S. Harachand07.15.09
The medical devices market in India is heading for a boom even as a policy guidance to regulate the rising multitude of these diverse instruments continues to lag way behind.
India's medical devices sector, which has seen a fast-paced growth in past several years, is expected to reach $1.7 billion in 2010, growing at an annual growth rate of 23%, according to a sector report by National Institute of Pharmaceutical Education and Research (NIPER), Ahmedabad, an autonomous body under the aegis of Ministry of Chemicals and Fertilizers, Government of India.
At this pace, the medical equipment industry could even reach $5 billion by the year 2012, forecasts a recent study by Federation of Indian Chambers of Commerce & Industry (FICCI) and Ernst & Young.
Affordability and increasing awareness among patients, improved hospital infrastructure and rising disease patterns are listed as the primary drivers boosting growth, while a free market environment, investment in health infrastructure, and medical tourism feed the growth of high quality medical devices.
Majority of the high-end devices market - which depends heavily on imports - is controlled by multinationals such as B Braun, Becton Dickinson and Company, Bayer, Johnson & Johnson, Phillips, Roche, Siemens and GE.
However, MNCs believe the future growth of the sector will be propelled largely by the demand for "economy" segment devices from the rapidly growing rural and semi-urban regions of India.
"A large portion of this growth is expected from the tier 2 and tier 3 towns," said R. Sridharan, head, marketing, Philips Healthcare India. To target the economy segment, the Netherland-based electronics major acquired to two Indian X-ray equipment makers - Alpha and Meditronics - last year. The economy segment product range from both these companies complements Philips' existing high-end range. Philips also has plans to make India production hub to serve the emerging markets in Asia Pacific.
Roche Diagnostics is another leading transnational that sees big-time opportunities coming from Indian rural markets. "At present, healthcare services are limited to large cities, there is a huge potential for percolation to smaller cities and rural areas," commented Dr. Bhuwnesh Agrawal, chairman and managing director, Roche Diagnostics India and South Asia.
Roche leads the diagnostics kits segment, which has more than 50 foreign and local players compete including Transasia, Bayer, Span Diagnostics, Piramal Healthcare, Orchid, Tulip Diagnostics, Zephyr Biomedical, Biorad, and Liliac. Diagnostic kits are the fastest growing segment in India's medical devices sector, which is predominated by diagnostics, surgical equipment and imaging instruments.
Like Philips Healthcare, many other multinational devices makers would prefer to outsource or relocate their manufacturing operations to India as the country offers an attractive mix of engineering expertise, comparatively lower wages, high quality of product development and proven experience with long distance project execution.
Since India has a vast pool of best-in-class research scientists, highly qualified medical and surgical specialists (most trained in the U.S. and Britain), treatment-nave patients, and cost-effective operations, the country offers the possibility of conducting all phases of trials including pivotal studies, observed Dr. Darrell DeMello of ALQResearch, the Indian affiliate of Minneapolis-based Alquest Inc., a CRO specialized in medical devices.
Besides the regular clinical trial services, medical writing and clinical training, the Indian CRO sector has the potential to deliver high quality, yet cost-effective, safety surveillance services in pre-approval and post-marketing settings. "Not just for products used in India but for all products manufactured and sold anywhere in the world," averred Dr. DeMello, who has been involved in the Indian medical devices industry since late 1970s.
Indian companies have expanded their manufacturing capabilities through the strictest of standards and most of them are ISO certified. Indian vendors have also added clinical trial and regulatory certification processes to their portfolios.
Regulations for devices, in contrast to the sharp rise of the industry, are far too rudimentary or still in its nascent stages in India. There is no separate regulator for medical devices. Select categories of devices are classified as drugs and are required to go through the approval procedure followed by pharmaceutics, including clinical trials.
Meanwhile, a vast section of devices, mainly in the domestic sector, remain unregulated. Lack of standardization creates wider gaps of quality and cost within the same category of devices. Further, facilities or labs to test the quality or efficacy are yet to be in place.
India has been working on a Medical Devices Regulation Bill for the last two to three years. The bill, which proposes the creation of a Medical Device Regulatory Authority empowered to fine and imprison defaulters, is still in its draft stage.
However, stakeholders in the devices and equipment industry are rather optimistic that the government would soon put a framework in place and provide them a level-playing field.
"We are hopeful that once implemented, [the Bill] will help the industry in standardizing and raising the overall quality benchmarks," said R. Sridharan of Philips.
