P har m a c e u t i c a l e x p o r t p rom oti on

strategy

BY : ACHAL ROHITKUMAR DOSHI

Roll Number : 08
First Semester,
Department of Pharmaceutical management,
N.I.P.E.R.
S.A.S.Nagar,Punjab
Flow Of Presentation

Current Pharmaceutical Status

Opportunity ahead

Promoting strategies

International co-operation&
internal regulation

Role of Pharmexcil
 Current Pharmaceutical Status
INDIAN PHARMACEUTICAL INDUSTRY

ØExport of drugs,pharmaceuticalsand fine chemical increased at CAGR

21.33% for 5 years 2003-2004 to 2007-2008 reaching Rs 39,139.57crores
(8.61$bn)
Ø
ØTotal pharmceuticalindustry size $18bn at end of 2007
Ø
ØDomestic pharmaceutical market $10.76bn in 2008
Ø
ØExpected to grow at 9.9% till 2010 and then 9.5% till 2015
Ø
Ø4th in terms of volume but 14th in terms of value
Ø
ØAPI segment india ranks 3rd largest with 500 different APIs
 Current pharmaceutical status
CURRENT PLACE IN THE WORLD

ØLow-cost skilled producer of pharmaceuticals

Ø
ØManufacturing base for APIs and formulation & emerging hub for
biotechnology, bioinformatics, contract research, clinical data management
and clinical trials.
Ø
ØUS FDA inspected plants (119 plants), MHRA UK, MCA South Africa, TGA
Australia , HPB Canada have approved scores of plants in India .
Ø
ØOne third of drug master files (DMFs) in USA.
Ø
ØThirty percent of all approved ANDAs in the US are from India, ranking the
country number 2 next only to USA
 Current pharmaceutical status
CURRENT PLACE IN THE WORLD

Weakness of the indian pharma export….

ØIndia good at chemistry but not so well in biology.

Ø
ØThe number of approved GLP labs is very few.
Ø
ØThe clinical investigators are a fraction as that of USA.
Ø
ØConsidered as the Hub of the counterfeited and spurious medicines.
Ø
ØTight price control regulations by DPCO and NPPA.
Ø
ØLack of understanding of international Pharmaceutical marketing/pricing
practices and market environment in various countries.
Ø
Ø
Ø
Current pharmaceutical status
CURRENT PLACE IN THE WORLD
Current pharmaceutical status
CURRENT PLACE IN THE WORLD
Current pharmaceutical status
Import Of Pharmaceuticals
 Current pharmaceutical status
US $ mn

year
Rs. Crores
Current pharmaceutical status
 Opportunities

The main opportunities for the Indian pharmaceutical industry are in the
areas of:

ØGenerics/ Bio pharmaceutical generics

Ø
ØContract manufacturing services for MPCs
Ø
ØContract R&D services like custom synthesis,
clinical trials,
clinical data management,
bioequivalence testing,
Stability testing,
chemistry and biology services.
Opportunities
Opportunities
 Opportunities

Opportunity in Developing Economies

ØTRIPS Doha round 2001:

“Each Member has the right to grant compulsory licenses and
the freedom to determine the grounds upon which such licenses are
granted.”

ØIn Thailand and South Africa, there are situations when patented drugs
become too expensive for developing countries and consequently, they
import cheaper copies of these drugs

ØIndian companies such as Cipla and Aurobindo have been at the forefront
of exporting drugs in these situations.
Opportunities
 Promotional Strategies

Source : pharmexcil research

 Promotional strategies

Accelerating the Growth of Generic Pharmaceutical Industry

1.Building Portfolio for Untapped Highly Attractive Opportunities

2.Engineer Alliances to Protect Strategic Interests of the Country

3.Enhancing Pool of Trained Professionals

4.Treat Investments in Quality on Par with R&D to Enhance Quality and Skilled

Scientific Personnel

5.Reviving Indian Drug Intermediate Industry

6.Looking At Narcotics Formulations as an Important Opportunity and Not Just a

Menace
 Promotional Strategies

Accelerating the Growth of Generic Pharmaceutical Industry

7.Reviving Fermentation Capabilities of India

8.Attracting Talent to Chemistry, Biology and Law

9.Thrust in developing Economies

10.Shared Marketing Services

11.Identifying Strategies to Participate In Regional Clusters

12.Anti-diversion Mechanism in case of exports against compulsory

licensing
 Promotional Strategies

Enhancing India’s R&D

1.Treatment of R&D Expenditure for Tax Purposes

2.Permitting Commercial R&D Subsidiaries for Tax Exemption

3.Focusing on Immediately Commercialisable technologies By Government

Institutions

4.Banks should provide certain capital for taking up commercialisable R&D

5.Encouraging Public Private Initiatives in R&D

6.Intense scrutiny of patentability of research is needed for grant of funds

7.
 Promotional Strategies

Enhancing India’s R&D

7.R&D Incubators to Promote Entrepreneurship and New Ventures

8.Enhancing Availability of Clinical Investigators/Researchers

9.Enhancing Capacity for Clinical Trials, Animal Toxicity/BE centres

10.Facilitate Learning and Legislation with Respect to IRBs

11.Service Tax Exemptions for Pharmaceutical R&D

12.VC Funding for CROs to Promote Value Chain in Drug Discovery

13.Major impetus to R & D should be given through the creation of synergy

between the industry and academia where the ‘cluster’ model of the United
States could be adopted.

