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Financial & Regulated

Health Sciences & Diagnostics

India's healthcare and pharmaceutical sector is one of the largest globally, supplying over 20% of the world's generic medicines and serving as a key hub for clinical research, medical devices, and healthcare delivery. With rising demand for quality healthcare, digitization of medical services, and government initiatives like Ayushman Bharat, the sector offers vast opportunities but also faces stringent regulatory oversight.

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Health Sciences & Diagnostics

Our Healthcare & Pharmaceuticals Practice provides comprehensive legal and regulatory support to pharmaceutical manufacturers, medical device companies, hospitals, clinical research organizations, digital health startups, and investors.

Our Team and Approach

Our team draws on cross-disciplinary expertise in corporate law, regulatory compliance, intellectual property, employment law, and dispute resolution. We assist clients across the entire healthcare value chain — from drug development and manufacturing, clinical trials, product approvals, hospital operations, telemedicine platforms, to cross-border licensing and M&A transactions. We combine legal acumen with sector-specific knowledge to deliver pragmatic solutions that help clients remain compliant, protect IP, and scale operations.

Applicable Laws & Regulatory Framework

Approval, manufacture, and sale of drugs and cosmetics.

Protection of pharma patents, biosimilars, and trademarks.

Classification, import, manufacture, and sale of medical devices.

Healthcare waste compliance.

Price regulation of essential medicines.

For nutraceuticals, dietary supplements, and food-linked healthcare.

Digital healthcare, online consultations, and data protection.

As applicable on medical data under applicable laws, including the Health Data Management Policy and Electronic Health Record Standards for India, 2016.

Regulatory & Statutory Authorities

Drug and medical device approvals.

Clinical trial guidelines and ethics.

Licensing and enforcement.

Policy approvals.

Licensing & Approvals

  • •Drug manufacturing & marketing licenses from state authorities and CDSCO
  • •Import licenses for APIs, drugs, and devices
  • •Medical device registration & licensing under MDR, 2017
  • •Telemedicine registration & digital health compliance
  • •Patent and trademark filings for pharmaceutical products and healthcare brands
  • •Hospital, diagnostic, and clinical establishment registrations under state laws

Key Service Offerings

CDSCO/DCGI approvals, drug/device licensing, and marketing compliance.

Drafting PPAs, distribution agreements, hospital management contracts, telemedicine agreements.

Structuring acquisitions, FDI compliance, and cross-border collaborations.

Pharma patent litigation, regulatory enforcement disputes, and healthcare malpractice claims.

On medical data under applicable laws, including the Health Data Management Policy and Electronic Health Record Standards for India, 2016.

Patents, trademarks, biosimilars, and licensing strategies.

Frequently Asked Questions

We start with a scoping consultation to understand your business model, current regulatory posture, and immediate priorities — then propose a tailored engagement rather than a one-size-fits-all package.

Yes. Our clients range from early-stage startups navigating their first licensing requirements through to established operators and multinational investors. We scale our advisory to the client's stage and scale.

Yes, representation before Central Drugs Standard Control Organization (CDSCO) & Drug Controller General of India (DCGI) and other applicable regulators is part of our practice in this sector, alongside the advisory and transactional work outlined above.

Yes — our sector teams combine regulatory advisory with litigation and dispute resolution capability, so clients have continuity of counsel if a compliance matter escalates into a contentious one.

Working In Health Sciences?

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