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pharmexcil Digest September 2009
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DISCLAIMER This monthly update has been prepared as a service to pharmaceutical exporters from India and pharmaceutical importers in other countries, by PHARMEXCIL (Pharmaceuticals Export Promotion Council of India). No part of this report may be reproduced, stored in a retrieval system or transmitted in any form or by any means, without prior permission, in writing from PHARMEXCIL and Datamonitor, India.
PHARMEXCIL does not recommend or endorse any specific companies or commercial products and brand names which may find mention in these Monthly News Digest. Through the information contained within these monthly updates PHARMEXCIL does not express any opinion whatsoever concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries.
Table of Contents
1. Chairman’s Message .................................................................................................. 2
2. Executive Director’s Desk ......................................................................................... 4
3. Features ...................................................................................................................... 7
3.1 Big Pharma Eyeing India – Inherent strengths of Indian players driving M&A 7
3.2 Boosting Pharma R&D in India – Government Initiatives ............................... 10
3.3. IP laws shouldn’t interfere with access to generic medicines and parallel
imports ..................................................................................................................... 14
4. Country Focus .......................................................................................................... 17
4.1 The US Pharmaceutical Market: Authorized Generic Agreements – Indian
companies pathway to US Generics Market ............................................................ 17
5. Pharmexcil Activities ............................................................................................... 21
5.1 Pharmexcil activities during August 2009 .......................................................... 21
5.2 Upcoming Pharmexcil activities ........................................................................ 28
5.3 Pharmexcil study reports .................................................................................... 29
6. Indian Pharma in Media .......................................................................................... 33
Knowledge Partner
Vol.1 Issue 3 September 2009
PHARMACEUTICALS EXPORT PROMOTION COUNCIL (Set up by Ministry of Commerce, Govt., of India)
H.O.: 101, Aditya Trade Centre, Ameerpet , Hyderabad – 500038 Tel: 040-23735462/23735466, Fax: 91-40-23735464
E-mail: [email protected]
For more information, visit www.datamonitor.com
pharmexcil Digest September 2009
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1. Chairman’s Message
Dear Member,
I would like to
inform you that the
proposed “Indo-
Africa Pharma
Business Meet” was
postponed to September 25 -27, 2009 on
the advice of our embassies in West
African countries, who apprehended that
many visitors from these countries may
not be able to attend due to Ramzan on
September 21 2009. I am happy to share
with you that Shri Anand Sharma,
Hon’ble Minister of Commerce and
Industry obliged our request for
presenting the “Pharmexcil Export
Award” for outstanding export
performance under various categories and
“Best Patent Award” for patents secured
during the “Indo-Africa Pharma Business
Meet” at Hyderabad, which is coinciding
with the fifth Annual General Body
meeting (AGM) of our Council.
During the month on August 11 2009, I
have made a representation to “Board of
Trade” and is headed by Shri Anand
Sharma, Hon’ble Minister of Commerce
and Industry. I have taken up the issues
related to exemption of service tax for
pharmaceutical exporters and allocation of
a separate fund of Rs.1, 000 crore for
Small and Medium Enterprises (SME) in
exports, etc.
On the eve of announcement of Foreign
Trade Policy (FTP) by Shri Anand
Sharma, Hon’ble Minister of Commerce
and Industry has convened a meeting with
all the industry promotion council’s in
India and I have represented Pharmexcil. I
am happy to share with you that
Directorate General of Foreign Trade
(DGFT), GOI has considered many of
our representations in the FTP which
include: Addition of several countries in
the focus countries/ product schemes and
extension of export obligation period to 6
months to 12 months for certain products
like Penicillin’s and other drugs imported
under advance license schemes. I take this
opportunity to express sincere thanks to
Dr. Surinder Singh, DCGI and Shri R.S.
Gujral, DGFT who have taken extreme
interest in attending to the representations
pharmexcil Digest September 2009
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of Pharmexcil for promotion of
pharmaceutical exports.
On August 13 2009, Pharmexcil’s third
regional office was opened in
Ahmedabad. I express sincere thanks to
Shri Hemant G Koshia, Commissioner,
Gujarat State Food and Drug Control
Administration who has taken special
interest in establishing the office.
Also during the month, I have attended
and submitted a representation to the
Ministry of Environment & Forests
suggesting some changes to the proposed
draft amendment to an ACT focusing on
pollution control measures.
I am happy to inform you that after
satisfying service of 2 years as Chairman
of Pharmexcil, I am going to handover
charge to Shri Smitesh C. Shah, Chairman
& Managing Director, Calyx Chemicals &
Pharmaceuticals Ltd during the
Pharmexcil’s fifth AGM (September 25 –
27, 2009). During this period, I have
enjoyed the confidence and support of my
colleague members of the council and
senior government officials from
Department of Commerce, Department
of Pharmaceuticals and Drug Controller
General of India (Department of Health).
I will be failed if I don’t express sincere
thanks to Secretariat of Department of
Pharmaceuticals, Government of India,
who have been extremely supportive in
implementing my ideas and suggestion for
promotion of pharmaceutical exports
from India.
Thanking you,
Yours Sincerely,
Venkat Jasti
pharmexcil Digest September 2009
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2. Executive Director’s Desk
Dear Member,
I am happy to
bring to the
notice of the
members that a
Nigerian
delegation
headed by Dr. Paul Orhii, Director
General (National Agency for Food and
Drug Administration and Control), had
visited India during August 01 – August
06 2009. This visit organized by
Department of Pharmaceuticals, is indeed
opportune for us given the backdrop of
reports of counterfeit generics
manufactured in China with “Made in
India” labels seized in Nigeria during the
last few months. In the meeting chaired
by Secretary, Department of
Pharmaceuticals, Pharmexcil made a
presentation to the visiting Nigerian
delegation at Delhi on August 3 2009, and
highlighted the credentials of Indian
players in the global pharmaceutical
industry. During the visit, Dr. Paul Orhii
expressed his confidence in the Indian
generics with respect to cost and quality
but the lack of infrastructure in Nigeria to
assess the quality posed a challenge in
adopting the medicines and sought India’s
help in creating awareness programmes to
enhance the adoption of Indian made
generics, training of drug regulatory
personnel and improving curriculum of
pharmacy education in Nigeria, etc.
On August 21 2009, Pharmexcil had
organized an interactive meeting with
Drug Controller General of India Dr.
Surinder Singh at Hyderabad and
representatives from about 100 companies
participated at one day’s notice. Dr.
Surinder Singh while addressing several
queries informed the participants about
the progressive steps being taken up by
Central Drugs Standard and Control
Organization (CDSCO) to address various
competing interests of stakeholders within
the pharmaceutical industry including
those of international regulatory agencies
such as USFDA, WHO and ICH
requirements. He mentioned that his
department had received approval for
substantial addition of manpower that
would enable quick turnaround times for
drug approvals. Dr. Surinder Singh also
pointed that the Government of India has
tightened its regulations such that strict
pharmexcil Digest September 2009
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action could be taken against
manufacturers of counterfeit/ spurious
drugs. Dr. Singh has assured full co-
operation for promoting Indian
pharmaceutical exports.
An interactive meeting with Indian
ambassador to Azerbaijan, Mr. Debnath
Shaw was organized by Pharmexcil on
August 28 2009, in New Delhi to assist
the Indian exporters to Azerbaijan and
address. The meeting was fruitful with
participation of about 30 members of the
council.
Pharmexcil had a meeting with Her
Excellency, Patricia Figueroa Rodriguez,
Ambassador of El Salvador to India at
New Delhi on September 03 2009. During
the discussion, the Ambassador has
expressed El Salvador’s interest for a Joint
Venture/ Collaboration with the Indian
companies for supply of low cost quality
medicines to El Salvador. We were also
requested to organize a Buyer’s Seller’s
meet in El Salvador.
We also had a meeting with Shri Mahesh
Sachdeva, Ambassador to Nigeria and
Shri Ashok Kumar, Secretary, Department
of Pharmaceuticals on September 03
2009, to discuss the measures to be taken
for India brand image building. A
proposal for establishing a retail pharmacy
chain by experienced Indian/ Nigerian
agencies was discussed to ensure the
distribution of genuine Indian made
generics.
During the month Pharmexcil has
successfully participated in CPHI, South
America in Sao Paulo during August 26-
28, 2009 with participation of 25 members
in India Pavillion supported by
Department of Commerce, GoI.
There has been a good response for
participation in PHARMED 2009
(September 23-26) in Vietnam and about
30 members are participating in the India
Pavillion organized by Pharmexcil.
On September 07 2009, Pharmexcil has
attended a meeting convened by Drug
Information Association (DIA) at
Hyderabad on the subject ‘Quality of
APIs’. The meeting was attended by
senior personnel from regulatory
authorities of USFDA in Delhi/ Mumbai,
WHO, EDQM and TGA – Australia. The
meeting has dealt with some of the good
information of high value to API
exporters from India. The Director and
Deputy Director, USFDA has visited
Pharmexcil’s Head Office in Hyderabad.
DIA has expressed an interest in entering
pharmexcil Digest September 2009
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into a Memorandum of Understanding for
organizing events involving overseas drug
regulatory authorities and other technical
experts.
