India's biotech industry emerging as world innovator

India's biotech industry emerging as world innovator

Monday, 09 April 2007, 07:00 Hrs
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Washington: 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 lesser costs compared to giant Western companies.

The budding of an innovative Indian biotech sector holds major implications for the global industry and for improving health and prosperity in the developing world, according to a new Canadian research published.

"India is innovating its way out of poverty," says co-author Peter A. Singer of the McLaughlin-Rotman Centre for Global Health, University of Toronto. "With a massive and increasingly well-educated workforce, India is poised to revolutionise biotechnology just as it did the IT industry," he added.

"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, Sarah E. Frew, Monali Ray, Rahim Rezaie and Stephen M. Sammut warn that the lure 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 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 20-30 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.

Said 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 Hyderabad, helped cause a 30-fold domestic price cut - from about $15 for a comparable imported product to roughly 50 cents - and credits Shantha's innovative, efficient manufacturing process and subsequent local competition.

Shantha today supplies nearly 40 percent of the UN Children's Fund's (UNICEF) global Hepatitis-B vaccine supplies, distributed in Africa, Latin America and elsewhere.

Citing several other examples of a surging Indian health biotech industry, the paper says if this "trend continues, the cost of biopharmaceuticals produced by both domestic and overseas suppliers will continue to decrease as more domestic companies manufacture these products locally".

It says many Indian firms are scaling up to manufacture such drugs as insulin and interferon, their facilities "refurbished or built in accordance with the standards of international regulatory agencies, such as the US Food and Drug Administration (FDA), European Medicines Agency (EMEA) and WHO, to facilitate access to international markets not only for bio-generics but also novel protein products currently in their pipelines.

"Indian companies are likely to accelerate the development of products for sale in the US and European markets, particularly the bio-generics for which they have developed significant manufacturing capacity," the paper says.

Notes co-author Daar: "It will be vital to the industry that Indian companies expanding their capabilities in clinical trials management pay close attention not only to good clinical practice guidelines, but also to bioethical principles, to provide a high level of care and protect the rights of patients.

"Most people think only of information technologies as the driver behind India's economic emergence but a lot of innovative research is underway in biotech and other life sciences as well," he says. "This study documents for the first time what is happening at the individual biotech company level."
Source: IANS
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