India Vaccine

REPORT NO.
72
PARLIAMENT OF INDIA
RAJYA SABHA
DEPARTMENT-RELATED PARLIAMENTARY STANDING COMMITTEE

ON HEALTH AND FAMILY WELFARE
SEVENTY SECOND REPORT
Alleged Irregularities in the Conduct of Studies using Human

Papilloma Virus (HPV) Vaccine by Path in India (Department
of Health Research, Ministry of Health and Family Welfare)
(Presented to the Rajya Sabha on 30th August, 2013)
(Laid on the Table of Lok Sabha on 30th August, 2013)
Rajya Sabha Secretariat, New Delhi

August, 2013/Bhadra, 1935 (Saka)
Website:http://rajyasabha.nic.in
E-mail:[email protected]
Hindi version of this publication is also available
PARLIAMENT OF INDIA
RAJYA SABHA
DEPARTMENT-RELATED PARLIAMENTARY STANDING COMMITTEE

ON HEALTH AND FAMILY WELFARE
SEVENTY SECOND REPORT
Alleged Irregularities in the Conduct of Studies using Human

Papilloma Virus (HPV) Vaccine by Path in India (Department
of Health Research, Ministry of Health and Family Welfare)
(Presented to the Rajya Sabha on 30th August, 2013)

(Laid on the Table of Lok Sabha on 30th August, 2013)
Rajya Sabha Secretariat, New Delhi

August, 2013/Bhadra, 1935 (Saka)
CONTENTS
P AGES
1. COMPOSITION OF THE C OMMITTEE ......................................................................................... (i)-(vi)
Composition of the Committee (2009-10) .................................................................. (i)

Composition of the Committee (2010-11) .................................................................. (ii)
Composition of the Committee (2011-12) .................................................................. (iii)-(iv)
Composition of the Committee (2012-13) .................................................................. (v)-(vi)
2. PREFACE .................................................................................................................................. (vii)-(viii)
3. ACRONYMS .............................................................................................................................. (ix)-(x)
4. R EPORT ................................................................................................................................... 1—19
(I) Background ................................................................................................................ 1—3
(II) Nature of Project ...................................................................................................... 3—4
(III) Role of Department of Health Research/ICMR .................................................... 4—7
(IV) Role of Drug Controller General of India ............................................................. 7—8
(V) Marketing Approval to HPV Vaccine in India ....................................................... 8—9
(VI) Inquiry Committee ..................................................................................................... 9—16
(a) Composition and Terms of Reference ....................................................... 9
(b) Conflict of Interest ....................................................................................... 9—10
(c) Adverse Events Reporting ............................................................................ 10
(d) Informed Consent ......................................................................................... 11—13
(e) Role of Ethics Committees .......................................................................... 13
(f) Use of Official Machinery ........................................................................... 13—14
(g) Action taken on the Inquiry Committee Report ....................................... 14—16
(VII) Programmes for Appropriate Technology in Health (PATH) .............................. 16—19
5. OBSERVATIONS/RECOMMENDATIONS — AT A GLANCE .......................................................... 20—24
6. MINUTES ................................................................................................................................. 25—34
7. ANNEXURES ............................................................................................................................. 35—41

