BERLIN: India’s pharmaceutical companies are gearing up to become a major global player, not only in producing low-price generic medicines but also as innovators in drugs and vaccines, according to a study.
 “India is innovating its way out of poverty,” said Nature Technology study co-author Peter Singer of the McLaughlin-Rotman Centre for Global Health in Toronto.
The McLaughlin-Rotman Centre for Global Health is a major new initiative in the ID Division is the McLaughlin-Rotman Centre for Global Health (MRC).
India could revolutionise biotechnology on the basis of its large and increasingly well-educated workforce, just as it did information technology, Singer believes.
The costs are considerably lower for companies operating in India, the study published in the April 9 issue of the journal says, citing as an example the way launch of an Indian hepatitis B vaccine cut prices to one-thirtieth.
“The biotech industry is globalising rapidly,” Singer said, adding that the world market for generics was expected to increase significantly in the next few years as several major drugs lost patent protection.
India is well placed to take advantage of this, according to the study that looked at 21 Indian firms.
“India’s biotech sector is like a baby elephant – when it matures, it will occupy a lot of space. The biotech industry is globalising rapidly and the impact of India’s market entry and contribution to improving world health is potentially huge.”
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.
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% 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-?) product Shanferon at about $6.50, undercutting the previous market price for a comparable imported drug by 75%. 
“If the above 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,” according to the paper.
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.
Some such agencies are the US Food and Drug Administration (FDA), European Medicines Agency (EMEA) and the World Health Organization (WHO), to facilitate access to international markets not only for biogenerics but also novel protein products currently in their pipelines.”
“Indian companies are likely to accelerate the development of products for sale in US and European markets, particularly the biogenerics for which they have developed significant manufacturing capacity,” the paper says.
Indian firms are actively pursuing drugs to combat many medical problems, including tuberculosis, encephalitis, malaria, rotavirus, rabies, avian flu, Hepatitus-B, diabetes, cancer, heart disease, cholera, HIV-HCV, tetanus, meningitis, measles and anemia.
The study was published ahead of a conference in Toronto May 2-4 of biotech firms from the US, Canada, India, China, Brazil and Africa. – Agencies