Life Sciences & Healthcare

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.

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.
  • 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.
  • 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. 
  • All stages of regulatory compliances and defense of enforcement actions and investigations.

Notable Representations

  • Goldfinch Bio – The Kidney Company, advised on the compliances required to be met for the export of DNA samples from India to USA including under ICMR Guidelines for Exchange of Human Biological Material for Biomedical Research Purposes, notification issued by DGFT and New Drugs and Clinical Trial Rules, 2019, assisted and represented Goldfinch Bio in regard to its proposed master service agreements for accessing patient samples and to use data related to patient samples and other data for the research, development, regulatory and commercial purposes in the Kidney disease field, for obtaining clinical and non-clinical related genomic services including to ensure compliances under Indian medical laws and data protection laws.
  • Memorial Sloan Kettering Cancer Centre (MSK), advised on the requirements under medical laws in India for providing telemedicine consultations to physicians in India by MSK’s physician located in New York and the export of human biospecimen to MSK at New York for the purpose of reviewing the biospecimen through MSK’s genomic sequencing test, in preparation of its transactional documents for providing telemedicine consultations to physicians in India by MSK’s physician located in New York through an Indian telemedicine platform called ‘iCliniq’.
  • 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.
  • 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. 
  • All stages of regulatory compliances and defense of enforcement actions and investigations.
  • Indore Cancer Foundation Charitable Trust, assisted and represented the charitable trust operating the Indian Institute of Head and Neck Oncology in Madhya Pradesh, in connection with its agreement with a service provider for supply, installation and commissioning of the Cobalt-60 Teletherapy Machine in the cancer institute; 
  • NSF International, advised on the requirements prescribed by the Agricultural and Processed Food Exports Development Authority for obtaining accreditation for certifying organic products; 
  • Farcast Biosciences Private Limited, 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.