Experts contest new vaccine policy document

Thursday 15 September 2011

Say they were not consulted

A document on the National Vaccine Policy, 2011, released in August by the Union health ministry has come under the scrutiny of public health experts. The new policy, they say, is a one-man’s job and drafted in favour of private vaccine manufacturing companies.



The document lays down policy guidelines for evidence-based research and introduction of vaccines in the Universal Immunisation Programme (UIP) in India. N K Ganguly, former director general of Indian Council of Medical Research (ICMR), was asked to prepare a draft policy by National Technical Advisory Group on Immumisation (NTAGI)--a group of experts from vaccination and immunisation fields under the Union ministry for health in 2010. Once drafted, the policy was to be opened for comments from public health experts. But they were never consulted, they say.

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The minutes of the NTAGI meeting held with the health ministry on August 23, 2010, states that the task of drafting the national vaccine policy was handed to Ganguly. It committed that the policy document prepared by Ganguly will be circulated for comments before the final draft is discussed in the NTAGI meeting.

“The government took such an important policy decision, which involves huge funds, without the approval of the Cabinet or the Parliament,” says Jacob Puliyel, a Delhi-based paediatrician and member of NTAGI.

“There was no attempt to make it a collective exercise despite protests. The draft is a Ganguly draft,” say Y Madhavi and N Raghuram in a note to Down To Earth. Madhavi from National Institute of Science, Technology and Development Studies in New Delhi and Raghuram from School of Biotechnology, Indraprastha University, Delhi alongwith other experts had prepared a draft on the policy which was rejected by the health ministry. “The Ganguly draft was suddenly released in July (though dated April, 2011) as the official government policy in a five-star hotel function, without further validation through the NTAGI, ministry, Cabinet or the Parliament,” they add.

Ganguly refutes the claim. “The draft was reviewed by the government agencies involved. From there it went to the health ministry for approval and later sent to the UN bodies for their comments. It is definitely not drafted by one person.”

Ajay Khera, deputy commissioner, child health and immunisation at the health ministry clarifies that the expert team was consulted a number of times during the drafting procedure and the ministry tried to incorporate whatever comments were made. He adds there is no need to go to the Parliament for any approvals. “The health ministry has the expertise to take such decisions,” he says.

The work on the draft policy was initiated in response to a Supreme Court order in February 2009 asking for revival of the public sector vaccine units and formulation of a national vaccine policy based on scientific evidence.

Procurement under scanner

Other than lack of transparency in the drafting method, the policy also promotes certain contentious procedures for procurement. For one, the policy says it should be “mandatory for the government to support advance market commitments and honour the commitments”. It also adds that the government should have an “innovative funding mechanism”.

This means that the government will request a vaccine manufacturing company to produce vaccines needed for the country’s immunisation programme. Once committed, the country cannot withdraw from the deal and will have to purchase the vaccines from that company itself, no matter what. Global Alliance for Vaccines and Immunisation (GAVI), an organisation of vaccine manufacturers, the Bill and Melinda Gates Foundation and the World Health Organization, say on their website that “these commitments provide vaccine makers with incentives to invest in manufacturing plants needed to develop vaccines and produce them on a large scale. Developing countries can then purchase the vaccines at guaranteed prices they can afford.”

Puliyel, however, says this will be a financial burden on countries entering into such commitments. “If government enters into such commitments, it will have to first deposit the money to be given to the manufacturing companies in the World Bank even before the vaccine is manufactured. Once the vaccine is produced, the government will have to buy it even if it is not effective or if the country does not need it,” he notes.

Ganguly clarifies that the government will ask the manufacturers to make vaccines not easily available. “The government will commit to the manufacturers so that they invest in vaccine production. If governments do not commit, the company which will set up the plant exclusively for the need of the country, may sink because no one else would want that vaccine and the company would be producing it exclusively for the country which demanded it,” he says.

