Pharmaceuticals

May 2025
For updated information, please visit www.ibef.org
Table of Contents

Executive Summary 3

Advantage India 4

Market Overview 6

Recent Trends and Strategies 13

Growth Drivers 18

Opportunities 27

Key Industry Contacts 29

Appendix 31

2
Executive summary
1. Leading pharma producer 5. Robust growth in biotech
• According to a recent EY FICCI report, as
industry
there has been a growing consensus over • India is among the top 12 destinations for
providing new innovative therapies to biotechnology worldwide and third largest
patients, Indian pharmaceutical market is 5 in Asia Pacific. The country holds 3-5% of
estimated to touch US$ 130 billion in
value by the end of 2030 and US$ 450 1 the global biotechnology industry pie. In
2022, India’s bioeconomy was valued at
billion market by 2047. US$ 137 billion and aims to achieve US$
• India ranks 3rd worldwide for 300 billion mark by 2030.
pharmaceutical production by volume and
14th by value. The country has an
established domestic pharmaceutical 4. Rapidly growing
industry, with a strong network of 3,000 healthcare sector
drug companies
manufacturing units.
and ~10,500 2 4 • India’s healthcare sector is projected to
reach US$ 320 billion (Rs. 27,28,320
crore) by 2028, according to the latest
2. One of the highest report by Great Place to Work.
• Indian hospital market valued at US$
exports 3 98.98 billion in FY23 and projected to
grow by 8% CAGR and reached to
• India’s drugs and
US$193.59 billion by FY32.
pharmaceuticals exports stood at
Rs. 2,59,658 crore (US$ 30.38 3. Among fastest growing industries
billion) in FY25 and Rs. 2,43,119 • During FY18 to FY23, the Indian pharmaceutical industry logged a compound annual growth rate (CAGR) of 6-
crore (US$ 27.82 billion) in FY24. 8%, primarily driven by an 8% increase in exports and a 6% rise in the domestic market.
• According to Government data, • The Indian pharmaceutical industry has seen a massive expansion over the last few years and is expected to
the Indian pharmaceutical reach about 13% of the size of the global pharma market while enhancing its quality, affordability, and
industry is worth approximately innovation.
Rs. 4,70,085 crore (US$ 55 • Indian pharmaceutical sector is expected to grow at a CAGR of 22.4% in the near future. The government has
billion) with over US$ 25 billion of set ambitious target to boost the medical devices industry in India, aiming to elevate it from its current US$ 11
the value coming from exports. billion valuation to US$ 50 billion by 2030. India is the second-largest contributor of global biotech and
• About 20% of the global exports pharmaceutical workforce.
in generic drugs are met by India. • India is emerging as a key player in the global pharmaceutical supply chain, with its CRDMO industry set to
double to Rs. 1,21,282 crore (US$ 14 billion) by 2028, says Macquarie.

Source: News Articles, Make in India, Press Information Bureau

3
Advantage India

4
Advantage India

2. ECONOMIC DRIVERS 3. POLICY SUPPORT

 Indian pharma market expected to reach US$ 130 billion • PLI scheme: US$ 2.04 billion (Rs. 15,000 crore) outlay (2020–21 to
by 2030 and US$ 450 billion by 2047. 2028–29) to boost manufacturing, investment, and product
 Domestic market likely to touch US$ 57 billion by FY25 diversification.
with operating margins rising by 100–150 bps. • Strengthening of Pharmaceutical Industry (SPI): Rs. 500 crore (US$
 Industry revenue projected to grow by 9–11% in FY25, 60.6 million) to support pharma clusters and MSMEs in productivity,
driven by strong performance in the US, Europe, and quality, and sustainability.
emerging markets. • Pradhan Mantri Bhartiya Jan Aushadhi Kendras (PMBJKs): Target of
 India has the largest number of USFDA-compliant plants 10,500 Kendras by March 2025; product basket includes 1,451 drugs
outside the US and over 2,000 WHO-GMP approved and 240 surgical items.
facilities, exporting to 150+ countries. • Government disbursed Rs. 604 crore (US$ 69.76 million) under the
 CRDMO industry expected to double to Rs. 1,21,282 crore PLI scheme in H1 FY25
(US$ 14 billion) by 2028, reinforcing India’s role in global
supply chains

4. INCREASING INVESTMENTS
 FDI policy: Up to 100% FDI allowed via
1. COST EFFICIENCY automatic route for Greenfield pharma
 India has emrged as the medial tourism hub projects; up to 74% for Brownfield via
of the world providing cost-effective automatic, beyond that with government
treatments with the latest technology approval
enabled by several pathbreaking reforms  FDI inflow: Rs. 2,00,166 crore (US$ 23.41
billion) into Drugs & Pharmaceuticals
and provisions in healthcare sector.
 Access to affordable HIV treatment from 2 3 sector (April 2000–March 2025)
 Union Budget 2025–26: Allocation of Rs.
India is one of the greatest success stories 5,268.72 crore (US$ 602.90 million) for the
in medicine. India is one of the biggest Department of Pharmaceuticals, up 28.8%
suppliers of low-cost vaccines in the world, over previous budget estimates.
thereby rightly making it the ‘Pharmacy of
the World’. 1 4
Source: Make in India, Department of Pharmaceuticals, DPIIT

