INDIA CHINA PHARMACEUTICAL TRADE A COMPREHENSIVE STUDY

hyuh
INDIA CHINA
PHARMACEUTICAL
TRADE
A COMPREHENSIVE STUDY
2013
INDIA CHINA ECONOMIC AND CULTURAL COUNCIL
7/23/2013

July 2013 Page 2
Acknowledgements
Our team is highly indebted to Mr. Anjani Jha (Employee at BUREAU OF RESEARCH ON INDUSTRY AND
ECONOMIC FUNDAMENTALS), Mr. Prashant Kumar who had given us the proper guidance throughout
the making of this report and Mrs. Nipika Walia Sharma (Former Intern at India China Economic and
Cultural Council) for her valuable comments and suggestions on earlier work done on this report.
Disclaimer
ICEC Working Papers intend to disseminate preliminary findings of the research in progress to
encourage the exchange of ideas about development issues. The papers carry the names of the authors
and should be cited accordingly. The findings, interpretations, and conclusion expressed in this paper
are entirely those of the authors. They do not necessarily represent the views or policies of the ICEC. The
feedback and comments may be directed to the author(s).
Abstract
The objective of this paper is to address the key issues evolved in the India China
pharmaceutical trade. It highlights the current state of Indian and Chinese
pharmaceutical industries and latest pacts made between the two countries. This
report focuses on hindrances existing between the two countries in respect to
pharmaceutical trade. This report found that there is large elbow room for
pharmaceutical trade which can make better off both countries. What challenges our
Indian exporters are facing to export goods to China and what are the major non tariff
barriers working as obstacles in trade. Some key suggestions to improve the bilateral
trade relationship between the two countries by improving the procedure in China and
make it more for Indian exporters.

July 2013 Page 3
CONTENTS
1) INTRODUCTION……………………………………………………………………………………………………4
a) THE GLOBAL PHARMACEUTICAL TRADE………………………………………………...………4
i) TOTAL PHARMACEUTICAL TRADE IN THE WORLD………………………….…………4
2) PHARMACEUTICAL INDUSTRY IN INDIA………………………………………………………….…….4
a) COMPOSITION OF INDIAN PHARMACEUTICAL MARKET…………………….…………..6
b) INDIAN PHARMA INDUSTRY GROWTH……………………………………………………….…..6
c) IMPORTS…………………………………………………………………………………………………........8
d) EXPORTS…………………………………………………………………………………….……………………8
3) PHARMACEUTICAL INDUSTRY IN CHINA…………………………………………………….………….9
a) COMPOSITION OF CHINA PHARAMACEUTICAL MARKET…………………………………10
b) CHINA PHARMACEUTICAL INDUSTRY GROWTH………………………………………………11
c) IMPORTS…………………………………………………………………………………………………….…..12
d) EXPORTS…………………………………………………………………………………………………….…..13
4) CURRENT OUTLOOK OF PHARMACEUTICAL GIANTS IN INDIA AND CHINA…………..14
5) RECENT DEVELOPMENTS IN ECONOMIC TIES……………………………………………………….16
a) NINTH SESSION OF JOINT WORKING GROUP………………………………………………....16
b) MOU’S ON PHARMACEUTICAL AGREEMENTS……………………………………………..….18
6) MAJOR NON TARRIF BARRIERS IN PHARMACEUTICAL TRADE……………………………….20
a) REGISTRATION………………………………………………………………………………………………..20
i) PAPERWORK……………………………………………………………………………………………..22
ii) PAYMENTS…………………………………………………………………………………………………23
b) WEAK IPR’S……………………………………………………………………………………………………...23
c) LANGUAGE PROBLEM…………………………………………………………………………………..….25
d) PROTECTIONISM………………………………………………………………………………………………26
7) CONCLUSION……………………………………………………………………………………………………….…26
a) SUMMARY OF MAJOR FINDINGS AND KEY POINTS OF THE REPORT
i) REGISTRATION………………………………………………………………………………………….…26
ii) WEAK IPR…………………………………………………………………………………………………….27
iii) PROTECTIONISM……………………………………………………………………………………..….27
iv) LANGUAGE……………………………………………………………………………………………….....27
b) Policy recommendations…………………………………………………………………………………...28
Annexure A: Export-Import Data of India & China with Trade Potential…………………..29
Annexure B: The details of some of the major NTMs that are maintained against Indian
exports……………………………………………………………………………………………………………..………30
Annexure C: Application and approval procedure for imported drugs (1)………………………..…31
Annexure D: Application and approval procedure for imported drugs (formulations) (2).....31

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1. INTRODUCTION:
The word pharmaceutical comes from the Greek word pharmakeia.The pharmaceutical industry
involves task of discovering potential drug, production and then marketing of final
pharmaceutical product. This production involves two categories of products i.e. branded drugs
and generic drugs. The difference between Generic drugs and branded drugs is that generic
drugs are marketed under the chemical substance without any advertisement. This industry is
acknowledged as venturesome because of high cost of innovation, low approvals of drugs and
low expected returns. It takes around 12 to 15 years to discover a potential product which
requires a lot of patience and focal point of attention. There are many cases of counterfeiting of
product in recent times, another reason to consider this industry as risky one. Although there
exist some watchdogs like medicines authorities, media who take care of this facsimile1
.
THE GLOBAL PHARMACEUTICAL INDUSTRY: The top 10 largest drugs companies in the world
represents around one third of the whole market. These companies’ sales hover around US$10
billion a year and profit margins of about 30%. Six are based in the United States and four in
Europe. It is predicted that North and South America, Europe and Japan will continue to
account for a full 85% of the global pharmaceuticals market.
TOTAL PHARMA TRADE IN THE WORLD: Pharmaceutical trade is growing at exponential trade.
Total expenditure spent on drugs in 2011 found to above $ 954billion. United States accounted
35.63 % of global pharmaceutical market followed by Europe and Japan. According to premier
think tank in medicines ‘IMS’ this figure will reach $ 1.1 trillion by 2014.
2. PHARMACEUTICAL INDUSTRY IN INDIA:
Indian pharmaceutical sector enjoy world class reputation because of its reputed research and
development facilities and low cost products. Indian pharmaceutical market mainly produces
generic drugs. Both multinational companies and domestic firms are taking steps towards
maximizing potential returns from branded generics, making Indian market more lucrative.
Domestic firms are also looking to increase their share of the branded generics market.
The Indian pharmaceutical market is expected to grow at a compound annual growth rate
(CAGR) of 14-17 per cent during 2012-16.It is also have a one of the highest success rate for
approval of drugs from overseas authorities. India has largest no. of approval drugs from USFDA
(United States food and drug administration). India also supply large no of retroviral to
countries like South Africa where about 33 % of population suffered from AIDS.
Some of the leading Indian Pharmaceutical companies derive 50% of the total value of total
sales from their exports. There was tremendous spurt in the exports of pharmaceutical sector,
1
Wikipedia entry, ‘Pharmaceutical Industry’, retrieved from http://en.wikipedia.org/wiki/Pharmaceutical_industry

