The Lex Witness 12th Annual Pharma Legal & Compliance Summit 2026
9th October 2026, Taj Santacruz, Mumbai
10th Annual Edition
Pharma Legal & Compliance Summit 2024
25th October, 2024
Friday
Taj Santacruz, Mumbai
Santacruz East, Mumbai
Science. Scale. Scrutiny.
When Science Moves Faster, Can the Law Keep Up?
India’s pharma, life sciences and healthcare sectors are entering a new regulatory cycle. Drug and device rules are evolving. AI is reshaping discovery and diagnosis. E-pharmacy is testing traditional models. Compliance, pricing, competition, patient data and IP are becoming increasingly interconnected.
Â
PLCS 2026 brings together senior legal leaders, policymakers and industry decision-makers to examine the rules shaping the new healthcare ecosystem. 4 focused conversations. 1 rapidly evolving sector. And a legal landscape where innovation, access, accountability and patient safety increasingly meet.
Power Packed & Scintillating Discussions.
Panel Discussions, Focused Presentations & Veteran Talks
08:30 AM – 09:30 AM
#1
REGISTRATION & NETWORKING OVER POWER BREAKFAST
09:30 AM – 09:40 AM
#1
RESERVED FOR SPECIAL ADDRESS
09:40 AM – 09:50 AM
#1
WELCOME REMARKS BY LEX WITNESS
09:50 AM – 10:00 AM
#1
RESERVED FOR SPECIAL ADDRESS
10:00 AM – 11:15 AM
#1
WHO CONTROLS THE CURE? THE NEW HEALTHCARE MARKET
- Draft Drugs, Medical Devices and Cosmetics Bill, 2026 - From approvals and licensing to quality, enforcement and penalties - how could the proposed overhaul reshape the regulatory framework for pharma, MedTech and life sciences?
- The Changing CDSCO Rulebook - How are digitisation, streamlined approvals, post-approval change management, evolving product classifications and licensing pathways, and an increasingly interventionist regulator changing compliance strategy?
- Schedule M - From Deadline to Daily Compliance: GMP, quality systems, data integrity, vendor qualification and pharmacovigilance - what does implementation now demand across manufacturers and marketers?
- Product Quality, Recalls & Liability - FDC action, substandard products, recalls, authentication and post-market responsibility - when does a regulatory action become a boardroom crisis?
- NDCT Rules - The 2026 Reset: As prior approvals give way to prior-intimation pathways, does faster clinical research shift greater compliance risk onto sponsors and researchers - and where should India draw the line between ease of doing business and regulatory oversight?
- Similar Biologics Guidelines, 2025 - How will the revised regulatory pathway reshape biosimilar development, comparability requirements, clinical evidence, approval timelines and market entry in India?
- Drug Pricing & NPPA - Ceiling prices, formulation classification, overcharging, trade margins and patient affordability - where are the next regulatory fault lines?
- M&A, Consolidation & Competition - As pharma, diagnostics, hospitals and healthcare platforms consolidate, what do evolving merger-control norms mean for transactions, due diligence, market definition and post-deal integration?
- Make in India, PLI, Trade & Supply Chains - How are manufacturing incentives, localisation, FTAs, APIs, contract manufacturing and global supply-chain shifts changing investment, sourcing and compliance decisions?
- ESG & Sustainable Healthcare - Environmental compliance, pharmaceutical waste, responsible sourcing, sustainability reporting and governance - is ESG becoming an operational legal issue rather than an annual-report exercise?
11:15 AM – 11:45 AM
#1
NETWORKING BREAK
11:45 AM – 12 NOON
#1
RESERVED FOR A FIRESIDE CHAT / FOCUSED PRESENTATION
12 NOON – 01:00 PM
#1
WHO OWNS THE NEXT CURE? THE IP BATTLEFIELD
- Draft Drugs, Medical Devices and Cosmetics Bill, 2026 - From approvals and licensing to quality, enforcement and penalties - how could the proposed overhaul reshape the regulatory framework for pharma, MedTech and life sciences?
- The Changing CDSCO Rulebook - How are digitisation, streamlined approvals, post-approval change management, evolving product classifications and licensing pathways, and an increasingly interventionist regulator changing compliance strategy?
- Patent Strategy After the Recent Reforms - How are faster examination, disclosure requirements and pre-grant/post-grant challenges reshaping life-sciences prosecution and litigation strategy?
