The document outlines the pharmaceutical sector in India, highlighting its significant growth, particularly in Gujarat, which leads in manufacturing and exports, accounting for a substantial share of India's pharmaceutical turnover. By 2020, India's pharmaceutical market is projected to reach USD 55 billion, with strong export capabilities in generics and vaccines. Government initiatives aim to enhance drug discovery infrastructure, attract foreign investment, and foster local manufacturing and research capabilities.

1. Pharmaceuticals
Sector Profile
Vibrant Gujarat 2017

2. 2
Pharmaceuticals
India Scenario

3. 3
Overview
Sources: CRISIL research
• Indian pharmaceuticalsectoraccountsforabout 2.4%ofthe global
pharmaceutical industry in value termsand 10%in volume terms
• The sectorincreased at a CAGR of ~13%over10 yearperiod and is expected
to grow at a CAGR of ~22% to reach USD55 billion by 2020 (from2015)
• By 2020, India is expected to be 6th largest marketglobally
• Leaderin exports: Exported productsworth USD15 billion in FY15 and
exports are expected to reachUSD 40 billion by 2020
• India accounts for 20%ofglobal exportsin generics,largest providerof
generic medicinesglobally
• Attracted FDI worth USD13.5 billion during January 2000 toDecember
2015 (5% oftotal FDI)
2010-11
(USD billion)
2015-16E
(USD
billion)
2020-21P
(USD billion)
Past 5 year
CAGR upto
2015-16
Future 5 year
CAGR upto
2020-21
Domestic Formulation (E) 7.41 13.03 23.83 – 26.01 11.9% 13%-15%
Formulation Exports (E) 6.7 12.6-12.9 20.7-23.1 13.8% 10.5%-12.5%
Bulk Drugs Market (E) 11.3 13.9-14.2 23.9-26.7 4.4% 10%-12%
Total Pharmaceuticals 25.3 29.3-40.1 69.8-77.8 6.8% 12%-14%
E=Expected; P=Projected

4. 4
Hub of the global pharma industry
Source: DISSO 2016
75% of the world’s vaccines are manufactured in India
India exports medicines to 220 countries
1/3rd of the tablets sold in USA are manufactured in India
Major stakeholders in India’s pharmaceuticals success story
And many more…

5. 5
India’s Advantage in Pharmaceuticals
Cost leadership: Cost ofproduction ofpharmaceuticals in India is ~60%lowerthan thatofUS and
almost halfofthat ofEurope
Diverse range of products: Over60,000generic brandsacross 60therapeutic categories are
manufactured in India
Globallyrecognizedcapabilities: 49%ofall drug masterfilings from Indiaare registered
in the USA
Leaderin DrugApplications: Indian pharmaceutical industry accountsforthe 2nd largest
numberofAbbreviated New Drug Applications(ANDAs)
Rapidly expandinghealthcaremarket: India’shealthcare market expected to grow to USD
280 Billion by 2020,as compared to USD83.36 Billion in 2014
Leaderin Medical Tourism: Medical value travel market in India is expected to grow at a
CAGR ofapproximately 30 percent from USD 2.8 Billion in 2014 to 10.6 Billionin 2019
Segments with vast potential: Vaccines market expected to grow to USD 1.7 Billion by 2020, up from current USD
250 Million; Biologics market expected to grow to USD 3 Billion from current USD 300 Million
Sources: KPMG-FICCI report: Healthcare the neglected GDP Driver;
IBEF; McKinsey report: India Pharma 2020

6. 6
Key Statistics
Sources: Department of Commerce India, IBEF
*April 2014 – December 2014
70%
21%
9%
Revenue share of Indian
pharmaceutical
sub-segments in2015 (%)
Generic Drugs
OTC Medicines
Patented Drugs
10.1
12.6
14.5 14.9
3.6
4.4 4.6
3.7
FY12 FY13 FY14 FY15*
Trade data of Indian pharma sector
(USD billion)
Export Import