As part of the Republic of Korea’s co-
operation project to SAARC countries
Mr. P. Balaram, Assistant Director,
Pharmexcil, is attending a special training
programme on Intellectual Property
Rights from September 03 -19, 2009 as
nominee of Government of India Yours Sincerely,
P.V. Appaji
pharmexcil Digest September 2009
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3. Features
3.1 Big Pharma Eyeing India – Inherent strengths of Indian players driving M&A Expert Opinion from Datamonitor
Global multinational pharma companies
are scouting for alliances and acquisitions
in the Indian generics market in order to
compensate for slower growth in the
branded business with the expiry of many
blockbuster drugs and declining R&D
productivity. India is a prime example,
where acquisitions allow vertical
integration with active pharmaceutical
ingredient (API) suppliers and access to
low cost and high quality resources like
man-power & facilities (both
manufacturing & R&D). In the long term,
this strategy has the potential to create
synergies, build critical mass and establish
a stronger position in the market.
Expiring branded product patents and drying up of R&D pipelines are major growth drivers for M&As The impetus behind M&As is attributable
to the declining number of new drugs
entering clinical trials; looming patent
expiration dates with more blockbuster
drugs; generic competition eroding market
share; the need to broaden and deepen a
product portfolio; cost savings from
synergy; sharing risk to dilute pressure;
and geographical expansion. Worldwide,
the top 50 pharma companies face patent
expiries worth $115bn on 36 drugs from
2007-2012 (Source: Datamonitor).
The most acquisitive companies overall
remain Big Pharma like AstraZeneca, Eli
Lilly, GSK, Johnson & Johnson, Merck &
Co., Novartis, Pfizer, Roche and Sanofi-
Aventis due to threat of lower earnings
growth with huge patent expirations
(biggest losses include Pfizer’s Lipitor –
Atorvastatin Calcium, AstraZeneca’s
Nexium – Esomeprazole Magnesium,
AstraZeneca’s Seroquel – Quetiapine
Fumarate, GSK’s Seretide – Fluticasone
propionate and BMS’s Plavix –
Clopidogrel Bisulfate) and declining
product pipelines. Apart from this,
governments all across the globe are
working towards bringing healthcare costs
The Drivers for M&A Patent expiry & generic
competition Declining R&D Productivity Gaps in the pipeline Cost savings Risk sharing Geographical expansion
pharmexcil Digest September 2009
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down through the increasing use of
generics.
Targeting India to tap un-locked growth potential through partnerships/acquisitions Some of the leading Indian pharma
companies like DRL, Ranbaxy, Sun
Pharma, Cipla, Glenmark, Aurobindo
Pharma, Cadila Healthcare, etc. are
realigning their business strategies and
showing willingness to be part of big
pharma’s business through acquisitions
and long term supply agreements. The
recent acquisition of Ranbaxy
Laboratories by Daiichi Sankyo Company;
DRL’s marketing alliance with GSK; and
Pfizer’s alliance with Aurobindo are few
examples indicating the mind set of global
pharma majors.
In an unexpected move, Japan’s Daiichi
Sankyo has recently acquired a majority
stake in Ranbaxy. This has changed the
landscape of Indian pharmaceutical
industry, with Daiichi Sankyo becoming
the second largest pharma company in
India. The deal provided Daiichi Sankyo
with Ranbaxy’s low-cost manufacturing
Big Pharma Vs. India - Major strategic acquisitions/alliances in 2008 & 2009
S.No. Year Acquirer
Target company Nature of
acquisition/ alliance
Total Value Company Country
1 Jul-09 Sanofi Aventis
France, through Merieux Alliance
Shantha Biotech (hiked stake from 60% to 80%)
Acquisition US$783mn (550mn euros)
2 Jul-09 Abbott Laboratories U.S. Wockhardt (nutrition
business) Acquisition US$130mn
3 Jun-09 Vetoquinol SA France Wockhardt (Animal Care Subsidiary) Acquisition US$31.2mn
4 Jun-09 Pfizer (Animal health business) U.S.
Vetnex Animal Health Ltd. (earlier ICICI Venture acquired from Ranbaxy)
Acquisition NA
5 Jun-09 GlaxoSmithKline U.K. Dr Reddy’s Laboratories Ltd
Marketing Agreement NA
6 May-09 Pfizer U.S. Claris Life Sciences Strategic Alliance NA
7 Mar-09 Pfizer U.S. Aurobindo Pharma Marketing Agreement NA
8 Aug-08 Fresenius Kabi AG Germany Dabur Pharma Strategic
Alliance NA
9 Jul-08 GSK-Aspen U.K.-South Africa Strides Arcolabs Supply
Agreement NA
10 Jun-08 Daiichi Sankyo Company Ltd. Japan Ranbaxy Laboratories Acquisition ~US$4.6bn
Source: Datamonitor Research
pharmexcil Digest September 2009
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expertise, in addition to allowing it to
launch its innovative products in India at
competitive prices. This transaction
reflects a global pharma industry trend,
and although this trend is still in its
infancy, it is expected to continue due to
cost-cutting incentives and as a means of
differentiation and finding new streams of
revenue.
On the biotechnology front, France-based
Sanofi-Avenits has agreed to purchase
additional 20% stake in Hyderabad-based
Shantha Biotechnics (already bought 60%
stake in 2006) at a cost of US$783mn
(Source: Indian Express) from Merieux
Alliance indicating that big pharma is on
an acquisition spree even with biotech
companies. Given the rise of pandemics
that arise from other vectors, animal
healthcare now seems like an attractive
market to be in for big pharma as a part of
their new growth avenues. India is one of
the top five poultry and live stock markets
in the world with market size of
approximately INR 1.2bn (Source: IBEF)
and this market is growing in double digits
year on year. Thus, animal healthcare units
of domestic companies are now
increasingly becoming acquisition targets
for global pharma companies; Pfizer’s
acquisition of Ranbaxy’s Vetnex Animal
Health Ltd. being the case in point.
India Pharma Inc. likely to benefit from the global consolidation process The global pharma companies would
continue to close more collaborations,
M&As and strategic alliances to
consolidate their presence in India
depending on the business model and size
of the target company. Most of the times,
these deals are resulting in a win-win
situation for both domestic companies
and big pharma, wherein the former
establishes front end presence by gaining
access to wider geographic reach and
innovator drugs, whereas the latter gets
access to low cost man-power and
manufacturing processes and facilities
along with wide spread marketing and
distribution channels. As the western
market becomes more saturated, vertical
integration in India can prove incredibly
valuable for reaching critical mass and to
reduce costs, which is especially
advantageous in the generic sector.
By Sharmila Ponakala, Senior Consultant,
Healthcare Consulting, Datamonitor
pharmexcil Digest September 2009
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3.2 Boosting Pharma R&D in India – Government Initiatives Expert Opinion from Datamonitor
The Indian pharmaceutical market has
grown from a mere US$0.3bn in 1980 to
~US$19bn in 2008 capturing 10% of
global market share in volume terms
(ranking 3rd) and 1.5% in value terms
(ranking 14th) (Source: Department of
pharmaceuticals, Government of India). In
India, the total investment in R&D as on
June 2008 stood at Rs.29.73bn, 9.9% of
revenues (Source: CMIE Prowess, data for an
aggregate of 151 companies). This investment
in R&D seems abysmally low when
compared to the $ 65.2 billion that the US
pharma industry spent on R&D (17.4% of
total sales) during 2008.
As per Department of Scientific &
Industrial Research (DSIR),
there are 1327 in-house
R&D units (of these nearly
1245 are in the private sector
and the remaining are in the
public/joint sector) having
valid recognition as on 31st
December 2008 across the
industries. In India low
investments in innovative
R&D is mainly due to
limited size of balance sheets
and profitability compared to developed
countries. Although there has been a
significant improvement on NCE (new
chemical entity) research over the past few
years especially post the new ‘product’
patents regime, there is a strong need for
government support to develop the
financial muscle to boost innovative
R&D.
There have been several initiatives taken
by the Indian government to boost R&D
in India and towards that end the vision
of the task force on ‘Strategy for
Increasing Exports of Pharmaceutical
Products’ formed by the Ministry of
Commerce and Industry, Department of
pharmexcil Digest September 2009
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Commerce, is worthy of mention: "To
provide intellectual capital to make available safe,
cost-effective, contemporary, quality therapeutics to
the people of India and help reduce percentage of
mortality and morbidity while emerging as a
significant player in the global market place."
Major Initiatives from the Government
Pharma Vision 2020 envisions India
among the top five global pharma
innovation hubs by
the year 2020. It
aims to create more
than 5 lakh high
value jobs with an
investment of
Rs.50bn to
Rs.100bn with
substantial
contribution from
private bodies under the public private
partnership (PPP) model. The department
of Pharmaceuticals (DoP), which was
created in July 2008, is contemplating
setting up major projects including
Pharma City at Hyderabad, two pharma
clusters, four R&D hubs, vaccine
development centres and educational
campuses in various parts of the country
to augment R&D activity in India.
DoP has worked out various proposals to
encourage innovative R&D and
manufacturing activities in the domestic
pharmaceutical industry. The department
has also set apart Rs.200mn for promoting
research and development activities of
small and medium sized pharmaceutical
companies. The government is granting
soft loans to set up R&D units and setting
aside US$422.96mn (Source: IBEF) for
establishing 6 National Institutes for
Pharmaceutical Education and Research
(NIPER) in India
over the next five
years. The
government is also
creating a synergy
between the
pharmaceutical
industry and
academic
institutions and
publicly funded R&D organizations to
provide major stimulus to R&D.
The National Biotechnology
Regulatory Authority (NBRA) bill is
aimed at consolidating and enhancing the
effectiveness and efficiency of
biotechnology regulation, promoting
public confidence in the regulatory system
and at increasing collaboration within
state governments. The bill is set for
Cabinet approval and introduction during
DoP- Major R&D Proposals
Innovative drug discovery through clinical trials for 34 molecules
Development of Pharma incubatorsVenture Finance and Incubation Fundfor Innovative R & D in Pharmaceuticals
Setting up of GMP Compliant Biological / Bio Pharmaceutical
testing Lab; GLP Compliant ChemicalLab and Large Animal House Facility
pharmexcil Digest September 2009
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the next parliament session. The health
ministry in India is also taking initiatives
to regulate human genetic research and
setting up a Biomedical Research
Authority to govern the sector.