5
 Market Overview

MARKET OVERVIEW

6
Structure of pharmaceuticals sector in India

Pharmaceuticals

Active Pharmaceutical
Formulations
Ingredients/ Bulk drugs

Branded Generics Branded Generics

 Cardiovascular  Anti-infectives

 Anti-Diabetes  Respiratory

 Gastro-Intestinal  Pain

 Neurological  Gynecology

Source: Dun and Bradstreet

7
Evolution of the sector

1970-90 1990-2010 2010-2013 2013- 2015 2016 onwards

 Indian Patent Act passed  Liberalised market.  Increased patent filings  Leading Indian pharma  The National Digital Health Blueprint
in 1970.  Indian companies by pharma players. companies are raising funds has the potential to generate nearly
 Several domestic increasingly launch  Likely adoption of newer aggressively to fund acquisition US$ 200 billion in added economic
companies start operations in foreign sales models such as in domestic as well as value for India's healthcare industry
operations. countries. channel management, international market to over the next 10 years.
 Development of  India a major destination KAM and CSO. increase their product  The PLI scheme for pharmaceuticals
production infrastructure. for generic drug  The National portfolios. launched with a total outlay of the
 Export initiatives were manufacturing. Pharmaceutical Pricing  Patent Act Amendment 2015, it US$ 1.8 billion (Rs. 15,000 crore), to
taken.  Approval of Patents Policy, 2012 (NPPP- includes amendments in boost India's manufacturing capacity,
(Amendment) Act 2005, 2012). Patent Act 2002. elevate investment, and diversify
which led to adoption of  2013: New Drug Pricing product offerings in the sector.
product patents in India. Control Order issued by
Directorate of Food and
Drugs this will reduce the
prices of drugs by 80%.

Source: TechSci Research

8
Important segments in Indian pharmaceutical sector

2. CONTRACT RESEARCH AND

MANUFACTURING SERVICES (CRAMS) 3. BIOSIMILARS
• Contract research and manufacturing services (CRAMS) is one • The biosimilars market in India is estimated to grow at
of the fastest growing segments in the pharmaceutical and a compounded annual growth rate (CAGR) of 22% to
biotechnology industry. The pharmaceutical market uses become US$ 12 billion by 2025. This would represent
outsourcing services from providers in the form of contract almost 20% of the total pharmaceutical market in India.
research organizations (CROs) and contract manufacturing
organizations (CMOs).

4. FORMULATIONS
• Largest exporter of formulations in
1. ACTIVE PHARMACEUTICAL terms of volume, with 14% market
INGREDIENTS (APIS) share and 12th in terms of export
value.
• Active Pharmaceutical Ingredient (or • Double-digit growth is expected
API) is a crucial segment of the pharma over the next five years.
industry, contributing to around 35% of • According to Allied Market
the market. API is the biologically active Research, the Indian
component of a drug that causes an pharmaceutical packaging market
intended medical effect.
• India is the 3rd largest producer of API
2 3 was valued at US$ 1,434.1 million
in 2020 and is expected to reach
accounting for an 8% share of the Global US$ 3,027.14 million by 2030, at a
API Industry. About 500+ different APIs CAGR of 7.54%.
are manufactured in India, and it
contributes 57% of APIs to prequalified
list of the WHO.
1 4

Source: News Articles, Make in India

9
Indian pharmaceuticals market
Indian Pharmaceutical Market (US$ billion)

500.0
450.0
400.0
350.0
300.0
250.0
450.0
200.0
150.0
100.0
50.0 130.0
42.0 49.78 65.0
-
2021 2023 2024P 2030P 2047P

 Indian pharmaceutical industry is known for its generic medicines and low-cost vaccines globally. Transformed over the years as a vibrant sector,
presently Indian pharma ranks third in pharmaceutical production by volume. The Pharmaceutical industry in India is the third largest in the world
in terms of volume and 14th largest in terms of value. The pharma sector currently contributes to around 1.72% of the country’s GDP.
 The Indian pharmaceuticals industry is expected to grow 9-11% in the financial year 2024, as per ICRA.
 In FY23, the Indian pharma market saw a year-on-year growth of nearly 5%, reaching US$ 49.78 billion. During FY18 to FY23, the Indian
pharmaceutical industry logged a compound annual growth rate (CAGR) of 6-8%, primarily driven by an 8% increase in exports and a 6% rise in
the domestic market.
 Major Segments of the Pharmaceutical Industry are Generic drugs, OTC Medicines and API/Bulk Drugs, Vaccines, Contract Research &
Manufacturing, Biosimilars & Biologics.
 Market size of India pharmaceuticals industry is expected to reach US$ 65 billion by 2024, ~US$ 130 billion by 2030 and ~US$ 450 billion market
by 2047.
 India is 3rd largest market for APIs globally, 8% share in the Global API Industry, 500+ different APIs are manufactured in India, and it contributes
57% of APIs to the prequalified list of the WHO.
 Pharmaceutical is one of the top ten attractive sectors for foreign investment in India. The pharmaceutical exports from India reach more than 200
nations around the world, including highly regulated markets of the USA, West Europe, Japan, and Australia.
 The market size of the medical devices sector in India was estimated to be US$ 11 billion in 2023 and its share in the global medical device
market is estimated to be 1.5%. The government has set ambitious target to elevate the medical devices industry in India to US$ 50 billion by
2030.
 The pharmaceutical sector targets Rs. 11,08,380 crore (US$ 130 billion) by 2030, while biotechnology aims for Rs. 25,57,800 crore (US$ 300
billion) by the same year.

