Health Biotech Sector

Health Care Health Biotech Sector - A Defining Moment Health Biotech Sector - A Defining Moment The first ever, independent survey of 21 homegrown health biotech firms in India (Frew SE, Rezaie R, Sammut SM, Ray M, Daar AS and Singer PA. 2007. India's health biotech sector at a crossroads. Nature Biotechnology 25 (4): 403-417, April 2007) has revealed that they are not only headed for future growth but also, in some cases, for developing innovative products for world markets. The interview based study found that while policies and support of the government and the expertise and efficiencies of the private sector have each contributed to the development of this sector, it is the creativity and astute management of the firms themselves that has been a crucial element of success. Lessons learnt The study provides the following valuable lessons for all developing countries wishing to strengthen their health innovation systems and for individual companies planning to develop or enhance their biotech capacity. Many local firms started small with one or a few familiar products and/or services to generate early revenues, and leveraged early success for later growth Firms have been resourceful in exploring various financial opportunities from both domestic and international sources, without having to surrender much equity Successful firms have proactively established and maintained collaborations and partnerships with both public and private organizations in India and abroad Firms are aiming to become more competitive by patenting their products and technologies globally. At the national level, they have been able to capitalize on the domestic policy of emphasizing process patenting over product patenting to build strong capabilities on generics manufacturing Successful Indian firms have been able to establish and maintain favourable reputations internationally Barriers to success However, the survey also pointed out several obstacles that are hindering the development of the health biotech sector: Delays in commercialization caused by multiple regulatory agencies Shortage of advanced training programmes and scarcity of qualified personnel Overall lack of public-private collaionboration Few Indian academics show entrepreneurial ambition in biotech Dearth of financial resources and burdening bureaucracy Lack of national prioritization diverts focus from domestic health needs High cost associated with domestic distribution

Recommendations for development
On the basis of the study, the authors made six recommendations to
encourage continued growth of the sector:

• Harmonize pharmaceutical regulatory system into one regulatory agency and ensure adequate training for regulatory personnel
• Increase training programmes in advance biotech through a single agency for science mentoring and guidance
• Ensure translation of initiatives in the draft Biotech Strategy into policies that increase effective public-private collaboration and encourage academic scientists to pursue entrepreneurial ventures to commercial research
• Create a favourable and enabling financial environment for enterprise creation and private sector development, including early stage research and product development
• Identify national priorities for public health and use a targeted funding approach to ensure development of products and services that address local health needs
• Improve public health infrastructure and/or give incentives to private firms to develop innovative distribution strategies

The findings of this survey will be of interest to biotech firms across the globe seeking partnerships with Indian firms, venture capitalists seeking investment opportunities, foundations interested in global health solutions and developing world governments seeking ideas about successful innovation strategies.

SPECIAL SUPPLEMENT

BOSTONMay 6-9, 2007
BIOPHARMA SECTOR IN THE COUNTRY

India: A New Hub for Clinical Research

Large, diverse and therapy-naïve population with varying gene pool

Low trial cost per unit patient

Suitable legislation in place

Clinical research extended to chronic diseases (e.g cardio, nephro, neuro, joints, reproduction etc.)

World Class Clinical Research Training and Translational Centres

Large number of CROs for initiating collaborative multinational trials

Clinical trial units coming up in medical colleges and pharma units