Public Interest Petition (PIL) Vaccine case 3rd affidavit and Delhi High Court order of 15/9/10

Prashant Bhushan on behalf of petitioners


Writ Petition (Civil) No. 13698 Of 2009





I, Dr. Jacob M Puliyel S/o Late Shri P. M. Mammen Head, Dept. of Pediatrics, St. Stephans Hospital, Tis Hazari, New Delhi-110054, do hereby solemnly state and affirm as under:

1. That I am the Petitioner No. 8 in the above writ petition and being conversant with the facts and circumstances of the case, am competent to swear this Affidavit.

2. Petitioners (who are generally pro-vaccines and pro-vaccination/immunization) have filed the above writ petition highlighting how in the absence of a rational evidence-based vaccine policy, newer and newer vaccines of questionable efficacy and of huge costs are being pushed into the public health system at the behest of pharmaceutical industry and international bodies like World Health Organization (WHO). Petitioners have specifically challenged the proposed introduction of Pneumococcal, Hepatitis B, Hib and Pentavalent vaccines into the country’s Universal Immunization Programme (UIP). The above writ petition has highlighted the serious short-comings in the present regulatory system wherein, for instance, a vaccine was recommended for introduction in the UIP which was not even available and was recommended without any tests or epidemiological study.

3. Government’s own draft Multi-Year Strategic Plan 2010-2017 states the following as regards to the principles to guide the addition of new vaccines:
a) There should be sufficient disease burden to warrant introduction of the vaccine into the national programme.
b) The vaccine available should be effective.
c) The vaccine available should be safe.
d) The cost of the vaccine should be judged reasonable and suitable for absorption into the budget provision, even if the initial introduction is funded.
Copies of the relevant pages of the said plan are annexed as Annexure P1. But this is still a draft and so far no policy has been formulated by the Government on immunization and vaccines.

4. Yet the Government plans to introduce the Hib vaccine in the form of the Pentavalent vaccine (DPT + Hepatitis B + Hib) violating each one of the above basic principles as is shown in the petition, petitioner’s interim application, petitioner’s rejoinder and is shown below.

5. Numerous studies have been done to prove the vaccine is needed in Asia and India and each has proved the opposite. The studies have been summarized in an Editorial in the Indian Journal of Medical Research (IJMR). The said editorial is annexed as Annexure P2.

6. The vaccine recipients were no better off than those who received the placebo. This was discussed in the British Medical Journal and in the IJMR. The relevant page of BMJ is annexed as Annexure P3.

7. More importantly the same Pentavalent vaccine was used in Sri Lanka in 2008 and was withdrawn after 5 deaths. It was used in Bhutan in July 2009 and withdrawn after 8 deaths. It was used in Pakistan and it killed 3 children – one healthy infant within 30 minutes of getting the vaccine. Under pressure from the WHO the vaccine has been reintroduced in Pakistan and Sri Lanka but not in Bhutan.

8. Government produced a document to the Court to say the vaccine was unrelated to the Sri Lankan deaths. Now, after a farce of a re-examination, a core committee has again recommended the vaccine. The document that was produced to the court (to show the vaccine was not related to the deaths) actually shows the deaths were probably related to the vaccine but the WHO changed its classification of adverse effects and removed the category "probably related to vaccine". The story came out in the British Medical Journal (Annexure P4), Down to Earth (Annexure P5) and Tehelka (Annexure P6). The DG ICMR has told Down to Earth that they did not know the classification was changed by WHO when they made the recommendation to introduce the vaccine. Thus the Core committee recommended the vaccine even without reading the WHO committee report carefully. This issue also came up in Parliament that the Core Committee did not exercise due diligence when it recommended the vaccine. Relevant pages of the Parliamentary Debate are annexed as Annexure P7.

9. Recently the Advisory body (National Technical Advisory Group on Immunization or NTAGI) met again and recommended the introduction of Pentavalent in 2 states in spite of the call by some members (including Petitioner No. 8) that it would be negligent on the part of NTAGI to recommend the vaccine without even looking at the full report on the adverse effects of the vaccine and deaths.

10. At present 50% of our population do not get the basic vaccines which cost Rs 30 altogether. Yet the NTAGI under the clear influence of international agencies and other vested interests have recommended a Pentavalent vaccine (combining the DPT that costs Rs 5/per dose with Hib and Hepatitis B vaccine) be introduced in India, that by itself costs Rs 350 per child. In effect the cost of DPT will jump from Rs 15 (three doses) to Rs 350.

