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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12dg@pharmexcil.com

ありがとう！

THANK YOU!