Medical Affairs function at bio-pharmaceutical companies plays a vital role in bridging the gap between commercial and R&D operations. Evidently, across the global healthcare landscape, the Medical Affairs function is essential to meeting current challenges in clinical development, market education, and regulatory compliance. In India, the Medical Affairs function is still developing, following a similar path to maturity as that traveled by MA groups in Mature Markets. Medical Affairs groups in India need to establish a clear value proposition in order to evolve beyond their traditional roles. Best Practices, LLC's recent case study illustrates how mature and Indian biopharmaceutical companies include Abbott, Alkem Laboratories, AstraZeneca, Biocon, MSD Pharma, Ranbaxy, Sanofi & Astellas Pharma are structuring and managing their Medical Affairs organizations today. The study also examines recent trends in budget and staffing resources, key challenges and top success factors for the function particularly for Indian organizations.

1. BEST PRACTICES,
®
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Best Practices, LLC Strategic Benchmarking Research
Building Best-in-Class Medical Affairs
Capabilities In India – A Case Study
For High-Growth Emerging Markets

2. BEST PRACTICES,
®
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Table of Contents
 Executive Summary pp. 3-12
 Research Overview pp. 3
 Participating Companies pp. 4-5
 Key Recommendations pp. 7-8
 Maturity of Medical Affairs pp. 9
 Key Findings & Insights pp. 10-12
 Scope & Structure pp. 13-18
 Leadership & Oversight pp. 19-25
 Regulatory Landscape & Challenges pp. 26-30
 Spend Allocation pp. 31-36
 Staffing pp. 37-46
 Functional Responsibility pp. 44-50
 Budget Trends & Success Factors pp. 51-54
 Participant Demographic Data pp. 55-59
 About Best Practices, LLC pp. 60-61
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Field Research & Insight Development:
Surveyed 68 Medical Affairs leaders at 50 different
pharmaceutical and medical device companies
across mature Global markets.
Compared an India market class from 8 respon-
dents at 7 India companies with global benchmark.
Conducted Deep-dive interviews with Medical
Affairs veterans at seven leading companies. .
 Optimize Budget Allocation
 Improve Staff Management
 Increase Overall Effectiveness
Research Objectives & Methodology
Research Objectives:
 Illustrate how leading Global and Indian pharmaceutical and medical device companies structure and
organize their Medical Affairs functions based on industry and market changes.
 Identify trends expected to impact the allocation of resources across different Medical Affairs functions.
 Analyze how regulatory requirements are internalized and managed by Medical Affairs.
 Describe the success factors and top current challenges regarding Global & Indian Medical Affairs.
 Identify what percentage of MA budget leading companies allocate to outsourcing.
 Trace how successful Medical Affairs organizations work cross-functionally to enhance effectiveness.
Business Objectives:
Across the global healthcare landscape, the Medical Affairs function is essential to meeting current
challenges in clinical development, market education, and regulatory compliance. This research – which
delivers current comparative metrics, executive insights, and best practices from Medical Affairs leaders
throughout the industry – specifically probes the state of Medical Affairs in the India marketplace.
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Universe of Learning: Participants in Benchmark Study
Benchmark Class
This study engaged 68 Medical Affairs leaders from 50 leading healthcare companies in a
benchmarking survey. Best Practices, LLC analysts also conducted deep-dive interviews with
executives at seven leading companies to harvest additional insights.
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5. BEST PRACTICES,
®
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Defining Medical Affairs and Key Functions
Best Practices, LLC conducted this benchmarking study to identify best practices and innovative
methods for developing a Medical Affairs function capable of meeting diverse goals.
Medical Affairs: Refers to all the functions dedicated to building and maintaining
relationships with physicians and the medical community, including, but not limited to, the
following:
Medical Education: Responsible for CME & educational grants.
Medical Communications & Publications: Develops or reviews scientific/medical content--including
medical journal articles--for communications to healthcare professionals, patients, consumers and
payers. Develops/ manages publication plan. Includes medical information call center.
Medical/Clinical Research Operations: Creates and guides strategy for clinical development
programs. Develops and executes investigator and company-initiated clinical studies, including cost-
marketing/ Phase IV studies. Includes Medical Directors.
Medical/Scientific Liaisons (MSLs): Non-sales field force responsible for medical relations & training.
Outcomes Research: Collects and analyzes Health Outcomes/ Economics data.
Phamacovigilance/Safety: Oversees the collection and analysis of information on adverse drug
reactions.
Thought Leader Management: Responsible for the identification, recruitment and development of
physicians who can influence the medical perspective and practice of their peers.
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Demonstrate Medical
Affairs Value to
Commercial/
Marketing
 Medical Science Liaison (MSL) groups are virtually non-existent in India,
though they are rapidly growing in mature markets focused on clinical
education. The concept of clinical and off-label communication is evolving in
India. As the market becomes more research-driven, the need for MSL staff
equipped to handle diverse clinical discussions is expected to grow.
MSL Staffing
Increase Likely
Engagement with
Management and
Commercial
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High-Level Key Findings: Medical Affairs Function in India
Ensure Medical
Affairs Directive
Comes from Top
 Successful Medical Affairs groups often thrive because Corporate realizes
they provide value-added services. In India, the Medical Affairs group is still
seminal, and removing ambiguity in reporting relationship and structure will
be beneficial in future.
 Traditionally. the Indian Pharmaceutical industry is sales & operations
driven. Moreover, it is still rapidly evolving. The Indian Medical Affairs
function is highly focused and linked to commercial. Mature markets have
been shifting reporting away from commercial. Clear metrics highlighting
MA value is a current and future need for continued evolution in India.
 India-based management teams give less importance to MA because their
primary focus is sales and commercial development. MA must show that
clinical excellence and commercial growth are married in mature markets.
 India MA are starting to make the case that sound clinical practices, which
safeguard customers and the company, is also sound business practice.

