4th Annual Edition

PLCS 2015
Pharma Legal & Compliance
Summit 2015
in association with
IP SOLUTIONS PARTNER

COMPLIANCE PARTNER

GOLD PARTNER

SILVER PARTNERS

ASSOCIATE PARTNERS

GMP PARTNERS

TECHNOLOGY SOLUTIONS PARTNER

LEGAL RESEARCH SOLUTIONS PARTNER

LANYARD PARTNER

16th October 2015 | The Leela, Mumbai

MEDIA PARTNERS

SUPPORTING PARTNERS

FRATERNITY PARTNERS

HEALTHCARE COMMUNICATIONS PARTNER

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LITCOM PARTNER

summit
concept
THE INDIAN PHARMACEUTICAL MARKET A BACKGROUND
The Indian pharmaceuticals market is third largest in terms of volume and thirteen largest in terms of value, as per a
pharmaceuticals sector analysis report by equity master. The market is dominated majorly by branded generics
which constitute nearly 70 to 80 per cent of the market. Considered to be a highly fragmented industry,
consolidation has increasingly become an important feature of the Indian pharmaceutical market. India has
achieved an eminent global position in pharma sector. The country also has a huge pool of scientists and engineers
who have the potential to take the industry to a very high level.
The Indian pharmaceutical industry is estimated to grow at 20 per cent compound annual growth rate (CAGR) over
the next five years, as per India Ratings, a Fitch Group company. Indian pharmaceutical manufacturing facilities
registered with US Food and Drug Administration (FDA) as on March 2014 was the highest at 523 for any country
outside the US. (IBEF)
UNFOLDING THE LEGAL HASSLES & CHALLENGES
The Indian Pharmaceutical Industry has been one of the most vibrant and forward moving business fabrics of the
economy. At the same time, the industry has been through roadblocks in terms of the stringent legal and regulatory
environs of the country.
The summit kick-starts COMPLIANCE as its key mandate and focus as its Key Note Session. The session. The
session encompasses various aspects right from the manufacturing hubs to the doorstep of pharmacists. On the
other hand, the digital boom hasn't been so well for this part of the India Inc. as players struggle yet to understand
the regulatory aspects attached. And that's not all would there be a player who would confess non-compliance if
so why and how!
Creating a property is where the wars begin from. In today's scenario of a rat race across industry sectors,
protecting a creation for successful monetization happens to be the key to standing apart. The session elaborates
on all possible strata of INTELLECTUAL PROPERTY right from the phases of implementing it and sustaining the
commercial value. Having said that, counterfeiting happens to be struggle even today and unfortunately for the
creators! This and much more to hear to.
M&A and FDI talks of the legal corridors! India Inc. has witnessed and set benchmarks via noticeable mergers and
acquisitions in place. Whether it is the pre-existing legal liabilities of an entity being eyed on for acquisition or a
typical case of a merger, it is indeed a fine eye that's required to keep all checks in sync. Can there be master check
list to be followed? Let's see what the experts have to say.
The PATENTS ecosystem in India has been as innovative and inventive as the nature of the sector itself. The legal
aspects around the patenting complexes include not one but many areas of complications and challenges at the
same time. Whether, the introduction of a new product or licensing as a subject, the sector needs clarity and global
intellect in place to combat the global pressures that India is currently facing. An overview of the topical talk points.
REGULATIONS by the literal sense intends at controlling and not limiting. Is there a misbalance between
sentiments of a patient and that of the industry? Is there a need of relooking at Regulations from a global
perspective? Howsoever, complicated and complexed the situations may be, it is inevitable for the industry to
adopt and comply with the regulations in place, and keeping all business interests in place as well. Listen to the
veterans to know the award winning secrets.