Note: P-Projected
Source: Department of Pharmaceuticals, Make in India

10
Pharmaceuticals export to continue witnessing positive growth
Drugs & Pharmaceuticals Exports from India (US$ billion) Major Export Destinations in India’s Pharma Export in FY24 (%)

35.00 NAFTA Europe

30.38
30.00 27.82 12.97%
24.60 25.39
25.00 22.44 5.90%
20.70 34.40%
19.14 Africa LAC
20.00 16.89 16.78 17.28 5.97%
15.00
6.54%
10.00 ASEAN WANA
5.00 14.16%
0.00 20.06%
FY16 FY17 FY18 FY19 FY20 FY21 FY22 FY23 FY24 FY25 Others

 Indian pharmaceutical industry is known for its generic medicines and low-cost vaccines globally. Transformed over the years as a vibrant sector,
presently Indian Pharma ranks third in pharmaceutical production by volume. Indian drugs are exported to more than 200 countries in the world,
with the US as the key market.
 India’s drugs and pharmaceuticals exports stood at Rs. 2,59,658 crore (US$ 30.38 billion) in FY25 and Rs. 2,43,119 crore (US$ 27.82 billion) in
FY24.
 About 20% of the global exports in generic drugs are met by India.
 India's pharmaceutical industry is projected to experience substantial growth, with exports expected to reach Rs. 30,76,500 crore (US$ 350 billion)
by 2047, a 10-15 times increase from current levels.
 The government has set ambitious target to elevate the medical devices industry in India from its current US$ 11 billion valuation to US$ 50 billion
by 2030.
 Building on the outstanding performance in FY21, Indian pharmaceutical exports registered a healthy performance in FY22 and FY23. The
pharma exports in FY22 sustained a growth despite the global trade disruptions and drop in demand for COVID-related medicines.
 The Indian vaccine industry developed Covid vaccine with indigenous technology in collaboration with India's research institutions like Indian
Council of Medical Research (ICMR) and the National Institute of Virology (NIV) within the shortest time on par with highly developed countries
like America and EU. India has provided 301 million doses of vaccines to more than 100 countries.

Source: Department of Commerce India, Department of Pharmaceuticals, Global Trade Atlas, KPMG, Pharmexcil, News Articles, Media Reports

11
R&D spending in Indian pharmaceuticals
R&D spending by top pharma companies in FY23
R&D Investment by Indian Pharma Companies (% of sales)
(US$ million)
320
10.0 280
301
240
200 247
8.0 8.7 8.6 160
8.5 8.4
7.9 120 176 171 163
6.0 7.2
80
40 66 34
4.0 0

Sun

Lupin

Torrent
Aurobindo

Cipla
Dr.reddy's

Wockhardt
2.0

-
FY16 FY17 FY18 FY19 FY20 FY21

 R&D investments: Projected at Rs. 17,000 crore (US$ 2 billion) by FY28.

 Policy focus on IP, tech commercialization, procurement, education, skill development, and regulatory reforms to attract private R&D investment.
 New initiative to promote pharmaceutical research through centres of excellence and priority fields; plan to set up 157 nursing colleges
alongside government medical colleges
 ICMR labs to open for joint research by public/private medical faculty and private R&D teams.

 Interim Budget 2024–25:

o US$ 120 million (Rs. 1,000 crore) for bulk drug parks.

o Total pharma industry development outlay raised to US$ 156.5 million (Rs. 1,300 crore).

o Medical device parks promotion budget raised to US$ 18 million (Rs. 150 crore).

 2023 initiatives: National Policy on R&D and Innovation in Pharma-MediTech, PRIP scheme, and Human Resource Development scheme for
MedTech.

 PRIP scheme: Rs. 720.97 crore (US$ 82.5 million) to fund Centres of Excellence at NIPER and milestone-based private R&D projects

Note: NIPER - National Institute of Pharmaceutical Education and Research

12
 Recent Trends and Strategies

RECENT TRENDS AND STRATEGIES

13
Notable trends in the Indian pharmaceuticals sector

• About 20% of the global exports in generic drugs are met by India.
Increasing Exports • India’s drugs and pharmaceuticals exports stood at Rs. 2,59,658 crore (US$ 30.38 billion) in
FY25 and Rs. 2,43,119 crore (US$ 27.82 billion) in FY24.