National Vaccine policy on the cards
The Government of India is planning for
a comprehensive national policy on
vaccines to ensure self sufficiency in
vaccine production. This policy will
enable to establish a separate vaccine
regulatory authority boosting R&D in
development of vaccines. This will also
ensure affordable and stable supply of
vaccines to the national immunization
program addressing national health
security and bio-security concerns and
preventing mortality and morbidity of
diseases that affect large populations,
including children.
Stimulus package for non
communicable diseases - The
government is framing an action plan in
its 11th plan by allotting around
Rs.16.61bn (Source: Pharmabiz, July 2009)
under the National Program for
Prevention and Control of Diabetes,
Cardiovascular Diseases and Stroke
(NPDCS). This program focuses on
health promotion and ensuring early
detection and appropriate management of
life style diseases through nation wide
awareness programs. In a similar fashion,
the government has also sanctioned
Rs.25bn (10-fold increase compared to
10th plan) for the National Cancer Control
Program under the 11th plan for early
diagnosis taking facts like shortage of
oncologists and lack of diagnostic facilities
into consideration.
The Pharmaceutical Research &
Development Support Fund was
established by the Department of Science
& Technology (DST) in 1994-95 to
promote collaborative R&D in the
pharmaceuticals sector. The allocation for
this fund by DST has increased in the
recent past. Currently, DST has allotted a
total of Rs.1500mn, of which Rs.800mn
are to be allocated for loans and
Rs.700mn for grants-in-aid. A total of 22
agreements have been signed in 2006-07
with 2 patents filed and 15 projects
recommended for funding (Source: Research
and Development in Industry, an overview Nov
2007 Issue by DST).
Foreign Direct Investment- In India,
the pharmaceuticals sector has been able
to attract FDI worth Rs.21.41bn during
the period from April 2007 to April 2009
pharmexcil Digest September 2009
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(Source: Department of Industrial Policy &
Promotion, Ministry of Commerce & Industry)
with contribution from 36 countries, of
which top 5 include- Mauritius (56.36%),
Singapore (11.18%), USA (5.81%), UAE
(4.73%) and Canada (4%), constituting
approximately 82% of FDI in the area of
pharmaceuticals. For the drugs and
pharmaceuticals sector in India, FDI limit
up to 100% is permitted on the automatic
route based on certain conditions.
Tax breaks to boost pharma & biotech
R&D- Under the Union Budget 2009-10,
the government has provided tax breaks
like extension of scope of current
weighted deduction of 150% on in-house
R&D expenditure to all manufacturing
businesses with few exceptions.
India is gearing up to become global
innovation R&D hub by 2020
The market size of Indian pharma
industry is expected to reach US$30bn by
2020 with increase in healthcare
expenditure as a % of GDP from 7% in
2007 to 13% by 2015. The drug discovery
market in India was worth US$800mn in
2007 and is expected to grow at annual
growth rate of 30%. The government has
been paying special attention to promote
and support innovative R&D in the
country over the years in the form of
giving several fiscal incentives and other
support measures to help pharma
companies establish their own in-house
R&D units. With its leadership in generics
space, the domestic pharma industry
needs to grow strong in drug discovery
and innovation mainly by creating world
class R&D infrastructure, setting up
mechanisms for R&D funding through
the public-private partnership route and
upgrading human resources for drug
discovery innovation.
By Sharmila Ponakala, Senior Consultant,
Healthcare Consulting, Datamonitor
pharmexcil Digest September 2009
14
3.3. IP laws shouldn’t interfere with access to generic medicines and parallel imports Feature article by Pharmexcil
[Pharmexcil review on Working paper by Kevin Outterson, May 2009. Boston University, School of law, USA] The term counterfeit should be reserved for
goods that violate trademark laws, the
classic definition of counterfeit under U.S.
law focuses exclusively on violations of
trademark law and does not concern itself
with patent or copyright infringement.
Current U.S. law, the TRIPS Agreement,
and the historic WHO definitions all
agree: counterfeit drugs must bear a false
trademark.
Substandard, contaminated or adulterated
medicines are a health risk hence the
import safety rules should focus on these
safety issues rather than IP disputes. If a
drug is legally generic in both the country
of production and the destination market,
customs authorities in third countries
should not impound it during transit. And
yet this is exactly what happened in recent
cases of the Dutch seizures.
These rules are not related to safety at all,
but are solely focused on protecting the
patent rents of the pharmaceutical
industry. The traditional WHO definition
of counterfeit focuses on trademark issues
of drugs “deliberately and fraudulently
mislabeled with respect to identity and/or
source”, but some patent-based drug
companies are now attempting to expand
the definition to include any violation of
any IP right. For example, a United
Nations Interregional Crime and Justice
Research Institute report recently defined
counterfeiting as “illegal reproduction or
imitation of products, given that this
illegality is the result of a violation of any
type of intellectual property rights”.
Likewise, (Anti-Counterfeiting Trade
Agreement) ACTA is reported to apply to
any violation of IP rights, broadly
interpreted.
This shift illustrates the need for a
transparent and accountable process in
IMPACT and ACTA. Under TRIPS, the
only conduct that must be criminalized is
“willful trademark counterfeiting or
copyright piracy on a commercial scale”.
This distinction is also found in U.S. law.
Nothing in TRIPS requires criminalization
of patent infringement. Furthermore, the
Doha Declaration’s mandate that TRIPS
be interpreted in a way “supportive of
WTO Members’ right to protect public
health and, in particular, to promote
access to medicines for all” suggests that
pharmexcil Digest September 2009
15
IP laws should not interfere with access to
generic medicines and parallel imports.
Criminalizing unintentional acts of
infringement by generic manufacturers
will likely chill entry of affordable generic
drugs into the market.
Statistics on counterfeit medicine are
widely distributed but are neither reliable
nor transparent. Estimates on the scope
of the counterfeit drug problem vary
greatly. Estimates on prevalence in various
countries range from 1% to 50% of the
drug supply. Recently, IMPACT estimated
the prevalence of counterfeit medicines to
be less than 1% of sales in developed
countries – despite the fact that the
potential profit of criminal counterfeiters
is highest in these countries – and
between 10% and 30% in developing
countries, where the profit potential is
lower. These estimates do not come from
peer-reviewed journals, and many actually
come from the pharmaceutical companies
themselves.
IMPACT seeks to expand border
enforcement against drugs subject to IP
disputes. This effort goes well beyond the
TRIPS, WHO and U.S. definitions of
counterfeit, and may reduce access to
desirable generic drugs or cheaper brand
name drugs parallel traded from other
countries. Both IMPACT and ACTA seek
new IP and customs enforcement rules
for an expanded array of products. These
expanded definitions may serve the
interests of patent-based drug companies.
IMPACT has also had some success in
pushing developing countries to adopt
laws providing for stronger intellectual
property protection.
Kenya’s recently enacted Anti-
Counterfeiting Act provides several
measures aimed at targeting the general
availability of counterfeit goods in the
country. While the bill does have some
positive aspects, it also contains several
provisions that could hamper the
government’s ability to provide access to
essential medicine to the estimated 1.4
million Kenyans living with HIV/AIDS.
The bill needlessly confuses counterfeiting
with violations of non-trademark
intellectual property rights. The bill also
weakens existing Kenyan legislation
allowing parallel imports. Uganda, where
over 5% of the adult population is
infected with HIV/AIDS, is also
considering a similar bill. The Ugandan
legislation reportedly calls for the death
penalty for drug “counterfeiters;” the
pharmexcil Digest September 2009
16
mixture of imprecise definitions and
capital punishment may chill legitimate
markets in generic drugs.
In addition to the legislative changes being
encouraged by IMPACT, international
laws on counterfeit goods may soon be
dramatically altered by ACTA. ACTA is
being negotiated by 13 countries, led by
the U.S. and the European Union. It is
difficult to say anything definitive about
ACTA because the negotiations are taking
place in secret, and no verified draft of the
agreement has been circulated. Several
points are notable in the leaked drafts,
which we can only assume are authentic.
First, the 20 May 2008 and 25 June 2008
ACTA texts covered only trademark and
copyright; in the text dated 7 July 2008 the
scope was expanded to cover all
intellectual property rights described in
TRIPS. This is precisely the expansion of
IP rights criticized with respect to
IMPACT. Second, ACTA proposes to
modify existing criminal standards and
sanctions, as well as border measures,
giving customs officials more authority to
seize and destroy infringing shipments
and to disclose information to right
holders on those shipments. One proposal
by Japan would expand the definition of
“counterfeit” well beyond the accepted
bounds of “willful trademark
counterfeiting” to include criminal
penalties for “trademark infringement
caused by confusingly similar trademark
goods”. These changes could expose
generic manufacturers to significant risks
without justification. Third, the U.S.
proposed that ACTA cover “in-transit”
shipments as well as import and export,
the precise issue raised by the Dutch
seizures.
Clearly, a new international organization is
being formed. It is important not to be
too distracted by the details in ACTA,
because we are speculating in the shadows
rather than engaging in a transparent and
robust debate. But it certainly seems
plausible that public health concerns are
raised by some of the provisions of
ACTA, and should be fully vetted with
open and democratic processes. Both
Canada and the European Parliament
have called for transparency in the ACTA
negotiations, but reportedly the U.S.
government is blocking disclosure as a
national security secret.