message from
the summit chairs desk

message
Dr. Lalit Bhasin,
President, SILF
Dear Patrons,
The Indian Pharmaceutical Sector has been through a stride of legal and
regulatory affairs and shall continue to go through keeping in mind the
huge stakes involved and sensitivities like patient care etc. It becomes
inevitable for the industry to have the best of legal intellect and force in
place to efficiently combat with the business challenges involved while
adhering to the law.
The 4th Annual Pharma Legal & Compliance Summit 2015 scheduled
for 16th October 2015, The Leela, Mumbai has been created and
architectures for over 3 years now focusing on the legal undercurrents of
the Indian Pharmaceutical Sector.
I am happy to see yet another knowledge sharing initiative that Lex
Witness & The Society of Indian Law Firms are jointly bringing to the
industry. The summit shall focus and deliberate on various subjects right
from Compliance to Patents.
I am sure that the summit shall provide great take home learnings and
messages keeping in mind the impressive line-up of speakers and
partners associated.
Look forward to your participation at the summit.
Dr. Lalit Bhasin,
President, Society of Indian Law Firms

confirmed
speakers
Debolina Partap, Vice President Legal & General Counsel, Wockhardt Group,
Summit Chair, PLCS 2015
Dr. Rajesh Kumar Singh, Assistant General Manager - IPR, Indoco Remedies
Ameet Datta, Partner, Saikrishna & Associates
Ameya Kamat, Country Manager: Enterprise Content Management, IBM Analytics
Bhawna Sharma, Patent Agent, S.S. Rana & Co.
Ghanashyam Hegde, Associate Director - Legal, Abbott India
J. Sai Deepak, Associate Partner, Saikrishna & Associates
Jayashree Swaminathan, Director, Dhir & Dhir Associates
Mahalaxmi Andheria, Vice President, Intellectual Property Cell, Panacea Biotec
Meera Vanjari, Sr. Vice President and General Counsel, Glenmark Pharmaceuticals
Nanda P.B.A. Kumar, Executive Vice President & Board Member, Pharm Ops
Nishant Singh, Partner, IndusLaw
Rahul Gupta, General Manager, Corporate Regulatory Affairs, Piramal Enterprises
Rajiv Joshi, Partner, Fraud Investigation & Dispute Services, EY
Ray Thomas, Global Subject Matter Expert (Legal & Data Privacy), IBM
Rajgopal Kumar, General Manager - Legal, Lupin Pharmaceuticals
Rupali Lonkar, Asst. Manager - Legal, Wockhardt
Sanjay Kumar, Head Legal, Piramal Imaging SA
Subodh Prasad Deo, Partner, Saikrishna & Associates
Suraj Singh, Head Legal & Compliance, Sandoz
Taranpreet Singh Lamba, VP - Intellectual Property, Glenmark Pharmaceuticals
Vivek Mittal, Legal Counsel, Lupin Pharma

the agenda
09:00 SUMMIT REGISTRATION & MORNING REFRESHMENTS
09:30 OPENING REMARKS BY LEX WITNESS
09:50 SPECIAL ADDRESS BY SUMMIT CHAIR
DEBOLINA PARTAP, VICE PRESIDENT LEGAL AND GENERAL COUNSEL, WOCKHARDT GROUP
10:05 KEYNOTE SESSION: DEMYSTIFYING COMPLIANCE
Ever wondered, what is the cost of compliance? Or shall we say the cost of non compliance. In the current scenario of
governance where Manufacturing has been a key point agenda under the Make In India initiative, the legal
undercurrents and hence the criticality of staying compliant has increased manifold. The session encompasses various
aspects right from the manufacturing hubs to the doorstep of pharmacists. On the other hand, the digital boom hasnt
been so well for this part of the India Inc. as players struggle yet to understand the regulatory aspects attached. And
thats not all would there be a player who would confess non-compliance if so why and how!
Good Manufacturing Practices | Good Supply Chain Practices | USFDA Compliance Issues: Backup Strategy
Anti-Trade/Bribery/Corruption - FCPA, UK Anti-Bribery & PCA
Product Promotion - UCPMP & Global Perspective
Voluntary Disclosure of Non Compliance
Pharma Covigilance
Product Liability Compliance

11:15

NETWORKING AND REFRESHMENT BREAK

11:45

FOCUS PRESENTATION by Ray Thomas Jr., Esq.,Global Subject Matter Expert (Legal & Data Privacy), IBM
INFORMATION GOVERNANCE (IG) AND THE USE OF TECHNOLOGY TO SATISFY LEGAL REQUIREMENTS & ACHIEVE
REGULATORY-COMPLIANCE
Counselor Thomas is a member of the Enterprise Content Management Groups world-wide Information Lifecycle
Governance Team. This IG-focused presentation will include industry specific use-cases to illustrate how technology can
help Indian pharmaceutical companies satisfy legal requirements & achieve regulatory-compliance.