COMPOSITION OF THE COMMITTEE
(2009-10)
RAJYA SABHA
1. Shri Amar Singh — Chairman
2. Shrimati Viplove Thakur
#
3. Dr. Radhakant Nayak
4. Shri Janardan Dwivedi
5. Shri Balbir Punj
6. Dr. Prabhakar Kore
7. Shrimati Brinda Karat
8. Shrimati Vasanthi Stanley
@
9. Dr. M.A.M. Ramaswamy
10. Dr. Anbumani Ramadoss
LOK SABHA
11. Shri J. M. Aaron Rashid
12. Shri Ashok Argal
13. Shrimati Sarika Devendra Singh Baghel
14. Shri Vijay Bahuguna
15. Dr. Chinta Mohan
16. Shrimati Tabassum Hasan
17. Dr. Sanjay Jaiswal
18. Shri S. R. Jeyadurai
19. Dr. (Shrimati) Kruparani Killi
20. Shri N. Kristappa
21. Dr. Tarun Mandal
22. Shri Datta Meghe
23. Dr. Jyoti Mirdha
24. Shrimati Jayshreeben Patel
25. Shri R.K. Singh Patel
26. Shri M. K Raghavan
27. Dr. Anup Kumar Saha
28. Shrimati Meena Singh
29. Dr. Arvind Kumar Sharma
30. Shri Pradeep Kumar Singh
31. Shri Ratan Singh
SECRETARIAT
Shrimati Vandana Garg, Additional Secretary
Shri R. B. Gupta, Director
Shrimati Arpana Mendiratta, Joint Director
Shri Dinesh Singh, Assistant Director
Shri Satis Mesra, Committee Officer
#
Ceased to be a Member w.e.f. 1st July, 2010.
@
Ceased to be a Member w.e.f. 30th June, 2010.
(i)
(2010-11)
RAJYA SABHA
1. Shri Brajesh Pathak — Chairman
4. Dr. Vijaylaxmi Sadho
5. Shri Balbir Punj
@
9. Shri Rasheed Masood
*
10. Shrimati B. Jayashree
LOK SABHA
14. Shrimati Tabassum Hasan
17. Dr. Kruparani Killi
18. Shri Nimmala Kristappa
SECRETARIAT
Shri R.B. Gupta, Director
Shri Satis Mesra, Committee Officer
*
Ceased to be a Member w.e.f. 18th August, 2011.
@
Nominated to the Committee w.e.f. 21 st September, 2010.
(ii)
(2011-12)
RAJYA SABHA
*
2. Shri Janardhan Dwivedi
%
5. Shri Balbir Punj
^
10. Shri Derek O'Brien
LOK SABHA
&
12. Shrimati Harsimrat Kaur Badal
@
14. Shrimati Raj Kumari Chauhan
15. Shrimati Bhavana Gawali
16. Dr. Sucharu Ranjan Haldar
17. Dr. Monazir Hassan
20. Shri P. Lingam
24. Shri Sidhant Mohapatra
25. Shrimati Jayshreeben Kanubhai Patel
29. Shri Radhe Mohan Singh
31. Dr. Kirit Premjibhai Solanki
*
ceased to be a Member w.e.f. 27th January, 2012 and re-nominated to the Committee on 2 nd February, 2012.
%
Vacant vide resignation w.e.f. 2 nd April, 2012.
^
Vacant vide resignation w.e.f. 9th March, 2012 and renominated as Member w.e.f. 04 th May, 2012.
&
ceased to be a Member w.e.f. 29th June, 2012.
@
vacant vide resignation w.e.f. 30 th April, 2012.
(iii)
(iv)
SECRETARIAT
Shrimati Vandana Garg, Joint Secretary
Shri Dinesh Singh, Deputy Director
(2012-13)
RAJYA SABHA
*3. Dr. K. Chiranjeevi
6. Shri Jagat Prakash Nadda
7. Shri Arvind Kumar Singh
&
8. Shri D. Raja
9. Shri H. K. Dua
^
11. Shri Mohd. Ali Khan
%
12. Shri Rajkumar Dhoot
LOK SABHA
@
14. Shri Kirti Azad
15. Shri Mohd. Azharuddin
17. Shri Kuvarjibhai M. Bavalia
18. Shrimati Priya Dutt
20. Mohd. Asrarul Haque
24. Shri Mahabal Mishra
25. Shri Zafar Ali Naqvi
27. Shri Harin Pathak
28. Shri Ramkishun
31. Dr. Raghuvansh Prasad Singh
32. Shri P.T. Thomas
#
33. Shri Chowdhury Mohan Jatua
*
Ceased to be Member of the Committee w.e.f. 28 th October, 2012.
&
Ceased to be Member of the Committee w.e.f. 24th July, 2013.
^
Nominated as a Member to the Committee w.e.f. 27 th August, 2013.
%
Nominated as a Member to the Committee w.e.f. 27 th August, 2013.
@
Ceased to be Member of the Committee w.e.f. 9 th January, 2013.
#
Nominated as a Member to the Committee w.e.f. 14 th December, 2012.
(v)
(vi)
SECRETARIAT
Shri P.P.K. Ramacharyulu, Joint Secretary
Shri Pratap Shenoy, Committee Officer
PREFACE
I, the Chairman of the Department-related Parliamentary Standing Committee on Health and