July 2013 Page 5
which found to be around Rs. 47551crores. The Indian Pharmaceutical industry is on the
threshold of becoming a major global market by 2020. As per the IMS Health data, the
pharmaceutical market will grow at a CAGR of 13.7 per cent during 2011 to 2016 with the
growth for 2013 expected around 11-15 percent. Many experts believe that the Industry has
the potential to grow at an accelerated 15 to 20% CAGR for the next 10 years to reach between
US$49 billion to US$74 billion in 2020. This industry grew at 16.9% in financial year 2012. Indian
pharmaceutical sector accounted for 10% of total world’s volume of production while 1.4 % in
value terms. For Indian pharmaceutical industry, most of the revenues come from exports.
India sells large part of generic products to United States, Europe, and other markets.
Biopharmaceuticals recently became the center of interest given the limited competition in the
sector.
The drug price control order seems to create hurdles for Indian pharmaceutical industry. With
policy of 354 drugs, it has control over the prices of drugs which are considered as relevant
under its control. This has been opposed by pharmaceutical industry constantly. With the
advent of GDUFA (Generic drug user fee Act) in US, Indian companies are required to pay more
amount than ever before. United States uses this fund to generate additional resources to
speed up the process. Most of the companies saw increase in raw material and employee costs.
Companies continued to increase their strength and expand their reach to rural areas. Rupee
depreciation had benefitted most of the domestic forms. This led to increase in the volume of
goddess exported. USFDA is the regulator in United States which gives authority to overseas
firms to operating in their market after conducting clinic trials and other tests. Last year, most
of the Indian companies got green signals from USFDA indicating the efficacy of Indian
products. It has been found in case study that about 1-2 % whole market is patent drug market
which clearly indicates the current outlook of Indian patent drug market. In numbers, this figure
is around $120-130 million of the total drug market.
There are other reasons as well impeding foreign institutional investors to come to Indian
market like the existence of counterfeiting of product due to weak patent laws creating a lot of
hurdles for them. To avoid counterfeiting, patent act in line with TRIPS (trade related aspects of
intellectual property rights) needs to be amended. Three offices of IPR (intellectual property
rights) had been opened within the offices of PHARMAEXIL to spread the information on
patents like current status of Indian pharmaceutical industries in the world, how to use patent
rights. In the future with growing affordability and steady improvement in Intellectual Property
Rights (IPR), patented product launches should increase.
There had been many reforms taken place in recent times, these reforms include exemption of
drug price control on innovative products, building hospitals, boosting health care sectors,
increased government expenditure on health sector, health care insurance, special financial
scheme given to firms innovating a product, patents granted for long number of years to

July 2013 Page 6
incentivize firms to keep investing in research and development. The R&D investment of all
other firms hovered around 4 percent of sales. Ranbaxy and Dr. Reddy’s invested 16 per cent of
sales turn over in R&D in 2005-06. The R&D intensity of DR. Reddy’s reached 18 percent in
2004-05 and Ranbaxy’s 20 per cent in 2005-06. But this came down to 9 per cent for Dr.
Reddy’s and 11per cent for Ranbaxy by 2009-10.Government spent US$293 million on the
promotion of healthcare through programmes for the prevention and cure of diseases such as
cancer, diabetes, heart ailments and stroke in 2011-12.Health care insurance industry is at low
level now but it is expected to grow at 15% by 2015. Medical expenses account large
proportion of pocket expenses which limits Indian propensity to spend. Therefore health care
insurance comes to discount this problem of under purchasing power; this is another factor to
push this industry in India.
COMPOSITION OF INDIAN PHARMACEUTICAL MARKET: Majority of Indian pharmaceutical
market is inclined to urban market (comes in TIER 1) which accounted for 38 % of the whole
market, stood at around $3.4 billion. While rural sector (comes in TIER 7 and the bottom part of
TIER system) accounted just 17 % of the whole market, stood at around $ 2 billion. As we
mentioned above in the report, that big MNCs and domestic firms will converge to rural market
because of lot of room for expansion. It has been found that less than 20% of population has no
access to health care services, clearly showing the massive gap between the amount of
treatment required by rural households and the degree of hospitality services given to them. In
future we can expect expansion in rural health sector. Recently government has also shown its
interest in its political agenda through a channel of rural health care programmes. There is one
more reason to believe expansion in rural segment that is increase in rural income heralds an
increase in rural expenditure. Over past few years, government has given subsidies to rural
people followed by rural households tilted their consumption towards healthcare services2
INDIAN PHARMA INDUSTRY GROWTH IN 2010-12:
The financial performance of the Drugs and Pharmaceutical industry for the year2010-11 and
2011-12 are given in Table below
2
Wikipedia entry, ‘Pharmaceutical Industry in India’, retrieved from
http://en.wikipedia.org/wiki/Pharmaceutical_industry_in_India
Sales
RURAL
AREAS
URBAN
AREAS
OTHERS

July 2013 Page 7
Drugs and Pharmaceuticals: Growth and Profitability in the year 2010-113
(%age Change over year ago)
S. No. Particulars Quarterly Annual
June’11 Sept.’11 Dec.’11 March’12
2009-
10 2010-11 2011-12
Estimates
Rough
estimates
Rough
estimates
Rough
estimates
1 Income 10.9 10.0 17.9 17.4 15.0 10.9 14.1
2 Net sales 9.2 11.0 17.1 16.3 11.9 12.4 13.5
3 Total expenses 11.6 -1.8 18.8 14.8 3.1 19.2 10.3
4 Raw materials 13.6 14.0 19.0 16.8 8.0 14.8 15.9
5 Salaries & wages 15.5 13.0 13.3 13.6 18.2 21.1 13.8
6 Power & fuel 10.2 24.0 24.0 10.0 2.5 20.1 17.1
7 Selling & marketing 9.0 15.1 10.0 9.0 0.1 11.9 10.7
8 Other expenses 2.8 28.0 11.1 12.1 -19.3 15.9 13.7
9 Depreciation 9.1 13.0 11.5 12.0 14.3 12.4 11.4
10 Interest expenses 15.6 20.0 25.0 18.0 -0.3 6.6 19.4
11 Tax provision 37.5 -78.6 90.6 75.9 108.8 73.6 -37.2
12 PBDIT 17.3 -4.3 19.9 18.9 105.7 -1.1 12.6
13 PAT 15.7 - 7.1 25.8 210.8 -31.6 55.6
14 PBDIT/Net Sales (%) 18.8 17.2 21.5 17.1 21.4 19.0 18.7
15 PBDIT/Income (%) 22.8 20.8 24.9 20.9 25.4 22.7 22.4
3
Annual Report 2011-12, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers. Retrieved from
http://pharmaceuticals.gov.in/annualreport2012.pdf

July 2013 Page 8
16 PAT/Income (%) 13.7 11.4 14.5 10.9 15.0 9.2 12.6
The improvement in sales growth largely driven by higher realization of export oriented
Pharmaceutical companies. The sector generated around 40 percent of its sales from exports. A
sharp depreciation in the rupees led to result in higher export realizations, which enhanced the
overall growth of the sector.
The pharmaceutical sector import raw materials like chemical intermediates and active
pharmaceuticals ingredients. Imports accounted 38% from raw materials. Depreciation of rupee
made imports more costly.
IMPORTS
Year Value of Import of “drugs and
Pharmaceuticals”(Rs. in Crore)
Growth (%)
2010-11 5504.46 49.26
2011-2012 813,1.1420 47.71
It was observed that the imports declined in terms of growth in the year 2011-12 compared to
previous year. The country is almost self-sufficient in production of most of formulations/
pharmaceuticals products
EXPORTS
Year Value of Exports of “drugs and
Pharmaceuticals”(Rs. in Crore)
Growth (%)
2010-11 30383.22 28.76
2011-2012 40816.85 34.34
It was observed that value of exports had positive growth as compared to previous year.
Reason could be favorable changes in exchange rate in recent past.
PROJECTED GROWTH
YEAR DOMESTIC EXPORTS TOTAL
VALUE GROWTH VALUE GROWTH VALUE GROWTH
2016-17 130000 21% 158000 16% 288000 18%
2019-20 233000 22% 248000 17% 481000 19%
As this table showing that forecasted growth is increasing overtime and will reach to 17 % by
2020.

