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Can India Become Knowledge And Professional Services Hub To The World For Medical Device Industry?


Opportunities & Challenges


As India emerges as a key economy globally, like many other sectors, it is not only the manufacturing companies in the Medical Device Industry which are lining up fresh investments for the market but also professional services firms considered the backbone of the corporate world.


Medical device companies need strong technical support in their quest to bring safe and effective products to patients and their doctors. A broad array of services is needed to support device development and manufacturing - from materials selection and device design through manufacturing and lot release.


There are many different testing procedures like Biomedical testing, sterilization services, Toxicology testing, Custom device performance and materials testing, Complete biocompatibility testing, Toxicology discovery and safety studies, Product validation programs for all commercially available sterilization methods, Lot release, raw material and vendor qualification testing, Complete testing services for controlled environments etc. in accordance with the GMP (Good Manufacturing Practices) guidelines for different types of medical devices like Single-Use Devices, Implantable Devices, Tissue-Based Products, Combination Products, Cardiovascular Products, Orthopedic Products, Neurological Products, Reusable Device and Research Devices/Materials.


The global market for medical device industry is US$ 220 billion. The Indian Medical Device industry market is likely to cross US$ 5 billion by 2012. Medical devices industry is an innovation-driven industry. A past study indicates that the level of R&D spending in the medical device and diagnostics industry, as a percentage of its sales, has been consistently increasing from 5.4% in 1990, to 8.4% in 1995, to 12.9% post 2000. This level of spending is on par with spending by the pharmaceutical industry. Thus the Indian Medical Device Industry has posted a considerably effective growth in the past decade and hence shows that the industry is bound to grow further and will convert challenges into opportunities.


Generation of knowledge, capability and the capacity in the biomedical area confronts a complex milieu. This milieu is defined by the notion of and the practice of health and the structures and institutions of the biomedical market, which in turn depends upon the dynamics of contests between three major types of economic and innovative institutions of – the drugs, the medical devices and the physicians. Most often capability in developing drugs has alone been considered as the indicator of capability in the biomedical, leaving aside two other important facts – (1) the contests between physicians, medical devices and the drugs to control innovation outcome and also the fact that (2) physicians and devices constitute very important factors contributing to the formation of significant portion of the market of health.


For a Medical device designing and prototype stage, a new innovative idea for designing a medical device needs, defining the market, identify performance specifications, refining clinical uses and anticipating the regulatory and clinical trial requirements.


India is fast emerging as an attractive destination for conducting global clinical trials due to availability of vast pool of patients and also well-trained medical professionals and sophisticated technological infrastructure.


Over the last several years, medical device companies have discovered that there are many advantages to conducting medical device clinical trials in India. These benefits include lower costs, faster patient enrollment and higher subject retention. This has made India as one of the most popular choices for everything from Phase I clinical trials to multisite Phase III global.


The clinical research outsourcing market in India was valued at Rs 3.1 billion in 2005 and is expected to grow to Rs 13.2 billion by 2010. Most of the US and European nations are outsourcing clinical trials to India. A huge patient population, genetically distinct groups, speciality hospitals with state-of-the-art facilities, nearly 700,000 hospital beds and 221 medical colleges, skilled English speaking investigators are India’s trump cards.


The entire world is watching the growth and performance of India in this segment of business. There are positive signals and reports which justify the trends for pharmaceutical sponsors to look seriously at India for carrying forward their drug development initiatives. A CII study predicts that the clinical trials market
will grow to $200 million by 2007 and anywhere between $500 million and $1 billion by 2010.


Several trials also being carried out in psychiatry, neurology, cardiology, gastroenterology, endocrinology, dermatology, respiratory and ophthalmic areas. India’s experience in clinical trials, while most of them are for USFDA and European submission, suggest that the quality of the data is acceptable to meet the global standards.


Today India’s regulatory framework is also compliant to international standards in areas such as Good Manufacturing Practice and Good Laboratory Practice and the country has its own Good Clinical Practice guidelines. India has emerged as a desirable destination for outsourcing clinical trials. It maybe significant to note that the worldwide revenues projected from clinical trials is in the region of $20 billion. About 54 percent of clinical trials is conducted in USA, Europe accounts for 24 percent, whilst Asia contributes 22 percent. The clinical research market in India is expected to grow at a conservative CAGR of nearly 36 percent by 2011 and is estimated to register revenues worth $900 million or higher. By 2011, India is expected to conduct around 15 percent of the total global clinical trials, and thereby become one of the fastest growing clinical trial destinations in the world. The Central Drugs Standard Control Organization (CDSCO) has a daunting and challenging task to meet the growing requirements of clinical trial applications under several categories, study phases, types of products, scientific designs and rationale based on new emerging clinical practises and scientific methodologies. In response to this challenge, CDSCO is constantly evolving new processes, guidelines etc to increase transparency, whilst taking all decisions primarily in the interest of Indian patient’s safety.


With a large Scientific, Engineering and Medical Expertise,


Can India Become Knowledge And Professional Services Hub To The World For Medical Device Industry? The Industry Leaders share their views and vision in the following pages.


Dear Readers,


If you believe yes, please elaborate what makes you think so.
If no, what are the challenges.


As a thought leader for the Indian Medical Device Sector, we shall be obliged to receive your valued opinion.


This is a part of our endeavor to get the best minds to debate and discuss the challenges for Indian Medical Device Industry and shall be shared with the Industry in the coming issues of the this magazine as well as the Internet portal, www.medisourceasia.com

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