12:05

UNLEASHING THE SCIENCES OF TRADEMARKS & COPYRIGHT

Creating a property is where the wars begin from. In todays scenario of a rat race across industry sectors, protecting a
creation for successful monetization happens to be the key to standing apart. The session elaborates on all possible
strata of intellectual property right from the phases of implementing it and sustaining the commercial value. Having said
that, counterfeiting happens to be struggle even today and unfortunately for the creators! This and much more to hear
to.
Trademarks Enforcement Issues
Trade Dress
Madrid Protocol in India
Copyright
INN Names
Trade Secrets

13:05 NETWORKING LUNCH

14:00 M&A AND FDI RIDES OF THE INDIAN PHARMA SECTOR

India Inc. has witnessed and set benchmarks via noticeable mergers and acquisitions in place. FDI no doubt has played a
very active role in creating a favourable environment in the sector. However, these realms have always been through
their own set of challenges especially in the regulatory frameworks. Whether it is the pre-existing legal liabilities of an
entity being eyed on for acquisition or a typical case of a merger, it is indeed a fine eye that's required to keep all checks
in sync. Can there be master check list to be followed? Let's see what the experts have to say.
Due Diligence
Regulatory Bodies FIPB | DIPP | CCI
Challenges in executing a M&A Transaction

14:45 FOCUS PRESENTATION by Rajiv Joshi, Partner, Fraud Investigation & Dispute Services, EY
15:05

AN INSIGHT INTO THE CURRENT PATENT SCENARIO IN INDIA

The patents ecosystem in India has been as innovative and inventive as the nature of the sector itself. The legal aspects
around the patenting complexes include not one but many areas of complications and challenges at the same time.
Whether, the introduction of a new product or licensing as a subject, the sector needs clarity and global intellect in place
to combat the global standards that India is poised towards. An overview of the topical talk points.
Patents as incentives for R&D
Patent Criteria
Patent Enforcement
Compulsory Licensing
Voluntary Licensing - In Licensing/Out Licensing
Compliance Protocol of the Indian Patents Act
Challenges of Introducing a New Product
Global Pressures on Indian IP Policies
IP Portfolio - Identify, Protect, Valuate, Monetize
Data Exclusivity

16:05 NETWORKING BREAK

16:35 THE REGULATORY SAGAS & THE CHALLENGES WITHIN
Regulation by the literal sense intends at controlling and not limiting. Is there a misbalance between sentiments of a
patient and that of the industry? Is there a need of relooking at Regulations from a global perspective? Howsoever,
complicated and complexed the situations may be, it is inevitable for the industry to adopt and comply with the
regulations in place, and keeping all business interests in place as well. Listen to the veterans to know the award winning
secrets.
Clinical Trials
Drug Price Control Order 2013
Competition Act
Co Manufacturing & Co Branding Practices
D&C Act Counterfeiting (Misbranding & Adulteration)
UCPMP & MCI Guidelines

17:30

CLOSING REMARKS BY SUMMIT CHAIR

17:45

CLOSING REMARKS BY LEX WITNESS

18:00

SUMMIT CONCLUDES

audience
profile
The Pharma Legal & Compliance Summit ever since its inception in 2012 has been gaining huge
interests of participation across various industry sectors and individual profiles. Below are a few
mentioned organizations as well as individual profiles that have direct relevance with the summit.

Law Firms &

Solution Providers

focus
groups
law
firms
Generic Pharmaceutical
Manufacturers
Innovative Pharmaceutical
Manufacturers
API Manufacturers
Regulatory Consultants

pharma
firms

bio
pharma
firms

bio tech
firms

regulatory
authorities

Ingredient and Material Supplier

Analytical Laboratories
Laws Firms specializing in
Pharmaceutical law
Patent Filing Consultants
Business Strategy Consultants
Legal Firms
Associations
CROs
Bio Tech Firms
Medical Device Manufacturers
Pharma/Bio Pharma Firms

regulatory
consultants

patent
filing
consultants

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The summit has a huge range of participation scopes in the form of

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