July 2013 Page 9
3. PHARMACEUTICAL INDUSTRY IN CHINA:
The pharmaceutical industry is one of the fastest growing industries in China. China accounts
for 20% of the world’s population but only 1.5% of the global drug market. Changes in China’s
pharmaceutical environment were brought to give an access to medicines to large portion of
population of china. These development changes ensure china’s expansion in pharmaceutical
sector. Research and development sector deepening its roots in Shanghai. Recent example is
Novartis, major pharmaceutical firm who just installed its research and development
department in Shanghai, could prove to be its drug development engine4
.
According to IMS health, China's pharmaceutical revenue is growing fast and that the market
there may double by 2013. Sales of prescription drugs in China will grow by US$40 billion
through 2013, the report said.
According to national research for science and technology for development, gap had became
widened between Chinese and global pharmaceutical firms. The study was titled as “can
biotechnology industries catch up with world class industries”. Less government initiatives,
poor intellectual property rights and other factors led to lack of development in pharmaceutical
industries of china.
To maintain the same pace with other competitive countries, china must develop patents. It
had been found in study that most of the patents are about to expire in few years. Patents give
major protection and incentives. This step will give a new shape to its industry.
According to statistics from China Chamber ofCommerce for Import & Export of medicines & he
alth Products,China’s pharmaceutical industry saw revenue of 272.4 billion yuan ($43.9 billion) i
n the firsttwo months of this year up 22.7 percent over the same period last year bringing profit
of 25.billion Yuan, an increase of 24.3 percent. Chinese pharmaceuticals are well recognized by
global pharmaceutical companies and global giants have desire to leverage Chinese market
because of local market knowledge and administrative resources to take a bigger market
share, especially in the grassroots sector in china "On the flipside, the Chinese companies are
also ambitious. They are eager to getinternational market access, realize technical upgrades an
d even build their brandsthrough platforms abroad," said Zhang Fabao, a member of China Phar
maceuticalTechnology Organization Expert Committee."That can be seen as a shortcut for Chin
ese pharmaceutical enterprises to go globaland a win-win strategy for both sides," he added5
.
COMPOSITION OF CHINA PHARAMACEUTICAL MARKET
Large number of MNCs are setting up their research facilities in various biotech parks situated
in China because of Shanghai Zhangjiang Hi-Tech parts has attracted many such as Novartis
4
Wikipedia entry, ‘Pharmaceutical Industry in China’, retrieved from
http://en.wikipedia.org/wiki/Pharmaceutical_industry_in_China
5
China Daily USA, ’Chinese Pharma Companies look West’,(July 23, 2013) by Liu Jie in Beijing and Cecily Liu in London (China
Daily). Retrieved from http://usa.chinadaily.com.cn/business/2013-05/20/content_16510864.htm

July 2013 Page 10
Pfizer and others. Due to lower energy costs in China in the past, fermentation industry has
moved to China from several countries including India. Several biotech products need
fermentation. China follows aggressive pricing and has gone through huge capacity expansion
which has helped China to capture global markets.
Even Contract Research Organizations such as HD Biosciences, Medicilon have established there
R&D centers in China as biopharmaceutical companies are looking for cost efficiencies in R&D.
The market for CRO (Contract Research Organization) is worth RMB 22 to RMB 28 billion
(US$3.5 billion to US$4.5 billion) in 2011, a news report says.
Chinese pharmaceutical market is highly fragmented with strong rivalry. The three major firms
share broadly 10% of the market6
. And distribution is criticized for lack of transparency and
inefficiency. More than 90% of pharmaceutical industry is comprised by API’s (Active
Pharmaceutical Ingredients), PCF’s (Pharmaceutical Chemical Formulations), TCM’s (Traditional
Chinese Medicines), biologics, and herbals in terms of sales and output value.
Lupin Pharma Director-Corporate Affairs Mr. Kuldeep Wakhloo stated “The abundant Human
Resources, less expensive clinical trials and availability of extensive R & D bases make the
Chinese environment favorable for foreign players in pharmaceutical industry”. Huge benefits
are available by investing in China such as the large patient pool available in China which is
cheap and easily accessible. Since past few years this has led to strong growth in China-based
clinical trials. Major benefit of investing in China is government support for Chinese
pharmaceutical and biotechnology industry which includes tax reliefs, direct funding
opportunities, as well as the development of numerous technology parks.
Taxation
The investments made by government of China are tremendous and have a far more efficient
infrastructure compared to India. Since past few years China has taken steps to encourage R&D
activities in country such as provides incentives by passing Corporate Income Tax Laws such as
the enterprises which are qualified as High/New Technology Enterprise (HTNE) incentive will be
entitled to Corporate Income Tax rate of 15% as compared to standard rate of 25%, also to
encourage fresh investment newly established HTNEs in five Special Economic Zones and the
Pudong New Area within Shanghai enjoy a tax holiday of 2 years of full exemption followed by
50% reduction in CIT. But the criteria to qualify as a HTNE is might not be that easy even if it
seems like ownership of core proprietary intellectual property rights7
, products/services falling
under the scope of encouraged domain and R&D expenditure and both income from relevant
activities and even headcount of R&D/technical personnel meeting certain minimum
6
Working paper, The rising Chinese pharmaceutical industry: local champions vs global players (October 2012), written by
Francesca Spigarelli and Hao Wei
7
PWC report, Investing in China’s Pharmaceutical Industry – 2nd Edition (March 2009). Retrieved from
http://www.pwc.com/gx/en/pharma-life-sciences/assets/en-pharma_03-26-small.pdf

July 2013 Page 11
thresholds, but still some companies obtain HTNE status successfully in various local
jurisdictions.
China is a leading API producer in the world only to India it makes a contribution of about ---- of
pharmaceutical imports. A weak rupee is making imports of raw material costlier for Indian
pharmaceutical industry. China has been appreciated for faster decision making and
investments, there is a CIT super-deduction policy including pharmaceuticals in which they are
allowed an extra 50% deductions for R&D costs including expenditure incurred through
development of new technology and products, up to the extent that they even cover the salary
expenses of R&D personnel and making for the costs of depreciation of instruments and
equipment used for R&D purposes. And the kind of policies which make them outstanding
compared to neighboring countries includes income tax exemption for the transfer of
technology which states that the portion of income derived from the transfer of technology
during a tax year not exceeding RMB5 million can be exempt from CIT. The portion exceeding
RMB5 million is eligible for a 50% reduction in CIT.
CHINA PHARMACEUTICAL INDUSTRY GROWTH
China is a country with huge population their demographic factors show large potential market.
Due to their one child policy they have an ageing population. There is a migration of large
population to urban areas. It has led to easy access to retail pharmacies with better lifestyles.
Pharmaceutical needs are growing because of an increase in number of lifestyle diseases and
new needs of Chinese consumer such as respiratory illnesses, cancer, diabetes, as well as
obesity due to environment and air pollution. Therefore there is a booming demand for new
lifestyle drugs. State-owned enterprises, foreign enterprises and private enterprises compete in
the market. SOEs average size has increased but there numbers have reduced significantly.
Large and medium-sized pharmaceutical firms in 2010 were 1,125 out of the 7,039 controlling
694.8 billion Yuan ($102.64 billion) of the pharmaceutical industrial output value (59.17% of
total value). In China Medium-sized Industrial Enterprises refers to those enterprises in which
number of employed persons is between 300 and 2000, the sale revenue is between 30 and
300 million Yuan.
Low cost electricity at subsidized rates is a huge benefit for investing in China than any other
countries, incentives are given in infrastructure development and basic amenities. Taxes are
very low in China as compared to other countries. Since manufacturing segment pharma
products avails all benefits from the government. Also there is a bulk procurement policy as
every company in China is being regulated under government supervision, the demand and
supply is through government authorities."Chinese domestic players not only produce dosage
forms but also own the pharmacies where they are dispensed as well as the distribution
networks that deliver them to the hospitals. Their budget for R& D activity is very less as
compared to MNC’s but they enjoy these advantages” Mr Kuldeep Wakhloo said. They (China)