• Cipla: Received CDSCO approval to market plazomicin for complicated urinary tract infections
(cUTI), impacting ~150 million patients annually
• Lupin (Nov 2023): Launched world’s first fixed-dose triple combination drug for managing
COPD
Product Launch • Emcure Pharmaceuticals: First to launch Orofer FCM 750, targeting iron deficiency and
anaemia
• Glenmark: First in India to launch Akynzeo I.V. to prevent chemotherapy-induced nausea and
vomiting, under license from Helsinn

• In October 2022, Lupin signed an agreement to acquire two inhalation brands from Sunovion
Pharmaceuticals Inc.
• Glenmark became the first Indian pharmaceutical company to launch Indacaterol +
Expansion Mometasone fixed-Dose combination drug for Asthma.
• Sanofi announced its plans to invest US$ 435 million over the next six years to expand its
global capability center (GCC) in Hyderabad, India by increasing the headcount and further
developing the facility.

• June 2023: MoU signed for recognition of Indian Pharmacopoeia in Suriname.

• May 2023: Ministry of Minority Affairs and Ministry of Ayush partnered to promote Unani medicine
in India.
Partnerships • Japanese firms invited to invest in Indian pharmaceutical and medical device sector; cooperation
aims to strengthen global supply chains for APIs and medical devices.
• Q1 2024: Indian pharma industry saw 24 M&A deals worth US$ 456.3 million.

Source: Company Website, News Articles, Media Reports

14
COVID-19 fightback from the Indian pharmaceuticals sector

2. R&D RELATED TO COVID-19 3.GOVERNMENT INITIATIVES

• In light of the COVID-19 pandemic, Department of • The Department of Biotechnology (DBT), initiated the implementation of the Ind-
Biotechnology and Biotechnology Industry Research CEPI Mission entitled “Epidemic preparedness through rapid vaccine
Assistance Council (BIRAC) launched the ‘DBT–BIRAC development: Support of Indian vaccine development aligned with the global
COVID-19 Research Consortium’ as part of the initiative of the Coalition for Epidemic Preparedness Innovations (CEPI)”.
comprehensive efforts to facilitate development of • The Mission is focused on strengthening infrastructure for development of
indigenous research solutions to tackle COVID-19. vaccines for emerging infectious diseases of epidemic potential through
• Mission COVID Suraksha- the Indian COVID-19 vaccine academia-industry interface; enabling skill development and capacity building
development Mission: ‘Mission COVID Suraksha- The activities.
Indian COVID-19 Vaccine Development Mission’, was • Biotechnology Industry Research Assistance Council (BIRAC) under Department
announced as part of the third stimulus package, of Biotechnologies offers funding assistance through initiatives such as the
Atmanirbhar Bharat 3.0, for promoting research and Biotechnology Ignition Grant (BIG), Sustainable Entrepreneurship and Enterprise
development of Indian COVID-19 vaccines. Development (SEED), and Launching Entrepreneurial Driven Affordable Products
(LEAP) schemes. The funding ranges from Rs. 30 Lakh (US$ 35,824.41) to Rs.
100 Lakhs (US$ 1,19,414.70) per startup, enabling them to refine their ideas.
• The Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) has reached a
1. COLLABORATIONS noteworthy milestone, achieving sales of Rs. 1,000 crore (US$ 119 million) in
• Under the Ind-CEPI Mission, Financial support is October 2024.
being provided for ‘Global Chikungunya Vaccine • A Centrum report highlights that government initiatives like the Production-Linked
Clinical Development Program’ (GCCDP), a Incentive and Bulk Drug Parks will boost India's pharma sector by reducing costs,
collaboration between Bharat Biotech International enhancing competitiveness, and attracting investment, with US$ 353.4 million
Limited (BBIL) and the International Vaccine allocated for bulk drug production.
Institute (IVI) to advance the development of a
novel inactivated vaccine candidate for 4. INDIAN PLAYERS GLOBAL
Chikungunya (CHIKV), BBV87.
• As of 30th June 2024, the Department for
EXPOSURE
Promotion of Industry and Internal Trade (DPIIT) • In February 2021, the Russian Ministry of
has recognized a total of 1,40,803 entities as Health allowed Glenmark Pharmaceuticals to
startups, of which 2,127 are from the
pharmaceutical sector.
2 3 market its novel fixed-dose combination nasal
spray in Russia.
• In August 2021, Uniza Group, an Ahmedabad-
based pharmaceutical firm, signed an
agreement with Lysulin Inc. (an US-based
1 4 firm) to introduce Lysulin, a nutritional product
for Indian consumers.

15
States hosting key pharmaceutical ventures

 Sun Pharma's API manufacturing  Wockhardt's facility covers an area of

facility at Toansa, Malanpur, 40,468 sq. meters in Baddi, Himachal
Guwahati, Ankleshwar, Panoli, Pradesh.
Ahmednagar, Maduramthakam.
 Baddi is also home to Cipla’s
formulations manufacturing facility.

 Mandideep in Madhya Pradesh is

 Dholka in Gujarat houses a major the manufacturing hub for Lupin’s
manufacturing facility of Cadila, cephalosporin and ACE-
which spans over 100 acres. Inhibitors.

 Cipla has a formulations

manufacturing plant at Indore.
 Lupin has an USFDA-approved
plant at Tarapur, Maharashtra. The
facility forms the core of Lupin's
fermentation capabilities.  Piramal’s USFDA-approved manufacturing plant
in Hyderabad.