Click on the following link For Complete Report. http://www.pharmexcil.com/data/uploads/anti_counterfeit.pdf
pharmexcil Digest September 2009
17
4. Country Focus 4.1 The US Pharmaceutical Market: Authorized Generic Agreements – Indian companies pathway to US Generics Market Expert opinion by Datamonitor
Authorized Generics (AG) Agreements
are a lifecycle management strategy for
drugs entering into their final phase of
patent protection. Innovator companies
often enter into AG agreements in order
to avail of a continued revenue stream
from mature brands as well as to minimize
the impact of generic erosion in well
regulated markets. However, this strategy
is more of a deterrent and often viewed as
yet another ‘market entry barrier’ by
generic companies who would like to
ensure that the market has an even
‘playing field’ for all the generics of drugs
with recent patent expiries. AG
agreements will effectively ensure that
‘innovator’ companies can keep their
fingers in both the pies: the branded
market as well as the ‘own-generics’
market – this will lead to increased
competition and hence extra marketing
and promotional effort from generics
companies.
Exhibit No.1: Final Settlement Agreements during fiscal year 2004-08 which included AG Provisions, US
Source: Datamonitor Research, Federal Trade Commission (FTC) Interim Report, June
pharmexcil Digest September 2009
18
AG agreements are usually struck between
a company with an ‘original’ branded drug
and a generic company willing to market a
branded version of the generic, under a
different brand name. In many cases the
generic company is often a subsidiary of
the innovator company; in such cases the
company retains all the revenues
generated by the branded generic too,
thus reducing the impact of generic
erosion on the parent brand. Therefore
such ‘own-AGs’ represent the best-case
scenario for branded companies.
According to Datamonitor analysis,
between 2004 and 2008, 40 AG
agreements were entered into by 14
branded companies. Of these nearly 45%
of agreements were own-AG agreements
that were drawn-up by just one third of
the companies (4-5 companies). It is
interesting to note that during this period
Pfizer was involved in the maximum
number of AG agreements (30% of all
AG launches) and it was also the most
frequent branded partner involved in
own-AG launches.
Source: Datamonitor Research
Exhibit No.2: Authorized Generics Agreements- Key Drivers & Resistors
Authorized Generic
Resistors•Will lose considerable market share as more
generics enter•Likely to capture little
market share in the absence of a 180-day exclusivity
period
Drivers•Gain considerable market
share during 180-day exclusivity period
•Advantage in markets where stakeholders are reluctant to make generic substitution
Branded Pharma
Share revenues with generic partner (if external)
Maximize revenues post-generic entry
Generic PharmaShare Revenues with branded partner (if external)
Enter market without engaging in costly litigation
Authorized Generic
Resistors•Will lose considerable market share as more
generics enter•Likely to capture little
market share in the absence of a 180-day exclusivity
period
Drivers•Gain considerable market
share during 180-day exclusivity period
•Advantage in markets where stakeholders are reluctant to make generic substitution
Branded Pharma
Share revenues with generic partner (if external)
Maximize revenues post-generic entry
Generic PharmaShare Revenues with branded partner (if external)
Enter market without engaging in costly litigation
pharmexcil Digest September 2009
19
Correlation between therapeutic class and generic erosion It is not surprising to note that most
innovator companies tend to defend their
most profitable brands, usually
blockbusters, through the AG strategy.
And most of these profitable and often
blockbuster brands belong to the top
three therapeutic categories including
drugs for cardiovascular (CVD) diseases,
infectious diseases (ID), and central
nervous system (CNS) disorders. In the
2004-2008 nearly two thirds of all the AG
launches were for drugs belonging to
these therapeutic categories. The pre-
generic quarterly sales of these three
therapeutic categories in the US had
totaled $6 billion in the analysis period.
Correlation between the US and Indian markets Ranbaxy, Dr. Reddy’s Laboratories and
Sun Pharma, leading generic players in
India, usually opt for first-to-file (FTF)
advantage which confers on them the
advantage of the 180-day exclusivity. It
has been observed that once authorized
generics are launched, the market share of
Para-IV challenged products often
reduces resulting in marginal decline in
profitability (~10% to 20% based on the
type of the product). Hence, generic
companies are factoring the presence of
authorized generic products for every
FTF product in the US. The Indian
generic companies are finding ways to
resolve this problem by entering into
supply agreements with innovators. The
classic example is, Dr.Reddy’s
Laboratories Limited (DRL), the first
authorized generics supplier from India
for Merck’s Proscar (Finasteride) and
Zocor (Simvastatin). DRL is also the first
company to launch generic version of
GlaxoSmithKline’s Imitrex (sumatriptan
succinate), under the AG agreement, in
the United States in February 2009 ahead
of its competitors. DRL had to settle a
patent litigation with GlaxoSmithKline in
October 2006 in order to gain the AG
agreement. DRL’s sumatriptan
contributed Rs.7,188 Mn in sales revenues
(10% of company’s revenues) for DRL
for FY2008-09 (Source: Company annual
report, 2009).
The authorized generics outlook
The dominance of the innovator
pharmaceutical companies in the US has
long been an issue for debates. The recent
lack of innovative products entering the
global market has been further intensified
by delays in the launch of ‘cheaper’
generics – these phenomena are often
viewed as strong-arm tactics adopted by
pharmexcil Digest September 2009
20
innovator companies to ensure continued
market dominance and these have led
regulators in the US to look more closely
at the business ethics within the
pharmaceutical market.
However, whether AGs can be viewed as
anticompetitive business measures
remains to be seen even though the issue
has come under scrutiny of the regulators.
As of now, AGs seem to be a well
accepted business practice according to a
recent report by the FTC which implies
that AGs are pro-consumer because they
have an impact on generic prices.
Despite the efforts made by large generics
companies, AGs seem to have a firm
business footing in the US market in the
short term. Hence AGs are here to stay at
least until such time that the US Congress
passes the bill
(Rockefeller/Schumer/Leahy Bill) that
makes AGs illegal. However, this need not
be viewed as an entry barrier for Indian
generics players since they can always opt
for entering into supply agreements with
innovator companies to benefit from this
business model.
By Sharmila Ponakala, Senior Consultant,
Healthcare Consulting, Datamonitor
pharmexcil Digest September 2009
21
Brand India campaign in South Africa
5. Pharmexcil Activities
5.1 Pharmexcil activities during August 2009
Following are the major activities/ events
that Pharmexcil is associated with during
the month
A. Delegation to South Africa, Mozambique, Zambia and Botswana Pharmexcil has organized a trade
delegation to South Africa, Mozambique,
Zambia and Botswana as a part of project
“Brand India Campaign” for Indian
Pharmaceuticals in Africa being
undertaken by Pharmexcil with active
support of the Department of Commerce,
GoI. An interaction with the local players,
media, regulatory authorities, etc and
explained about the quality of generic
drugs supplied by Indian pharmaceutical
companies. The delegation has met Health
Ministers of these countries and Indian
mission to these countries has extended
Participants at interactive meeting with importers of Zambia
Inauguration of Buyer Seller Meet by Indian Ambassador at Mozambique
Participants at interactive meeting with DrugController of Botswana
pharmexcil Digest September 2009
22
full co-operation in organizing the
meetings and the event.
B. Meeting with Shri Rajeev Kher, Joint Secretary, Minister of Commerce & Industry, GoI Shri Rajeev Kher, Joint Secretary, Minister
of Commerce & Industry, GoI held a
meeting with 6 pharmaceutical exporters
who have been referred by Pharmexcil
and are impacted with the issue of seizure
of generics by EU authorities under the
disguise/ categorization as counterfeits
during transit in European ports. Senior
officials from the Department of
Commerce, GoI has discussed in detail
about the products and issues involved in
the seizure. They requested the members
to provide complete information so that
GoI can file a case with Dispute
Settlement Mechanism of WTO regarding
the seizure of Indian generic medicine
consignments in transit at European
ports. The exporters impacted by these
seizures have appreciated the serious
approach taken by GoI in support of
Indian Pharmaceutical players.
C. Representation to “Board of Trade”, Department of Commerce, Government of India
On August 11 2009, Pharmexcil’s
Chairman Mr. Venkat Jasti made a
representation to “Board of Trade”,
which advises the Government of India
on policy measures connected with India’s
foreign trade on issues related to
exemption of service tax for
pharmaceutical exporters and allocation of
a separate fund of Rs.1, 000 crore for
Small and Medium Enterprises (SME) in
exports and Registration, Evaluation,
Authorization and Restriction of
Chemicals (REACH) for exports of
certain chemicals and intermediates to the
European Union.
D. Pharmexcil opens its 3rd regional office in Ahmedabad On August 13 2009, Pharmexcil’s third
regional office was opened in Ahmedabad
by Shri Hemant G Koshia, Joint
Commissioner of Gujarat State Food and
pharmexcil Digest September 2009
23
Drug Control Administration. Apart
from Chairman, Vice-Chairman and
Committee of Administration of
Pharmexcil, Pharmexcil’s immediate past
President has participated in the inaugural
function. Pharmexcil has assured local
members that complete information will
be provided through the regional office
including Registration-Cum-Membership
Certificate (RCMC). Following is the
address of the new office: Pharmaceutical Export Promotion Council
7-C, Trade Centre Near Stadium Cross Road Navarangpura Ahmedabad, India Tel: 079-40050497. Email id: [email protected]
E. Patent litigation as barrier in international trade
On August 21 2009, Pharmexcil has
organized a seminar on “Patent Litigation
as Barrier in International Trade” at
Mumbai. Shri Arun Jha, IAS, Jt. Secretary,
Dept. of Pharmaceuticals, Government of
India was the Chief Guest during the
event and addressed the gathering.
