PHARMACEUTICALS, FOOD AND DRUG

The team has advised several multinational companies and Indian businesses in the area of Healthcare, Food and Pharmaceutical/ Drug. The team has acquired experience, in-depth knowledge and understanding of the legal and regulatory framework relating to legislations dealing with healthcare, food and pharmaceutical industry including prevention of food adulteration legislation.

The team members have offered comprehensive service and advice to clients on introduction, import and marketing of Generic and New Drugs including bulk drugs in the Indian market. Further, the team members have advised several companies on legal and regulatory issues relating to clinical trials (phases 1, 2 and 3), post marketing survey and various issues relating to indemnity and insurance of subjects/ patients. We have capabilities to advise and opine on various issues arising out of international treaties such as Declaration of Helsinki, Good Clinical Practice guidelines and the Agreement on Trade Related Aspects of Intellectual Property Rights especially Article 39.3 concerning interpretation of data exclusivity/ protection.

The team members have extensive experience in advising and providing legal assistance on the following matters:

  • Agreements relating to manufacturing, marketing, import, sponsorship of drugs (generic and non-generic drugs including ayurvedic and unani medicines) in India, etc.
  • Regulatory approvals from relevant statutory authorities including the Drug Controller General (India)
  • Approvals and compliances in relation to Clinical Trials
  • Intellectual Property protection and registration such as Patents, Trademarks etc. and agreements relating to licensing of know-how etc.
  • Labeling and packaging guidelines
  • Issues relating to Food Adulteration
  • Advisory to Hospitals and World Class Health Institutions in structuring their businesses in Cross Border Jurisdictions
  • Advisory and assistance in corporate commercial issues including company incorporation, joint venture partnerships, acquisitions etc, and
  • Advisory and assistance on tax related issues
  • Structuring of Foreign Investment and related regulatory approvals