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[NEW DELHI] India's new vaccination policy stresses increased domestic research and surveillance on local diseases; but has drawn criticism for endorsing new vaccines in the national immunisation programme without ascertaining need.

The April 2011 policy, made public by India's ministry of health and family welfare in August, provides guidelines for vaccine research and development; strengthening the evidence base for new vaccine introduction and regulation and patent issues.

It highlights lack of indigenous baseline surveillance data on, and diagnostic tools for, certain vaccine preventable infectious diseases; shortage of trained human resources and limited economic evaluations as hurdles for new vaccine introduction.

India supplies an estimated 43 per cent of global vaccines and its universal immunisation programme (UIP) is among the largest in the world, targeting 27 million infants and 30 million pregnant women.

The new policy gives priority to research and the manufacture of vaccines for locally prevalent diseases such as pneumonia, diarrhoea, Japanese encephalitis, dengue, cholera, typhoid and leishmaniasis.

It also suggests that India examines best practices followed in other countries to manage 'biorepositories', or banks of biological samples collected during disease surveillance, epidemics or clinical trials for later research use.

The policy sees collective management of intellectual property rights (IPR) and open access agreements as vital in improving innovation and access; and moots creation of a new body to acquire and hold IP rights for technologies used in public health.

Some public health experts, however, have criticised the policy as blurring the lines between universal and selective immunisations; and supporting introduction of new vaccines even before generating scientific evidence for their need.

"It doesn't talk about need-based and evidence-based vaccination, and assumes that all new vaccines are good for the Indian population and should be introduced in Indian UIP," Madhavi Yennapu, scientist at the National Institute of Science, Technology and Development Studies, New Delhi, told SciDev.Net.

"New vaccines in the Indian UIP should be introduced only when proven for need, safety, efficacy and suitability in the Indian population with unambiguous scientific evidence," Yennapu said.

She was also critical of the "policy suggestion that if there is no domestic data, modelling studies and data from countries with either geographical proximity or similar demography may also be used for the decision making".

"The whole purpose of having an evidence-based policy gets defeated by such statements," she said.

Ritu Priya Mehorotra, professor at the centre for social medicine and community health, Jawaharlal Nehru University, New Delhi, said the policy relies on the "outdated and discredited" scientific rationale of a single germ being the cause of a disease, and a vaccine as the preventive tool.

Vaccines cannot holistically address multi-causal diseases such as diarrhoea where water and sanitation are involved, or those caused by multiple strains of the same microbe, she observed.