July 2013 Page 12
import raw material in bulks and then distribute to their respected companies which reduces
the price of the final product. Whereas in India, companies acts and deals as individuals which
has effect on pricing.
New reforms are taking place in China according to the Guidelines on Deepening the Reform of
Health-care System, which aims to increase the Basic Medical Insurance (BMI) to reach a 90% of
population coverage by 2011 and revision the reimbursable medicines under BMI. Second
phase of reform targets at bringing universal health care system in to effect.
In 2010, the gross output of Chinese pharmaceutical market was $183.57 billion.
Some of the world’s best-selling drugs, including Pfizer’s cholesterol-lowering Lipitor and Lilly’s
antipsychotic Zyprexa have lost patent protection in 2011.And within next 3 years lot of drugs
are going to off patent with estimated value8
about 77 billion $. Big players such as Novartis,
Pfizer, Merck Serono, AstraZeneca, and Roche have established research centers in China. The
strategy of the companies is to have good R&D departments in home country and to carry out
implementation phase and applied research activities in China. This leads to reduced time for
drug improvement and lowering of costs. Development of core phases of drugs is left to the
West, partly because of stringent rules of trials required by the U.S. and European agencies.
Further activities such as trials and market extension are done in China where appropriate
environment is available with University research centers and talented scientists.
IMPORTS
With Chinese government strong support, China’s import and export of biopharmaceuticals are facing
good development opportunity. China’s bio-pharmaceutical industry has made great progress and is
becoming increasingly closely linked with the international bio-pharmaceutical industry. China imports
bio-pharmaceuticals from 43 countries and regions, mainly from Europe and North America, from which
the bio-pharmaceutical import value accounted for up to 96.55% of China's total.
China's human vaccine import value amounted to US$196 million, up 6.41% year on year.
An increasing number of TCM (Traditional Chinese Medicine) and health care products were exported in
the first half of 2011, contributing to the persistent growth of export volume. The foreign trade of TCM
has undergone a steady increase with its total import and export volume to be 1.438 billion dollars, or a
year-on-year increase of 41.43 %. Compared with the import volume of 326 million dollars, or a year-on-
year increase of 36.50 %, the export still retains its dominance in the trade with its volume totaling
1.111 billion dollars, or a year-on-year increase of 42.95 %. Data on imports of pharmaceutical products
show a strong expansion (+195% of the value of flows from 2006 to 2010), and in parallel, exports are
accelerating (+135% over the same period).
Import and Export trade in Medical & Pharmaceutical Product sector (data in million US dollars)9
8
9

July 2013 Page 13
There is a huge trading opportunity gap left between India and China. See Annexure 1, as India
exports major pharmaceutical products to the world and China imports similar products from
other countries but not from India. This shows that major trading gap and potential left
between Indian exporters and Chinese importers. One of the reasons can be Indian exporters
are discouraged to sell in China because of already mentioned cumbersome registration
procedure or IPR violation cases. Another possibility can be tariff barriers and custom
procedures for India. But more or less it’s both of these affects hampering India’s trade to
China. Major losses are being suffered in both of these economies due to this as being a
country in Asian region we are better off trading with each other in same products as compared
to other foreign country. Also there is a possibility that similar product is exported from India to
foreign based entity and then again imported to China from same foreign based entity, so there
is a loss of consumer surplus for Chinese based producers as there are two layers of exporting
instead of one and a similar loss for Indian exporters as they are exporting at a lower price
which they can receive if they actually trade directly with Chinese entity.
Exports
One of the drivers of Chinese pharmaceutical market growth is its exports. The strength of domestic
companies lies in manufacturing generics and exporting active pharmaceutical ingredients (API). Export
value of Active Pharmaceutical Ingredients (API) is USD10billion, growth rate 31percent, accounting for
53 percent of exported pharmaceuticals10
.
According to the statistics of China Chamber of Commerce for Import & Export of Medicines & Health
Products, China's import and export value of bio-pharmaceuticals was US$887 million, up 44.35% year
on year, of which the export value was US$87.175 million, up 53.16% year on year; and the import value
was US$800 million, up 43.35%. China's bio-pharmaceuticals were exported to 126 countries and
10
KPMG report, Page 7 Chapter 1 China’s Pharmaceutical Industry-Poised for a giant leap. Retrieved from
http://www.kpmg.com/CH/en/Library/Articles-Publications/Documents/Sectors/pub_20110601_Chinas-Pharmaceuticals-and-
Biotechnology-Industries_EN.pdf
0
5000
10000
15000
20000
25000
30000
35000
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
Import
Export

July 2013 Page 14
regions, but mainly to the Asian market, for which the export value accounted for 59.57% of the total.
The top destinations of China's bio-pharmaceutical exports were India, the United States, Hong Kong,
Canada, Egypt, Ethiopia, Vietnam, Indonesia, Thailand and Pakistan. The combined exports to these
countries accounted for 77.99% of China's total, and the exports to India alone accounted for 34.66% of
the total.
China's drug formulation export jumped 31.19% in 2010 and it was led by such export to emerging
markets like ASEAN, India, Brazil and Russia with growth rates at 44.88%, 72.96%, 61.73% and 65.27%
respectively. Lupin Pharma Director-Corporate Affairs Mr Kuldeep Wakhloo quoted “ In pharma sector
though India has the advantage of producing cheap medicines, China’s export to India far exceed its
exports.” Very recently three MOU’s were signed to take steps for fixing the issue of trade imbalances
including pharmaceuticals.
4. CURRENT OUTLOOK OF PHARMACEUTICAL GIANTS IN INDIA AND CHINA:
Indian giants like Glen mark Pharmaceuticals which with a growth of 37%, is the fifth fastest-
growing generic company globally, followed by Dr Reddy's which grew 34% in FY 2011-12 ,
according to global pharmaceutical research firm, Evaluate-Pharma . The third domestic
company on the list, Sun Pharmaceutical witnessed a growth of 29%, occupying the eighth rank,
right below its subsidiary Taro which had a 33% growth.
India has proven global quality standard capabilities as measured by number of abbreviated
new drug application approvals, united States, food and drug administration. Government is
currently working to bring trace and track mechanism, which would enable monitoring of the
supply chain possible at all the three levels namely primary, secondary and tertiary. This
response has come with recent event of penalized a firm on felony charges, it paid $ 500
million11
.
Indian pharmaceutical industry has position of low cost manufacturing unit and highest quality
of medicines. The government also believed that there could be desperate attempts by other
countries to target Indian companies by alleging under the name of spurious drugs.
There are more than 350 ,manufacturing sites endorsed by the European union for their good
manufacturing practice in India as on april30,2013.the government has taken a number of
steps to ensure manufacture and export good quality products,one of them is ‘trace and track’
mechanism12
.
11
Business News,‘Indian drug companies break into world's fastest growing list’ (August 30,2012), by Sukumar Balakrishnan.
Retrieved fromhttp://sukumarbalakrishnan.blogspot.in/2012/08/indian-drug-companies-break-into-worlds.html
12
The Hindu, ‘Centre rushes to defend Indian pharma firms’ (June 30, 2013), by. Retrieved from
http://www.thehindu.com/business/Industry/centre-rushes-to-defend-indian-pharma-firms/article4778505.ece

July 2013 Page 15
Coming to china, many international enterprises continue to see china as leading overseas
market with dazzling growth in this field. US and EU drug makers invested more than billion
dollars since 2009 in manufacturing and research & development.
Top five MNCs in China13
:
Company Sales (US $ million) Growth
(%)
Share(
%)
PFIZER 835 31 8.32
ASTRAZENECA 749 32 7.47
BAYER HEALTHCARE 663 20 6.61
SANOFI 620 31 6.18
ROCHE 531 31 5.29
TOTAL SALES (IN US $ MILLION) OF TOP FIVE MNC’s IN CHINA
After China’s entry into the WTO, many leading pharmaceutical companies are transferring
their research and development centers to China. For instance, Roche of Switzerland opened its
R&D center in Shanghai recently, GSK has established its OTC research and development center
in Tianjin, China, and Pfizer and Janssen Pharmaceutical (Johnson & Johnson) will carry out
13
KPMG report, China’s Pharmaceutical Industry-Poised for a giant leap. Retrieved from
http://www.kpmg.com/CH/en/Library/Articles-Publications/Documents/Sectors/pub_20110601_Chinas-Pharmaceuticals-and-
Biotechnology-Industries_EN.pdf
0
100
200
300
400
500
600
700
800
900