 GlaxoSmithKline has a major facility at

 Key pharma companies and CMOs
Rajahmundry, Andhra Pradesh.
such as Mylan NV, Albany Molecular
Research and Cambrex Corp. have
manufacturing facilities in Telangana.

Source: Company Website

16
Strategies adopted

Cost Leadership
• Reinvent and innovate will be the key mantra for the Indian pharma industry in the New Year as the 'pharmacy of the world' looks
to move from volume to value leadership, amid emerging challenges of inflation and pricing pressures in the global markets.

Differentiation
• R&D investment, market competitiveness, regulatory scrutiny, and domestic price regulations are expected to shape the growth
of generics and injectable products in the pharmaceutical industry in 2023.
• The industry believes that in view of India's G20 Presidency, digital health innovation, achieving universal health coverage,
improving healthcare infrastructure and delivery will continue to be the key driving factors in 2023.

Focus on new markets

• Lupin is making road into new markets such as Latin America, Russia and other East European countries.
• Sun Pharma decided to focus on specialty and chronic therapies such as neurology, oncology, dermatology segments.
• India plans to set up a nearly Rs. 1 lakh crore (US$ 1.3 billion) fund to provide boost to companies to manufacture
pharmaceutical ingredients domestically.

M&A in Biotech
• Sun Pharma (Mar 2023): Completed acquisition of Concert Pharmaceuticals, adding deuruxolitinib (oral JAK1/2 inhibitor for
alopecia areata) to its pipeline.
• MedGenome: Acquired stake in GenX Diagnostics to strengthen diagnostics reach in Eastern India
• Japanese firms invited to invest in Indian pharma and medical devices; mutual cooperation to help stabilize global supply chains
for APIs and devices
• Nirma (Sep 2023): Agreed to acquire 75% stake in Glenmark Life Sciences, expanding into APIs and life sciences sector

17
 Growth Drivers

GROWTH DRIVERS

18
Supply-side drivers of Indian pharmaceuticals sector
1. Launch of patented
drugs 5. Patent Expiry
• Following the introduction of product • About 120 drugs are expected to go
patents, several multinational companies off-patent over the next 10 years;
are expected to launch patented drugs in with expected worldwide revenue
India. 5 between US$ 80 to 250 billion.
• Growth in the number of lifestyle diseases
in India could boost the sale of drugs in
1
this segment. 4. Over-The-Counter
• High Court allowing to export patent
drugs, to foreign players in the Indian
(OTC) drugs
market. • The Union government, in 2022,

2. Medical infrastructure 2 4 proposed to introduce over-the-

counter (OTC) drugs in India
through an amendment in the Drugs
• The presence of a skilled workforce as
and Cosmetics Rules and allow their
well as high managerial and technical
sale in the retail market without
competence is a source of attraction for
private players. Pharma companies have 3 doctors’ prescription.
• A draft notification issued by the
already increased spending in the country
Union health ministry has proposed
to tap rural markets and develop better
that the 16 drugs, which include
infrastructure.
common antipyretic medicine such
• Promotion of Medical Devices Parks: 3. Scope in generics market as paracetamol 500 mg, some
Objective of the scheme is Creation of
• India has the second-highest number of US FDA laxatives, nasal decongestants and
world class infrastructure facilities in order
approved plants outside the US and is the largest topical antifungal creams be
to make Indian medical device industry a
provider of generic drugs globally. included in the OTC drug category.
global leader.
• In March 2024, Union Minister for • According to Mr. Bhagwant Khuba, Minister of State
Chemicals & Fertilizers and Health & (MoS) for Chemicals and Fertilisers, India's
Family Welfare Dr. Mansukh Mandaviya pharmaceutical industry is the third largest by volume
inaugurated 27 greenfield bulk drug park and the 14th largest by value in the world, generating
projects and 13 greenfield manufacturing more than 60,000 generic drugs across 60 therapeutic
plants for medical devices. categories.
• About 20% of the global exports in generic drugs are met
Source: Make in India, News Articles
by India.

19
Demand drivers of Indian pharmaceuticals sector

3. PRADHAN MANTRI BHARTIYA

2. ACCEPTABILITY JANAUSHADHI KENDRAS
• Rising levels of education to increase • As of January 2024, the total number of Jan Aushadhi Kendras
acceptability of pharmaceuticals. in the country are 10,607.
• Patients to show greater propensity to self- • Prime Minister Mr. Narendra Modi during his Independence Day
medicate, boosting the OTC market. 2023 speech said that the government has plans to increase the
• Acceptance of biologics and preventive number of 'Jan Aushadhi Kendras' from 10,000 to 25,000.
medicines to rise. • The Government plans to provide free generic medicines to half
• Surge in medical tourism due to increased the population at an estimated cost of US$ 5.4 billion.
patient inflow from other countries.

1. ACCESSIBILITY 4.STRATEGIC
• New business models expected OPPORTUNITY
to penetrate tier-2 and 3 cities. • The Trump 2.0 agenda, expected
• Over 160,000 hospital beds to prioritize the China Plus One
expected to be added each year approach in pharmaceutical
in the next decade. manufacturing and diversify
• India’s generic drugs account for
20% of global exports in terms
of volume, making the country
2 3 supply chains, presents a growth
opportunity for Indian drug
makers. Moreover, potential
the largest provider of generic increases in tariffs on Chinese
medicines globally. products could create space for
Indian pharma companies to
bridge supply gaps in the US
1 4 generic drug market.

