As the world’s second largest populated country, India presents unmatched opportunities for businesses in life sciences and healthcare sector, with a fair share of regulatory and enforcement issues. Today pharmaceutical, medical devices and biotech companies are looking at opportunities for manufacturing, marketing, distribution, collaboration and other alliances in India. The contribution of India in the drug discovery process shortening time-to-market is significant, interspersed with occasional debates concerning conduct of widespread clinical trials.
The Firm also advises on agricultural biotechnology including regulatory and licensing approvals for import, export, transportation and handling of hybrid and transgenic seeds, genetically engineered organisms and cells and conduct of field trials.
Members of the Firm advise ethics committees, and have been members of reputed independent and institutional ethics committees.
The Firm represents a number of biotech and pharmaceutical companies, medical device manufacturers and clinical research organizations with competence to advise on sector specific critical legal issues including:
- Promotion, advertising and marketing of products and devices in India, permissibility of ingredients and product formulations under food and drug laws, contents of product literature, packaging, package declarations and disclosures.
- Legal and regulatory issues pertaining to clinical trials, informed consent and other documentation, presentations before the ethics committees, reporting of completion of studies and adverse drug reactions.
- Financial and technology collaboration between entities within the sector, financing and acquisitions with tax efficient structures.
- Drafting and negotiation of agreements governing distribution, outsourcing, franchising, marketing, licensing and consulting of pharmaceuticals and medical devices and establishment of research and development facilities in India.
- Compliance with data protection and privacy covenants and conditions and confidentiality of results and records.
- Avoidance and resolution of product liability disputes by litigation and mediation.
- Proposed regulatory and legislative changes, submitting suggestions and opinions with the expert committees and the Government.
- Aspects of professional ethics guidelines governing the conduct of physicians in recruitment of subjects for clinical trials and in dissemination of information about new drugs and medical devices. and
- All stages of regulatory compliances and defense of enforcement actions and investigations.
Notable Representations
- Vision, Cyprus concerning applicability of food and drugs laws to Bioactive Food Supplements. and
- Biogen Idec on legal issues in clinical research and trials in India.