July 2013 Page 16
similar plans in the near future. AstraZeneca, Bayer, Eli Lilly and Company, and Hoffman-La
Roche, has also set up R&D or clinical trial centers in China14
.
A poll on 33 foreign pharmaceutical enterprises in China shows that seven out of the 33
companies have R&D centers in China, accounting for 22% of the surveyed. The remaining 26
pharmaceutical enterprises have no R&D centers in China, accounting for 78% of the surveyed.
5. RECENT DEVELOPMENTS IN ECONOMIC TIES:
Keeping the view of trade in mind, both countries had signed major agreements in recent
times. It is of no doubt that there is large scope of having bargaining power over other nations,
if both countries continue to co- operate like this. Beside it also improves bilateral relations
reinforcing existed relations between the two.
(a) NINTH SESSION OF JOINT WORKING GROUP (AUGUST 2012)
The Union Minister of Commerce, Industry and Textiles Shri Anand Sharma, met Chinese
Commerce Minister Mr. Chen Deming for the 9th session of India-China Joint Economic Group
(JEG) on August25, 2012.
The Indian side led by Minister Anand Sharma raised the issue of growing trade deficit. Export
of pharmaceutical products, diamonds and export of sea food to China were also discussed. The
Chinese side brought to the front the ways to strengthen cooperation in goods and services
trade. The border trade issues between India and China, and modes to improve investment and
operation environment for Chinese enterprises in India were put to discussion. The total
bilateral trade between India and China for the financial year 2011-12, stood at USD 75457.42
million as compared to USD 59000.36 million during 2010-11. During FY 2011-12, the exports
stood at USD 17902.98 million while the imports stood at USD 57554.44 million. The trade
deficit for 2011-12 stood at USD 39,651.46 million15
.
14
China Daily USA, ’Chinese Pharma Companies look West’,(July 23, 2013) by Liu Jie in Beijing and Cecily Liu in
London (China Daily). Retrieved from http://usa.chinadaily.com.cn/business/2013-
05/20/content_16510864.htm
15
The Hindu, ‘India, China plan to set up joint working group to boosttrade’(27 August,2012), by BinduMenon. Retrieved from
http://www.thehindubusinessline.com/economy/india-china-plan-to-set-up-joint-working-group-to-boost-
trade/article3827225.ece

July 2013 Page 17
INDIA CHINA TRADE (IN US $ MILLION) IN LAST TWO YEARS
Mergers and acquisition activities had declined from 1135 in 2010 tom 806 in 2011 indicating
lack of collusion and economic cooperation. India and China had formed joint working group to
solve some trade issues including issues on
pharmaceutical trade between the two. The decision
for the JWG was taken at the meeting of India-China
Joint Group on Economic Relations, Trade, Science and
Technology held here recently.
The issue of growing trade deficit between the two
countries and the exports of pharmaceuticals also
featured the discussion between the Union Commerce
and Industry Minister Anand Sharma and Chinese
Commerce Minister Chen Deming. “We want to buy
more from India to have a more balanced trade. We
encourage Indian industry to promote their products in
our country,” said Chinese Commerce Minister Deming.
Currently, China and India are the strongest in the pharmaceuticals market. China is the largest
manufacturer of active pharmaceutical ingredients (APIs) and intermediates besides having a
well-established pharmaceutical packing industry.
“We have been assured by China of support on the issues of trade deficit and greater access to
the Chinese market for the Indian pharmaceuticals sectors, apart from Information technology
(IT) and ITES services,” Commerce and Industry Minister Sharma said16
.
16
Pharmabiz.com,‘India, China form JWG to address pharma trade &investments’(7 Sept,2012), by Nandita Vijay. Retrieved
from http://pharmabiz.com/PrintArticle.aspx?aid=71022&sid=1
0
10000
20000
30000
40000
50000
60000
70000
80000
2010-11 2011-12
. “We have identified key
areas and nodal authorities
who will be working to put
the development plan,”
Commerce & Industry
minister Sharma said.

July 2013 Page 18
India has green chit to Chinese companies to invest in the proposed National Investment and
Manufacturing Zones (NMIZs), both countries also agreed to work on a five-year plan on
economic cooperation, proposed by Deming. Currently, investments from China are to the tune
of around $580 million. In April, this year, the two countries delegates met on to strengthen the
business environment under the Strategic Economic Dialogue (SED) which also called for larger
market access for pharmaceuticals. Currently, China and India are the strongest in the
pharmaceuticals market globally. Moreover China is one of the world’s largest pharmaceutical
markets globally with sales of around $52.3 billion. “India pharmaceutical industry has been
lobbying with the government to address of issues of Export Obligations’ and take a re-look on
‘Norm Fixation’ and rationalize the registration process and fee, said Anjan K Roy, managing
director RL Fine Chem17
.
According to Espicom Business Intelligence, Brazil, India, China and Russia together represent
$160 billion in pharmaceutical market at retail prices. The top 10 local pharmaceutical
manufacturers, including China Pharmaceutical Group, Harbin Pharmaceutical Group, North
China Pharmaceutical and Shanghai Pharmaceuticals, have total revenue of around US$ 10.0
billion in 2010.
(b) RECENT MOU’S (MEMORANDUM OF UNDERSTANDING) ON PHARMACEUTICALS (2013)
With the maiden visit of Chinese premier Le Kequiang, both Asian giants had signed on several
Memorandum of Understanding including agreements on pharmaceutical field. The agreement
on pharmaceutical sector signed between Indian pharmaceutical export promotion council of
India and china chamber of commerce for export and import of medicine and health care
products. This will significantly increase the pharmaceutical trade between the two as the trade
base is too low because of some obstacles like rigid regulations and high registration fees. This
agreement is a win win situation for both countries18
.
India used to convince china to have diplomacy on these trade issues but nothing much had
come in positive, because globally economies are struggling to get back to high growth
trajectory, so it is high time for china to give a nod to several trade agreements to survive its
economy. China has shown some concern about trade imbalance which has widened to $40.8
billion in 2012-13 from $39.4 billion in 2011-12, in China's favor19
.
17
ibid Pharmabiz.com
18
The Hindu, ‘India China take steps to reduce trade gap’(20 May 2013).Retrieved from
http://www.thehindu.com/business/Economy/india-china-take-steps-to-reduce-trade-gap/article4733147.ece
19
The Hindu,‘China signs pacts with India to help bridge trade deficit’ (20 May, 2013) . Retrieved from
http://www.thehindubusinessline.com/economy/china-signs-pacts-with-india-to-help-bridge-trade-deficit/article4733245.ece

July 2013 Page 19
Mr. Salman Khurshid, minister of external affairs visited china to address border and trade
issues. New report revealed that Indian exports had come down by almost 24 % in April
compared to last period. India’s trade deficit with China, after four months of this year, has
ballooned to almost half of the entire trade volume.
Bilateral trade after four months of this year reached $20.87 billion, down 6.2 per cent. Trade
last year fell by 12 per cent to $66 billion, even as both
countries set an ambitious target of $100 billion by 2015.
India has been finding it difficult to expand its trade with
China in the pharmaceutical sector. The signing of the MoU
is expected to facilitate access to the China market in
pharmaceuticals
India and china are the important trading partner and
expect bilateral trade to reach $100 billion by 2015.India
wants more access to china markets for its exports without
any obstacles; it is worried about by rising trade account
deficit which accounted about 5 % of gross domestic
product last year. It exports mainly raw materials and
unprocessed goods like iron ore, cotton etc.
Although India had also shown some uncooperative
behavior to protect new born industries from Chinese well
known products. Many researcher believe that it is very
challenging task to compete with Chinese low cost products, for instance, "It is impossible for
Indian manufacturers making things like ceiling fans or toys to compete with Chinese goods,"
said Brahma Chellaney, professor of strategic studies at the Centre for Policy Research, a New
Delhi-based think tank20
.
6) MAJOR NON TARRIF BARRIERS IN PHARMACEUTICAL TRADE
a. Registration
The Chinese government is not very liberal in registering a product. Few of the industries which
have tried to settle in china have failed. The process of application for registration is often
delayed and the registration charges are quite high which makes it difficult for the product
registration. It often seems that China looks at its competitors as more of a threat to them so as
to imposing more barriers and also consume a lot of time.
20
The Wall Street Journal, ‘China’s Li Promises to Reduce Indian Trade Surplus’ (21 May,2013), By William Davies. Retrieved
from http://online.wsj.com/article/BT-CO-20130521-704197.html
"In areas where India is
strong—
pharmaceuticals, IT—
the Chinese have all
sorts of visible and
invisible barriers which
limit Indian access. Also
the Chinese are buying
primary goods from
India, such as iron-ore,
and selling finished
goods back," Mr.
Chellaney said.