Both Khera and Ganguly say the government can get into such contracts with several companies at the same time and it will be flexible to move from one company to the other.

“Vaccines are not available over the counter. Their shelf life is also less. Large quantities of vaccines need to be procured for UIP and to make sure it is available, we have to make commitments so that we get the vaccine from the manufacturers,” says Khera. “This doesn’t mean we are tied up. This is just a concept. There can be several companies we can have commitments with. The shift over from one company to the other will be flexible. This is just one mechanism. The nitty-gritty of it will be worked out later,” Khera adds.

“One contract will last for a year for one programme. Once the programme is over, the government will revise the programme and select new companies. If the government wants to discontinue a particular vaccine after a year, it can easily do that,” Ganguly notes.

For placing large orders for vaccine production to the companies, the policy suggests that the government to go for innovative funding mechanism. This means that the country floats bonds and raises money from the public for paying the manufacturing companies.

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  • When the policy emerged we

    When the policy emerged we were surprised how the NTAGI could vote for such a policy. The NTAGI's internal communications reveal that it is against the introduction of the new vaccines into the Universal Immunization Program (UIP) as the incidence of the diseases are low in India and the vaccines are not cost effective. In some cases the vaccines have raised public health concerns in countries where they have been introduced. Also we do not understand the politics behind renaming the UIP into the National Immunisation Program (NIP). Interestingly the IAP which has included all vaccines available into its immunisation schedule had asked for just this! Does this mean that the health ministry gives a nod to the IAP immunisation schedule? The IAP is known to represent the vaccine industry, more international than national. The question now is who is responsible for the safety of the health of our children? If not the health ministry and not the IAP then who? Should the judiciary step in here? We suggest that it should.

    Posted by: Anonymous | 7 years ago | Reply
  • The Government of India in

    The Government of India in its National Vaccine Policy to go the PPP way and ignoring the huge conflicts of interests, is a matter of concern. The National Vaccine Policy projected to push newer vaccines, the position stated making it, ÔÇ£ÔǪmandatory for Government to support developments with Advance Market Commitments and honor the commitmentsÔǪÔǪand setting up a Vaccine Fund through ÔÇÿinnovative financing mechanismsÔÇÖÔǪÔǪ.., for introducing new vaccinesÔǪÔÇØ This clearly makes the Government of India's commitment clear to the vaccine manufacturers without having any mechanism what so ever to identify or manage conflicts of interests. CAn GOI make an attempt to provide its people with a policy to manage conflict of interest before taking such public health decisions?

    What makes GOI go for not so effective vaccines in public system while it is yet to make a time bound promise to complete 100 % coverage of the agreed primary vaccines .

    The story reveals that the NTAGI is more inclined to get comments from the UN and not its own people while UN is at the receiving end of criticism to perpetuate conflict of interests. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)61463-3/fulltext It is therefore important for the GOI to begin a process of consultation in various parts of India and bring what is in peoples's interest.

    Arun Gupta

    Posted by: Anonymous | 7 years ago | Reply
  • It is a shame that the voice

    It is a shame that the voice of people are totally ignored and dangerous medicines and so called nutritious foods" are being thrust upon unsuspecting public in the name of development.

    Today the medical vaccines are not different to the anti virus programs you get for computers. The virus and the anti virus are created by one and the same company !

    Why have the basics - safe drinking water and good sanitation not provided across the globe to reduce incidence of infections and the consequences of repeated infections? Instead the focus is on pushing vaccines and the much hyped manufactured nutritious foods and food fortification! The reason is if you promote and provide safe drinking water, good sanitation and wholesome organic fruits and vegetables and non genetically modified foods, then pharma and food manufacturers will go out of business ! They are no different from drug barons and the mafia.

    Posted by: Anonymous | 7 years ago | Reply
  • Dear Editor, This is really

    Dear Editor,

    This is really an eye opener how government of India is proceeding to acquire interventions, utility of which is still to be established for the country. There is a push for such technologies as newer vaccines by vaccine manufacturers and capital philanthropists.

