Healthcare and Pharmaceuticals

“Unparalleled expertise that ensures your innovations are safeguarded, compliance is simplified, and your focus remains on delivering world-class healthcare solutions.”

Our

Healthcare and Pharmaceuticals Practice

India’s health and pharma sector is witnessing unprecedented growth, becoming a global hub for healthcare innovation, pharmaceutical production, and biotechnology. Exceptional levels of investment, advancements in online healthcare platforms, and increased government focus on universal healthcare are driving this transformation. With India being one of the largest producers of generic medicines and vaccines, the sector significantly contributes to the global healthcare ecosystem. The future promises even greater potential, with cutting-edge developments in telemedicine, personalized medicine, and artificial intelligence reshaping the way healthcare is delivered. This growth not only improves the nation’s healthcare capabilities but also refines economic prospects by creating jobs, boosting exports, and fostering technological innovation.

However, the sector faces challenges such as stringent regulatory requirements, intellectual property disputes, and complexities in clinical trials and drug approvals. Legal frameworks play a pivotal role in addressing these challenges, ensuring compliance, mitigating risks, and fostering ethical practices. Our law firm offers tailored legal solutions to navigate the complexities of this sector, providing expertise in regulatory compliance, contract management, and intellectual property protection. By aligning legal strategies with the sector’s evolving demands, we empower stakeholders to innovate with confidence, ensure sustainable growth, and contribute to the creation of a robust and resilient healthcare ecosystem that meets the needs of tomorrow.

Service lines
Regulatory Compliance
  • Advising on compliance with the Drugs and Cosmetics Act, 1940, and other relevant laws.
  • Compliance with the Medical Device Rules, 2017.
  • Advisory on Food Safety and Standards Act (FSSA) compliance for nutraceuticals.
  • Guidance on GST, pricing regulations under NPPA, and DPCO.
Intellectual Property Rights (IPR)
  • Patent filing and prosecution for pharmaceutical and biotechnology innovations.
  • Trademark and copyright protection for branding and marketing materials.
  • Enforcement and litigation of patent rights, including compulsory licensing issues.
  • Advisory on data exclusivity and trade secrets protection.
Clinical Trials and Research
  • Legal support for clinical trial agreements and investigator contracts.
  • Compliance with Good Clinical Practice (GCP) and Schedule Y requirements.
  • Ethical committee approvals and documentation.
  • Risk mitigation in clinical research, including participant consent and liability.
Litigation and Dispute Resolution
  • Representation in disputes involving patent infringement and trademark violations.
  • Defense in product liability cases and medical negligence claims.
  • Arbitration and mediation for contractual disputes and licensing agreements.
  • Consumer dispute resolution under the Consumer Protection Act.
Product Liability and Recall Management
  • Advising on liability issues for defective drugs, medical devices, or vaccines.
Data Protection and Privacy
  • Ensuring compliance with data protection laws, including the Personal Data Protection Act (PDPA).
  • Advisory on HIPAA compliance for cross-border operations.
  • Data security and patient confidentiality policies for digital health platforms.
Digital Health and Telemedicine
  • Legal advisory for telemedicine platforms, mobile health apps, and AI-driven healthcare tools.
  • Compliance with the Telemedicine Practice Guidelines, 2020.
  • Structuring agreements for software licensing, development, and partnerships.
Contract Drafting and Management
  • Drafting and negotiating contracts for supply chain, distribution, and manufacturing agreements.
  • Service level agreements with hospitals, healthcare providers, and pharma companies.
  • Agreements for technology transfer, licensing, and intellectual property sharing.
Employment and Labor Laws
  • Compliance with labor regulations for hospitals, manufacturing plants, and R&D centers.
  • Drafting employment contracts, non-compete clauses, and confidentiality agreements.
  • Handling employee disputes, disciplinary actions, and workplace safety compliance.
Biotechnology and Life Sciences
  • Legal advisory on bioethics and bioprospecting laws.
  • Structuring collaborations and agreements for biopharmaceutical research.
Health Insurance and Medico-Legal Advisory
  • Advisory on health insurance claims, disputes, and regulations.
  • Legal support for medico-legal issues, including malpractice and negligence cases.
Ethics and Compliance Programs
  • Development and implementation of compliance programs for ethical practices.
  • Advisory on anti-bribery and anti-corruption laws in the healthcare sector.
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