Generic Drags-India’s PerspectiveMeeting Global Needs
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05th Feb 2020, Tokyo
Udaya Bhaskar Ravi
Director General
• Organises Export Promotional events and Trade delegations
• Industry’s Voice - Represents issues with concerned Agencies
FACILITATOR
• Make suggestions to Govt. of India & Regulators on policy issues relating to Pharma exports
ADVISOR
• Market / Regulatory reports of countries
• Importers / Distributors in overseas countries
EDUCATE
Pharmaceuticals Export Promotion Council of India(Set up Ministry of Commerce & Industry, Govt of India)
An Overview of Global Pharma Industry
North America, 384.4, 32%
LAC, 63, 5%
Asia Pacific, 340, 29%
Eastern Europe, 70, 6%
Middle East & Africa, 35, 3%
Western Europe, 295, 25%
Market size $ bn
Global Pharma industry is estimated to have touched $ 1200 Billion by the end of 2018 and is forecast to grow at a CAGR of 4.4% during the next five years.
Source: IQVIA/BMI
Top Ten Formulation Exporting Countries
Germany0196224 - (15.63%)
Switzerland02
France06
Belgium05
Ireland03
USA04
UK07
Italy08
Netherlands09
India10
Exports in 2018 ($ M) Growth (%)
52664 - (40.24%)
47580 - (10.10%)
29644 - (-8.95%)
22195 - (-6.85%)
Exports in 2018 ($ M) Growth (%)
75217 - (7.02%)
48865 - (7.50%)
33486 - (10.64%)
27785 - (8.63%)
14340 - (11.04%)Source: Un comtrade
INDIAPharmacy of the World
• India provides generic medicines to almost 180 countries.
• 3rd Largest exporter of formulations by volume & 10th by value
• 8 out of 20 Global Generic companies by 2018 values are from India
• 70% of WHO’s vaccines requirement are sourced from India
• 90% of WHO Pre Qualified API’s are sourced from India
• Thirty percent of US generic imports are sourced from India & India is the fourth Largest formulations Importing partner of USA
Domestic $23.87BnExports,
$19.13Bn
Indian Pharma Industry:$ 43 Bn in FY 2019
Indian Pharma Industry
• No.of USFDA approved sites: 722 (as of July 2019)
• No.of EUGMP complied Units: 826 (as of July 2019)
India exported Generics worth $15 billion in 2019 Growing over 12 %.
Form
ula
tio
ns
&B
iolo
gica
l,
API & IntermediatesSurgical
& Vaccines
Ayush & Herbal Products
Export Outlook
71%
20%6%3%
2
3
1
North America, 31%
Africa, 19%
Europe, 16%
Major Export Destinations
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Over 55% Exports to Highly Regulated Markets
Exports during April-March$ Million USD
Category Fy-18 Fy-19 Gr% Contbn%
North America 5348.00 6145.67 14.92 32.12
Africa 3346.97 3436.44 2.67 17.96
EU 2752.64 3003.91 9.13 15.70
Asean 1181.45 1310.14 10.89 6.85
LAC 1135.15 1308.30 15.25 6.84
Middle East 869.05 1074.11 23.60 5.61
South Asia 764.33 812.84 6.35 4.25
CIS 733.17 788.27 7.52 4.12
Asia (Excluding Middle East) 627.30 693.62 10.57 3.62
Oceania 320.25 340.84 6.43 1.78
Other European Countries 150.99 162.86 7.86 0.85
Other America 52.48 57.38 9.33 0.30
Grand Total 17281.81 19134.49 10.72 100.00
Source: DGCIS
Exports to JAPAN by Category $ Million (2018-19)
Bulk Drugs & Drug Intermediates,
114.18, 65%
Drug Formulations & Biologicals,
55.12, 31%
Others, 6.51, 4%
Indian Pharma Exports to Japan (April-December)
FY 19 FY 20 Change %
121.56 mn USD 151.23 mn USD 24.43%
175.81, 19.06%
Source: IQVIA MIDAS MAT Q4 2016; Rx bound; Europe includes Turkey; Generics include Non-original branded products and unbranded products
Generics are Taking an Increased Share of Market GENERICS MARKET SHARE (Volume, Value) 2006 VS. 2016
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Japan’s Medicine Requirement As India Understands
Japan offers best of Healthcare to its citizen and
Government makes continuous efforts to improve.
Country has largest Percentage wise Senor Citizen
Group to support.
Currently Japan’s Generic usage is around 60% (By
Volumes) of available opportunity and the country
plans to raise it to 80% by end of 2020.
This translates to 15% generic Usage by value of its $107
billion market size.(Source: 2019 Fitch solns)
India, to assist Japan in its Mission of increased usage
of Generics akin to US or UK.
Japan can utilize Highly skilled Chemistry Workforce
by investing in India to produce highest quality
products at most competitive prices.
India-Perfect Partner
India- Japan Collaboration
Recognition of Indian standards for medical devicesmanufactured in India till MutualRecognition Agreement is executed between thecertification agencies.
Green Channel/ fast-track approval for Indianpharma companies producing high standardgenerics and already possessing USFDA/EMAapprovals
Japan requires API DMF to be firstaccessed by a Formulator unlike USA,where one can file a portfolio ofDMFs and look for attractive partnerslater.
India develops dossiers with universally accepted bioequivalence studies and dose linearity concept which are well accepted by most of the Regulatory agencies across the Globe including USFDA, UKMHRA & EMA etc.
Waiver for the requirement to perform localbioequivalence studies in Japan which would helpin speeding upon market access approvals.
Medical Devices
Recognition
Fast Track Approvals
Independent
DMF Review
Mandated Submission of Local BE study data
Concerns of Indian Industry wrt Japan Market
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