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Centralized
organization
(serving entire
enterprise under
one
administration/
budget), 22%
Decentralized
by region,
22%
Decentralized
by
therapeutic
area, 33%
Hybrid (some
functions
centralized &
others
decentralized),
22%
Medical Affairs Is Decentralized at Indian Companies
The Indian regulatory and market landscape is very different from those in mature markets. Moreover, the
Indian pharmaceutical industry is highly fragmented with more revenue coming from OTC drugs. Due to
this, 77% of Indian benchmark companies prefer some form of decentralization for Medical Affairs,
compared with 56% of the mature markets companies.
Q. Which of the following best describes the current structure of Medical Affairs at your company?
(choose one)
Centralized
organization
(serving entire
enterprise under
one
administration/
budget),
42%
Decentralized
by region,
11%
Decentralized
by
therapeutic
area, 9%
Hybrid
(some functions
centralized &
others
decentralized),
36%
Other , 2%
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Current Structure
(n=9)(n=53)
Mature Markets Segment: India Segment:
*
*Other:
• Decentralized by region and TA

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Reporting Patterns Not Clearly Set in Indian Bio-Pharma
Companies
Q. What is the job level of the person who currently heads Medical Affairs? (choose one)
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Leadership
(n=8)(n=53)
Mature Markets Segment: India Segment:
Chief Medical
Officer, 19%
Senior/
Executive
Vice
President,
25%Vice
President,
38%
Senior/
Executive
Director, 11%
Director, 8%
Even though a dedicated Medical Affairs function exists at most of the benchmarked companies in India,
there is no clearly defined reporting relationship, indicating the group is still in its formative stages. At
33% of companies Medical Affairs reports into a Director, while 34% report into a VP. On the other hand,
63% of mature market companies report to the Vice President level or above.
Chief Medical
Officer
11%
Vice
President
34%
Senior/Execut
ive Director
22%
Director
33%

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4%
2%
2%
2%
2%
10%
4%
4%
6%
2%
4%
44%
46%
25%
33%
25%
19%
31%
23%
26%
44%
25%
40%
40%
23%
19%
24%
25%
33%
33%
34%
44%
Medical Education
Pharmacovigilance/Safety
Thought Leader Management
Medical/Clinical Research Operations
Medical Communications &
Publications
Medical/Scientific Liaisons
Outcomes Research
Much Less Important Somewhat Less Important No Change Somewhat More Important Much More Important
In India, Outcomes Research & MSLs Are Rapidly Gaining In
Importance for Medical Affairs
Although spend and resource allocations favor Medical/Clinical operations, 67% of benchmark
participants in India consider Outcomes Research as gaining in importance for a company’s future
success, while 74% spotlight MSLs as gaining importance. This trend is similar to the mature market
benchmark class.
Q. In your recent experience, have the following Medical Affairs functions become more or less
important to the overall success of your company? (choose one response for each functional area)
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India Segment: Importance of Medical Affairs Functions
(n=8)

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About Best Practices, LLC

11. BEST PRACTICES,
®
LLC
Best Practices®, LLC is an internationally recognized thought leader in the field of best practice
benchmarking®. We are a research, consulting, benchmark database, publishing and advisory firm that
conducts work based on the simple yet profound principle that organizations can chart a course to superior
economic performance by leveraging the best business practices, operating tactics and winning strategies of
world-class companies.
Learn More About Our Company:
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Chapel Hill, NC 27517
(Phone): 919-403-0251
www.best-in-class.com
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(Phone): 022-2515 1836