Breakthroughs don’t happen because of the medicine. Real breakthroughs happen because someone is scared to death to stop trying – Grey’s Anatomy
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.
Our top lawyers for healthcare and life sciences field 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.
- Our top lawyers for healthcare and life sciences advise 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.
- 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.
- Our best lawyers for registration of medical devices advise on all stages of regulatory compliances and defense of enforcement actions and investigations.
Notable Representations
- Pfizer, , on various facets of drugs and pharmaceuticals related laws in India;
- New York University School of Medicine on international taxation and local registration requirements related to faculty members working on research projects with Indian medical colleges;
- Stanford Health Care, US on license/permission requirements concerning ‘record review’ of Indian patients;
- Takeda Pharmaceutical Company Limited, on issue concerning to conduct of clinical research in India;
- Farcast Biosciences on aspects related to cancer related research on live tissues in India;
- Biogen Idec on legal issues in clinical research and trials in India;
- Verily on deep learning algorithms using health data;
- Apple Inc. on laws governing collation of data concerning development of apps;
- Unistem Biosciences Private Limited on issues concerning stem cell therapies in India;
- IQVIA (formerly Quintiles) on various aspects of clinical research and trials in India;
- Represented Indian Society of Clinical Research in the proceedings of Swasthya Adhikar Manch, Indore & Anr. vs. Union of India, in the Supreme Court of India;
- PARTAKE (Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment) towards its establishment;
- Member in the committee to review the Ethics Guidelines for Biomedical Research involving neonates and children, developed under the Center for Advance Research on neonatal health at All India Institute of Medical Sciences, supported by Indian Council of Medical Research;
- Medanta Duke Research Institute (a joint venture between Global Health Private Limited and Duke Medicine) on various issues concerning clinical research;
- Vision, Cyprus, concerning applicability of food and drugs laws to Bioactive Food Supplements;
- Healthians, a leading network of testing laboratories in India on various legal issues;
- ARA Healthcare Private Limited, a biopharmaceutical research and development company focusing on the development of novel biologicals, biosimilars and molecular diagnostic services on issues concerning its regulatory and statutory compliances;
- Product Law Firm, France on issues concerning import, use, labelling and transport of genetically modified micro-organisms in India for R&D purpose, industrial purpose, and packaging/labeling and transport requirements for such import;
- Global Health Private Limited, operating various hospitals under the name and style of “Medanta” on various aspects concerning clinical trials, medico-legal issues, ethical conduct of medical practitioners and the institution itself, etc.;
- Providence Equity in its investment in Lal Path Labs Private Limited, a diagnostic centre with pan India presence;
- Goldfinch Bio, on issues related to export of DNA samples and regulations/compliances under applicable Indian Medical laws;
- Memorial Sloan Kettering Cancer Centre, on various issues related to facilitating medical services related to provision of second opinions concerning the medical condition, diagnosis, mitigation and treatment through video consultation and provision of ‘MSK Impact’ test to the patient in India, which included export of the human biospecimen;
- Boston Scientific, on the India leg of the global acquisition (at USD 1.07 Billion upfront) of the surgical business of Lumenis Ltd. by Boston Scientific;
- Lumenis , in obtaining registration of its medical devices in India under the Medical Devices Rules, 2017; and
- LabourNet Services India Private Limited, on setting-up and the operation of Telemedicine Centres/Clinics in India.
- Indore Cancer Foundation on various legal aspects;
- NSF International, advised on the requirements prescribed by the Agricultural and Processed Food Exports Development Authority for obtaining accreditation for certifying organic products;
- Orient Bell Limited, advised on proposed marketing and publicity material (including for print, social media and television) for its recently launched line of products for potential implications under the ASCI Code, Consumer Protection Act, 1986, national standards for quality assurance prescribed by Bureau of Indian Standard, Grievance Against Misleading Advertisement, Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, Drugs and Cosmetics Act, 1940 and Drugs and Magic Remedies (Objectional Advertisements) Act, 1954.
- Farcast Biosciences Private Limited, our best lawyers for Import of medical devices assisted, advised and represented the client, a global leader in oncology research and developer of CANscript clinical laboratory service before the state ministry of health and department in a notice received from the state health department requesting certain information concerning the compliances followed by the company in the course of undertaking the business activities, advising on the Drugs and Cosmetics Act, Medical Device Rules, Karnataka Private Medical Establishments Act etc. Firm also assists the client in its day to day corporate advisory requirements including review of the agreements to be executed with the consultants, hospitals, donors, etc
