Agenda

08:30 AM SUMMIT REGISTRATION & MORNING REFRESHMENTS
09:30 AM OPENING REMARKS BY LEX WITNESS
09:35 AM OPENING REMARKS BY DR. LALIT BHASIN, PRESIDENT, BAI & SILF
09:45 AM THE SUMMIT CHAIR’S ADDRESS BY DEBOLINA PARTAP, VICE PRESIDENT LEGAL & GENERAL COUNSEL, WOCKHARDT
10:00 AMINDIA’S STAND ON THE PHARMA TURF – GOOD ENOUGH?

Challenge to Strike Balance between Righteous Use of Trademarks & Commercial Interests
US Pricing Pressures – Continued Overhang & Impact on R&D – Anti Trust Investigations
China’s Turn for Indian Pharma as U.S. Trade Seems Cloudy?
The MedTech Europe Code – Is India Inc. Ready?
USFDA’s Approval on 1st AI based Medical Device – Encouraging Enough?

The IFPMA Code of Practice – India’s Readiness & More
Non-Compliance with Global Standards – Shutting Down of Plants – Role of Counsel

Accounting Standards – Disclosure Requirements
Is India Inc. Ready for the MDSAP?
BEPS Guidelines – A Stump Off to Pharma Sector?
Ayushman Bharat Yojna vis-à-vis Fate of MNCs – Legal and Business Challenges
The Biosimilars Debate – Regulatory Challenges in Indian Legal Framework
Lack of Regulations – Guidelines Interpretation and Current Regulations
Proposal to Introduce Stem Cell Research Under D&C Rule – Good for Science?

Committee of Experts Under DPCO, 2013 – Blissful Hope?
Para 3 of DPCO – Autocratic Application?
Para 32 of DPCO – A Thoughtful Implication?
Scarcity of Frusemide Syrup – Contrasting Opinion on Drug Pricing Control?
Focus Shift – Need to Shift from Price to Quality?
NITI Aayog’s paper on ‘Rationalisation of Trade Margins in Medical Devices’
Need to Relook at Cost Mechanisms – Input Costs, Cost of API etc.

11:10 AM FOCUSSED PRESENTATION – EFFECTIVE HANDLING OF PHARMA DISPUTES THROUGH ARBITRATION BY LAW SENATE
11:30 AM NETWORKING BREAK
12:00 PMIPR – IS THE INDIAN PHARMA SECTOR POISED TOWARDS INNOVATION?

India’s IPR Regulation – Unfriendly to Global Businesses?
Proposed EU IPR Enforcement Mechanism – Impact on Indian Generic Drugs
Lack of Incentivisation to Academics, Research & Innovation – Compromise on Quality?

Big Debate – Process Patents vs Product Patents
Section 16 of the Patents Act – Delineating Frivolous Filings?
Patent Linkage – Still a Requisite for Indian Pharma?
Patents vs. Early Market Entry of Indian Generics
Managing the Issue of Reduced Patent Life

Indian Patents Act & Rules – A Journey from TRIPS Compliance to a Mature Patent Regime?
Selection Patents – An Area with Promising Thoughts Within?
Patent infringement Litigation – Recent Learnings & Key Takeaways
Patentability of Medical Devices & Medical Procedures – Business Assets?

Trademarks & Trade Dress wrt Confusion in Marks of Pharmaceutical Products – Pros & Cons
Counterfeit – Criminal Pursuits – Copyright Act Sec 63A, Sec 420 IPC – Relevance etc.
Risk Assessment wrt Portfolio Management
Brand Importance for Generic Medication
Trademark Infringement wrt Parallel Imports of Similar Names

01:30 PM NETWORKING LUNCH
02:10 PM FOCUSSED PRESENTATION BY ECONOMIC LAWS PRACTICE
02:30 PM THE REGULATORY RHYMES – GOOD TO KNOW!

Drugs and Cosmetics (Tenth Amendment) Rules, 2017
GMP wrt Audit and Inspection Challenges
Essential Commodities (Control of Unethical Practices in Marketing of Drugs) Order, 2017

Amendments to The National Medical Commission (NMC) Bill
Recent Labour Law Amendments – Gratuity/Maternity etc. – Impact Assessment
Medical Representatives – Defining Minimum Wages – Non-Uniformity
Patient Rights, Consumer Protection vis a vis Medical Negligence – An Ongoing Debate?

CCI’s Whip on Practice of Mandating NOC
Overlap between Competition Law and Indian Patent Act for Indian Pharma

Honouring the Confidentiality of Clinical Trial Data – Innovations Vs. Generics – Ongoing War?
Need to Increment Innovation – DPCO’s Blind Eye?
Third Party Due Diligence – Trade Sanction related Compliances

Bio Medical Wastes – Management & Control
Pollution Control Mechanisms – Impactful Enough?

Procurement of Medical Devices Under PPO 2017 – Justified Enough?
The Medical Devices Rules – Classification, Need for Autonomous Body?
Risk Classification of Medical Devices & IVDs – How Well is the Countdown Going?
Alteration to Definition of a Startup – A Relief For The Biotech Sector?
Grouping Guidelines for Medical Device Applications
Health Ministry’s Recent Notification to Cos. for Mandatory Disclosure

03:50 PM FOCUSSED PRESENTATION – CONTEMPORARY ISSUES UNDER INCOME TAX ACT – PHARMA FOCUS BY SINGH & SINGH LAW FIRM LLP
04:10 PM NETWORKING BREAK
04:30 PM DATA & TECH TALKS – IS INDIA INC. READY?

DISHA – Is India Gearing Up Well?
Access to Digital Health Data – Possible Breaches?
Absolute Prohibition – Impediment to Clinical Research?
Non-Compliance to Guidelines – Lack of Clarity? | Social Media as Threat to Confidential Information
Devising a Growth Strategy by Big Data Analysis – Data Protection & Privacy
Eliminating Chances of Breach of Confidentiality | Securing Patient Data – Leakage of e-prescription Information
The Growing Role of Automation in the Pharmaceutical Industry
Use of Artificial Intelligence for Drug Discovery
Cyber Security – Proactive Measures for Ransomware Attacks
Need to strengthen know-how in regulations including Cyber Security & Anti-Bribery
Data Driven Insights – Criticality for Drug Value Assessment & Decision Making
Developing Integrated Clinical Research Frameworks & Big Data Analysis
e-Pharmacies in India – Booming Present & Uncertain Future – Orphaned Regulations?
e-Pharma Liabilities – Intermediary Vs. Aggregator – Probable e-Pharmacy Models – Inventory & Marketplace
Cloud Computing – Legal & Regulatory Challenges w.r.t Indian Pharma Sector
Driving ROI & Risk Mitigation through effective Contract Lifecycle Management
Role of AI in Outperforming Rivals via Smart Contracting

05:15 PM GALA LUCKY DRAW FOLLOWED BY SUMMIT CLOSING

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