7. 7
ForeignInvestment in India
Sources: Indiastat, Ministry of Commerce, Government of India, Invest India
0.209
3.441
4.564
5.843
7.341
7.693
2010-11 2011-12 2012-13 2013-14 2014-15 2015-16
CumulativeFDI in Pharmaceutical
Sector(USD billion)
• 6th largest contributorin totalFDI attracted
during April 2000 – December2015
• Cumulative FDI USD 13.4 billion during the period
• 4.8%of total FDI attractedinpharmaceuticals
Major Foreign Investors
Up to 100% FDIallowed for pharmaceuticals sector
Up to 100% FDIallowed for manufacturingof medical devices/ equipment
Conducivepatentregimeto attract foreign investors
Key Growth Drivers

8. 8
Governmentof India Initiatives (1/2)
■ Aims at making India a majorhub forend to end drug discovery
■ Provides support by way ofworld classinfrastructure, internationallycompetitive
scientific manpowerforpharmaR&D and venture fund forresearch in the public and
private domain
Pharma Vision
2020
■ To boost drug discovery and strengthen pharma infrastructure, the Government plans to
setup venture capital funds
Industry
Infrastructure
■ Up to 100% FDI is allowed throughautomaticrouteforgreenfieldprojectsand
through government routeforbrownfield project in the sector
FDI
■ Full exemption from excise duty forHIV/AIDS drugs and diagnostic kits supplied under
National AIDS Control Programme fundedby the Global Fund to fight AIDS,TB and
Malaria (GFATM)
■ Customs dutieson thesedrugs alsoexempted
Duty Exemptions
Source: IBEF

9. 9
Governmentof India Initiatives (2/2)
■ Focus productscheme
■ Special focus product scheme
■ Focus market scheme
■ Export promotion capital goods scheme
Export Incentive
Schemes
■ Scheme for the development of common facilities like effluent treatment, testing centres
etc.
Units in Clusters
■ Industry/private sponsored research programmes
■ Duty free import ofPharmaceuticals reference standards
■ Weighted tax deduction forbothcapitaland revenue expenditureincurred on scientific
research and development
R&D benefits
Source: Make in India,

10. 10
Pharmaceuticals
Gujarat Scenario

11. 11
Leading the Way
Source: FDCA, IBEF
India’s orthopaedic
implants are
manufactured in Gujarat
of India’s cardiacstents are
manufactured inGujarat
More than 110 years of
excellence
110
of India’s intraocular
lenses are manufactured in
Gujarat
50%
60%
40%
of India’s machinery for
pharma sector is
manufactured in Gujarat
40% Diagnosticreagent
manufacturer in Indiato
obtainproduct
prequalification from WHO
Geneva,is based outof
Gujarat
1st
78%
3415
40%
80%
Only manufacturer of
Dapsone in India
1
World’s Isoniazid (used
for treatment of
tuberculosis)is produced
in Gujarat
Of CRAMS companies
Manufacturing
licenses in Gujarat
CRO of India is based
in Gujarat
33%
Of India’s pharma
sector turnover 28%
Of India’s pharma
exports
35%
Of India’s Diagnostic
Reagent
manufacturing

12. 12
Overview
• Turnover of Gujarat Pharmaceutical industry was worth ~USD 6.7 Billion in
2015-16; while exports was worth ~USD3.06Billion
• Provides employment to around 85,000people
•255WHO-GMP certifiedmanufacturing facilities inIndia are from Gujarat
• As of February 2015, 135 medical devices manufacturers are based in Gujarat
which accounts for 53% of the total medical devices manufacturers in the
country

13. 13
Leader in pharmaceuticals
manufacturing in India
2338
679
390
8
Manufacturing Licenses inGujarat
Allopathic
Ayurvedic
Cosmetics
Homeopathic
The State manufactures and exports different dosage forms including:
Generic drugs, intricate vaccines, r-DNA products, cytotoxic drugs
external preparations, sex hormone drugs, small and large volume
parenteral, APIs, hi-tech cardiac stents bio-pharma products etc.
Major Export Destinations:
African Countries, USA, European
Union, Philippines, Sri Lanka,
Thailand