Following presentations were given by
eminent people
1. Key note address was delivered by Prof.
(Dr.) Shamnad Basheer, Professor in IP
Law, National University of Juridical
Sciences, Calcutta, Govt. of India on
“Barrier to International Trade through
Patent Litigation and New Trade
Agreement”
2. Patent Opposition Procedures &
Strategies by Mr. Essenese Obhan,
Obhan & Associates, New Delhi
3. Patent Litigation – A Non-Tariff Barrier
by Mr. Sanjay Mariwala, Managing
Director, Omniactive Health
Technologies Ltd, Mumbai
pharmexcil Digest September 2009
24
4. Cross Border Seizures by Dr. Alka Mehta,
Patent Attorney, Cipla Ltd
All the presentations can be accessed in the following location on the pharmexcil’s website: http://www.pharmexcil.com/v1/aspx/Conferences.aspx F. Meeting with DCGI at Hyderabad
An interactive meeting with Drug
Controller General of India Dr. Surinder
Singh was organized by Pharmexcil at
7.30pm on August 21 2009 at Hotel Taj
Krishna at
Hyderabad. The
interaction with
industry arranged at
one day’s notice was
attended by the top
management of over
100 companies that
include Alkali
metals, Aurobindo pharma, Apex Drugs,
DRL, Enon Drugs, Fleming, Glochem,
Matrix, Meenaxy, Metrochem, MSN,
Ogene, Relisys, Sarvotham,
Shantabiotech, Sipra, SMS, Suven,
Synthokem etc. Dr PV Appaji welcomed
the dignitaries Dr Surinder Singh, DCGI,
Shri R P Meena, Director General, Drug
Control Administration, AP.
Shri Venkat Jasti, Chairman, Pharmexcil
gave a presentation on the Pharmexcil’s
activities. Mr R P Meena said that the AP
State Drugs Administration is working
with an open mind to facilitate the
industry. The pending files with the
department are taken up on FIFO basis.
Earlier there were cases of pending files
for 1-2 years. He said that 294 cases of
fixed dose combinations are restricted for
manufacture in AP from Sept 2007.
However products manufactured in other
states are marketed in AP as there is a stay
granted by TN High court.
Dr Surinder Singh
gave a detailed view
of the current
scenario of Indian
Pharma industry in
the international
market. Dr. Surinder
Singh while
addressing to various queries informed the
participants of various progressive steps
being taken up by Central Drug Standards
and Controller Organization (CDSCO) to
address various competing interests of
stake holders including those of
international regulators agencies such as
WHO and ICH requirements. He noted
that his department received approval for
additional manpower which would enable
quick turnaround times and drug
approvals by the regulator. Dr. Surinder
pharmexcil Digest September 2009
25
Singh also pointed that the Government
of India has tightened the regulation to
take strict action against manufacturers of
counterfeit drugs. He has also informed
that drug registration details with his
office would shortly available on DCGI
website and DCGI is considering opening
zonal offices at Bangalore and
Chandigarh. Later it is proposed to open
offices at Indore, Goa and Sikkim.
G. Meeting with Ambassador of India, Republic of Azerbaijan
An interactive meeting with Indian
ambassador to Azerbaijan, Mr. Debnath
Shaw was organized by Pharmexcil on
August 28 2009, in New Delhi to assist
the Indian exporters to Azerbaijan and
address their concerns. The meeting was
fruitful as about 25 members of the
council have participated in the interaction
with a short notice of a day.
Mr. Raghuveer Kini, Additional Executive
Director, highlighted Pharmexcil
initiatives and future plans to help
exporters promote trade in CIS countries.
During the interaction, Mr. Debnath Shaw
briefed about the pharmaceutical market
dynamics in Azerbaijan and the
neighboring countries and highlighted the
steps taken by the Embassy in Azerbaijan
to counter the misconception of
counterfeit drugs from India. Some of the
issues highlighted by participants were
presence of unregulated distribution
channels, lengthy and tedious registration
process (2-3 years), negative publicity on
drugs supplied from India, presence of
one quality check laboratory, limited
payment security cover for exports by
banks in Azerbaizan or Indian banks/
EXIM bank, high cost of visa process to
Azerbaizan, etc. Further to boost
pharmaceutical exports to Azerbaijan,
Pharmexcil is leading a trade delegation in
the month of November 2009. After the
buyer’s sellers meet during the visit an
interactive session with local doctors,
regulatory authorities, media and Indian
residents are being planned during the
visit.
H. Medical Device Training Programme
Central Drugs Standard Control
Organization (CDSCO) in association
with WHO organized two days training
programme during August 28 – August 29
2009 on regulation of Medical devices in
Hyderabad. Dr.S.Eswara Reddy and Mr.
Chandra Sekhara Rao conducted the
programme on behalf of CDSCO. The
event was organized with the objective of
pharmexcil Digest September 2009
26
discussing the proposed Schedule M-III,
GMP guidance for medical devices. About
70 delegates from Industry and various
state drug control authorities participated
in the event. The session was inaugurated
by Chief Guest Shri R.P. Meena, Director
General, Drug Control
Administration, AP. Dr.
P.V. Appaji, Executive
Director, Pharmexcil has
given the concluding
remarks and distributed
certificates to the
participants.
I. CPHI Brazil
Pharmexcil has
participated in CPHI,
South America in Sao
Paulo during August 26-28, 2009 with
participation of 25 members in India
Pavillion supported by Department of
Commerce, GoI. The event was
successful with good leads received by the
participated members and the Indian
Pavillion was inaugurated by Indian
Counsel to Brazil. J. Meeting with ambassador of El Salvador to India Pharmexcil had a meeting with Her
Excellency, Patrica Figueroa Rodriguez,
Ambassador of El Salvador to India at
New Delhi on September 03 2009. During
the discussion, the Ambassador has
expressed El Salvador’s interest for a joint
venture/ collaboration with the Indian
companies for supply of low cost quality
medicines to El
Salvador. We were also
requested to organize a
Buyer Seller Meet in El
Salvador.
K. DIA meeting on
Quality of API’s
Pharmexcil has attended
a meeting on September
07 2009 with Drug
Information Association
(DIA) at Hyderabad on
the subject of Quality of API’s. The
meeting was found to be of high
importance to the exporters of API’s to
the regulated markets. Senior Drug
regulatory officials of USFDA in Delhi/
Mumbai, WHO, EDQM and TGA
Australia have participated in the meeting
and have given presentations related to
Quality of API’s. The Director and
Deputy Director, USFDA, Delhi has
visited Pharmexcil’s head office in
Hyderabad and had a fruitful meeting on
matters related to Indian Pharmaceutical
pharmexcil Digest September 2009
27
industry. DIA has expressed an interest in
signing a Memorandum of Understanding
for organizing future events involving
overseas FDA officials and technical
experts.
L. List of circulars issued by
Pharmexcil during the month
Following are the list of circulars issued by
pharmexcil to the members for the period
August 01 2009 – September 08 2009
List of circulars issued by Pharmexcil during the period, August 01 2009 – September 08 2009
Date of
issue Subject of Circular
3 Sep 2009 Awards for companies who secured patents-last date extended 27 Aug 2009 Meeting with Ambassador of India, Republic of Azerbaijan (Urgent -Short Notice Programme)
25 Aug 2009 Pharmexcil Awards for Outstanding Export Performance - Extension of Last Date for Submission of Nominations to 7.09.2009
25 Aug 2009 9th SAARC Trade Fair in Thimpu, Bhutan 24 Aug 2009 Ahmedabad Office Address- Reg
17 Aug 2009 “Indo-Africa Pharma Business Meet” at Hyderabad during 25-27th September 2009 at Hotel Marriott, Hyderabad
12 Aug 2009 Patent Litigation as Barrier in International Trade 7 Aug 2009 CPhi Worldwide 2009, Madrid, Spain 5 Aug 2009 Invitation - Inauguration of Branch office at Ahmedabad 4 Aug 2009 “Indo-Africa Pharma Business Meet” at Hyderabad during 17-19th September 2009 at Hyderabad.
3 Aug 2009 Nominations are invited for Election as ‘Member of Committee of Administration’ for the years 2009-11 against retiring members
3 Aug 2009 Elections 2009 – Enroll as Ordinary Members 1 Aug 2009 Pharmexcil Digest (News Letter – August 2009) 1 Aug 2009 Visit of Director General, NAFDAC To India Note: The complete text of the circulars can be accessed in the following location on the Pharmexcil’s website. http://www.pharmexcil.com/v1/aspx/NewsBulletin.aspx
pharmexcil Digest September 2009
28
5.2 Upcoming Pharmexcil activities
S. No
Event/ Conference
Date Description/ comments
1 Pharmed 2009, Vietnam
September 23 – 26, 2009
Pharmexcil is participating in Pharmed 2009 by organizing an India pavilion. For the benefit of members in Pharmaceuticals / Medical devices & Surgical sectors, stalls of 6 and 9 sq. meters sizes will be offered. There is also provision of Common Space for small exporters.
2
Indo - Africa Pharma Business Meet, Hyderabad
September 25 – 27, 2009
Pharmexcil is organizing an international event, “Indo-Africa Pharma Business Meet” as a part of project approved by Ministry of Commerce & Industry. About 80 delegates representing Drug Regulators, Procurement Agencies, Media and Manufacturers/ Distributors from about 18 countries are expected to attend this business meet and Pharmexcil is also organizing an exhibition, buyers/ sellers meet and technical sessions.