India's medical devices sector, which has seen a fast-paced growth in past several years, is expected to reach $1.7 billion in 2010, growing at an annual growth rate of 23%, according to a sector report by National Institute of Pharmaceutical Education and Research (NIPER), Ahmedabad, an autonomous body under the aegis of Ministry of Chemicals and Fertilizers, Government of India.
At this pace, the medical equipment industry could even reach $5 billion by the year 2012, forecasts a recent study by Federation of Indian Chambers of Commerce & Industry (FICCI) and Ernst & Young.
Affordability and increasing awareness among patients, improved hospital infrastructure and rising disease patterns are listed as the primary drivers boosting growth, while a free market environment, investment in health infrastructure, and medical tourism feed the growth of high quality medical devices.
Majority of the high-end devices market - which depends heavily on imports - is controlled by multinationals such as B Braun, Becton Dickinson and Company, Bayer, Johnson & Johnson, Phillips, Roche, Siemens and GE.
However, MNCs believe the future growth of the sector will be propelled largely by the demand for "economy" segment devices from the rapidly growing rural and semi-urban regions of India.
MNCs Eye Economy Pie
"A large portion of this growth is expected from the tier 2 and tier 3 towns," said R. Sridharan, head, marketing, Philips Healthcare India. To target the economy segment, the Netherland-based electronics major acquired to two Indian X-ray equipment makers - Alpha and Meditronics - last year. The economy segment product range from both these companies complements Philips' existing high-end range. Philips also has plans to make India production hub to serve the emerging markets in Asia Pacific.
Roche Diagnostics is another leading transnational that sees big-time opportunities coming from Indian rural markets. "At present, healthcare services are limited to large cities, there is a huge potential for percolation to smaller cities and rural areas," commented Dr. Bhuwnesh Agrawal, chairman and managing director, Roche Diagnostics India and South Asia.
Roche leads the diagnostics kits segment, which has more than 50 foreign and local players compete including Transasia, Bayer, Span Diagnostics, Piramal Healthcare, Orchid, Tulip Diagnostics, Zephyr Biomedical, Biorad, and Liliac. Diagnostic kits are the fastest growing segment in India's medical devices sector, which is predominated by diagnostics, surgical equipment and imaging instruments.
Huge Offshoring Potential
Like Philips Healthcare, many other multinational devices makers would prefer to outsource or relocate their manufacturing operations to India as the country offers an attractive mix of engineering expertise, comparatively lower wages, high quality of product development and proven experience with long distance project execution.
Since India has a vast pool of best-in-class research scientists, highly qualified medical and surgical specialists (most trained in the U.S. and Britain), treatment-nave patients, and cost-effective operations, the country offers the possibility of conducting all phases of trials including pivotal studies, observed Dr. Darrell DeMello of ALQResearch, the Indian affiliate of Minneapolis-based Alquest Inc., a CRO specialized in medical devices.
Besides the regular clinical trial services, medical writing and clinical training, the Indian CRO sector has the potential to deliver high quality, yet cost-effective, safety surveillance services in pre-approval and post-marketing settings. "Not just for products used in India but for all products manufactured and sold anywhere in the world," averred Dr. DeMello, who has been involved in the Indian medical devices industry since late 1970s.
Indian companies have expanded their manufacturing capabilities through the strictest of standards and most of them are ISO certified. Indian vendors have also added clinical trial and regulatory certification processes to their portfolios.
Regulations for devices, in contrast to the sharp rise of the industry, are far too rudimentary or still in its nascent stages in India. There is no separate regulator for medical devices. Select categories of devices are classified as drugs and are required to go through the approval procedure followed by pharmaceutics, including clinical trials.
Meanwhile, a vast section of devices, mainly in the domestic sector, remain unregulated. Lack of standardization creates wider gaps of quality and cost within the same category of devices. Further, facilities or labs to test the quality or efficacy are yet to be in place.
India has been working on a Medical Devices Regulation Bill for the last two to three years. The bill, which proposes the creation of a Medical Device Regulatory Authority empowered to fine and imprison defaulters, is still in its draft stage.
However, stakeholders in the devices and equipment industry are rather optimistic that the government would soon put a framework in place and provide them a level-playing field.
"We are hopeful that once implemented, [the Bill] will help the industry in standardizing and raising the overall quality benchmarks," said R. Sridharan of Philips.