14. 14
Key statistics
*1 USD = 65 INR
~445%increaseinexports
562
3060
2006 2016
Pharma Exports from Gujarat
(~USD Million*)
97
158
255 WHO Compliant Units in Gujarat
Bulk Drug
(API)
Formulations
18 16 14 12
33
7 10
4
0
10
20
30
40
50
60
US FDA MHRA TGA PICS
Formulation Unit API Units

15. 15
Pharma Clustersin Gujarat (1/2)
Ahmedabad
cluster
Bharuch and
Ankleshwar
cluster
Vadodara
cluster
Vapi/ Valsadcluster
SEZs
SIRs
Zydus InfrastructurePvt.
Ltd.
Location: Ahmedabad
Area: 49 hectare
Likely activities:
Pharmaceuticals
CPL InfrastructurePvt.
Ltd.
Location: Ahmedabad
Area: 122 hectare
Likely activities:
Biologicals,
APIs & Pharmaceuticals
HBS PharmaceuticalsSEZ
Location: Bharuch
Area: 125 hectare
Likely activities: R&D, Bulk
drugs, Intermediates&Contract
manufacturing
Dishman Infrastructure
Ltd.
Location: Ahmedabad
Area: 106 hectare
Likely Activities: Bulk
drugs
Country’s first National Government
Medical DevicesLaboratory
announced in Gujarat. Medical
DevicesPark also announced and to
be operational soon

16. 16
Pharma Clustersin Gujarat (2/2)
Characteristic of Pharma clusters in Gujarat
Location Existing
Products
Export
Potential
Market-based/
Resource-based/
Infrastructure-based
Potential future
products
Ahmedabad • API
• Finished Dosages
• Biological Products
• Contract
Manufacturing
High Marketand
Infrastructure
• Biological
Manufacturing
• Medical Devices
• CRO
• CRAMS
Vadodara • Finished Dosages
• Bio-generics
High Marketand
Infrastructure
• API
• CRAMS
• Biological
Manufacturing
Bharuch &
Ankleshwar
• APIs
• Formulations
• Vaccines
High Resource • APIs for global
companies
Vapi & Valsad • APIs
• Formulations
• Deviceand Diagnostics
High Resource • Intermediate &
Finished
Dosages

17. 17
Educational Infrastructure
• L M College ofPharmacy,
Ahmedabad
• Institute ofPharmacy - Nirma
University,Ahmedabad
• National Institutefor
PharmaceuticalEducation and
Research (NIPER) - Ahmedabad
• Faculty ofPharmacy, MS
University,Vadodara
• B.V. Patel Perd Center
• Zydus Cadila HealthcareLtd.
• Claris Life sciences Ltd.
• Cadila Pharmaceuticals Ltd.
• Intas Pharmaceutical Ltd.
• Sun Pharma
• Torrent PharmaceuticalsLtd.
• Dishman Pharmaceuticals
• Abott Laboratories
• Wyeth
• Jubilant Organosys
• Lambda Therapeutics
• Quintiles Research(India)
Private Limited
• Thermofisher Biopharma
Services (i) Pvt. Ltd.
• Synchron ResearchServices
Private Limited
• B A Research India Limited
Education / research
institutes
R&D, Manufacturing,
MarketingandExports
Contract research
organizations
Provisional Intake Capacity of
Pharmacy Colleges in Gujarat in 2015
was 4284 (4049 in Self Financed
institutions and 235 in Govt. / Grant
in Aid Institutions)
L M College of Pharmacy, Ahmedabad, established in 1947, is theoldest Pharmacyinstitutein India

18. 18
State GovernmentAssistance for
Micro,Small and Medium Enterprises (1/2)
Assistance of Capital Investment Subsidy
• @ 10% and @ 15% on loan amount in Municipal Corporation areas and in
areas other than Municipal Corporation areas respectively
Assistance for Interest Subsidy
• @ 5% and @ 7% for period of 5 years in Municipal Corporation areas and in
areas other than Municipal Corporation areas respectively
Assistance for Venture Capital
• Assistance to raise promoter contribution in the form of equity or loan
through GVFL
Assistance for Quality Certification
• 50% of capital cost for installing Enterprise Resource Planning (ERP) system,
for obtaining ISO certification, for obtaining WHO GMP, for testing equipment
and machinery required
Resolution No. SSI-102014-924840-CH
Date. 19.01.2015