11. The Government has not drafted a policy on immunization in spite of the Courts directive. If there is such a policy, it may become impossible to introduce the expensive and irrational vaccines on the prompting of vested interests. The Government says it will study impact of the vaccine components Hib and Hepatitis B. If it wants to do such an impact study it may study the vaccines given separately. The Government must be restrained from introducing the Pentavalent vaccine till the reports of the deaths in Pakistan and Bhutan can be examined by the court. The NTAGI minutes talk about starting an insurance scheme for vaccine deaths. This is no substitute. Lives cannot adequately be compensated with money. The Government must report the results of the impact studies to the court before roll out to the country. Only the separate vaccines Hib and Hep B may be allowed to be used (without combining it with essential EPI vaccines of DPT) till vaccine side effects reports from Pakistan and Bhutan are available.


I, the deponent above-named, do hereby verify that the contents of the above affidavit are true to my knowledge, no part of it is false and nothing material has been concealed therefrom.
Verified at New Delhi on 13th day of September 2010.

Annexure 1
Multiyear Plan

Strategic Area 5:
Accelerated introduction of licensed new and underutilized vaccines against diseases with the significant mortality and morbidity in the country
The last two decades have seen a number of new vaccines becoming available in the global market. These vaccines have also been introduced in the National Immunization Programs of almost all developed and majority of the developing nations. As part of cMYP, the choice of newer vaccines to be included in the UIP will be determined and periodically reviewed by the MoHFW, taking guidance from the NTAGI. The institutional mechanism for clinical and operational studies for newer vaccines will be encouraged to provide inputs for NTAGI. These studies will provide evidence for decisions on the timing and selection of new vaccine introduction and provide guidelines for the use of these new vaccines. Such analysis will include the major mortality-causing diseases of children in India, namely acute diarrhoeal diseases and acute respiratory diseases etc. The disease burden and health economic analyses will help assess the cost–benefit ratios of new vaccine introduction. Specific recommendations of the NTAGI on the introduction of new vaccines have been taken into account to develop this goal.
Principles to guide the addition of new vaccines:
1. There should be sufficient disease burden to warrant introduction of the vaccine into the national programme.
2. The vaccine available should be safe and effective.
3. The cost of the vaccine should be judged reasonable and suitable for absorption into the budget provision, even if the initial introduction is funded.
4. Financial sustainability should be built into the plan of new vaccine introduction.
To ensure that institutional mechanisms are in place to adequately obtain, review and utilize information for deciding on the introduction of new and underutilized vaccines
• Number of burden of disease studies ongoing or completed on newer vaccines
• Number of states having established and expanded the surveillance facilities for the potentially new vaccines
• Availability of clear policy guidelines for new vaccine introduction

• A technical group for new vaccine review is established with functional links with the GoI and research institutes.
• The NTAGI has subcommittees on new vaccine being considered for UIP in India.
• A research sub-committee on newer vaccines is formed.
• A new vaccine focal point is established at the national level.
• National Immunization Policy is in place and available.

1. Enabling institutional mechanisms: The introduction of new vaccines involves reviewing all licensed vaccines in different global regions and identifying those that would be relevant to India in the context of the country’s disease profile. There are vaccines that are popular in the private market, and those that are recommended by the Indian Academy of Pediatrics. Accurate information on which to base the decision of introducing a new vaccine to the UIP requires periodic review by all agencies concerned. This process requires strong coordination and collaboration. There are three main agencies, concerned with the introduction of new vaccines in India:
o National Technical Advisory Group on Immunization (NTAGI)
o Indian Council of Medical Research (ICMR)
o Central drug Standard Control organization (erstwhile, called office of the Drug Controller General of India)

The development partners (WHO, WHO/NPSP, UNICEF, USAID) technically support these agencies in carrying out the responsibilities assigned. A technical group for new vaccine review will be established with members from three agencies and development partners. This technical group will have the mandate to advise the GoI on:
o Designing and drafting the National Immunization Policy for the GoI
o Defining policies on vaccine use against typhoid, Varicella, Japanese encephalitis, Hepatitis A, Human Papilloma Virus Vaccine; both within and outside the UIP
o Coordination of studies on disease burden, vaccine efficacy trials and health economic issues of new vaccine introduction (with special focus on the Hib and Pneumococcal vaccine).
o Together with academic institutes review new immunization technologies and research as appropriate to the Indian context.

2. Strengthening the country capacity to assess the disease burden and analyze cost effectiveness: An appropriate mechanism will be devised to assess the burden of diseases, for which the vaccines are becoming available and/or are expected to be available in the near future. The capacity will also be built to assess the cost effectiveness of new vaccines and technologies by the standard tools available.
3. Assisting the country decision making: build upon an evidence base of country experiences and methodology, the partners will assist the government in informed decision making for the introduction of new vaccines. The exiting global tools and information on the decision making process for the introduction of new vaccine will be utilized, as appropriate.
4. Integrate the introduction of new vaccines: The efforts will be made to integrate the introduction of new vaccines in UIP, by addressing this issue in cMYP and by providing financial analysis for the same.
5. Better coordination and collaboration: The need for a formal mechanism of coordination and collaboration between governmental agencies and development partners was urgently required to establish closer links, pool resources more efficiently, plan research more effectively and share results of studies more freely. The IHSCC, which has a representation from different government organizations, ministries and development partners, will plays this role in India.

