Publications/ India
| Presented in Pacific Bridge Medical Webcast |
2008 |
| By Ames Gross and John Minot |
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| The India Pharmaceutical Regulatory Report comprehensively covers all aspects of pharmaceutical regulations in India. It includes overviews of the laws and procedures on registration, manufacturing, distribution, price control, marketing, research and development, and intellectual property protection. It also includes an overview of the Indian pharmaceutical market and foreign involvement in the market up to 2007. How suited the country is to different kinds of market entry – such as manufacturing, sales, or research – is discussed in relation to the regulatory and market environment. |
| Presented in Pacific Bridge Medical Webcast |
December 2007 |
| By Pacific Bridge Medical |
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| India combines many opportunities and many challenges for the medical device industry. India’s medical device market is currently the fourth largest market in Asia. With projected growth rates of 12-16% for the next five years, one cannot ignore India’s potential and vast market opportunity. This webcast will provide an overview of India’s medical device market as well as discuss the most recent regulatory issues. This 90-minute webcast CD will include a 60-minute presentation, followed by 30 minutes of Q&A. |
| Presented in Drug Delivery Technology |
October 2007 |
| By Ames Gross and John Minot |
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After decades of slow growth, India’s economy is now advancing rapidly. From 1996 to 2006 its GDP grew at an average rate of 7% yearly, and this growth figure increased to 10% in 2006. It is expected to keep growing at 7% or higher over the next five years. With the fourth-largest economy in the world (as measured by purchasing power parity), India is finally coming into its own as a major world economy.
Total medical spending in India is growing quickly, driven by better-off Indians willing to pay privately for modern care from private hospitals. This increased spending creates many opportunities for foreign pharmaceutical companies. India’s $9 billion pharmaceutical market saw 10% growth in 2006, and double-digit growth is predicted to continue through 2012. In addition, the country’s low labor costs, large existing pharmaceutical manufacturing base, and sizable patient population make it an excellent location for Western companies to do contract manufacturing, clinical research, and R&D. |
| Presented in MX |
Mar/April 2007 |
| By Ames Gross |
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| For a long time, India was closed to many foreign markets through government protectionism and a nationalistic tariff system. Today, however, India is ripe for market entry for many industries, including medical devices. Entering soon (or expanding one’s business there) will help keep Western enterprises from being left out of India’s exponential growth. |
| Presented in Pacific Bridge Medical Webcast |
February 2007 |
| By Pacific Bridge Medical |
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| India is exploding! India’s medical device market is currently the fourth largest market in Asia. With projected growth rates of 12-16% for the next five years, one cannot ignore India’s potential and vast market opportunity. This webcast will provide an overview of India’s medical device market as well as discuss the most recent regulatory issues. |
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| Presented in Pacific
Bridge Medical Webcast |
November 2006 |
| By Pacific Bridge Medical |
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| This
webcast provides an overview of India's pharmaceutical
markets as well as discusses the most recent regulatory
issues. Topics covered include overview
of India's healthcare system, product registration
requirements for drugs, health insurance, reimbursement,
how to expedite the registration process, etc. |
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| Presented in Pacific
Bridge Medical Webcast |
May 2006 |
| By Pacific Bridge Medical |
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This
webcast provides an overview of India's medical
markets as well as discusses the most recent regulatory
issues. Topics covered include overview
of India's healthcare system, product registration
requirements for drugs, new medical device regulations,
reimbursement, how to
expedite the registration process, etc. |
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| Presented at Canadian
Association for Pharmacy Distribution Management
Annual Conference 2005 |
May 2005 |
| By Ames Gross |
 As
China and India continue to improve their pharmaceutical
regulatory environments through the implementation of
new and stricter regulations, an increased number of
foreign companies are entering these markets. This presentation
provides information on sourcing medical products in
China and India, including how to identify product manufactures,
communication issues, pricing, contract negotiations
and due diligence. Outsourcing strategies are also described,
such as outsourcing clinical trials and R&D, and
numerous company examples are given. This presentation
also reviews the various types of business structure
options in China and India, such as a representative
office, branch office, and joint venture. |
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| Published by Pacific
Bridge Medical |
May 2002 |
| By Ames Gross and Sunil
Patel |
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| After India’s entry into the World
Trade Organization (WTO), consumer goods imports and
free imports greatly increased, allowing the market to
slowly open up to foreign investment and medical products.
This article covers the major features of the market,
law and policy associated with the pharmaceuticals industry
in India. There are several departments and regulations
in India which help control pharmaceutical regulation;
including the Drugs and Cosmetics Act (DCA), the Department
of Chemicals and Fertilizers, Ministry of Chemicals and
Petrochemicals, the Drug Controller of India (DCI), and
the Drug Prices Control Order Act (DPCO). These regulatory
bodies and acts help maintain pharmaceutical regulatory
procedures like product approval, manufacturing, importing
and licensing, tariffs, pricing, marketing and distribution,
patents and trademarks, and market entry and investment. |
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| Published by Pacific
Bridge Medical |
February 1999 |
| By Ames Gross |
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| This article discusses some
of the major issues facing foreign pharmaceutical companies
looking to invest in the Indian market. India’s
pharmaceutical sector continues to grow at an annual
rate of 15%-20%, and currently its pharmaceutical market
is ninth in the world. Despite the widespread use of
ayurvedic medicine and homeopathy, the demand for imports
from foreign drug companies continues to increase. The
Drugs Controller of India (DCI) and State Food and Drug
Administrations (FDAs) are responsible for drug regulation
and control, while the Drug Price Control Orders (DPCO)
have been implemented to assist with price control. Additionally,
the Trade-Related Intellectual Property Rights (TRIPs)
has been put into effect by the Indian government to
protect foreign drug products. Understanding these regulatory
procedures, price control and patent protection issues
is key to foreign companies hoping to ensure their long-term
place in the industry. |
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| Published
in Medical Device & Diagnostic Industry |
November 1995 |
| By Ames Gross |
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| Despite a burgeoning population exceeding
1 billion, India’s government is aiming to protect
its citizens by providing quality medical care to all
Indians, including those living in rural areas. This
national priority will require increased numbers of imported
medical device equipment, which already constitutes about
half of the Indian medical market. With information regarding
India’s healthcare structure, medical device market
and market entry strategies, this article draws attention
to the changes that are being made by the government,
the promise of growth in the medical device market, and
the particularities of entering the market in India.
There are many ways in which medical device suppliers
can receive assistance with their entry into the market,
including finding a domestic partner or hiring a domestic
distributor or agent to help market and sell the product
in India. |
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| Published in Clinica,
a publication of PJB Publications, Ltd. |
September 1994 |
| By Ames Gross |
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| This article provides information
on the growing possibilities of the Indian medical market
in the coming years. India’s increasing affluent
middle class, the public versus private hospital question,
growing rates of cancer and other deadly diseases, and
local agreements between foreign device manufacturers
and Indian manufacturers are some of the main factors
that are affecting the growth of the Indian medical market.
As the wealthier middle class grows, demands for better
medical treatment with higher technology products will
be met at private hospitals, rather than the government-run
public hospitals. Market entry can be facilitated by
working with local companies
– General Electric (GE) has maintained one of the
most successful positions in the medical market by partnering
with the Indian manufacturer Wipro. |
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