14.
Promotional Strategies
 Promotional Strategies
Contract Manufacturing
1.Government should promote capacity building in testing laboratories for stability

studies

2.Bioequivalence studies and third party analytical laboratories urgently through

policy action

3.Appropriate incentives and venture capital. Such facilities can be made available

to SMEs at Subsidized rates to reduce entry barriers and encourage

competition from start-ups in drug

4.Discovery and other key growth segments.

Promotional Strategies
Fostering Indian Clinical Trials Industry
 Promotional Strategies

Fostering Indian Clinical Trials Industry

1.Enhancing Availability of Clinical Investigators/Researchers

2.Enhancing Capacity for Clinical Trials, Animal Toxicity/BE centres

3.Government Body Should Facilitate Learning and Legislation with

Respect to IRBs

4.Simplifying approval procedures for Clinical Trials Export/Import

Materials

5.Service Tax Exemptions for pharmaceutical R&D

6.VC Funding for CROs to Promote Value Chain in Drug Discovery

7.Decentralisation of Approval System

 Promotional Strategies
Background of AYUSH Industries in India
ØIn 2008, India exported herbal products worth US$ 116.8 million.

ØAYUSH products worth US$ 85.9 million.

ØIn the last four years (2004-2008), growth in exports of AYUSH products

(CAGR:16.75%) was higher than that of herbal products (13.98%).

Ø200,000 U.S. adults used Ayurvedic medicine in the previous year.

ØMany of the significant Indian plants do not find place in the list of
importable herbs in many countries. For example,
TGA Australia does not recognize any of the Indian
pharmacopoeias while it recognizes Pharmacopoeia of the PRC of China

Ø
 Promotional Strategies

ؙ World market for Natural Products US $ 62 billion and having

double digit growth.
ؙ Market for Dietary supplements growing in both USA and EU
markets.
ؙ More than 70% of population in developed countries have tried
and regularly depend on Natural products for health care
solutions
Ø
 Promotional Strategies
Background of AYUSH Industries in India
 Promotional Strategies
Helping The Ayush Industry
ØFocus Product scheme : Top 25 plants and top 50 formulation thrust

ØThe Vishesh Krishi and Gram Udyog Yojana (VKGUY) should also include
extracts as well as compounds isolated from the herbs so identified under
the Focus product scheme.

ØEthanol availability to recognized Ayush industries producing these

products should be on a fast track basis.

ØIt is mandatory to submit batchwise testing report for all Herbal,Ayurveda

Siddha, Unani medicines that are exported from approved laboratories,
certifying that heavy metals are within permissible limits

ØChina has the maximum number of medicinal plant species (4,941), and it
is also the world’s top exporter of medicinal plants

ØIndia 2nd in terms of volume, 4th after USA and Germany in terms of
value.
 Promotional Strategies
Helping The Ayush Industry
ØProvide a meaningful financial assistance (for example Rs. 50 lakhs) as a

grant if the product satisfies certain parameters such as:

•Complies with guidelines on heavy
metal/pesticide/mycotoxin/microbial residues
•Efficacy is proven by controlled trials
•Analytical/chromatographic methods have been developed which
facilitate both qualitative and quantitative estimation of ingredients
•At least 2 publications in reputed journals of pharmaceuticals on the
product.
 Promotional Strategies
International CO-operation

1.Partner countries may not include pharmaceuticals in their sensitive lists.

2.Drug registration process in partner countries may be harmonized and should

not become a Non-Tariff Barrier (NTB).

3.NTBs such as sanitary and phyto-sanitary regimes may not be adopted or if

adopted may be harmonised.

4.A mutual pharmaceutical cooperation regime can be negotiated which can

complement each other’s capacities. Since United States adopts a market
restrictive approach in respect to pharmaceutical exporting countries which
do not have free trade agreements with United States, it may be a good idea
to examine the likelihood of entering into an enabling agreement with the US
which would negate this artificial barrier created by US
 Promotional Strategies

Technical barriers to Trade

1.Multiple Approvals by Various Drug Regulatory Authorities

2.
3.Legislation for Import Permissions Should be Strengthened
4.
5.Bioequivalence Studies for Generics in Local Populations – An Emerging
Technical Barrier: Japan, Mexico and now Thailand, etc., want the
bioequivalence to be studied in their local populations in their countries.
6.
7.Drug Registration Fees : Realigning Registration Fees for Formulations APIs
and Intermediates on par with other countries
8.
9.Reference Standards
10.
11.Requirement for Local Presence
12.
 Promotional Strategies

Technical barriers to Trade

7.Government Procurement : USA government bidding;

Eg, India chile usa case

7.Counterfeit & Spurious Drugs

8.Drug Regulatory Information Availability : language and subjective regulations.

Centralised Regulatory Support for Export Promotion

9.European Regulation of ‘REACH’ - an Emerging Barrier :Making indian price no

more competitive
 Promotional Strategies
Aligning Internal Regulation

1.Price Controls : Fixing the overall marketing expenditure and trade discounts as
percentage of sales for all existing products. Such a mechanism will help
avoidance of low investments in quality and help industry to reach global
standards.

2. Quality and GMP Regulation : For example, based on manufacturers from

countries like India, Wal-Mart is able to give monthly supply of select drugs for just
US$ 4 per month. This clearly dispels the fear of cost escalation while pursuing
quality.

3.Foreign Site Inspections

4. Orientation & Training of Personnel involved in Drug Regulation and control

1.
5. Amendments to procedures
Role Of Pharmexcil
Thank you

Any
Questions..???????
Promotional Strategies