Family Welfare, having been authorized by the Committee to present the Report on its behalf, do
hereby present this Seventy Second Report of the Committee on the “Alleged Irregularities in the
Conduct of Studies Using Human Papilloma Virus (HPV) Vaccine” by Programme for Appropriate
Technology in Health (PATH) in India.
2. The Committee first took up the issue about the trial of HPV vaccine on the children in
Khammam district of Andhra Pradesh and Vadodra district of Gujarat and reported deaths of the
children therefrom in its meeting held on 06th April, 2010 during the course of examination of
Demands for Grants (2010-11) of Department of Health Research and sought exact status in this
regard from the Secretary, Department of Health Research. Subsequently, taking serious view of
the procedural and ethical lapses on the part of the Ministry, the Committee sought the matter of
allowing trial of the vaccine as also the approval for its marketing in the country to be enquired
into. The Committee also desired the Ministry to take further appropriate action in the matter and
apprise it of the follow-up action taken in this regard at the earliest. As a sequel to the Committee’s
recommendation, a Committee was appointed by the Government of India to enquire into”Alleged
Irregularities in the Conduct of Studies Using Human Papilloma Virus (HPV) Vaccine” by
Programme for Appropriate Technology in Health (PATH) in India on 15th April,2010. The Final
Report of the Committee appointed by the Government of India to enquire into”Alleged Irregularities
in the Conduct of Studies Using Human Papilloma Virus (HPV) Vaccine” by Programme for
Appropriate Technology in Health(PATH) in India was made on 15th February,2011.
3. The Committee thereafter deliberated on the subject in its meetings held on 25th July, 2011
th
and 24 May, 2013.
4. During the course of examination of the subject, the Committee heard the views of the
Secretary, Department of Health Research and other officials of the Department on 25th July, 2011
and Secretary, Department of Health Research and Drug Controller General of India (DCGI) on
24th May, 2013.
5. During the finalization of its Report, the Committee relied upon the following documents/
papers:–
(i) Background note received from the Ministry;
(ii) Final Report of the Committee Appointed by the Government of India to enquire
into “Alleged Irregularities in the Conduct of Studies Using Human Papilloma Virus
(HPV) Vaccine” by Programme for Appropriate Technology in Health (PATH) in India;
(iii) Oral Evidences tendered by Secretary, Department of Health Research and DCGI; and
(iv) Replies to the questionnaires received from the Department of Health Research.
6. The Committee considered the Draft Report and adopted the same in its meeting held on
29th August, 2013.
(vii)
(viii)
7. For facility of reference and convenience, observations and recommendations of the

Committee have been printed in bold letters in the body of the Report.
BRAJESH PATHAK,
NEW DELHI; Chairman,
29th August, 2013 Department-related Parliamentary Standing
Bhadra 7, 1935 (Saka) Committee on Health and Family Welfare
ACRONYMS
1. AE – Adverse Event
2. AEFI – Adverse Event Following Immunization
3. ANM – Auxiliary Nurse Midwife
4. AP – Andhra Pradesh
5. AIIMS – All India Institute of Medical Sciences
6. ASHA – Accredited Social Health Activist
7. CDSCO – Central Drugs Standard Control Organisation
8. CTRI – Clinical Trials Registry- India
9. CORT – Centre for Operations Research and Training
10. DCGI – Drug Controller General of India
11. DGHS – Director General of Health Services
12. DHR – Department of Health Research
13. DG, ICMR – Director General, Indian Council of Medical Research
14. FCRA – Foreign Currency Regulation Act
15. FERA – Foreign Exchange Regulation Act
16. FEMA – Foreign Exchange Management Act
17. GCP – Good Clinical Practice
18. GAVI – Global Alliance for Vaccines and Immunizations
19. HPV – Human Papilloma Virus
20. HMSC – Health Ministry Screening Committee
21. HoD – Head of Department
22. ICMR – Indian Council of Medical Research
23. MEA – Ministry of External Affairs
24. MHA – Ministry of Home Affairs
25. MoU – Memorandum of Understanding
26. MEA – Ministry of External Affairs
27. MHA – Ministry of Home Affairs
28. NGO – Non-Governmental Organization
29. NRHM – National Rural Health Mission
(ix)
(x)
30. NTAGI – National Technical Advisory Group on Immunization

