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1

Export of Pharmaceuticals to Africa General Issuesto Africa – General Issues

[ Vishnu M Sriram ][ Vishnu M. Sriram ]AVP Emerging Markets (Formulations)

Indian Pharma Industry

Synonymous withQuality and Affordable drugs

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2

Assets

Low Cost ManufacturingMan powerRaw Materials

High Quality Research & Manufacturing FacilitiesHigh Skill LevelsHigh Skill LevelsAncillary Infrastructure

Source: WHO website, Pharmexcil Research

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3

FactsIndia is the 4th largest producer of pharmaceuticals by volume

8% of global products8% of global productsIn value terms: 1.5% of world total

Indian Pharma Industry employs around 500,000 people directly

More than 250 large R&D based Pharma Cos.Incl. MNCs, Govt. owned & Private Cos.

More than 5000 small licensed manufacturers

Source: Research&Markets, Ireland

Transformation…The advent of Pharma Product Patent Recognition in the year 2005 changed the face of Indian pharma companies

Post Patent era – Industries started evolvingMaximun patents filed by MNCs like Pfizer and J&J

R&D is moving from reverse-engineering to developingNovel drug delivery systemsCombination drugsNew drug discoveryNew drug discovery

Development ofCROs (Contract Research Organizations) &CRAMS (Contract Research & Manufacturing Services)

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Entry Strategies

Partnership with established local generic companies

Own sales & marketing setupOrganic or through acquisitions

Having the manufacturing plant in focused countries

Focus [Exports]

US, EU, Russia & CIS countries

Africa & Lat. America

New Regions: Australia, Japan & other Asian t icountries

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India’s ARV Registrations in Africa (Under WHO)

90

20

30

40

50

60

70

80Among the top 30 countries where ARVs are registered,

26 are in Africa

0

10

20

Nig

eria

Tanz

ania

Uga

nda

Côt

e d'

Ivoi

re

Moz

ambi

que

Rw

anda

Zam

bia

Cam

eroo

n

Buru

ndi

Con

go

Keny

a

Gha

na

Ethi

opia

Mal

awi

Gam

bia

Mau

ritan

ia

Sout

h Af

rica

Cha

d

Sier

ra L

eone Mal

i

C. A

frica

n R

ep

Burk

ina

Faso

Beni

n

Suda

n

Zim

babw

e

Bots

wan

a

Gui

nea

DR

Con

go

Nam

ibia

Sene

gal

Alge

ria

Mad

agas

car

Gab

on

Togo

Boliv

ia

Source: WHO website, Pharmexcil Research

Threat

Low cost countries…Counterfeit / Spurious drugsHigh CompetitionEntry BarriersHurdles – in transit

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Critical Issues [Africa]Regulatory Approvals

Long timelinesSome cases, an approval takes 12-24 months

Need of harmonizationUniform requirements

Long term stability data – Mandatory requirement12 months data Vs. 3months data (US)

No. of batches during registration process3 b t h V 1 b t h (US) & 2 b t h (EU)3 batches Vs.1 batch (US) & 2 batches (EU)

Lack of Fast Track ApprovalsBased on Pre qualifications (WHO, US FDA etc)For Life saving drugs

Thank You!