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India: Biotech world innovator and competitor

Researcher: It isn't a question of if, but when drug product breakthroughs will start arriving from India

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India’s health biotech firms are emerging as a major global player, with growing means and know-how to produce innovative as well as generic drugs and vaccines at costs small relative to those of giant Western firms, according to ground-breaking Canadian research published April 9.

The budding of an innovative Indian biotech sector holds major implications for the global industry and for improving both health and prosperity in the developing world.

“India is innovating its way out of poverty,” says co-author Peter A. Singer, MD, of the McLaughlin-Rotman Centre for Global Health (University Health Network and University of Toronto). “With a massive and increasingly well-educated workforce, India is poised to revolutionize biotechnology just as it did the information technology industry.

“India’s biotech sector is like a baby elephant – when it matures, it will occupy a lot of space. The biotech industry is globalizing rapidly and the impact of India’s market entry and contribution to improving world health is potentially huge.”

However, Singer and co-authors Abdallah S. Daar, MD, Sarah E. Frew, PhD, Monali Ray, Rahim Rezaie and Stephen M. Sammut, MBA, warn that the allure of world market profits may divert much needed Indian research attention away from treatments for specific developing country illnesses, unlikely to be created by Western-based firms. “India needs to take steps to avert this outcome,” they say.

Published April 9 by Nature Biotechnology, the authors say their study of 21 home-grown firms sheds unprecedented public light on India’s private sector biotech efforts and reports “a sector preparing not only for future growth but also, in some cases, for developing innovative products for global markets.”

It is the first known “detailed, independent, publicly available research” revealing product development capabilities and strategies used by India’s private firms to survive and grow amid developing country challenges.

It also recommends ways India and others in the developing world can help domestic biotech firms succeed.

The paper helps set the stage for a Toronto conference May 2-4 at which 20 to 30 North American biotech firms will convene with more than 25 similar firms from India, China, Brazil and Africa – thought to be the biggest-ever assembly of emerging market biotech companies. The goal: to encourage more biotech success and innovation in developing countries and North-South as well as South-South partnerships to address pressing global health problems.

Impacts on drug prices already felt

According to the paper: “The global market for … generic biopharmaceuticals is expected to increase significantly in the next few years as several ‘blockbuster’ drugs lose patent protection. Indian companies appear well positioned to leverage their cost-effective manufacturing capabilities to corner some of this market share and compete on a global scale.”

The paper says the 1997 launch of hepatitis B vaccine Shanvac-B, developed by Shantha Biotechnics of Hyperabad, helped cause a 30-fold domestic price reduction – from about $15 for a comparable imported product to roughly $0.50 – and credits Shantha’s innovative, efficient manufacturing process and well as subsequent local competition.

Shantha today supplies nearly 40 percent of the UN Children’s Fund’s (UNICEF) global Hep-B vaccine supplies, distributed in Africa, Latin America and elsewhere. Says Dr. Singer: “Think about the impact on health of supplying all that vaccine to UNICEF at those prices.”

Shantha also priced its recombinant interferon alpha (IFN-á) product Shanferon at about $6.50, undercutting the previous market price for a comparable imported drug by 75 percent.

The Serum Institute of India (Pune), meanwhile, has become the country’s largest domestic vaccine supplier and exporter, its products reaching 138 coun

Filed under india, biotechnology, Asia
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