The Lex Witness 11th Annual Pharma Legal & Compliance Summit 2025
26th September 2025, Taj Santacruz, Mumbai
10th Annual Edition
Pharma Legal & Compliance Summit 2024
25th October, 2024
Friday
Taj Santacruz, Mumbai
Santacruz East, Mumbai
Molecule to Market – The Legal Compass for Tomorrow’s Pharma
Join the ultimate confluence of Pharma, Healthcare & MedTech Legal Minds.
With high-impact sessions spanning regulatory reforms, compliance challenges, intellectual property battles, and future-ready tech adoption, the 11th Annual Pharma Legal & Compliance Summit 2025 brings together the sharpest legal experts, policymakers, and industry leaders. From navigating global M&A compliance hurdles to decoding revised GMP mandates and the new DPDPA landscape, this is where India’s Pharma, Healthcare, and Medical Devices sectors set the legal and compliance agenda for the future.
Power Packed & Scintillating Discussions.
Panel Discussions, Focused Presentations & Veteran Talks
REGISTRATION & WELCOME REFRESHMENTS
WELCOME REMARKS BY LEX WITNESS
RESERVED FOR SPECIAL ADDRESS
KEYNOTE ADDRESS
COMPLIANCE Rx: SUSTAINABLE GROWTH IN A REGULATED ERA
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Priyam Dhamankar
Legal & Compliance Director, Company Secretary, Servier India
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Nishita Koltharkar
Sr. Legal Counsel, GlaxoSmithKline Pharmaceuticals Ltd.
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Rajesh Chitre
Sr. Compliance & Data Privacy Officer, Merck
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Ravi Shah
Partner, Cyril Amarchand Mangaldas
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Sanjeev Bhatli
Head- Legal, Compliance and Risk Management, Roche Diagnostics India
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Sonal Verma
Partner & Global Leader, Dhir & Dhir Associates
- Compliance benchmarks under PLI scheme expectations – is India Inc. ready?
- Dealing with stricter CCI merger norms and post-deal compliance.
- Navigating global anti-bribery laws (FCPA, UKBA) in cross-border ops.
- Incorporating ESG, whistleblower and sustainability mandates.
- From tariffs to treaties – FTAs with the EU and US are reshaping Indian pharma’s export outlook.
- India–UK CEPA’s impact on biologics, enforcement, and generics.
- Adjusting for tariff shifts under CEPA, US-China tensions.
- UCPMP and UCMPMD - how can companies adhere to the Codes while aligning with regulatory interpretations and business objectives?
- M&A execution across borders: Understanding post-deal compliance, merger control, and due diligence pain-points in different jurisdictions.
NETWORKING BREAK
FROM LAB TO LAW: NAVIGATING INDIA’S NEW REGULATORY FRONTIERS
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Mayur Vasani
Head of Legal, Southern Asia | Director & CS, India, Kenvue
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Ashwin Sapra
Partner (Head - Pharma & Healthcare), Cyril Amarchand Mangaldas
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Florra K Das
Head Legal - APAC Counsel & Compliance Officer, Carestream Dental
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Neha Ksshirsagar
Director - Legal, India Business R & D MEIC & GCC Global Diabetes Business, Medtronic India
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Vikramsinh Yadav
Legal Head - Business Partner, Bayer Pharma, Consumer Health & Radiology India
- Revised Drugs (Amendment) Rules, 2023, challenges with respect to pharmacovigilance obligations and adverse event reporting.
- With the December 2023 revision of Schedule M introducing stricter GMP norms and phased deadlines for large and SME manufacturers, how can the industry ensure timely upgrades and audit preparedness without disrupting production and supply continuity?
- The new age of indemnity: how evolving pharma risks are reshaping indemnity clauses.
- Import duty hikes, Schedule M, and India’s ‘Atmanirbhar’ push.
- Fixed-dose combination bans, GMP tightening, and product recalls.
- Navigating DPDPA requirements for clinical and patient data.
- Managing third-party distributor liabilities and supply chain due diligence.
- NPPA reform and proposed Drugs & Medical Devices Order updates.
RESERVED FOR A FIRESIDE CHAT
NETWORKING LUNCH
RESERVED FOR A FOCUSSED PRESENTATION
INNOVATION EQUATION: PATENTS, PATIENTS & PHARMA PRIORITIES
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Dr. Alok Kulshreshtha
Senior IP Professional, Glenmark Pharmaceuticals
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Amitavo Mitra
Partner, Saikrishna & Associates
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Dr. Latika Dawara
Assistant Controller Of Patents & Designs, Mumbai Patent Office
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Kartikay Vikrant Singh
Senior Associate, ADP Law Offices
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Mukund Thakkar
Senior Vice President-Legal, Zydus Group
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Rajeshwari Hariharan
Counsel, Delhi High Court
- Faster timelines and Form 27 reform under Patent Rules 2024.
- Expedited examination initiatives to reduce patent pendency and boost innovation speed.
- Reforms in pre-grant opposition and pre-grant proceedings for greater transparency and accountability.
- Branding through trademarks, trade dress.
- The naming puzzle – navigating Section 13 and brand-building challenges.
- Global IP changes: TRIPS waiver, EU exclusivity cuts.
- The compulsory licensing debate – competition vs. innovation.
- Delusion of IPR – Cross-border investigations, TRIPS blurring innovation protection?
- AI-driven drug patents and disclosure dilemmas.
- No data exclusivity in India – advantage or limitation?
MAN, MACHINE & COMPLIANCE: FUTURE-PROOFING PHARMA LAW
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Harshakumar Shetty
Compliance Head, Bharat Serums & Vaccines
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Debolina Partap
Senior Vice President Legal and Group General Counsel, Wockhardt
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Priyam Lizmary Cherian
Associate Partner, Saikrishna & Associates
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Rakesh Chandra Sinha
Vice President Legal, Sun Pharma
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Ruchita Mody Gandhi
Head - Legal & Compliance (India & South Asia), Galderma
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Tanhieya Ghosh
General Counsel - India, Singapore and Malaysia, Solventum
- Criminal liability for CXOs in cases of drug quality lapses and regulatory non-compliance.
- Labour Code rollout and revamped employment frameworks.
- POSH compliance enforcement and cultural transformation.
- Can consistent internal training and ethical reinforcement reduce legal risks?
- GenAI tools in workflows - mitigating risks of uncontrolled data exposure, IP leakage, etc.
- CDSCO’s expanding oversight to cover software and AI-based medical devices.
- NMC vs. pharma: gifts, ethics, and rethinking doctor engagement.
- Telehealth oversight, eRx fraud, and platform regulation.
- Cyberattacks and ransomware – reactive & proactive steps.
- AI/ML, IoT and robotics: managing regulatory blind spots.
- AI and digital health tools - striking the right balance between tech adoption, patient safety, and ethics.
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Whether you are a legal advisor to various corporates in the healthcare, pharma, med-tech domain or you are heading legal, risk, compliance, data protection mandates, this summit has a lot to offer.
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