Note: RSBY - Rashtriya Swasthya Bima Yojna

Source: ICRA Report on Indian Pharmaceutical Sector, Pharmaceutical Industry: Developments in India- Deloitte, Mckinsey

20
Growing health insurance

Visakhapatnam
Breakdown of non-lifeport traffic market
insurance (millionin
tonnes)
India (FY24) Gross Direct Premiums of Non-Life Insurers (US$ billion)

0.39% 8.91% 40.00 CAGR 11.36%

35.00
Health 30.00
25.00

34.90
Total size: 20.00

31.24
29.63
27.15
26.80
US$ 31.66 General 15.00

24.32
23.37
19.11
billion 10.00

14.71
5.00
90.70%
Others 0.00

FY22

FY24
FY16

FY17

FY18

FY19

FY20

FY21

FY23
 At present, there is a rise in the demand for healthcare insurance among the masses due to increasing medical costs. This, coupled with the
growing geriatric population, represents one of the key factors offering a favorable market outlook in India.

 Besides this, the Government of India is launching various schemes, such as the Pradhan Mantri Jan Aarogya Yojana (PM-JAY), Ayushman
Bharat Yojana, Pradhan Mantri Suraksha Bima Yojana, and Aam Aadmi Bima Yojana (AABY) to provide health insurance to the economically
weaker section of the country. They are also providing comprehensive healthcare facilities to central government pensioners and officials under the
Central Government Health Scheme (CGHS) in the country.

 COVID-19 Insurance Policy: COVID-19 insurance, like many other life insurance products, provides financial protection against the most terrifying
human life event: death. In light of this, the Insurance Regulatory Development Authority of India (IRDAI) authorised two basic COVID-19 Health
Insurance policies, Corona Kavach and Corona Rakshak, to help consumers protect themselves from the financial burden of COVID-19 medical
bills.

Source: News Articles

21
Favourable policy measures support growth… (1/3)
1
Strengthening of Pharmaceutical Industry (SPI)
The Ministry's scheme “Strengthening of Pharmaceutical Industry (SPI)" with a total financial outlay of US$ 60.9 million (Rs. 500 crore) extends
support required to existing pharma clusters and MSMEs across the country to improve their productivity, quality and sustainability.

2
Scheme for Development of Pharma industry – Umbrella Scheme.
• The Department of Pharmaceuticals has prepared an Umbrella Scheme namely ‘Scheme for Development of Pharma industry’. Which comprises
of the following sub schemes:
o Assistance to Bulk Drug Industry for Common Facilitation Centres
o Assistance to Medical Device Industry for Common Facilitation Centres
o Assistance to Pharmaceutical Industry (CDP-PS)
o Pharmaceutical Promotion and Development Scheme (PPDS)
o Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS)

3
Support for technology upgrades and FDIs
• Ayushman Bharat Digital Mission (ABDM): Under the ABDM, citizens will be able to create their ABHA (Ayushman Bharat Health Account)
numbers, to which their digital health records can be linked. This will enable creation of longitudinal health records for individuals across various
healthcare providers and improve clinical decision making by healthcare providers.
• The pilot of ABDM is completed in the six Union Territories of Ladakh, Chandigarh, Dadra & Nagar Haveli and Daman & Diu, Puducherry,
Andaman and Nicobar Islands and Lakshadweep with successful demonstration of technology platform developed by the NHA.
• During the pilot, digital sandbox was created in which more than 774 partner solutions are undergoing integration. As of September 4, 2023,
450,164,619 Ayushman Bharat Health Accounts have been created and 224,967 doctors and 218,602 health facilities have been registered in
ABDM.

Source: News Sources

22
Favourable policy measures support growth… (2/3)

4
Promotion of Medical Devices Parks
• Objective of the scheme is Creation of world class infrastructure facilities in order to make Indian medical device industry a global leader.
• Easy access to standard testing and infrastructure facilities through creation of world class Common Infrastructure Facilities for increased
competitiveness will result into significant reduction of the cost of production of medical devices leading to better availability and affordability of
medical devices in the domestic market.

5
Production Linked Incentive
• In September 2020, the government announced production-linked incentive (PLI) scheme for the pharmaceutical industry worth Rs. 15,000 crore
(US$ 2.04 billion).
• The production-linked incentive (PLI) scheme was introduced to encourage Indian manufacturers to produce critical key starting materials (KSMs),
drug intermediates (DIs) and active pharmaceutical ingredients (APIs). To support this, the government granted funds worth US$ 932.66 million.
• PLI scheme envisages manufacturing of 41 Bulk Drugs with a total outlay of Rs. 6,940 crore (US$ 838.16 million) during the tenure of the scheme
from 2020-21 to 2029-30.

