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Critics indicate flaws in India's new vaccine policy

T. V. Padma

1 September 2011 | EN

India has released a new vaccine policy

Jim Gathany / CDC

[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.

Comments (3)

Dr. Rajinder Singh ( India )

2 September 2011

This is absolutely rubbish! The Vaccine Policy does not state that new vaccines can be introduced without being “proven for need, safety, efficacy and suitability”. For the non-initiated, kindly refer to Section 5 of the Vaccine Policy (dated April 2011) and specifically section 5.1.2 which states the criteria for selection of vaccines for introduction which includes Disease burden (need), Safety and efficacy of the vaccine, affordability and financial sustainability of the vaccination program, Program capacity, production capacity and cost effectiveness of the vaccination program. It seems Madhavi Yennapu has really not done her homework well.

The vaccine Policy of the country will look at dealing with vaccines, immunisation and vaccine related issues. It will not address ‘water and sanitation’ issues in the policy since they are not related. Hence it is rather impractical for Ritu Priya Mehrotra to expect the Vaccine Policy to “holistically address multi-causal diseases”. Nowhere in the Vaccine Policy does it mention that all other interventions should stop since vaccine for one particular disease has been introduced into the system. A comprehensive approach for disease management must be adopted but that does not undermine the need for new vaccines in the system, which have been proven world over (including our neighboring countries like Bangladesh, Sri Lanka and Pakistan) to protect lives.
Without vaccines, could all these anti-vaccine propagandists ever imagine a polio-free and smallpox-free future?

Saleem Shaikh ( Pakistan )

2 September 2011

Very interesting story. Provides a lot of information about the thrust of new vaccine policy of India. Amazing to learn that 'India supplies an estimated 43 percent 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'.

N. Raghuram ( School of Biotechnology, GGS Indraprastha University, New Delhi | India )

7 September 2011

The article raises some very pertinent issues. Rajinder Singh is missing the moot point that the policy document is putting the cart before the horse by first endorsing a lot of new vaccines in the preamble and giving the criteria as "guidelines" later, which are not mandatory anyway. Indeed, as mentioned in the article, the policy document sees such criteria as "hurdles" in the introduction of new vaccines! The main text of the policy even makes grossly unscientific and misleading statements like calling an anti-rotaviral vaccine as a diarrhea vaccine and an anti-pneumococcal vaccine as a pneumonia vaccine etc., even though these diseases can happen due to many different pathogens, and even many more strains of rotaviruses or pneumococci than these vaccines can protect. This kind of statements create a conflict between the policy intent (stated or implied) in the preamble, and the guidelines mentioned in the end. One has to be very very crystal clear as to whether the primary intent is to protect the children or to promote the vaccines.

Such polices come up mainly because scientists and doctors making policies don't care for the basics of public health, and public health or policy experts are never involved in such policymaking. What is worse, any suggestions for more rational and evidence based vaccination is seen as anti-vaccine propaganda. Only a pro-vaccine lobby can have such blinkers. Otherwise, does Rajinder Singh or others who are enamoured by this new policy have an answer as to why we haven't eradicated polio in the Hindi belt, even though we ridiculously give many dozens of OPV doses per child? How about vaccine induced paralytic polio, which is cleverly called as vaccine-associated? Isn't it well known that OPV never works on the strains that cause polio in the Hindi belt? Is this a reflection of committment to polio eradication or OPV promotion?
No policy is better than bad policy.

N. Raghuram, Faculty of Biotech, bioethics & biosafety, GGSIPU

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