Pharma and Medical Devices

Life sciences regulation separates the product, the trial and the promotion, each with its own approval path. We advise across all three and on the contracts that connect them.

WHAT WE DO
• Drugs and Cosmetics Act licensing and CDSCO interface
• Medical device classification and registration
• Clinical trial approvals and site agreements
• Telemedicine practice guidelines compliance
• Uniform Code for Pharmaceutical Marketing Practices
• Drugs and Magic Remedies Act advertising restrictions
• Import, manufacture and loan licensing
• Pharmacovigilance and adverse event reporting
• Distribution, stockist and CFA arrangements
• Hospital and diagnostic centre licensing

HOW THE WORK IS ORGANISED
Product approval · Trials · Promotion · Distribution

KEY INSTRUMENTS
Drugs and Cosmetics Act, 1940 · Medical Devices Rules, 2017 · UCPMP · Telemedicine Practice Guidelines

FEES
Fixed fee for defined scopes, retainer arrangements for ongoing volume, and time based billing where scope cannot be fixed in advance. The basis is agreed in writing before work begins and discussed at first contact.