July 2013 Page 20
In the 2003, India-Swift registered its first pharmaceutical product named Clarathromycine, in
the Chinese market for the first time. This registration of product took 2 years and till it came in
market the demand of this particular product vanished. As there was no demand, company
could not sell in china market, see Annexure 2 for details.
Registration remains a problem for companies to enter into china. The rules and regulation by
which every company has to pass through, is more or less biased. They have rules for domestic
company and for foreign company. Every product which enters into china market has to pass
through various tests and inspection which runs under STATE FOOD AND DRUG
ADMINISTRATION (SFDA). The principal powers of the SFDA in the area of the administration of
pharmaceuticals are; regulation, enforcement, drug registration, monitoring-system and
supervision over quality. In practice, many of the powers of the SFDA have been delegated to
local level government authorities in charge of pharmaceuticals.
The quality control check is very stringent on foreign companies. The check for impurities is
very high on western countries as compared to domestic company. Going through product
specific regulation china has been biggest challenge for countries entering into china to meet
the guideline of SFDA.
Registration of pharmaceutical product requires about 2 years entering into china market.
Once the product is registered it is allowed to sell in for 5 years, after which the company has to
renew the registration for that particular product. Till the time the product is registered,
demand in the market changes, or similar products are already circulating in market.
Registering a pharmaceutical product in china takes more than 2 years. The time which the
Chinese document say is very less as compared to the actual time consumed in processes. On
the other hand registering a product in India takes maximum of 9 months. Details for
registration of product, step wise reveals that after the submission of the application to the
SFDA which is done through the local partner, the next step is dossier content and format
checking, notification of quality test and specification verification by SFDA, here Chinese have
quoted 30 days’ time limit. But actually this process takes a very long time, Chinese keep on
checking the process and system which consumes a lot of time. Every process is checked
thoroughly. The SFDA requires every paper to be accurate, and they keep on asking for
documents for every single process. The local partner has a very important role in registering a
product, as he/she is the intermediate person between the company and the SFDA.
If you have made changes in your product, the Chinese want each and every detail of the
changes with the respective documents. Here the prescribed time is said to be 30 days, which
actually is more than a year. After which the rest of the procedure takes more than another
year, which is why registering a product in china takes more than 2 years.

July 2013 Page 21
Similarly for formulations also, clinical trial consumes much more time than expected, which is
the reason they consume a lot of time in registering a product. Formulations have to pass
through clinical trial and any change made in formulations requires documents for every
particular change.
For selling a pharmaceutical product in china, the company needs to have an ideal registration.
It is only after this ideal registration the company will be approved to sell its product in the
market. And by the time the company gets it the demand of the particular product in the
market becomes low. Therefore selling a product in china and obtaining ideal registration is a
challenge for companies.
Government in China is not an open type of government, once the documents are submitted
for the registration, it’s difficult for companies to check the status of registration process unless
and until they approach you back. Companies have to wait for the time being. Chinese
companies are under the state administration there is no way of enquiring about the details of
progress. In China, companies are given on lease for certain years by the government with
having percentage of companies share. So the government has full authority to intervene in
companies issues.
In India, Chinese Pharmaceutical Company has registration within a year, and in between the
person can have a status update with meeting the concern authority from the company or
government agency.
(i) Paperwork
There is a considerable amount of work to be undertaken before the documentation of a deal is
sensibly generated. Firstly, the aim is to set out term sheet, letter of intent, or memorandum of
understanding which sets out nature of project in detail, contribution of the parties, and key
objectives (e.g., achieving a given exit).
In letter of intent, it is critical to make allowance for number of face-to-face meetings, possibly
including the intermediaries, to make them comfortable with each other. Although it is not
customary for international transactions (with certain carve outs), Chinese companies
sometimes want the letter of intent to be binding.
Once the letter of intent is executed, then it comes to due diligence on both parties proposed
contributions, and means of integrating the internal and external approval processes and
generating definitive agreement, which also generates timing issues due to need to produce
initial, interim, and final drafts of each agreement in both Chinese and English.

July 2013 Page 22
Sometimes, the Chinese party is not as experienced with these types of deals, and when it
begins to understand the proposed terms of the transaction in detail, it may seek to renegotiate
the terms of the transaction.
In addition, the foreign party (or certain groups within its organization) may not be familiar with
Chinese foreign investment and technology import regulations. Therefore, additional time and
energy may be needed to understand regulation-driven structures and terms, which may be
more rigid or less favorable, than those adopted by the Western organization in its domestic or
other international collaborations. There needs to be understanding on both sides about this.
By this point, however, when the parties are feeling more comfortable with each other, more
can be potentially handled through the exchange of drafts and the need for face-to-face
meetings may diminish. There must also be adequate time and resources set aside for
government and third-party approval processes, many of which occur from the date the
definitive agreements are signed until the closing of the proposed transaction.
The message is clear that getting a deal done in China is going to take considerable time,
commitment, and patience. From inception to conclusion to get a strategic partnering deal
takes around 12 – 18 months in Western countries. In relation to China, it is possibly a little
longer, so the Western rights holder wanting to announce a deal to sustain its share price and
to bring in money for underutilized assets should be under no illusion that trying to carry out a
deal in China will be a short-term phenomenon. Indeed, the foreign company needs to have the
commitment and drive to see things through. Over the next several years, we anticipate these
timelines shortening as the Chinese companies get more and more experience with such deals.
(ii) Payments
In international transactions Letters of credit (L/C) are often used to ensure that payment will
be received. The use of letters of credit has become a very important aspect of international
trade due to the nature of international dealings including factors such as distance, differing
laws in each country and difficulty in knowing each party personally. The bank also acts on
behalf of the buyer (holder of letter of credit) by ensuring that the supplier will not be paid until
the bank receives a confirmation that the goods have been shipped.
Payment remains to be one of the important issues while trading with china. Mode of payment
should be specified and open letter of credit should be provided as to improve trade relations
But many times Chinese issue a restricted L/C, as letter for credit cannot be consigned to a
specific bank. In restricted negotiable letter of credit, the authorization is limited to specific
nominated bank for issuing bank to pay the beneficiary. The notified bank will not release
payment until the buyers ensure their bank and confirms of product delivery. This procedure

