Pacific Bridge Medical
Publications/ India

India Pharmaceutical Regulatory Report 2008
$750/$1500
Presented in Pacific Bridge Medical Webcast 2008
By Ames Gross and John Minot
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.

New Updates on India's Expanding Medical Device Market Webcast
$400
Presented in Pacific Bridge Medical Webcast December 2007
By Pacific Bridge Medical
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.

Pharmaceuticals in India: A Business and Regulatory Outlook
Presented in Drug Delivery Technology October 2007
By Ames Gross and John Minot

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.


Medical Device Market Opportunities in India
Presented in MX Mar/April 2007
By Ames Gross
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.

Update on India's Medical Device Markets Webcast
$400
Presented in Pacific Bridge Medical Webcast February 2007
By Pacific Bridge Medical
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.

India's Pharmaceutical Webcast
$400
Presented in Pacific Bridge Medical Webcast November 2006
By Pacific Bridge Medical
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.

India's Medical Markets Webcast
$400
Presented in Pacific Bridge Medical Webcast May 2006
By Pacific Bridge Medical
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.

Dragon & Tiger - Emerging Power of India & China in the Pharmaceutical Industry
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.
 
Indian Pharmaceutical Industry: Market, Regulatory, Import and Investment Regime
Published by Pacific Bridge Medical May 2002
By Ames Gross and Sunil Patel
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.

New Trends in India's Pharmaceutical Market
Published by Pacific Bridge Medical February 1999
By Ames Gross
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.

Growing Opportunities in the Indian Medical Device Market
Published in Medical Device & Diagnostic Industry November 1995
By Ames Gross
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.

India's Medical Market -- In Its Infancy but Growing Fast
Published in Clinica, a publication of PJB Publications, Ltd. September 1994
By Ames Gross
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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