Life Sciences And Hospitals

Our Life Sciences & Hospitals practice delivers end-to-end legal support to pharmaceutical manufacturers, biotechnology innovators, medical-device companies, clinical-research organizations, and healthcare providers throughout India. We help clients navigate India’s complex regulatory environment from securing CDSCO approvals under the New Drugs and Clinical Trials Rules (2019) and Medical Devices Rules (2017) to obtaining Clinical Establishments Act registrations and NABH accreditation for hospitals and clinics

• Regulatory Approvals & Licensing: Navigating CDSCO processes for drug-manufacturing licences, clinical-trial approvals, and medical-device registrations under the New Drugs and Clinical Trials Rules 2019 and Medical Devices Rules 2017
• Ethics Committee Formation & Compliance: Establishing and registering Institutional Ethics Committees in line with ICMR’s National Ethical Guidelines (2017), drafting informed-consent forms, and ensuring DPDP Act and patient-data privacy compliance
• Hospital Licensing & Accreditation: Securing registrations under the Clinical Establishments (Registration and Regulation) Act 2010 and guiding hospitals through NABH accreditation to meet over 600 quality-and-safety parameters.
• Transactional & PPP Structuring: Advising on M&A, joint ventures, private-equity investments, and PPP frameworks for tertiary-care and multi-specialty hospital projects, including concession agreements, land leases, and project financing
• Intellectual Property & Technology Transfer: Handling patent prosecution, pre- and post-grant oppositions, and licensing for drugs, biologics, and medical devices under India’s post-TRIPS patent regime, which grants 20-year protection and accommodates pre-grant opposition
• Dispute Resolution & Litigation: Representing clients before CDSCO appeals, IP tribunals, consumer forums, and commercial courts in matters ranging from clinical-trial disputes to healthcare negligence and product-liability claims.
• Emerging & Digital Health Advisory: Guiding telemedicine platforms, digital-health startups, and insuretech ventures on regulatory approvals, intermediary obligations, and data-security requirements under India’s evolving healthcare and data-protection laws.

Our multidisciplinary team combines in-depth knowledge of India’s regulatory bodies (CDSCO, ICMR, IRDAI) and quality standards (NABH) with extensive experience advising both established market leaders and innovative startups. We offer practical, business-oriented legal solutions that anticipate regulatory shifts whether drafting clinical-trial protocols, securing market approvals, structuring hospital PPPs, or protecting cutting-edge biotech inventions. Partner with us to navigate India’s dynamic life-sciences and healthcare landscape with confidence and precision.