6
Interim Budget 2024-25
• In the Interim Budget 2024-25, the government earmarked US$ 120 million (Rs 1,000 crore) for the promotion of bulk drug parks for FY25, a
significant increase from the previous year.
• The total outlay for the development of the pharmaceutical industry for FY25 was increased to US$ 156.5 million (Rs. 1,300 crore) while the
budget for the promotion of medical device parks was raised to US$ 18 million (Rs. 150 crore) for FY25.
• The allocation for assistance to medical device clusters for common facilities (AMD-CF) was pegged at US$ 4.1 million ( Rs. 40 crore) for
FY25.
• The outlay for the Jan Aushadhi scheme, the initiative to provide affordable generic medicines in the country, was hiked to US$ 34 million
(Rs. 284.5 crore) for FY25, up from US$ 13 million (Rs. 110 crore) in the revised estimate for FY24.

Source: News Sources, Interim Budget 2024-25

23
Favourable policy measures support growth… (3/3)

7
Biotechnology Industry Research Assistance Council
• BIRAC has been established to promote research & innovation capabilities in India’s biotech industry. The council will provide funding to biotech
companies for technology & product development.
• BIRAC under Small Business Innovation Research Initiative (SBIRI) scheme supports innovations in biotechnology.

8
Biotechnology Based Programme for Women
• Programme on application of biotechnology for women was done to provide employment, skill development, awareness generation,health
improvement & socio-economic upliftment of the women population.

9
National Biopharma Mission
• The Industry - Academia mission was launched in June 2017 to boost development of biopharmaceuticals in India.

10
National Commission for Homoeopathy (NCH) Bill, 2018
• In December 2018, the Government of India approved the National Commission for Homoeopathy, Bill, 2018 in order to have more transparency
in the sector.

11
Scheme for Promotion of Research and Innovation in Pharma MedTech Sector (PRIP)
The Department of Pharmaceuticals will soon launch the Scheme for the Promotion of Research and Innovation in Pharma (PRIP) MedTech Sector.
The scheme has been approved by the Union Cabinet for a period of five years starting from 2023-24 to 2027-28 with a total outlay of Rs. 5,000 crore
(US$ 604.5 million).
Source: News Sources

24
Investments (1/2)
Production Linked Incentive (PLI) Scheme
 To achieve self-reliance and minimise import dependency in the country's essential bulk drugs, the Department of Pharmaceuticals initiated the
PLI scheme to promote domestic manufacturing by setting up greenfield plants with minimum domestic value addition in four separate ‘Target
Segments’ with a cumulative outlay of Rs. 6,940 crore (US$ 951.27 million) from FY21 to FY30.
 Under ‘Target Segment I’, five applications with an investment of Rs. 3,761 crore (US$ 515.52 million) have been approved.
 As of September 2023, a total of 26 projects were approved, of which 16 projects have been commissioned and manufacturing of 39 medical
devices has started. Investment of US$ 105 million (Rs.879 crore) has been grounded and employment generated for 4,546 people.
 The Production Linked Incentive (PLI) scheme for the pharmaceutical sector in India is allocated Rs. 2,444.9 crore (US$ 279.77 million) for the
FY26. This is a 14% increase from allocation of Rs. 2,150.5 crore (US$ 246.08 million) in FY25.

Companies under Target Segment II (Fermentation Based Niche KSMs/Drug Intermediates/APIs) are as follows:

Committed Production Capacity Committed Investment Committed Investment

Name of Approved Applicant
(in MT) (in Rs. crore)) (in US$ million)

Natural Biogenex Private Limited 12 31.43 4.31

Natural Biogenex Private Limited 10 26.19 3.59

Natural Biogenex Private Limited 15 39.29 5.39

Symbiotec Pharmalab Private Limited 15 5.00 0.69

Macleods Pharmaceutical Limited 200 198.36 27.19

Optimus Drugs Private Limited 200 35.00 4.80

Sudarshan Pharma Industries Limited 200 57.00 7.81

Optimus Drugs Private Limited 50 30.00 4.11

Source: BMI, Business Standard, DPIIT

25
Investments (2/2)

Companies under Target Segment III (Key Chemical Synthesis Based KSMs/Drug Intermediates) are as follows:

Committed Production Capacity Committed Investment Committed Investment

Name of Approved Applicant
(in MT) (in Rs. crore) (in US$ million)

Saraca Laboratories Limited 3,000 50.0 6.85

Emmennar Pharma Private Limited 1,500 21.94 3.01

Hindys Lab Private Limited 3,000 37.60 5.15

Aarti Speciality Chemicals Limited 4,000 77.87 10.67

Meghmani LLP 13,500 55.06 7.55

Sadhana Nitro Chem Limited* 36,000 197.27 27.04

 Companies have agreed to invest Rs. 862.01 crore (US$ 118.16 million) in these plants, resulting in ~1,763 employment opportunities. The
government approved a total of 19 applications totaling Rs. 4,623.01 crore (US$ 633.68 million) in committed investment.

Foreign direct investment (FDI)

 Up to 100%, FDI has been allowed through automatic route for Greenfield pharmaceuticals projects. For Brownfield pharmaceuticals projects, FDI
allowed is up to 74% through automatic route and beyond that through government approval.