July 2013 Page 23
consumes time, and an exporter has to keep a tab on bank as to when they will release their
payment.
b) Intellectual Property Rights
Intellectual property rights provide copyrights to its holder. It doesn’t not only give protection
but also gives quantum of incentive to the innovator. But in recent times, even domestic
companies start filing cases against the counterfeiting of their products, showing the ‘still
presence’ of thin divide line between duplicate and original products. American Chamber of
Commerce in Shanghai 2005 White Paper stated that percentage of counterfeit drugs sold off
over the counter drugs is as much as 10-15%, in China particularly in rural areas. Counterfeiting
cases had risen sharply in china and exceeded the no. of counterfeiting cases in U.S .China is
working hard with domestic and international demand for patents protection21
.
As pharmaceutical industry is venturesome, so here comes the critical role of patent laws.
Patent laws amended on January1, 1993. Application for the grant must be written in Chinese
language. Application for the grant needs to be examined to check the inventiveness, practical
applicability etc. Patented subject matter includes such as non-therapeutic cosmetic treatment,
diagnostic, handling and analytical methods, treatment, analysis and preservation methods etc.
Subject matter excluded from patent protection includes scientific discoveries, methods for the
diagnosis or for the treatment of diseases, and animal and plant varieties.
The previous approach had been replaced by the new one namely absolute novelty. In this
approach, authorities ask for the evidence of public use of the technology before issuing the
patent. If the technology is available to the public before the filing, then it will not be
considered as novel. In revised regulations, there had been increase in penalty amount too.
The regulations provide the protection to those products which were earlier excluded from patent list.
The patentee can file a case if another public health property produces the duplicate of that. Patentee
can also file a case if some other party produces without his permission, it means that patent right can
be sold too.
Amendment is a continuous process; it means with the rapid development in legislation environment
there occurs changes in patent protection too. But it often takes much time to understand the new
regulations.
It is unclear whether the protection granted extends as broadly as the original patent, or
whether it is limited to the particular pharmaceutical.
21
Deacons , Pharmaceutical Policies And Regulations In China (June 2007), by Annie Tsoi. Retrieved from
http://www.deaconslaw.com/eng/knowledge/knowledge_290.htm

July 2013 Page 24
According to the sources, there will be the fourth revision in Chinese patent laws to bring some
more harsh laws. It is recommendable that officers of local offices should be given more powers
to investigate and find evidence. But they are still confounded that how they are going to figure
out different level of infringement i.e. repeat infringement and group infringement.
China operates a bifurcated system for patent validity and infringement. At the moment, courts
often delay their decisions on patent infringement until a final decision has been made on
validity – either by the Patent Reexamination Board (PRB) or by a court if one of the parties
appeals the PRB’s decision22
.
In 2012 draft version of 3 major IP laws were presented and debated and National People’s
Congress passed a major revision to Civil Procedure Law, loosening up restrictions on expert
witness testimony in patent cases. Also a bill designed to address a number of longstanding
issues, from damages to bad faith registrations. The recent draft revision to the Trademark Act
has been completed and is circulating, though not made available to the general public. And of
course, the patent and copyright law revisions are still pending and have initiated vigorous
discussions despite the relative lack of recent activity23
.
If patent holder finds that his rights are being violated by some another party then he can file a
complaint in people’s court. However, few years ago these courts were not used to entertain
complaints lodged by foreign firms. But in recent times, few special IP courts had been
established. The Administration for Industry and Commerce is responsible for enforcement of
registered trademarks and unregistered rights pursuant to the Anti-Unfair Competition Law.
The Administrative Authority for Patent Affairs has power to enforce patents and designs. The
administrative authority can penalize the firm who infringe the patent laws.
Under Chinese law, monetary penalties on infringement are calculated as either the multiple of
three times the loss suffered by first firm(who got cheated) or benefits gained by the second
firm(who violated).In case of less reliable calculation of losses or gains, Chinese law defaults the
maximum threshold of RMB 1 million24
. In case of pharmaceutical cases, it is very difficult to
calculate the amount of losses or gains. Therefore, it is very important to calculate the right
amount of penalty amount.
22
Managing Intellectual Property, CONCERNS RAISED OVER CHINESE PATENT LAW AMENDMENT (19 April, 2013), by Emma
Barraclough. Retrived from http://www.managingip.com/Article/3194021/Concerns-raised-over-Chinese-patent-law-
amendment.html
23
Managing Intellectual Property, CHINA’S IP REFORMS ARE PICKING UP STEAM( 15 July 2013), by Peter Leung.
Retrieved from http://www.managingip.com/Blog/3231049/Chinas-IP-reforms-are-picking-up-steam.html
24

July 2013 Page 25
Ordered monetary awards may be difficult because of fragmented legal system and local
government protectionism. There are still some practical challenges in the Chinese law despite
the improvement in infringement laws and increase in the amount of penalties.
c) Language
Chinese language remains to be major issue in taking any trade to china. Every country willing
to trade with china faces language one of the biggest hurdles. It becomes difficult to have
access to markets and companies in such a country where English is not the business language.
The market information required to have a base in china is difficult to access due to language.
English considered as the main language for communication which is spoken by just a small
percentage of population in China. Registration of pharmaceutical product, documentation of
product details and company information is to be documented in Chinese. Product marketing
and labeling has to be in Chinese, which asks for very specific date product. At times the
information regarding registration and documentation is misunderstood due to the language
barrier.
Furthermore, every detail of company and product is required for translation and further
documented. Labeling of the product also has to be in Chinese language, company has to
provide information about the product to them for translation.
Obtaining market information is very difficult, as information is in Chinese. Therefore before
entering china company has to appoint one local representative. Local representative will act as
a channel through which the SFDA and the company will be connected. Generally, it is better,
for the time being, to approach these companies through an intermediary with Chinese-
language capability. Obviously, the intermediary needs to know the decision makers at these
companies and their decision-making processes. Many intermediaries claim to know many of
the key players, but the reality is that their contacts may not be with the right people within the
organization, or the contacts may be superficial.
Therefore, to establish good contact, it will be important to carefully research the potential
intermediaries, and to use two or three intermediaries in order to triangulate on the right
persons in such organizations. With the right intermediary, the whole process of
communication between the Western rights owner and the Chinese company may be greatly
facilitated. Realizing this, some of the key intermediaries are seeking remuneration through
finder’s fees or other success based compensation, along the lines of boutique investment
banks.

July 2013 Page 26
d) Protectionism
The government gives export subsidies and tax benefits to its domestic firm to increase the
exports and production respectively, a large number of manufacturing firms in China export all
or almost all of their production.
Exchange rate control had been the favorite policy for china which is worldwide known. China
had long history to control its exchange rate, primarily one of the major ingredients of export
growth for china over recent years. This makes Indian goods less competitive .Although this
makes Chinese consumers worse off (increase in the real price of imports for them).
On more protectionism policy in china is to impose anti-dumping duty on foreign firms.
Supporters of anti-dumping laws argue that they prevent "dumping’’ of cheaper foreign goods
that would cause local firms to close down.
7) Conclusion
Today India and china are the most important trading partners in the world. Due to
repercussion effects, this trade carry a major impact with itself .Trade between India and china
had been increased over last many years. But it is worthwhile to note that India continuously
experiencing current account deficit over last few years. There are major hurdles like
registration system, exchange control and language barriers which need to get solved. China’s
exports had been low as well for global reasons (recent global financial crisis), so it knows that
India has big market. China seems to give full support to Indian pharmaceutical firms. During
the last 9th
joint working group, Chinese commerce minister Mr. Deming confirmed to give
Indian firms a palpable environment. Even recently Chinese premier gave a green signal on
many issues. In future we can expect a trade balance for India and increase in total bilateral
trade between India and china.
a) Summary of major findings and key points of the report
(i) REGISTRATION
Medicine registration system has not functioned well and has hampered the healthy
development of pharmaceutical sector. The production of some essential medicines has been
problematic. Too many manufacturers are producing the same chemical medicine with
different dosages and packing is being sold at different prices. This system can be granted for
better pricing and needs to better regulated and managed under better coordination between
the drug regulatory and pricing authorities. Also sometimes the quality of medicines is a
concern of public especially in rural and remote areas.
Lack of regulation enforcement and unethical practice has been the key sticking points which
blocked the health development and good governance in the Chinese pharmaceutical sector.