    JP Dadhich

    Posted by: Anonymous | 7 years ago | Reply
  • Good

    Good

    Posted by: Anonymous | 7 years ago | Reply
  • the concept of immunizing a

    the concept of immunizing a child requires overall scientific review.it may sound foolish but I firmly believe that most of the newer vaccines recommended by IAP is a pure pure business. A vaccine purchased by a doctor for, individual has to pay 1,500 to 2,000 rupees.
    the concept of giving multiple vaccine in one is not very desirable, it only fools the parents to pay more. the idea of giving giving option for 'painless' and 'painful'Triple Antigen is another trick of making money.
    if a baby is given many vaccines for so many diseases, may make the immune system stressed and may lead to its failure. i feel that the vaccines against Rota virus, typhoid, H influenzae , S pneumonae are not essential.
    The govt should seriously think about a control regarding cost fixed erratically by individual doctor. To many doctors vaccination is the most profitable business.
    The existing National schedule with added Hepatitis B MMR IS SUFFICIENT for children and government should try to implement 100% coverage with this schedule.
    A serious thought should be considered to keep vigilance in the field of vaccination by the private sector

    Posted by: Anonymous | 7 years ago | Reply
  • Well, the govt. had once

    Well, the govt. had once again decided to go pro industry way. The unfortunate part is after accruing tha capacity of sending unmanned vehicle to space and sending space crafts to moon we are still thinking of buying the "the needed " vaccines.
    We need to look in the issue from the very basis.We need a living condition that would not need vaccines. But that would be detrimental to the interest of the Pharma industries.

    Indian Govt. should not be run by Gates and Cos. but it is a distant dream at present.

    Posted by: Anonymous | 7 years ago | Reply
  • This article clearly

    This article clearly showcases the intent of the government to foster the health of vaccine manufacturers rather than of the children of India.

    the sad thing is that the PNEUMOCOCCAL AMC ANNUAL REPORT ÔÇô 1 APRIL 2010 TO 31 MARCH 2011 on P. 16 that itself admits that the vaccine may not be effective in the countries where GAVI is trying to push it. "The epidemiology in GAVI-eligible countries may be different from the one in developed countries. It is too early to say if the conclusions from the studies conducted in Western countries will apply to GAVI-eligible countries."

    Thus this exercise is almost turning Indian children into guinea pigs for a vaccine manufacturer, with WHO monitoring "this issue in the future years through further analysis on the impact of pneumococcal vaccines" - once again on P. 16 of the PNEUMOCOCCAL AMC ANNUAL REPORT - 1 APRIL 2010 TO 31 MARCH 2011.

    A second point that is often forgotten is that the initial price fixed in the AMC to be paid by GAVI/countries guarantees vaccine makers a price to match corporate revenues and profits in affluent markets. Given that GAVI will fund only for five years and that in decreasing amounts (from 80% in the first year with a reduction of 20% each year), India has committed itself to procuring a costly but useless vaccine in the name of its children. Jai Ho!!!



    Posted by: Anonymous | 7 years ago | Reply
  • Amazing! A country that

    Amazing! A country that cannot universalize its current immunization programme is now taking this useless new vaccine on. This makes clear the governmentÔÇÖs intent to foster the health of the vaccine industry rather than of its children.
    In fact, it is making guinea pigs of the children, because GAVI admits that the effect of the vaccine in not known in children in developing countries. PNEUMOCOCCAL AMC ANNUAL REPORT ÔÇô 1 APRIL 2010 TO 31 MARCH 2011 on page 16 states: ÔÇ£The epidemiology in GAVI-eligible countries may be different from the one in developed countries. It is too early to say if the conclusions from the studies conducted in Western countries will apply to GAVI-eligible countries. WHO will continue to monitor this issue in the future years through further analysis on the impact of pneumococcal vaccines.ÔÇØ

    What is often not known to readers is that the AMC strategy of GAVI is to guarantee to vaccine manufacturers an initial purchase price to match corporate revenues and profits in affluent markets. So India is not just making its children guinea pigs, but paying a high price for this. Jai Ho!!!