3
Pharmexcil Awards for Outstanding Export Performance for the years 2005-06, 2006-07, 2007-08 and 2008-09
September 25 – 27, 2009
Committee of Administration of the Council has decided to institute ‘Pharmexcil Export Awards’ for the outstanding export performance. There will be one Trophy and one Merit certificates and one Award for Emerging Exporter in each of the product category covered under council for SSI, Non-SSI and Merchant Exporters separately. The circular can be accessed on the pharmexcil website (http://www.pharmexcil.com/v1/aspx/viewNewsBulletin.aspx?ID=568)
4 CPhI Worlwide, Spain
October 13 - 15 2009
Pharmexcil is participating in the event and has booked the India Pavilion at hall no.5. The minimum space to be booked by the exhibitors outside India Pavilion is 20m2 (shell scheme) and 30m2 (bare space). However, in India Pavilion minimum stall size is 12m2 and common space for 8 small exporters.
5
Delegation to CIS countries including Azerbaijan
November (Date to be finalized)
Pharmexcil is leading a delegation to Azerbaijan in November. After the buyer’s seller’s meet an interactive session with local doctors there, the regulatory authorities, media and Indian residents are planned. The delegation is planned in such a way that it coincides with the International fair in Baku.
6 CPhI India 2009, Mumbai
December 1-3, 2009
Pharmexcil will be participating in CPhI India 2009 to be held during 1-3rd December, 2009, at Mumbai. Due to cancellation of CPhI 2008, the exhibitors were given option either to take refund or transfer the amounts paid for CPhI 2009. The members who have opted to transfer the amounts to CPhI 2009 were informed that they would be given preference in allotment of stalls, apart from the benefit of getting the stalls at the same cost as that of 2008. Some of the participants in the India Pavilion at CPhI 2008 have opted to keep their amounts transferred to CPhI 2009. Out of 76 stalls, 43 stalls have been allotted to those members in CPhI 2009 as per their choice and the remaining 33 stalls are available for allotment
All the above information can be accessed from Pharmexcil website on the following link:http://www.pharmexcil.com/v1/aspx/NewsBulletin.aspx
pharmexcil Digest September 2009
29
5.3 Pharmexcil study reports
1. India is most attractive destination for pharmaceutical manufacturing: Reveals OPPI - E&Y study
As per OPPI-E&Y report, ‘Taking Wings
– Coming of age of the Indian
pharmaceutical outsourcing industry, the
inherent strengths of the Indian
Pharmaceutical Industry are
1. India has emerged as a growing
customs manufacturing and
outsourcing destination with a
growth rate of 43% that is thrice
the global market rate
2. Rates India as most attractive
among six prominent
manufacturing locations – India,
China, Eastern Europe, Puerto
Rico, Singapore and Ireland.
Outsourcing is no more an option
but a strategic imperative for
pharmaceutical companies across
the globe
3. The manufacturing cost of U.S.
FDA approved plants in India are
65% lower than in U.S.A and 50%
lower than in Europe
4. The facility setting-up cost in
India is 30% lower than in the
U.S.A.
5. India offers strong cost arbitrage
in end-to-end R&D with potential
savings of 61% compared with the
U.S.A. Research chemistry and
drug development are stages
where close to 85% of savings can
be achieved. (Source: http://www.indiaoppi.com/OPPI%20-
%20EandY%20Report%202009.pdf)
Pharmexcil research also reveals that India
is estimated to have 142 U.S. FDA
approved plants and 136 EDQM
approved plants accounting for over 28%
of Type-II active Drug Master Files
(DMFs) (1,947 out of total 6,876 as on
March, 2009). India accounts one out of
every four ANDA approvals from U.S.
FDA and one out of every five Certificate
of Suitability (CEPs) granted by European
Directorate of Quality Medicine (EDQM).
It is a well know fact that India is also
emerging as a hotspot for drug discovery
and development services growing at 65%
or more than 3.5 times the global rate.
The driving factors for R&D are:
Strong Chemistry Capability
Designing and managing CGMP
manufacturing facilities
Skilled manpower & lower capital
expenditure
Reverse Engineering potential and
The Cost-Value proposition
pharmexcil Digest September 2009
30
2. Effect of Economic crisis on Pharmaceutical consumption, expenditure & Prices IMS Health in a study report titled
“Indicators for Tracking the Effect of the
Economic Crisis on Pharmaceutical Cons
umption, Expenditures and Unit Prices”
sponsored by WHO reports that to date
[Q1 2009], there does not appear to be a
major change in overall volume of
medicines used, or a specific decline in
medicines used to treat chronic diseases -
both of which occurred during the Asian
economic crisis of 1997. Overall,
countries have absorbed moderate price
increases without affecting medicine
consumption, with the exception of
Estonia and the private sector in Russia
where three consecutive quarters of
volume decline have been observed. The
complete report can be accessed at http://www.who.int/medicines/areas/policy/WH
O_IMSreportonglobaldrugconsumption.pdf 3. Study report on “Indian Natural Medicinal Products: For Promotion of Exports”
Dept. of AYUSH in 2007 sponsored a
need assessment study to International
Trade Centre (ITC) for enhancing export
of Herbal and Ayurvedic products from
India. This study was carried by Mr. Josef
Brinckmann (ITC Consultant) and
submitted to Dept. of AYUSH in
Aug.2008. The study covers various topics
like of HS code classification, Regulatory
Status, Quality standards and Market
access of different countries pertaining to
Ayurvedic, Siddha, Unani and Herbal
Products. The countries of focus were
Australia, Belgium, Canada, Denmark,
European Union, Malaysia, South Africa,
UK and USA. The report gives
comprehensive web links of regulatory
guidelines and data bases of respective
countries in respect of products for the
study. Further need assessment study was
carried with questionnaire based
enterprise survey with Pharmexcil &
ADMA members. A total of 13 survey
responses were received by the consultant.
Based on these responses and findings
from other enterprise interviews during
visits to India various needs in the area of
export promotion pertaining to financial,
market intelligence, regulatory affairs,
sales & marketing needs were identified.
The report ends with priority objective
which identifies “What do the Indian
enterprises need to do?” and “What does
the Government of India need to do?”
Pharmexcil has studied the complete
report and prepared a Summary of the
pharmexcil Digest September 2009
31
same for easy reference of the important
content in the report. Summarized report
can be accessed at http://pharmexcil.com/data/uploads/Summary%
20Report%20on%20ITC%20Paper%20by%20Pha
rmexcil.doc and complete report http://pharmexcil.com/data/uploads/ITC-
Joseph_Brinkman.pdf
4. ANDA approvals received by Indian pharmaceutical companies in August 2009 About 33% of total ANDA approvals granted by USFDA in August 2009 are for India based generic pharmaceutical companies
US. FDA ANDA Approval to Indian Pharmaceutical Companies during the month of August 2009
S. No
Company Active Ingredient Marketing
Status Dosage
form Strength
1 Aurobindo Pharma Ltd Carisoprodol Prescription Tablet; Oral 350MG
2 Ranbaxy Laboratories Ltd Sumatriptan Succinate Prescription Tablet; Oral EQ 25MG BASE ; EQ 50 MG BASE
3 Dr Reddy’s Laboratories Ltd Sumatriptan Succinate Prescription Tablet; Oral
EQ 25MG BASE ; EQ 50 MG BASE; EQ 100MG BASE
4 Orchid Chemicals & Pharmaceuticals Ltd Sumatriptan Succinate Prescription Tablet; Oral
EQ 25MG BASE ; EQ 50 MG BASE; EQ 100MG BASE
5 Sun Pharmaceutical Industries Ltd Sumatriptan Succinate Prescription Tablet; Oral
EQ 25MG BASE ; EQ 50 MG BASE; EQ 100MG BASE
6 Aurobindo Pharma Ltd Sumatriptan Succinate Prescription Tablet; Oral EQ 25MG BASE ; EQ 50 MG BASE; EQ 100MG BASE
7 Ranbaxy Laboratories Ltd Glycopyrrolate Prescription Tablet; Oral 1MG ; 2 MG8 Unichem Laboratories Ltd Bisoprolol Fumarate Prescription Tablet; Oral 5MG ; 10 MG
9 Aurobindo Pharma Ltd Clindamycin Hydrochloride Prescription Capsule;
Oral
EQ 150MGBASE ; EQ 300MG BASE
10 Unichem Laboratories Ltd Clonidine Hydrochloride Prescription Tablet; Oral 0.1MG ; 0.2MG ;
0.3MG
11 Wockhardt Ltd Cetrizine Hydrochloride Prescription Syrup; Oral 5MG/5ML
Total Number of ANDA approval 34 Total Number of ANDA approval from India 11 (33% of total approvals) Source: Pharmexcil compilation from USFDA website & press releases
5. List of Regulatory Authorities in various countries and their contact details
Pharmexcil has compiled the list of
Regulatory Authorities in various
countries along with their contact details.
pharmexcil Digest September 2009
32
Members can access this information
from the following link: http://www.pharmexcil.com/v1/aspx/DLogin.aspx?url=../../data/uploads/Contact_details_and_web_link_Drug_Regulatory_Authorities.pdf 6. U.S. Observe significant rise in use of Complementary & Alternative Medicine
In 2007, adults in the United States spent
$33.9 billion out of pocket on visits to
complementary & alternative medicine
(CAM) practitioners and purchases of
CAM products, classes, and materials
[National Health Statistic Report, July
2009]. Nearly two-thirds of the total out-
of-pocket costs that adults spent on CAM
were for self-care purchases of CAM
products, classes, and materials ($22.0
billion). A total of 44% of all out-of-
pocket costs for CAM, or about $14.8
billion, was spent on the purchase of
nonvitamin, nonmineral, natural products.
