio stage.

Reviewed by CA Regi Tom Antony, Regi Tom Antony & Associates. Last updated: July 2026.