Indian Pharmaceutical Industry
Overview and Way Forward
August 2023
Indian Pharma: Global Manufacturing Powerhouse
Global Trade
20% 3rd largest 14th largest
of total global exports of
generic drugs Volume Terms Value Terms
Outcomes
Economic
2.7 Mn USD 17.5 Bn USD 50 Bn
Annual trade surplus;
Jobs created directly Total market size in
One of the top 5 sectors
and indirectly 2021-22
reducing trade deficit
02
India has played a significant role in global healthcare
36% 95% 100%
Lower per person disease burden Lower treatment costs of life-threatening Eradication of Polio by collaboration
in India (DALY, 1990-2016)3 diseases (Hep-C, Leukemia)1 between all stakeholders2
60% 37% 1 of 3
Global vaccine demand With access to affordable AIDS treatment in Pills taken in the US
Supplied by India5 Africa in 2009 through ARVs V/s 2% in 20036 are by Indian manufacturers4
1 Access to Costly New Hepatitis C Drugs: Medicine, Money, and Advocacy, Oxford Journals, Vol 61, Issue 12; Changing the cost of care for chronic myeloid leukaemia, PMC, October 2015; 2 Press Information Bureau, WHO;
3 Measured as Disability Adjusted Life Years (DALYs) after adjusting for changes in population age structure; ICMR, Public Health Foundation and Institute of Health Metrics and Evaluation; 4 IQVIA 2019;
5 Press Information Bureau; IDMA report; 6 African Business Magazine 2012;
7 Export Import Data Bank, Department of Commerce, PHARMEXCIL, IDMA report on “Journey towards Pharma 2020 & beyond”;
8 Indian life sciences: Vision 2030, FICCI June 2015, Growth estimated by IHS Market;
9 RBI Database on Indian Economy, Department of Industrial Policy and Promotion
03
The pharma industry has evolved over a period of time
Pre-1970s 1970 - 2005 2005 - 2020 2020 onwards
Prior to process Post impln. of Post reform & The next
patent regime process patent product patent decade
▪ Limited ▪ Decades of strong ▪ Gradual rerating of ▪ Innovation and Quality
penetration; growth and growth from 8-9% to
market penetration, driven 13-15% levels ▪ Building API
dominated by by low cost process Self-reliance
innovators reengineering and ▪ Driven by growth in
manufacturing affordability and ▪ Ease of Doing Business
some progress in
▪ Balance tilted access ▪ Significant build-up in
towards local players accessibility and
▪ Liberalized market acceptability
▪ Export initiatives -Indian companies
taken going beyond India ▪ Global strategic alliance
04
COVID-19 : Most unprecedented humanitarian crisis
❑ Indian Pharmaceutical industry showed resilience, supplied quality-assured medicines to over
150 countries
❑ The Industry, Government and Regulators worked together and constantly adapted to meet the
challenging environment : Collaboration among all stakeholders across the world
❑ Biggest vaccination program in the world -
44.9 Million 0.53 Million 2.2 Billion
Total Cases in India Total Deaths in India Total Vaccination in India
Note: Data as on 12 August 2023
05
India ensured an uninterrupted supply of medicines
❑ Industry stepped up to the plate to meet the challenges posed by COVID-19 with thrust on digitalisation
and collaboration
❑ High-level of engagement with the Government of India : Pharmaceuticals recognized as Essential Goods;
Permissions granted for ensuring continuity of Transport and Logistics
❑ Coordination with industry associations in India and with WHO, IGBA, AAM and others
85-90 90-95 85-90 90-95 85-90 90-95
75-80
65-70 65-70
15-20
<10 <10
Manufacturing Transportation & Logistics Ancillary Services
06
Ensuring employee safety and wellbeing at facilities
Successful implementation of safety protocols across the industry has limited the spread of COVID-19
07
Integrated efforts to upgrade and share the best practices
White paper on Reviving • A benchmark for digital White paper on
the domestic API infrastructure for Reviving the Pharma
Industry world’s largest Ancillary Industry
vaccination drive
Policy initiatives for
self-reliance on API • E-governance for
faster approvals of
drugs, vaccines
08
Key initiatives by the Government of India
Policy to boost manufacturing of APIs/KSMs and thrust on value-added
formulations
1 R&D Policy to enable an innovation ecosystem in the country:
• Industry-Academia Collaboration
2
• Regulatory Reforms
• Building Infrastructure
Initiatives
• Funding Mechanism in progress
3
4 High-level Regulatory Committee Setup for regulatory reforms and ease of
doing business
National Digital Health Mission announced for building a digital health
ecosystem
09
The global healthcare ecosystem is undergoing a paradigm shift
Shift in disease burden: from acute to chronic and in future degenerative
diseases
Technology Advancement: Convergence and emergence of newer innovative
research platforms across drugs, devices, delivery
Volatility in the environment because of the changing geopolitical
landscape; Uncertainty in pricing
Consumerization of holistic health: physical, mental and spiritual well being
Environmental, Social and Governance (ESG) Agenda
10
Opportunity in India: Robust healthcare ecosystem
❑ Demographic, Digital and Democratic Advantage
o Demographic advantage with largest working population (65% of India’s population less
than 35 years) to continue for next 30 years
❑ STEM Talent graduating every year: 110,000+ doctors (Current 1.4M + Doctors); 400,000+
pharmacy (Current 1.7M+ Pharmacists); 15,00,000+ engineers
❑ Conducive Policies: Regulatory Reforms with focus on quality, Self reliance in API, Thrust of
R&D through incentivizing innovation and industry-academia collaboration
❑ Service Delivery: CDMO, Clinical Trials and IT Services
❑ Global Lighthouse Network: Cipla and Dr Reddy’s plants declared by World Economic Forum
13
Way Forward: Building resilient & sustainable global supply chains
❑ Creating a global cooperative framework among nations with investments in critical areas,
technology exchange and procurement commitment:
o Health emergency prevention, preparedness and response with a focus on antimicrobial
resistance and the One Health framework
o Strengthening cooperation in the pharmaceutical sector with a focus on access and
availability to safe, effective, quality and affordable medical countermeasures (VTDs)
o Digital health innovations and solutions to aid universal health coverage and improve
healthcare service delivery
11
Way Forward: Building resilient & sustainable global supply chains
❑ Augmenting digital infra: Tech-enabled platforms for disease profiling and better flow of goods
and services etc
❑ Developing Government-2-Government information-sharing and crisis-response
mechanisms: Address supply chain vulnerabilities
❑ Strengthening supply chain & logistics infras: Integrating land, air, waterway, the maritime and
port facilities
❑ Establishing transparency in the supply chain: Balance between corporate risks and ESG
agenda
12
Thank you
13