July 2013 Page 27
Government agencies such as SFDA and MoH have taken certain steps but still a lot of work
needs to be done. Rigorous regulations should be developed to ensure that any new
pharmaceutical product that wants to get registered and produced should be more cost
effective than existing ones. Relevant policies and actions should be put in place to prevent any
corruption and other illegal practices in pharmaceutical registration, distribution and utilization.
Paperwork
Make Chinese environment more favorable and transparent as per international standards. So
that there is easy catching up of foreign MNCs with Chinese environment and smoother
functioning and understanding of the paperwork can take place. Also it would also be beneficial
for Chinese entities going to foreign market.
Payments
China should provide only with freely negotiable letter of credit, in which authorization from
the issuing bank to pay the beneficiary is not restricted to a specific bank; any bank can be a
nominated bank as long as the bank is willing to pay, to accept draft(s), to incur a deferred
payment undertaking, or to negotiate the L/C. The words "this credit is not restricted to any
bank for negotiation" or "this credit may be negotiated at any bank", or similar words, may be
indicated on the L/C. This should be done to improve Chinese business environment and make
it more favorable for foreign investors.
(ii) IPR
A long process for approval and the time consumed in process is a problem in Chinese
pharmaceutical industry so it preferred to have some initial approval even before the letter of
intent is established, especially if some arms of the local government are going to provide a
grant or some assistance via cash contribution in the development of the project.
To develop an effective intellectual property enforcement programme, experience shows that
the key element is building good relations with administrative authorities and effective
coordination of investigators, designated agencies and administrative authorities to solve
counterfeiting problems25
. Also the industry should tune up with government stakeholders to
bring more clarity to regulatory policies on drug development.
(iii) Language
Some of the largest Chinese pharmaceutical companies, especially the pharmaceutical arms of
key State Owned Enterprises (SOEs), are still organizing themselves to conduct international
25

July 2013 Page 28
business development, including establishing business development groups with English-
speaking capabilities and developing intellectual property departments, licensing departments,
and other assets necessary to conduct international transactions. At present, they do not tend
to participate in international partnering sessions in force, nor even to attend partnering
sessions in China that are largely conducted in English. Therefore, accessing these companies
who want to do deals can be difficult.
b) POLICY RECOMMENDATIONS:
 India and China should talk about notorious registration system existed in china for
ages. Indian pharmaceutical products already proved by world reputes like USFDA and
other Europe and UK government organizations. Chinese authorities can relook at
details of previous detailed examinations by other overseas authorities. This will not
only make the process faster but also give an impetus to other firms.
 Both countries India and china are currently working on these programmes very
frequently. There are many NGOs who organized cultural and language programmes
every year, for instance in 2011 Indra Gandhi National Open University's (IGNOU) School
of Foreign Languages (SOFL) had launched a Diploma in Chinese Language and Culture
(DCLC). This not only help to get familiar with each other’s languages but also to get
familiar with each other’s cultures which is very important from trade point of view.
 As mentioned in Annexure 1 both countries are better off if coordination is improved
and various hindrances working as non tariff barriers are removed for a better trading
partnership between India and China so both importers of China and exporters of India
can have a free trading passage.
 China should bring with some more reforms focusing on more transparency .This step
could give lot of impetus to Indian pharmaceutical firms to invest in china.
 During the recent visit of Chinese premier Le Kequiang, both countries had signed 8
MoUs, one of which related to pharmaceutical sectors. This sort of diplomacy needed to
happen at intermittent intervals.

July 2013 Page 29
AnnexureA:Export-Import Data of India & China with Trade
Potential
Product Description
Product
Code
Indian
export
Import
China
India to
China
Trade
Potential
Extracts of glands or other organs 300120 1633.497 98.564 0 1633.50
Antisera and other blood fractions 300210 12257.701 787866.421 4.945 12252.76
Vaccines for human medicine 300220 153273.42 228120.851 245.482 153027.94
Vaccines for veterinary medicine 300230 4575.814 107186.096 0 4575.81
Containing penicillins or derivativ 300310 71105.7 3329.371 7.249 71098.45
Containing other antibiotics 300320 146429.019 22155.238 748.124 145680.90
Containing alkaloids or derivatives 300340 756.461 5963.257 0 756.46
Containing penicillins or derivativ 300410 259770.708 120485.758 38.057 259732.65
Containing other antibiotics 300420 572588.311 620840.066 641.556 571946.76
Containing insulin 300331 1292.247 491014.735 0.587 1291.66
Containing corticosteroid hormones, 300432 2650.019 268755.833 0 2650.02
Containing alkaloids or derivatives 300440 39677.265 86459.867 35.255 39642.01
Other medicaments containing
vitamin
300450 221894.746 100151.277 54.733 221840.01
Adhesive dressings and other article 300510 3673.816 33033.234 0 3673.82
Sterile surgical catgut, similar st 300610 17412.735 73647.027 0 17412.74
Blood grouping reagents 300620 239.826 17513.223 0 239.83
Opacifying preparations for X-ray ex 300630 2867.558 59011.767 0 2867.56
Dental cements and other dental fil 300640 5280.594 31551.459 0 5280.59
First aid boxes and kits 300650 1016.814 2888.552 0.567 1016.25
Chemical contraceptive preparations 300660 35290.039 30097.24 0 35290.04
Gel preparations designed to be use 300670 1852.741 5321.858 0.293 1852.45
Containing insulin 300431 52123.257 0.322 52122.94
Waste pharmaceuticals 300680 2087.954 0 2087.95
Other mendicants(excl heading
3002,3005,3006)for therapeutic
prophylactic uses not put up for retail
sale
300390 239960.267 254862.276 17277.965 222682.30
Other medicine put up for retail sale 300490 3954776.854 3296870.863 7193.919 3947582.94
(In 1000 USD)

July 2013 Page 30
Annexure B: The details of some of the major NTMs that are
maintained against Indian exports
HS code Commodity Type Country Details
30000000 Pharmaceutic
als
Registratio
n
Argentina ANMAT (Drug regulatory authority) has not visited
Ranbaxy's facilities despite fees having been paid
als
Certificatio
n
Armenia Registration, permission for importation
als
Registratio
n
Brazil Clearances from Brazilian Health Surveillance Agency
(ANVISA), , inspection by ANVISA, registration of
products, issuance of licenses for sale, reports of bio
equivalence and procedural delays
als
Registratio
n
Colombia Registration takes 11-12 months, Colombian Drugs
Control & Certification Authority (INVIMA) undertakes
physical inspection, certifies Spanish translated
documents.
als
Registratio
n
Colombia 10% price preference for French Pharmaceutical
companies due to bilateral agreement
als
Public
Procurem
ent
Colombia Strict Registration procedures, 11-12 months’ time
lag, inspection to ensure environmental compliance
als
Certificatio
n
EC Import restrictions under the recently amended
German Code of Medical Law requiring permission for
microbiologically produced active pharmaceuticals
ingredients (API)
als
Import
Restriction
EC Quality control guidelines and complexities of product
registration inflate costs.
als
Standards EC Non harmonized maximum residue limit (MRL)
als
Registratio
n
El Salvador Delayed registration
als
Registratio
n
Honduras Delayed registration
als
Registratio
n
Panama Delayed registration even up to 18 months
als
Import
Restriction
Ukraine Import Licenses regulated by Cabinet of Ministers and
granted by Ministry of Economic Relations
als
Certificatio
n
Ukraine Compulsory Certification i.e. (a) Certificate of
acceptance of foreign certification by Derzh Standard
or (b) Conformance certificate by Ukrainian agency.
ISO 9000 standards adopted by Derzh Standard on
production systems. Foreign certification recognition
only to the extent of international treaty obligations of
Ukraine.
Source: http://commerce.nic.in/trade/international_ntm

July 2013 Page 31
Annexure C: Application and approval procedure for imported drugs
(1)
Annexure D: Application and approval procedure for imported
drugs (formulations) (2)

INDIA CHINA PHARMACEUTICAL TRADE A COMPREHENSIVE STUDY

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