Source: BMI, Business Standard, DPIIT

26
 Opportunities

OPPORTUNITIES

27
Opportunities abound in clinical trials and high-end drugs

2. HIGH-END DRUGS 3. PENETRATION IN RURAL

 Due to increasing population and MARKET
income levels, demand for high-
end drugs is expected to rise.  With 70% of India’s population residing in rural
 Growing demand could open up areas, pharma companies have immense
the market for production of high- opportunities to tap this market.
end drugs in India.  Demand for generic medicines in rural markets
has seen a sharp growth. Various companies are
investing in the distribution network in rural areas.
1. CLINICAL
TRIALS MARKET
• India is emerging as a key
destination for early-stage clinical 4. CRAMS
trials, driven by cost advantages
and market potential, especially  Contract research and
amid global disruptions. manufacturing services (CRAMS)
• Parexel a biopharmaceutical is one of the fastest growing
company from the US, plans to add segments in the pharmaceutical
over 2,000 employees in India over and biotechnology industry. The
the next five years. pharmaceutical market uses
• Due to a genetically diverse outsourcing services from
population and availability of skilled 2 3 providers in the form of contract
doctors, India has the potential to research organizations (CROs)
attract huge investments to its and contract manufacturing
clinical trial market. organizations (CMOs).

1 4

Source: BMI, Drug Controller General of India

28
Key Industry Contacts

29
Key industry contacts

Agency Contact Information

Kalina, Santacruz (E),

Mumbai - 400 098
Phone: 91-22-2667 1072
The Indian Pharmaceutical Association Fax: 91 22 2667 0744
E-mail: ipacentre@ipapharma.org
Website: www.ipapharma.org

Organisation of Pharmaceutical Producers of India

1620, C – Wing, ONE BKC
G Block, Plot No. C-66
Organisation of Pharmaceutical Producers of Bandra Kurla Complex, Bandra East
India Mumbai- 400051
Phone: +91 22 66627007 / 6662 7008
E-mail: admin@indiaoppi.com
Website: www.indiaoppi.com

102, Poonam Chambers, ‘A’ wing, 1st floor,

Dr A.B. Road Worli, Mumbai - 400 018
Phone: 91-22-24974308 / 66626901 / 49729227
Indian Drug Manufacturers' Association
E-mail: sapna@idmaindia.com | melvin@idmaindia.com
Website: www.idma-assn.org

C-25, Industrial Estate, Sanath Nagar

Hyderabad - 500018
Bulk Drug Manufacturers Association Phone: 91 40 2370 4804 / 2370 6718
E-mail: info@bdmai.org, bdma.hyd@gmail.com
Website: www.bdmai.org

30
Appendix

31
Glossary

 CRAMS: Contract Research and Manufacturing Services

 API: Active Pharmaceutical Ingredients

 FDI: Foreign Direct Investment

 GOI: Government of India

 Rs.: Indian Rupee

 US$ : US Dollar

 BPL: Below Poverty Line

 RSBY: Rashtriya Swastha Bima Yojna

 ESIC: Employees State Insurance Corporation

 Wherever applicable, numbers have been rounded off to the nearest whole number

32
Exchange rates

Exchange Rates (Fiscal Year) Exchange Rates (Calendar Year)

Year Rs. Equivalent of one US$ Year Rs. Equivalent of one US$
2004-05 44.95 2006 45.33
2005-06 44.28 2007 41.29
2006-07 45.29
2008 43.42
2007-08 40.24
2009 48.35
2008-09 45.91
2009-10 47.42 2010 45.74

2010-11 45.58 2011 46.67

2011-12 47.95 2012 53.49

2012-13 54.45
2013 58.63
2013-14 60.50
2014 61.03
2014-15 61.15
2015-16 2015 64.15
65.46
2016-17 67.09 2016 67.21

2017-18 64.45 2017 65.12

2018-19 69.89 2018 68.36
2019-20 70.49 2019 69.89
2020-21 73.20 2020 74.18
2021-22 74.42 2021 73.93
2022-23 78.60 2022 79.82
2023-24 82.80 2023 82.61
2024-25 86.47 2024 84.49
2025-26* 85.47 2025* 86.03

Note: *- Until April 2025

Source: Foreign Exchange Dealers’ Association of India

33
Disclaimer

All rights reserved. All copyright in this presentation and related works is solely and exclusively owned by IBEF. The same may not be
reproduced, wholly or in part in any material form (including photocopying or storing it in any medium by electronic means and whether or
not transiently or incidentally to some other use of this presentation), modified or in any manner communicated to any third party except with
the written approval of IBEF.

This presentation is for information purposes only. While due care has been taken during the compilation of this presentation to ensure that
the information is accurate to the best of IBEF’s knowledge and belief, the content is not to be construed in any manner whatsoever as a
substitute for professional advice.

IBEF neither recommend nor endorse any specific products or services that may have been mentioned in this presentation and nor do they
assume any liability, damages or responsibility for the outcome of decisions taken as a result of any reliance placed on this presentation.

IBEF shall not be liable for any special, direct, indirect or consequential damages that may arise due to any act or omission on the part of the
user due to any reliance placed or guidance taken from any portion of this presentation.

34