Annexure 2
Indian J Med Res. 2010 Jul;132:1-3.
Introducing pentavalent vaccine in the EPI in India: a counsel for caution.
Lone Z, Puliyel JM.

Annexure 3
GAVI (Global Alliance for Vaccines and Immunisation) and WHO. Demanding accountability.
Puliyel JM.
BMJ. 2010 Aug 4;341:c4081. doi: 10.1136/bmj.c4081.

Incomplete reporting of research in press releases: et tu, WHO?
Puliyel J, Mathew JL, Priya R.
Indian J Med Res. 2010 Apr;131:588-9.

Annexure 4
Probably related to vaccine
Report submitted by ICMR on Pentavalent deaths

Down To Earth • July 16-31, 2010
Officials push five-in-one vaccine
Pentavalent vaccine linked to child deaths in Sri Lanka, Bhutan; ball in high court

From Tehelka Magazine, Vol 7, Issue 24, Dated June 19, 2010
More Than A Pinprick

Annexure 5


SHRIMATI BRINDA KARAT (WEST BENGAL): Sir, even as the Javed Choudhury Report on the closure of the three P.S.U. vaccine producing units exposes the deeply compromised process behind the closures, comes a fresh warning on the vaccine issue. Fifty per cent of India's children do not receive the three doses of the triple vaccine against diphtheria, whooping cough and tetanus that costs Rs.7.50 per child, leading to many deaths. An Expert Committee has now suggested that a new vaccine produced by MNC pharma companies that costs Rs.525 per child replace DPT vaccine. Other experts have argued that the incidence of the two additional diseases to be covered, namely, HIB and Hepatitis- B, is not high enough to warrant change of vaccine. Cost is not the only factor. The vaccine meant to save lives has been associated with infant deaths in neighbouring countries of Sri Lanka, Pakistan and Bhutan. The investigation being done on the deaths by the prestigious British Medical Journal also implicates W.H.O. officials in the cover-up. W.H.O., it is alleged, may have changed classifications of safety of vaccines to suit the interests of companies. Why did the Indian Expert Committee, which has admitted that it did not know that the deaths in the neighbouring countries were probably related to the vaccine, not exercise due diligence in understanding the reasons for the deaths before recommending this vaccine? Their flawed report must be withdrawn. The Government must exercise caution on introduction of vaccines and prevent manipulation of our immunization system by powerful pharma lobbies.


W.P.(C) 13698/2009 and CM APPL. 1663/2010

DR. K. B SAXENA and ORS ..... Petitioners
Through: Mr. Prashant Bhushan, Advocate with
Mr.Pranav Sachdeva, Ms. Poulami
Putatunda and Ms. Pyoli Swatija,


UNION OF INDIA and ORS ..... Respondents
Through: Mr. A.S. Chandhiok, ASG with
Ms. Maneesha Dhir, Ms. Preeti
Dalal, Mr. Sandeep Bajaj and
Mr. K.P.S. Kohli, Advocates for
respondents No.1 and 2.
Mr. V.K. Rao, Senior Advocate with
Ms. Neha Bhatnagar, Advocate for R-3.


Heard Mr. Prashant Bhushan, learned counsel for the appellant
and Mr. A.S. Chandhiok, learned ASG for the Union of India.
In the course of hearing of this petition, it was submitted by Mr.
A.S. Chandhiok, learned ASG that a high level committee has been
constituted to formulate a comprehensive vaccination policy.

W.P.(C) 13698/2009 page 1
of 2.

At this juncture, Mr. Prashant Bhushan submitted
that the
committee has to keep in view the four vital aspects namely:-
(i) Incidents of disease in India and its effect potentiality,

(ii) the efficacy of the vaccine to prevent the disease as prevention is better
than cure,
(iii) the side effects of the vaccine, the nature of adverse side effects and
the approximate statistics of the persons who are likely to be effected by such
side effects and
(iv) the costs factor.

Quite apart from the above, it is submitted by Mr. Prashant
Bhushan that there is a universal immunization programme under which
certain new vaccines are likely to be introduced without doing the relevant
scientific studies thereof.
The said aspect shall be adverted to and deliberated upon as per
law on the next date of hearing.
List the matter on 08th December, 2010.


SEPTEMBER 15, 2010

W.P.(C) 13698/2009 page 2