India Strives To Create Regulatory Body For Devices With Help From Industry

Full article reprinted from PharmAsia News - July 15, 2008

The government of India is accepting input from manufacturers to help it develop a new medical device regulatory body, following a 2006 mandate to register certain medical devices.

Industry expects an initial structure for the government agency could be in place as early as the end of 2008, and India appears willing to harmonize its policy with world standards. Device manufacturers want more transparency and clarity in emerging markets such as India. "The industry will be more regulated, so that should help the better-run companies get an opportunity to register and keep out companies that are not as sophisticated," Ames Gross, president of consultancy Pacific Bridge Medical, told "The Gray Sheet." Firms Oppose Drug-Centric Oversight Until its medical devices agency is functional, India will continue to handle much of its device policy within its pharmaceuticals regulatory body, the Central Drug Standards Control Organization, created in the 1940s. A few years ago, very few medical devices were required to be registered in India. Although more devices need registration today, "they're still using the drug forms because they don't have any medical devices forms," Gross said. Ralph Ives, Executive Vice President of Global Strategy and Analysis for AdvaMed, explained that double-blind clinical trials required for pharmaceutical products would be inappropriate for a medical device and that some medical devices require education and services that pharmaceuticals do not. AdvaMed and other trade groups have lobbied the Indian government to create separate regulations for devices. "Obviously India is a sovereign government, and it can regulate any way it wants, but it is, to its credit, reaching out to industry - both foreign industry and domestic industry - to get guidance on how to regulate," Ives said. While the Indian government has indicated it would like to have the "beginnings of the structure" for a medical devices agency in place by the end of this year or early next, Ives said, AdvaMed wants India to take the time to do things right. "We know they want to get regulations in place as soon as possible," Ives said, "but given the complexity, we are urging that they take their time, do a deliberative process and try to harmonize [with international standards] as much as possible." "We have been asking the governments of India to make sure that all the regulations related to medical devices are transparent, predictable, based on principles of good governance and risk management, and use standards as adopted by the Global Harmonization Task Force," said Greg Kalbaugh, director and counsel for the U.S.-India Business Council. According to Ives, AdvaMed has recommended a risk categorization structure for India's device regulations. AdvaMed wants India to use guidance from the GHTF, but also to "implement the regulations consistent with India's resources" rather than try to initiate a full-scale [U.S.] FDA approach that it cannot afford. "It is a very complex undertaking, and the products are becoming ever more complex," Ives said. A country starting to regulate medical devices on its own rather than relying on established regulatory bodies like FDA faces many challenges, including hiring enough qualified people to review medical devices. Gross said he expects some of the drug regulatory personnel in India to move over to regulating medical devices. Adopting regulations consistent with the global marketplace would help the device industry within India become more competitive, Ives said. Consistent and harmonized regulations around the world would reduce costs and facilitate patient access to new technology, so both U.S. and Indian industry should benefit as India regulates devices, he added. Late last year, U.S.-India Business Council created the Coalition for a Healthy India to improve patient access to the latest medical treatments. USIBC members include device makers doing business in India such as GE and Johnson & Johnson, as well as companies whose employees depend on the health care system in India. Director Kalbaugh said USIBC would "welcome all comers" who want to help build critical mass to advocate on behalf of the medical devices industry in India. In addition to organizing life sciences trade missions to India, USIBC maintains a High Technology Cooperation Group and holds other meetings of private sector stakeholders to discuss how to advance the industry's agenda. India's Ministry of Chemical and Fertilisers recently created a separate department of pharmaceuticals to coordinate policy for the industry, which is subject to price controls as well as overlapping jurisdiction with the health ministry on research, manufacturing and distribution (PharmAsia News, July 9, 2008). India's Congress-party led coalition government has tried for two years to create a unified pharmaceutical policy and expand the number of price controls to 354, a move industry trade bodies have consistently opposed (PharmAsia News, March 8, 2008). India's Growth Offers Opportunity To New Entrants With an overall population of 1.1 billion people, India "is too big and growing too quickly for companies to ignore," Pacific Bridge Medical's Gross stressed. According to Gross, the medical devices market in India is growing at a rate of 15 to 17 percent per year, driven by an increasingly wealthy population, the construction of new health care facilities and an influx of diseases formerly confined to the West. "It is definitely a place [where] companies want to be engaged," Kalbaugh said, noting that India's middle class has 300 million people and is demanding better health care. Due to lifestyle changes such as eating more fast food, they tend to suffer from more cardiovascular disease and cancer rather than the diseases seen in the not-too-distant past, such as cholera or malaria, Gross said. While the market potential in India is enormous, U.S. device manufacturers should examine the country's logistical and cultural challenges before entering the market, Gross advises. For example, because the country is so large and still has considerable infrastructure problems, device companies looking to export to India may need to establish partnerships with two or three different distributors rather than relying on just one. A manufacturing plant in India offers "a great platform" for distribution throughout Asia, Kalbaugh said. Since India ranks number two globally in graduating Ph.D.s, right behind the U.S., "the ability to tap into that innovative talent pool is invaluable to our companies, [that] basically live and die based on their innovation," Kalbaugh said. Manufacturers that want to hire in India should pay particular attention to their retention efforts, said Gross. While there are many qualified people available for hire in India, there are a limited number on the regulatory side. And although wages in India have historically been very low, "they are growing quickly. Retention of people is just as important as hiring people, because people have a lot of opportunities." Gross recommends companies looking to expand into India open offices in New Delhi, "because that's where most things are done." What works for an international company doing business in Taiwan or Hong Kong or Korea may not be appropriate for India and its culture, Gross said. However, operating in India may be easier for U.S. companies because the countries share similar value systems, forms of government and language, Kalbaugh said. Kalbaugh said he's seen more of a convergence than a divergence in the type of problems Indian and U.S. businesses face when trying to expand the medical devices industry in India. "Especially as the market becomes more global, certainly harmonization is something everybody is looking at," he said. "It benefits everybody." - Monica Hogan [Editor's note: This article also appeared in "The Gray Sheet" - July 14, 2008.] PharmAsia News covers drugs, biotech and devices in the Pacific Rim. PharmAsia News brings you the news and analysis you need to succeed in the competitive global marketplace. Sign up for 30-day, risk-free trial of PharmAsia News online or call 1-800-332-2181.