19. 19
State GovernmentAssistance for
Micro,Small and Medium Enterprises (2/2)
Assistance for Quality Certification
• 50% of capital cost for installing Enterprise Resource Planning (ERP) system,
for obtaining ISO certification, for obtaining WHO GMP, for testing equipment
and machinery required
Assistance for Technology Acquisition
• Grant at the rate of 50%of cost of technology acquisition
Assistance for Patent Registration
• 75%of expenditure incurred for obtaining patents
Assistance for Saving in Consumption of Energy & Water
• 75%cost of energy/water audit conductedin a unit
• 25%of cost of equipment
Resolution No. SSI-102014-924840-CH
Date. 19.01.2015

20. 20
State GovernmentInitiatives
I.T. applicationfor
issuance of sales
license and
product license
implementedby
FDCA
Establishment of
National Institute
for Pharmaceutical
Education and
Research (NIPER)
for Human Resource
Development
Establishment of
Gujarat Genomics
Initiative,Genetic
Diagnostic centers
and Gene Banks
Promotionof
generic drugs by
giving them
preference in
government
purchases

21. 21
GrowthDrivers for Gujarat’s
pharmaceutical industry
• Increasing accessibility due to growth in medical
infrastructure, new business models
• Huge potential to tap rural markets
Accessibility
• Leveraging global technologies to cut down costs
• Rising income and increase in insurance coverageAffordability
• Rising populationand changing lifestyles
Rising Patient
Pool
• Loweredproduction cost and skilled manpower &
technicalcompetency
Generics Drugs
Market
• Conducive policies
• Ease of Doing Business
Government
Policy

22. 22
FDCA: Food and DrugsControl Administration
XLN is a software for transparent and speedydisposalof various Licensing applications and reducing
the time lag betweenthe Collectionof Samples to declarationof Results to disseminationof
informationto stake holders.
• End-to-end online system.No physical
file required.
• Auto reminder for renewal of licenses
• Centralizedapproval system for licenses
• One database accessedby states
• Single SignOn for multiple states
Gujarat model replicatedin 13states anddeclared as rapid roll out for all states by DeiTY, GoI.
FDCA – LaboratoryCapabilities
• Food and Drug Laboratory (FDL)– Vadodara and Patan; Regional Food Laboratory - Rajkot and Bhuj can carry
out testing ofAllopathicDrugs, AyurvedicDrugs, HomoeopathicDrugs, Cosmetics, Food Articles.
• These laboratoriesare equippedwith state ofthe art testing facilitiesAAS, Sparkemission,
spectrophotometers, HPLC with AutoSampler, Gas/Liquid chromatography, Spectrophotometers, FTIR
• FDCA is equipped with MobileDrugTestingLabhaving key sophisticated instrumentslikeRaman
Spectrophotometer, Near Infrared, XRS (X-RaySpectrometer). TheseMobileLabs (India’s first Mobile
DrugTestingLab)havefacilityof detectinganyspurious drugs on spot.

23. 23
Investment Opportunities
Manufacturing of Biopharmaceuticals
Pharma Machinery
Manufacturing of Active Pharmaceutical Ingredient
Medical Devices and Diagnostic Kits
High End Drugs
Opportunities in Contract Research and Manufacturing Services industry
(CRAMS)
Pharma Retail Chains

24. 24
Key Department/ State GovernmentAgencies
Health and Family Welfare Department
7th Floor, Block7,
SardarPatel Bhavan, Sachivalaya,
Gandhinagar, Gujarat, India- 382010
http://www.gujhealth.gujarat.gov.in/
Phone: 079-23251401
E-mail: sechfwd@gujarat.gov.in
Healthand Family
Welfare
Department
Food and Drugs Control Administration
BlockNo 8, Dr. Jivraj Mehta Bhavan, Gandhinagar, Gujarat, India – 382010
https://gujhealth.gujarat.gov.in/food-and-drug-control-administration.htm
Phone: 079-23253417
E-mail: comfdca@gujarat.gov.in
Food and Drugs
Control
Administration

25. 25
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