Adults spent $2.9 billion out of pocket on
the purchase of homeopathic medicine in
2007. Although results are not very
encouraging for Ayurvedic products,
which accounted for $18.8 million, there
exist enormous opportunity for growth.
According to a recent report from
Nutritional Business Journal, Ayurvedic
products registered a highest growth of
13% in 2008 as compared to 9% by
Traditional Chinese medicine. In times to
come CAM usage are poised to increase as
a result of the growing push in the Unites
states for a healthcare system that focuses
on disease prevention rather than disease
treatment because it is cheaper to prevent
disease than to cure it.
Click on the following link for complete report. http://nccam.nih.gov/news/camstats/costs/nhsrn18.pdf
pharmexcil Digest September 2009
33
6. Indian Pharma in Media 1. Dr. Manmohan Singh supports recommendations of Rajiv Kher Task Force to enhance Pharma Exports Prime Minister Dr. Manmohan Singh has
asked the Department of Pharmaceutical
(DoP) to implement the
recommendations of the Rajiv Kher Task
Force which was submitted in March this
year. These recommendations will
enhance pharmaceutical exports and also
reduce the hurdles faced by exporters.
The recommendations include strong
measures to boost the growth of several
key areas like generics production, R&D,
contract manufacturing, drug discovery &
clinical trials, and Indian system of
medicines and Ayush.
Prioritized funding by institutions such as
EXIM Bank through Special Purpose
Vehicles (SPVs) also featured in the
recommendations. In order to promote
R&D the task force recommended
commercial R&D firms that are promoted
by established firms should be allowed tax
holidays. Other recommendations in this
direction include commercializing
technologies and public private initiatives
in R&D.
The Rajiv Kher (joint secretary in the
Union Ministry of Commerce) task force
focuses exclusively on pharmaceutical
exports and its recommendation were
consolidated only after various rounds of
discussion between various stakeholders
in the pharmaceutical industry and
government officials.
2. DoP Aims at Setting up Pharma and Medical Devices Clusters As one of the projects under Phase I of
Pharma India Vision 2020, the
Government of India, with the help of
Department of Pharmaceuticals (DoP),
Ministry of Chemicals and Fertilisers is
likely set up two pharma clusters, a
Pharma City, a vaccine development
centre and four R&D hubs in the country.
This is to boost the growth of the Indian
pharmaceutical sector. The first phase of
the project will start in Andhra Pradesh by
setting up of a Pharma City which will be
a major R&D and manufacturing hub.
The centre is also looking at Mumbai,
Pune, Kolkata and Chennai to establish
R&D hubs.
United Nation’s South-South Centre and
the government plan to set up Pharma
hubs for clean technology and clean
pharmexcil Digest September 2009
34
technology demonstration systems in
Gujarat and Tamil Nadu wherein specific
investments will be put in by the DoP, the
UN and the related state government.
This proposal is yet to be discussed.
DoP is also considering discussions with
MNCs to start vaccine development units;
this will be either as an exclusive
partnership with a MNC or a joint
mission with more than one company. A
medical devices cluster is also proposed to
be established in Gujarat to support the
growing medical devices sector in the
country.
3. Tax Sops for Exporters sought in the New Foreign Trade Policy by Pharmexcil Mr. Venkat Jasti, Chairman, Pharmexcil
along with other Pharmexcil members, in
a meeting with the Board of Trade, which
is an advisory to the Government of India
on India’s foreign trade related policies,
has submitted a request for exemption of
service tax on pharmaceutical exports
under the new foreign trade policy.
For the Small and Medium Enterprises
(SME) in exports; for Registration,
Evaluation, Authorization and restriction
of Chemicals (REACH); and for
registration of exports of a few chemicals
and intermediates to the EU, the
Pharmexcil has requested the Board to set
up a Rs. 1,000 crores fund.
For encouraging exports, Pharmexcil has
also asked to extend 150 % average
reduction in duties on R&D activities for
export purposes.
4. Spurious drugs significantly less in Indian Pharma Market According to a survey undertaken by
DCGI, the number of spurious drugs in
Indian market is as low as 10 drugs in a
sample of 24,000. Although the official
announcement is awaited, the survey has
laid all the rumors regarding the presence
of fake drugs to rest.
The details of the survey remain
undisclosed, the ministry sources indicate
that east zone leads the list of spurious
drugs; out of 7,000 samples, 7 drugs were
found spurious. In the North zone 2 out
of 4,500 samples was spurious and only
one out of 5,500 samples in the West
zone.
A survey of this magnitude is one of its
first kind in India, it includes 62 popular
drugs from 9 therapeutic categories
including anti-tuberculosis, anti-allergy
diabetes, cardiovascular, anti-infectives,
pharmexcil Digest September 2009
35
anti-malarials, NSAIDs, anti-histamine
and multi-vitamin preparations.
5. DCGI reworking on approval timelines; aims at prompt disposal of pending applications The approval timelines are being revised
by the Drug Controller General of India
(DCGI). Efforts are being made to
streamline the approval process especially
on the pending cases filed prior to January
1, 2009. The timelines fixed for the
approvals will be calculated excluding the
weekend holidays.
In July, DCGI set timelines of two weeks
for applications related to Export No
Objection Certificate; three weeks for dual
use, rule 37 and neutral code; and four
weeks for additional indication and similar
applications. A six weeks timeline was
fixed for first response to new drug
applications, Fixed Dose Combinations
and bioequivalence studies for export
purposes. The revised timelines are meant
to accelerate the disposal of pending files.
The DCGI has communicated to the
applicants who have submitted approvals
prior to the beginning of this year, to
represent their cases to the authority by
September 10, 2009. The applicant should
produce the latest status of the pending
case along with the diary number of the
application.
6. India and Nigeria Join Hands to Promote the usage of Indian Generics in Africa In the wake of fake drugs seizure in
Nigeria with ‘made in India’ labels (later
discovered as being from China), India
has agreed to help Nigeria in its battle
against spurious drugs. Towards that end
India will help Nigeria in setting up bio-
availability and bio-equivalence study
centers.
Dr Paul Orhii, Nigeria’s Director General
of National Agency for Food and Drug
Administration and Control (NAFDAC)
held extensive meetings with the Indian
government officials. He expressed his
confidence in the Indian generics with
respect to cost and quality but also
mentioned that the lack of facilities that
assess the quality of imported drugs has
posed a challenge in adopting Indian
made medicines. Hence, Nigeria has
sought India’s help in creating awareness
programs to enhance the adoption of
Indian medicines and also work towards a
better regulatory and legislative
framework in Nigeria.
pharmexcil Digest September 2009
36
7. China Accepts the Nigerian Fake drugs cargo, promises to act tough The Nigerian Government had
confiscated a fake drugs cargo with “made
in India” labels on them. This is believed
to have originated from China. The anti-
malarial generic drugs that were
confiscated possessed the names and
addresses of the Chinese manufacturers.
NAFDAC (National Agency for Food
and Drug Administration and Control) of
Nigeria claims that the distribution of
these drugs could have affected 642,000
adults.
India expressed its disappointment and
urged the Chinese Government to take
strict action against such manufacturers,
as this event is likely to have a significant
impact on India’s pharma exports to
Africa as a whole, which contributes 15%
of India’s total drug exports.
In a similar incident, the Kenyan
Government has also seized medicines
shipped from Shanghai bearing
‘Government of Kenya’ labels. India is
making efforts to ensure quality norms in
order to intercept the movement of such
fake drugs.
8. The Indian HIV Tender Battle Grips Kenyan Medicines Supply Agency (Kemsa) The Kenyan Medicines Supply Agency
(Kemsa) which procures medicines for
public health facilities had earlier refused
to accept the tender documents submitted
by the India based globally recognized
pharmaceutical company, Hetero Drugs
Ltd (Hetero). The reason behind this is
the submission of scanned pricing
schedule submitted by Hetero Drugs
instead of original documents.
The High Court has allowed Kemsa’s
application to review its decision to
reopen its tender process for the
procurement of anti-retrovirals worth $12
million. Hetero applied for tenders for six
products in March, but was notified as not
being successful in June.
"It is a matter of procedure. These
documents need to be verified and
authenticated. That is why they were
rejected," said David Muttu, procurement
manager at the procurement and supply
management consortium of Kemsa. The
companies that won the HIV bids were all
Indian companies: Cipla won four, worth
$6 million; Ranbaxy won one, worth $3
million; and Emcure won one, worth $2.9
million, according to Muttu.
pharmexcil Digest September 2009
37
9. Panacea to supply pediatric vaccines to UNICEF Panacea Biotec Ltd wins a three-year
contract worth over Rs 1,067 crore from
UNICEF to provide the EasyFive vaccine
against the five dreaded pediatric diseases
(Diphtheria, Tetanus, Hepatitis B, and
Hemophilus Influenza). This is believed
to be a major growth driver for the
company’s overall performance.
EasyFive is the world’s first fully
pentavalent vaccine and was introduced in
India in 2005. The company has
partnership with WHO and UNICEF to
cater to the developing countries and
enhance the coverage of the vaccine. The
company has also received a pre-
qualification by WHO for Easyfour and
Ecovac vaccine.
10. Vaccine for Swine-flu soon to become a reality in India: WHO granted $2 m to SII The WHO has granted $ 2 m to Serum
Institute of India (SII) to develop and
manufacture a vaccine for swine flu and
seasonal flu. The vaccine should be ready
in two to four months. Although the
vaccine development is underway, the
prevention measures should continue.
Administration of Tamiflu is restricted
only in confirmed cases and until such
time that vaccines are made available.