- Data, Know-How & Trade Secrets - How should companies protect clinical, manufacturing, genomic, research and process information that sits outside conventional patent protection?
- Biosimilars & Biologics - Patent thickets, launch strategy, interchangeability, regulatory pathways and litigation risk - where are the next battles likely to emerge?
- Pharma Brands & Patient Safety - Brand-name extensions, look-alike/sound-alike names and deceptive similarity - where does trademark strategy meet patient safety?
- Licensing, Collaboration & Innovation Deals - Research collaborations, technology transfer, co-development, university partnerships and cross-border licensing — who owns tomorrow's molecule, platform or dataset?
- Compulsory Licensing, Public Interest & Access - Where should exclusivity yield to affordability, public-health need and patient access?
- Data Exclusivity & the Race to Market - Could stronger protection for innovators’ regulatory data reshape generic and biosimilar launch timelines, competition and access to medicines in India?
- Patent Term vs Regulatory Delay - Should India reconsider patent-term restoration for pharmaceuticals and biologics where regulatory approval consumes a substantial part of effective patent life — or would that unduly delay generic entry?
- IP Enforcement & Anti-Counterfeiting - As pharma and life-sciences supply chains become more global and digital, how should companies approach injunctions, cross-border investigations and anti-counterfeit enforcement?
01:00 PM – 02:00 PM
#1
NETWORKING LUNCH
02:00 PM – 02:15 PM
#1
RESERVED FOR A FIRESIDE CHAT / FOCUSED PRESENTATION
02:15 PM – 03:30 PM
#1
CODE BLUE FOR COMPLIANCE? HCP ENGAGEMENT TO ACCOUNTABILITY
- UCPMP 2024 - The Compliance Reality: Self-declarations, marketing expenditure, CME/CPD support, samples and documentation — how far has the industry's compliance baseline moved?
- UCMPMD & the Changing MedTech Compliance Framework - Foreign HCP training, travel, hospitality, samples, education programmes and disclosures — what do medical-device companies need to rethink?
- HCP & Hospital Engagement - Gifts, samples, speaker arrangements, consultancy, advisory boards, research grants and institutional relationships — where are today's red lines?
- Digital Promotion & Prescription Drugs - Websites, webinars, social media, influencers, patient campaigns and scientific exchange — when does information become unlawful promotion?
- Anti-Bribery & Third-Party Risks - Distributors, agents, procurement intermediaries, hospital relationships and government tenders — how should companies manage domestic and cross-border exposure?
- Enterprise GenAI — The Risk Inside the Company - Confidentiality, patient information, privileged material, proprietary research and IP leakage — what happens when employees bring public AI tools into everyday workflows?
- Whistleblowers & Internal Investigations - How should companies investigate allegations, preserve privilege and respond before an internal complaint becomes regulatory, criminal or reputational exposure?
- Employment, POSH & the Healthcare Workplace - Workforce investigations, senior-management accountability and the special compliance challenges of hospitals, laboratories, field forces and manufacturing facilities.
- Penalties, Prosecution & Personal Liability - What should boards, directors, senior management and compliance officers document and demonstrate when corporate non-compliance threatens personal exposure?
- Compliance vs Commercial Reality - Can ambitious sales targets, physician engagement, procurement pressure and ethical healthcare genuinely coexist without compliance becoming a box-ticking exercise?
03:30 PM – 04:30 PM
#1
DOCTOR, MEET ALGORITHM. THE NEW AGE PATIENT CARE
- AI-Powered Diagnostics & Clinical Liability: As AI increasingly interprets scans, tests and patient data and influences clinical decisions, how should accuracy and reliability be assured — and who is responsible when patient harm results?
- AI-Assisted Drug Discovery & Draft CRI Guidelines, 2025 - As algorithms increasingly contribute to drug discovery and digital therapeutics, how should India's patent framework approach inventorship, patentability, enablement and disclosure for AI-enabled healthcare innovation?
- Medical Devices Rules - The 2026 Reset - Faster licensing, risk-based scrutiny and revised audit requirements — will regulatory simplification accelerate MedTech innovation and market access without compromising quality and patient safety?
- Software as a Medical Device - Classification, validation, regulatory approval, software updates and post-market responsibility - when does software cross the line into a regulated medical device?
