Companies must balance innovation with compliance as India’s pharmaceutical and medical device sectors face evolving regulations. This panel will discuss navigating frameworks like anti-bribery laws, ESG, and trade compliance. Experts will explore strategies for sustainable growth while maintaining regulatory adherence.

• Sustainability and transparency in manufacturing with Good Manufacturing Practices (GMP), utilizing digital health records and blockchain.
• Implications of the FDC ban and compliance with drug safety standards under Section 26A of the Drugs and Cosmetics Act.
• US FDA and EU MDR guidelines for regulatory compliance and market access for designated manufacturers in pharma and medical devices.
• Updates on enforcing whistleblower protections and tackling white-collar crimes
• Navigating the complexities of USFCPA and UK Bribery Act to ensure global anti-bribery compliance.
• Integrating ESG metrics into due diligence processes to address geopolitical risks and environmental concerns in the pharma supply chain.
• UCPMP 2024 emphasizes transparency in digital marketing and influencer endorsements in the pharmaceutical sector.
• New advertising mandates for self-declaration in the food and health sectors and their implications for companies.
• Navigating global trade regulations to ensure seamless operations while managing legal and regulatory risks.

This session will explore the challenges and opportunities created by recent changes. From import duties to data protection, industry experts will discuss the critical regulatory shifts affecting production, compliance, and supply chain management.

• Exploring higher import duties under Atmanirbhar Bharat and industry concerns over financial strain.
• New licensing requirements for Class C and D medical devices to ensure affordability.
• Impact of price ceilings on essential devices and efforts to promote domestic manufacturing.
• Managing product liability litigation and regulatory safety compliance for product recalls.
• Resolving global contract disputes and IP conflicts through cross-border arbitration and mediation.
• Enhancing patient safety with improved pharmacovigilance compliance and adverse event reporting.
• Ministry of Health guidelines on ethical data use in clinical trials, DPDP regulations, and de-identified samples for commercial use.
• Addressing India’s data protection laws and ensuring patient privacy under the DPDPA.
• Managing third parties, compliance, and due diligence in the pharma supply chain.
• Stricter rules under new criminal laws on product liability, environmental impact, fraud, and corruption.

This session will delve into the intellectual property challenges faced by the pharmaceutical industry, particularly in light of technological advancements. Experts will discuss patent linkage, compulsory licensing, and AI-driven innovations while addressing global IP laws and the evolving patent landscape in India.

• Examining how patent linkage in India ties drug regulatory approvals to patent protection and its effects on innovators and generics.
• Simplifying patent procedures and timelines in the pharmaceutical sector under the Patents (Amendment) Rules, 2024.
• Understanding the significance of IPO Issued Form 27 for ensuring the proper utilisation of granted patents.
• The importance of design, trademarks, and trade dress in branding, product differentiation, and preventing counterfeiting.
• Exploring trends in global patent disputes, biologics litigation, and the impact of the TRIPS waiver on IP rights.
• Recent developments in compulsory licensing and their implications for India's pharmaceutical industry's competitiveness.
• Addressing legal uncertainties around the patentability of AI-driven medical devices and innovations in digital health.
• Balancing intellectual property protection with the affordability of biosimilars and generics in the context of data exclusivity.

The pharmaceutical industry's future lies in its ability to integrate new regulations, technologies, and workforce strategies. This session will explore the legal and regulatory aspects of AI, robotics, IoT, and biosimilars while preparing companies for evolving compliance needs.

• Enforcement trends and compliance readiness for POSH regulations in pharma companies and healthcare establishments.
• Reshaping employee contracts, benefits, and working conditions under the Labour Code Amendments.
• Implications of the New Medical Code of Ethics for maintaining ethical standards in the pharma and healthcare sectors.
• Regulatory monitoring of online pharma sales and prescription fraud, with the rise of new digital tools.
• Examining the impact of BoT culture on pharma lawyers and collaborations with third-party logistics providers.
• Managing bias, transparency, and safety concerns in AI-powered healthcare solutions under Responsible AI Use.
• Legal complexities in AI-driven diagnostics, devices, and drug discovery in healthcare.
• Challenges in adopting robotics in healthcare, focusing on patient safety and ethical considerations.
• Legal implications of IoT in healthcare and pharma, focusing on data privacy, cybersecurity, and patient monitoring.
• Exploring legal aspects of pharma and healthcare brands entering the medical devices space, including IP protection.
• Balancing innovation with fair competition in biosimilars, addressing recent litigation and regulatory compliance.