    Posted by: Anonymous | 7 years ago | Reply
  • Yes this is the reason. Full

    Yes this is the reason. Full faith not only on US science and also on the US way of decision making - profit for the corporates @ cost of peoples health.
    Please read the link below

    http://www.tsr.net.co/profiles/blogs/full-faith-in-us-science

    R.Selvam

    Posted by: Anonymous | 7 years ago | Reply
  • It is interesting that the

    It is interesting that the policy that has been made in response to a PIL asking for revival of public sector units, has so little to say about their revival. The policy accepts that India does not have capacity to manufacture the new vaccine to justify the involvement of the private sector. Why should'nt there be efforts to increase the capacity of these PSUs? This would also take care of the problems of advance market commitments.

    Posted by: Vibha Varshney | 2 years ago | Reply
  • There are obvious

    There are obvious contradictions in the Health Ministry's stance. Take the case of the Advanced Market Commitment (AMC). AMC's are entered into even before the vaccine is manufactured and evaluated for safety, and the commitment is for several years. But here upon being probed by the Down To Earth, the Govt says it will be for a single year! What will happen to the company manufacturing the vaccine after that? No private or public sector manufacturer will settle for a one year AMC! These AMC's involve huge funds the outcome of which is uncertain and the Indian Government will obviously not agree for such commitments. Probably this is why this policy is being surreptitiously foisted on the country without a public debate. The sooner this policy is scrapped the better. After the H1N1 vaccine scam the public confidence on the WHO has been hit, similarly the HPV vaccine fiasco made us loose confidence on the ICMR, at that time headed by none other than this very Dr N K Ganguly who has dictatorially drafted this vaccine policy. Let the Health Ministry not do anything foolish that will stain its reputation on matters of vaccines, an issue where the lives and health of millions of innocent Indian children is being carelessly compromised.

    Posted by: Anonymous | 7 years ago | Reply
  • There should be an Public

    There should be an Public Interest litigation.
    The govt cannot cheat the all the people of India.
    These are the ill effects of liberalization and
    should be nipped at the bud.
    Many Aricles need to be published in national news papers too.
    This is a shameless govt.
    murthypgk

    Posted by: Anonymous | 7 years ago | Reply
  • Please contact & involve the

    Please contact & involve the experts to formulate the Vaccination Policy.
    The Policy adopted is wrong & should not be formulated for whole Nation.

    Posted by: Anonymous | 7 years ago | Reply
  • Personally, I feel that the

    Personally, I feel that the supply of the vaccines that are at present available should be strengthened.There are times when children have to be turned away from the clinic/ health centre as one or other vaccine is not available. This causes a lot of distress to the patient and even more embarrasment to the health-care provider. Moreover how many more vaccines do we need? Not all the diseases that they are immunised against are "killer diseases".Appropriate diet and health care will reduce the virulence of many of these diseases.
    In the developed countries the immunisation schedule is much shorter. They live in a cleaner environment with cleaner food and water than we do. The health of the children and execution of the health care facilities are also better. Perhaps we should be more vigilent about these.
    I wonder if we should study the immunological system after vaccination to see what changes it brings about.
    After eliminating Smallpox (necessary, no doubt)have we replaced it with HIV/AIDS? Just a thought. After all "Nature abhors vaccum".

    Posted by: Anonymous | 7 years ago | Reply
  • There should be relevant

    There should be relevant studies to show incidence as well as efficacy in Indian conditions. Then and only then can we decide. We are used to acting , failing reacting and then investigating(thru commissions) our so called development procedures. Haste will definetly make waste!

    Posted by: Anonymous | 7 years ago | Reply
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