Thailand and Indonesia remain the worst
affected south East Asian regions with
11,398 cases of swine flu in Thailand and
771 cases in Indonesia.
11. FDA and EMEA Join Hands for Clinical Trial Inspections US FDA and EMEA have initiated a pilot
program to share information on good
clinical practice (GCP) inspections. This
initiative will ensure that there is
uniformity in conducting clinical trials
submitted in marketing applications in the
US and the EU.
EMEA executive director Thomas
Lönngren said that the initiative "marks an
important step to the building of a global
regulatory network for supervision of
clinical trials. By working together in a
collaborative and synergistic manner GCP
inspection resources can be used more
efficiently."
"The clinical development of medicines is
a global undertaking," FDA drugs centre
director Dr Janet Woodcock said, "With
limited resources available to address the
global nature of clinical research, this is an
outstanding opportunity for the FDA and
the EMEA to work together to carry out
inspections and share information."
pharmexcil Digest September 2009
38
Under the 18-month pilot program, which
will commence in September, products
that are regulated by FDA’s drug centre
and EMEA will be covered. This will be
done under the FDA-EMEA
confidentiality agreement.
The three main objectives under this
initiative are: to conduct periodic
information exchanges; to conduct
collaborative inspections; and to share
information on interpretation of GCPs.
The program will help in regulating the
clinical trial process by relevant GCP
inspection by which the selection of
studies and sites is well informed. The
regulators shall follow best practices on
GCP inspections and the resultant
feedback will be communicated to each
other by the regulators when the clinical
trials are of common interest.
All the inspection procedures, the GCP-
related legislation and regulation
information will be shared by the parties.
After this pilot program, FDA and EMEA
will amend the program as required. The
agencies are also looking for sponsors
who are willing to participate voluntarily
in a collaborative inspection.
12. Jordan initiates steps to create its space in the global pharmaceuticals arena The USAID Jordan Economic
Development Program (SABEQ) along
with the Jordanian Association of
Pharmaceutical Manufacturers (JAPM)
has launched workshops to raise
packaging standards and establish GMP to
enhance its exports to flourishing markets.
The workshop also aims at lessening the
supply-demand gap in the packaging
sector. The key elements of the workshop
are cGMP guidelines, legislations,
inspection models and also receiving
accreditation from International health
authorities.
The secretary general, JAPM Mr. Hanan
Shoul feels that this will certainly enhance
Jordan’s position in the global
pharmaceutical market by increasing
exports, creating more jobs and making
generic medicines available at an
affordable cost for the Jordanian patients.
13. Eli-Lilly is all set to help Russia improve its manufacturing standards Eli Lilly will be providing training for
Rozdravnadzor, the Russian equivalent of
FDA to improve its manufacturing
practices. This will also involve training to
improve the pharmaceutical
pharmexcil Digest September 2009
39
manufacturing standards and overall
quality control.
Eli Lilly also aims to use this training as a
channel to increase the dialogue between
the regulator and other agencies.
Mr Frank Deane, the president of
manufacturing operations at Lilly said that
this training will enhance the quality of
medicines in Russia, on the other hand it
will also help Lilly to fine tune its training
practices in the US.
The training will take place in
manufacturing simulation facilities at Lilly,
the Chao Center and the PDA (Parenteral
Drug Association) in the US.
14. UK to hold public consultation on Automatic Generic Substitution The UK Department of Health is
planning to hold a public consultation in
the autumn on the issue of automatic
generic substitution. This subject had
figured in the renegotiation of the
Pharmaceutical Price Regulation Scheme
(PPRS) when the department met with the
Association of the British Pharmaceutical
Industry last December, and they had
agreed to consider the possibility of
allowing pharmacists to dispense an
equivalent generic medicine against a
prescription for a branded product.
Norgine is objecting to automatic
substitution, and has funded a report that
calls for public consultation on the subject
and draws attention to some well-known
arguments against substitution, like patient
confusion and variations in bioavailability.
An online petition on the UK
government’s number10.gov.uk website
has collected nearly 8,700 signatures.
The Department of Health says: "This is a
complex issue with many interested
stakeholders. We want to make sure we
engage with all stakeholders in the best
way possible and we therefore intend to
formally consult in the autumn on our
proposals for implementation." Provision
would be made for prescribers to opt out
where, in their clinical judgment, they felt
a patient should receive a branded
medicine, and certain categories of
medicines might be excluded from
substitution altogether.
Subject to the outcome of consultations
with the affected parties, automatic
substitution could be introduced in
January 2010.
pharmexcil Digest September 2009
40
15. Sales of vitamins go up in Brazil whereas dietary supplements sales take a hit after ban of Noni Juice
According to reports, vitamin sales in
Brazil in 2008 have gone up by 11 per
cent in terms of value. Out of this, the
share of multivitamins was the greatest,
with a 14 per cent average annual growth.
This is in stark contrast to the sales of
dietary supplements, which shrank from
an average of 13 per cent to just 2 per
cent. This is perceived to be a direct
fallout after Brazil’s ANVISA – Agência
Nacional de Vigilância Sanitária, or
National Health Surveillance Agency,
Brazil, banned Tahitian Noni juice in
October 2007. ANVISA is Brazil’s
autonomous regulatory agency of the
supplements industry. Noni juice was
banned after claims of certain effects
(analgesic, antiseptic, anti-inflammatory
and anticancer) were not proven, and also
because of reported cases of
hepatotoxicity and renal toxicity. Though
the company obtained a laminar (a
temporary order) to resume sales in
August 2008, the future of Noni juice is
uncertain. Noni juice was launched by
Tahitian Noni International, a subsidiary
of Morinda Holdings, in 1996, and had
sales in the range of $500 million annually.
Tahitian Noni had no comments on the
issue.
Amongst the vitamins, fortified foods,
such as Danoninho and Yakult, or
convalescence products, such as Sustain
Kids are preferred by Brazilian parents for
their children. Vitamin C is the most
popular single vitamin. Bayer and Merck
recently introduced Redoxon and Cewin
brands respectively, which had vitamin C
along with calcium, zinc, glucose and rose
hips. Fish oils, with their blood
cholesterol-lowering and triglycerides-
lowering omega-3 fatty acids, showed the
greatest growth, 22 per cent, while
supplements for the old, like ginkgo
biloba and calcium supplements showed
about 13 per cent growth. Diary products,
such as probiotic yoghurts, have
challenged fiber supplements, with
yoghurt showing a 19 per cent growth in
2007.
Combination products commonly in use
are the mineral combinations (calcium,
magnesium and zinc, or fruit/vegetable
fiber with minerals), but ANVISA
requires them to exhibit safety and
efficacy, and therefore this area has not
seen a lot of investment.
pharmexcil Digest September 2009
41
16. South Korean Considering More Pricing Reforms
A special task force under the Ministry of
Health, Welfare and Family Affair, South
Korea, is considering reimbursement
pricing reforms for generic and branded
products and modifying the existing
Actual Transaction Price (ATP) system,
which could affect both the domestic and
multinational industry. Final decisions
from the ministry are expected in mid-
October. "One general aim is to reduce
the prices of generics," said I.B. Kim, a
director of the KRPIA, the Seoul-based
association representing multinationals.
"These are now seen as relatively high
compared with branded drugs."
Under changes effected at the end of
2006, the government cuts prices of
original products by 20% upon patent
expiry. First generic prices are then fixed
at 85% of this revised level (i.e., 68% of
the pre-expiry price). Expectedly, the
KPMA, representing the generics-
dominated domestic industry, has voiced
strong concern against this proposal.
The ATP system was introduced in 1999.
It aimed at narrowing the gap between
discounted actual and higher
reimbursement prices, resulting in an
initial price cut of about 31%, thereby
trying to reduce price competition and
cutting irrational prescribing driven by
profiteering. But according to Mr. Kim,
"In reality, however, ATP levels have been
stable since the system was introduced,
falling by only 1% or so a year, compared
with the 5% or more expected by the
government.”
With the present system providing no
incentives for the use of cheaper products,
a revamp is being considered. Foreign
groups have also expressed concern about
the practical implementation of the ATP
system in terms of transparency, price-
reporting accuracy and the influence of
product grouping.
The ministry is also discussing other issues
like pricing of branded drugs, dealing with
unethical business practices, and the
possible exclusion from reimbursement of
selected over-the-counter products.
Precise details of the discussions are being
kept a secret as of now.
pharmexcil Digest September 2009
42
PHARMACEUTICALS EXPORT PROMOTION COUNCIL (Set up by Ministry of Commerce & Industry, Govt. of India)
To create awareness and confidence
“India as a dependable source of quality generic medicines at affordable prices”
Pharmexcil, with the support of Govt. of India, organizes
INDO-AFRICA PHARMA BUSINESS MEET
25-27th SEPTEMBER 2009 HOTEL MARRIOTT, HYDERABAD
Participating countries
South Africa, Nigeria, Kenya, Ghana, Egypt, Mozambique, Ethiopia, Tanzania, Zambia, Botswana, Algeria, Tunisia, Libya, Benin etc.
Confirmed Participants
DG NAFDAC, Nigeria, 15 other Countries’ senior FDA/Procurement officials, 40 Formulators / importers (Pharma, herbal, medical devices, excipients etc.)
Inauguration by
Sri Anand Sharma, Hon’ble Minister for Commerce & Industry, Govt. of India
(Best Exporters & Patents Awards will be conferred by the Minister on this occasion)
For online Registration, visit our web site www.pharmexcil.com
Registration For Business Meetings & Technical Sessions, Exhibition, Advertisement in
Catalogue and other Sponsorship opportunities, contact us:
[email protected] 040-23735462/66 [email protected],[email protected],[email protected]