Publications on India

India Pharmaceutical Regulatory Report 2011

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 early 2011.

Indian Medical Device Manufacturers Push for Changes in Industry

A group of Indian medical device manufacturers are lobbying for the following: changes in the current duty structure on medical devices, currency stability, cheaper credit for exporters, and greater representation of their interests in a medical export council. In February 2010, the All India Medical Devices Industry (AIMED) wrote a letter to the commerce and industry minister of India proposing that either Pharmexcil (an organization representing pharmaceutical exporters) broaden its scope to include the interests of the medical device industry, or a new Medical Export Promotion Council be established.

Updates on the Medical Device Regulations in India

In today's global recession, innovation, creativity and resourcefulness are essential. Using these tools to determine the appropriate regulatory strategy for your medical device could decide the success or failure of your product in Asia. This article provides the most recent regulatory updates in Japan, China and India to help gain entry to those markets.

Updates on the Medical Device Markets in Japan, China and India

In today's global recession, innovation, creativity and resourcefulness are essential. Using these tools to determine the appropriate regulatory strategy for your medical device could decide the success or failure of your product in Asia. This article provides the most recent regulatory updates in Japan, China and India to help gain entry to those markets.

New Updates on India's Expanding Medical Device Market Webcast

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 CD 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.

Regulation Growth Equals Opportunity Growth

It may sound intimidating, but if foreign companies are willing to do the legwork, there are many good reasons to consider launching a medical device plant in India. Few statistics on the country's device market are available but, with the help of our medical partner who has been in India for more than 10 years, we estimate the market to be about $2 billion, growing at 15% per year. The market's growth has been driven by an increase in both government and private sector expenditures in healthcare, increased coverage of medical insurance, and rising incomes.

Doing Business in India Webcast

The Indian economy is booming! India is becoming increasingly popular as a low-cost place to manufacture goods and outsource services. But without a full grasp of the local business environment, cost savings can be elusive. This webcast covers topics from joint ventures and foreign investment to recruiting strategies in India. What are the risks and benefits of doing business in India? What types of candidates are available to fill key jobs in India? How is the Indian culture different from East Asian and Western culture?

Managing Asian Cultural Diversity: Cross-Cultural Issues in Asia

Managing Asian cultural diversity can be very complex for Western companies. Each country has its own culture, history, ideology, language and philosophy: a strategy in Taiwan may not work in China, and vice versa. Understanding the local mentality, beliefs, and even linguistic traits can make a world of difference in managing Asian employees effectively. Please attend our October 23, 2008 webcast on Asian Cross-Cultural Issues. This 90-minute session will include a 60-minute presentation, followed by 30 minutes of Q&A.

New Updates on India's Expanding Medical Device Market Webcast

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.

Pharmaceuticals in India: A Business and Regulatory Outlook

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.

Strategies for Success in China, Japan, and India

Tremendous opportunities abound in the China, Japanese, and Indian medical markets. Understanding how to enter or expand in these markets is key to surviving in the competitive global market. From setting up your own branch in Japan to conducting clinical trials in India, this webcast CD will delve into the key business and regulatory issues in China, Japan, and India.

Medical Device Market Opportunities in India

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

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 Market Webcast

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

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.

Drug and Device Markets throughout the Asian Region (PDF)

Pharmaceutical and medical device markets are expanding throughout Asia. This presentation covers the medical device and pharmaceutical markets in Taiwan, Hong Kong, Malaysia, Singapore, India and Vietnam, and provides country-specific information about drug, device and IVD regulations in these countries. Specific topics include registration, pricing and reimbursement, manufacturing and GMP, import licenses, patents, and clinical trials in these countries.

Dragon & Tiger - Emerging Power of India & China in the Pharmaceutical Industry (PDF)

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

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

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

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

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.