- The Hospital of the Future - As AI, robotics, personalised treatment, remote monitoring and hospital-at-home models reshape healthcare delivery, where do regulation, responsibility and patient safety need to catch up?
- A Clear Rulebook for E-Pharmacy - Would a dedicated, final e-pharmacy framework covering licensing, prescription validation, pharmacist oversight, storage, returns and platform responsibility unlock greater investment and consumer trust?
- Digital Prescriptions & Interoperability - Can authenticated e-prescriptions, ABDM-linked health records and interoperable pharmacy systems reduce fraud, duplicate dispensing and prescription misuse while making online fulfilment smoother?
- Marketplace vs Pharmacy - Clarifying Liability - Would clearer allocation of responsibility among platforms, licensed pharmacies, pharmacists, doctors and delivery partners make the business model easier to scale?
- Patient Data After DPDP - Consent, health records, research datasets, genetic information, secondary use and data-sharing across hospitals, laboratories, CROs, digital-health platforms and pharmaceutical companies.
- Cybersecurity & Connected Care - As hospitals, devices, pharmacies and digital-health platforms become more connected, how should they prepare for cyberattacks and ransomware while protecting patient safety and continuity of care?
04:30 PM – 04:45 PM
#1
VALEDICTORY / CLOSING ADDRESS
04:45 PM
#1
GALA LUCKY DRAW FOLLOWED BY ‘CHAI PE CHARCHA’
Block Your Seat Now!
Avail Special Discounts - Early Bird & More.
Explore More #PLCS2026
Varied Industry Audience with Even More Intense Discussions
0
+
Delegates
0
+
Speakers
0
+
Partners & Sponsors
0
+
Special Invitees
Invited & Confirmed Speakers
Meet the Mighty
Time’s Ticking & Discounts Drying Up
Get in Touch to Avail the Best Deal.
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.
We're Grateful
Sponsors & Partners
Industry Partner
Platinum Partner
Gold Partner
Gold Partner
Silver Partner
Silver Partner
Exibitor
Exhibitor
Restructuring Partner
Gold Partner
Industry Partner
Bronze Partner
Industry Media Partner
Supporting Partner
Supporting Partner
Supporting Partner
Silver Partner
Silver Partner
Supporting Partner
Industry Media Partner
Supporting Partner
Exibitor
Arbitration Partner
Supporting Partner
Supporting Partner
Supporting Partner
Supporting Partner
Silver Partner
Legal Operations Partner
Data Protection Partner
Showcase Yourself
Curate Your Own Sponsorship Wish
Network with a Perfect Blend of Legal Professionals
Audience Profile
Audience Profile
Corporate
In-house General Counsel Community – Legal and Regulatory Heads, R&D Heads, IPR Heads, Data Protection Officers, C level executives, Directors, Stakeholders
Core Legal Community
Judiciary, Law Firms, Law Practitioners and Experts, Managing Partners, Founding Partners, Partners, Allied Industry – CAs, CSs, LegalTech Companies, Solution Providers – SaaS Providers, Publishers
Government & More
Government Machinery – Ministries, Regulators and Policy Makers etc
Multiple Registration Options
Find Your Best Deal
Corporate Registrations
₹7,000 Onwards
TRENDING
1 Seat – INR 10,0002 Seats – INR 7,500 per Seat
3 Seats – INR 7,000 per Seat
Law Firms & Solutions Providers
₹9,000 Onwards
1 Seat – INR 12000
2 Seats – INR 10000 per Seat
3 Seats – INR 9000 per Seat
International Delegates
₹20,000 Onwards
1 Seat – INR 30000
2 Seats – INR 25000 per Seat
3 Seats – INR 20000 per Seat
The Lex Witness Annual Pass
₹40,000 Onwards
MOST PREFERRED
Access to all Lex Witness Summits - Validity: 1 Year1 Pass - INR 60000 per pass
2 Passes - INR 50000 per pass
3 Passes - INR 40000 per pass
Additional Discounts & Offers
Early Bird – 25% Discount for 1st 25 Delegates
Special 15% Discount for SILF Members
Special 15% Discount for all IWIRC India Members
Special Red Carpet for the Ladies – 10% Discount
Lex Witness Subscribers – 10% Discount
*No 2 discounts can be clubbed together
*Taxes Extra as Applicable
