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Healthcare & Pharmaceuticals Sector
Legal advisory for pharma companies, medical device manufacturers, and healthcare investors in India
India's pharmaceutical industry is the world's third-largest by volume, supplying approximately 20% of global generic medicines by volume and exporting to over 200 countries. The sector operates under a complex web of regulations — the Drugs and Cosmetics Act 1940, the Patents Act 1970, price control under DPCO 2013, and CDSCO licensing requirements — alongside FDI rules that treat brownfield and greenfield pharma investment differently. Medical device regulation, clinical trials, and biosimilar approvals each carry their own compliance frameworks. RevLaw advises foreign pharma companies, medical device manufacturers, and healthcare PE investors on the full spectrum of Indian healthcare law.
What We Do
Pharma FDI Structuring & DPIIT Approvals
Advising on the distinction between brownfield pharma FDI (which requires Government approval) and greenfield investment (automatic route at 100%), structuring equity arrangements, and filing DPIIT approval applications with supporting documentation.
Drug Licensing & CDSCO Compliance
Advising on manufacturing and import licences under the Drugs and Cosmetics Act 1940 and Rules 1945, clinical trial approvals, and CDSCO registration for new drugs and medical devices. Guidance on Schedule M GMP compliance for manufacturing facilities.
Pharmaceutical IP & Patent Strategy
Advising on Indian patent prosecution strategy for pharmaceutical compounds, including Section 3(d) patentability challenges, patent linkage issues at CDSCO, and compulsory licence risk assessment. Representing clients in IPAB/High Court patent disputes.
Drug Price Control & DPCO 2013
Advising on DPCO 2013 obligations — scheduled drug pricing, non-scheduled drug price increase limits, overpricing proceedings before NPPA, and structuring new formulations to manage price control exposure.
Healthcare M&A & PE Investment
Legal due diligence for PE/VC investment and M&A in Indian pharma companies, hospital chains, and medical device manufacturers. Reviewing licensing, litigation, regulatory compliance, and IP status as part of buy-side due diligence.
Medical Device Regulation
Advising on MDR 2017 (Medical Devices Rules) compliance, import registration, clinical investigation requirements, and post-market surveillance obligations for foreign medical device companies selling into India.
Key Legal Frameworks
Drugs & Cosmetics Act 1940 & Rules 1945
Primary legislation governing manufacture, import, sale, and distribution of drugs and medical devices in India.
Patents Act 1970 (Section 3(d))
India's unique patentability standard for pharmaceutical compounds — limits evergreening of known substances.
DPCO 2013 (Drug Price Control Order)
NPPA administers ceiling prices for scheduled drugs and monitors price increases for non-scheduled drugs.
Medical Devices Rules 2017 (MDR)
Risk-based classification and regulatory framework for medical devices, diagnostics, and in-vitro diagnostics.
Why RevLaw for Healthcare & Pharmaceuticals Sector
- Deep understanding of the intersection between pharma FDI policy, patent law, and CDSCO licensing
- Experience in patent disputes before Indian courts and the legacy IPAB, with current High Court IP Division practice
- Track record advising global PE funds on healthcare M&A due diligence across hospital chains and pharma
- Practical price control advisory that maps DPCO exposure before product launch
- Co-counsel relationships with US and European firms advising pharma clients on India market entry
Discuss a Healthcare or Pharma Matter
Initial calls are without obligation. We respond within 48 hours.