Pharmaceuticals

The Team

The Pharmaceuticals team of the firm comprises of expert lawyers with thorough understanding of the sector. The pharma team actively leads and advises diverse clients in active coordination with in house teams of clients as well as teams from other key practice areas including Antitrust & Competition, Dispute Resolution, Intellectual Property and Labour & Employment.

Our practice

The Pharmaceuticals sector is highly regulated in India, the firm provides definite advise on compliances. The firm’s regulatory and public policy team in active collaboration with the Pharmaceuticals team provide comprehensive advise on pharma sector especially on drug approvals, clinical trials, legal metrology etc.

We advise the clients in drug approvals from the statutory authorities such as Central Drugs Standard Control Organization and advise on navigating regulator such as the National Pharmaceutical Pricing Authority(NPPA) as well as labelling and packaging regulations and applicable FSSAI regulations, if any.

We also advise on manufacturing & distribution agreements, patent prosecution and litigation including pre grant and post grant opposition, revocation, compulsory licence, drafting and negotiating voluntary licence agreements, commercial litigation as well as on corporate restructuring, commercial agreements, joint ventures, Foreign Direct Investment and tax related advisory and compliances.

The firm leverages its extensive experience in the sector in advising on clinical trials in India as well extensive compliance related to clinical trial. We also assist in compliances related to import, manufacture and marketing of drugs in India.