31. O&G – Obstetrics and Gynaecology
32. PATH – Programme for Appropriate Technology in Health
33. PBC – Public Benefit Corporation
34. PPP – Public-Private Partnership
35. PSURs – Periodic Safety Update Reports
36. RoC – Registrar of Companies
37. RBI – Reserve Bank of India
38. SAE – Serious Adverse Event
39. UIP – Universal Immunization Programme
40. USFDA – United States Food and Drug Administration
41. WHO – World Health Organisation
1
REPORT
I. BACKGROUND
1.1 During March, 2010 the entire world was shocked by the media reports about the deaths
of some female children and adolescents in Khammam district of Andhra Pradesh after being
administered Human Papilloma Virus (HPV) vaccines. The vaccination trials were carried out by an
American agency viz. Programme for Appropriate Technology in Health (PATH). The project was
reportedly funded by Bill and Melinda Gates Foundation, an American charity.
1.2 Several questions were asked and concerns expressed in the media and well meaning
quarters on the role of government agencies including Indian Council of Medical Research (ICMR)
and Drugs Controller General of India (DCGI) in approving and facilitating the trials, which was
against all laws of the land and even international ethical norms and rules; misuse of government
funds, man-power, facilities and infrastructure for a private project of dubious nature; use of logo
of National Rural Health Mission (NRHM), an official programme of the Union Government during
these vaccination drives to give it respectability and official endorsement; and above all the blatant
violation by PATH of all regulatory and ethical norms laid down by the Government of India for
the purpose as also possible violations of such norms prescribed and very scrupulously enforced
in the Country of its origin viz. United States of America.
1.3 Taking cognizance of these reports, the Committee (2009-10) which was examining the
Demand for Grants (2010-11) of the Department of Health Research at that point of time sought
a detailed clarification from the Government in the matter. In response the Secretary of the
Department of Health Research and DG, ICMR informed the Committee that it was a vaccine
against the Human Papilloma Virus which causes cervical cancer in women. The Drugs Controller
General, India had given approval for marketing of HPV vaccines in India as a vaccine to be
prescribed by the clinicians as per schedule ‘Y’ of the Drugs and Cosmetics Rules and then for
a post-marketing surveillance trial. The Committee was informed that the proposal for trial came
two years earlier (though later on during the Committee’s examination it was proved that it began
in 2006) before the ICMR through PATH, an American agency, and the logic for allowing the trial
was to see acceptability of this vaccine on Indian population. Besides, these trials were approved
by the National Ethical Committee and the State Ethical Committee.
1.4 Attention of the Secretary was drawn to DCGI guidelines wherein Phase III trials cannot
be conducted on children until a similar trial was conducted on adults. It was admitted by the
Secretary that the DCGI guidelines were not adhered to in the present case but this vaccine is
given before the sexual activity begins and then it protects against cancer. That was the reason for
allowing trials on girls of the age of 10-14 years. The Committee was assured that State
Governments of Andhra Pradesh and Gujarat would be asked to get the ongoing clinical trial
stopped immediately.
1.5 Hugely perturbed by these blatant violations, the Committee in its Forty first Report on
Demands for Grants (2010-11) of the Department of Health Research made the following
recommendations on this issue:
“Taking serious view of procedural and ethical lapses on the part of the Ministry, the
Committee sought the matter of allowing trial of the vaccine as also the approval for its
marketing in the country to be enquired into by a premier investigating agency and to take
further appropriate follow-up action in the matter. It also asked that findings of the
investigating agency and the follow-up action taken in this regard may be furnished to the
1
2
Committee at the earliest. The Committee, taking a serious view in the matter, recommends
to the Department of Health Research that in future all guidelines and norms should be
adhered to before allowing trials of any drug including vaccines on Indian population. The
Committee also recommends that the DCGI should observe optimum precautions and follow
all norms and guidelines while allowing marketing of any drug including the vaccines in the
Indian market”.
1.6 The Department of Health Research in its Action Taken Note on the above recommendations
submitted the following:
“PATH in partnership with State Governments of Gujarat and Andhra Pradesh was
implementing an operational research study related to cancer of cervix prevention in India.
ICMR is providing technical support and consultation for development of protocol and plan
of monitoring.
The study utilized both the brands of HPV vaccines available in the market (Gardasil by
Merck in Andhra Pradesh; and Cervarix by GSK in Gujarat). In view of certain complaints
received, the State Governments have been advised not to carry out further vaccination till
further orders. To ascertain the facts of the matter, Minister for Health and Family Welfare
appointed a Committee comprising of Dr. S.S. Agarwal, former Director, Advanced Centre
for Training, Research, Education on Cancer, Dr. S.P. Aggarwal, former DGHS and Dr.
Sunita Mittal, HoD, Obstetrics and Gynaecology, AIIMS to investigate ethical issues raised
in the matter.”
1.7 Not being satisfied with the action taken by the Government on its Recommendations, the
Committee in its Forty eighth Report further recommended the following:
“The Committee observes that as a result of its intervention, the State Governments have
been advised by the Department not to carry out HPV vaccinations and a Committee has
been appointed to investigate ethical issues raised in the matter. The Committee is not aware
about the date of setting up of the Committee. However, the absence of any specific time-
line for submission of Report of the Committee in the Action Taken Note given by the
Department makes the Committee somewhat apprehensive. Like so many Committees set up
by the Government, findings of this Committee, as and when received, may remain on
paper only. The Committee, therefore, recommends that every effort should be made to
expedite the Report of this Committee so that real facts about the HPV Vaccine trial are
made known without any further delay and corrective measures not only in respect of this
case but for all such ongoing/proposed clinical trials of drugs/vaccines are taken. The
Committee also recommends that the Department should at least now work in close
coordination with other concerned departments/organizations to undertake a comprehensive
analysis of the process of granting permission to research studies having hazardous effects
on health and put in place a fool-proof system for pre-empting unethical research studies.”
1.8 Considering the enormity of the wrong doing/criminality involved, and the dilly-dallying
attitude of the Government in taking exemplary corrective action, the Committee took it up for
detailed examination. The succeeding paragraphs contain the details of the matter, Committee’s
findings and recommendations.
1.9 Cancer of the cervix (mouth of uterus) popularly called Cervical Cancer has been there ever
since the dawn of human race. Over the years, preventive and treatment protocols have been
developed by medical experts.
1.10 The Committee was given to understand that on June 1, 2006 the American drug regulator,
the U. S. Food and Drug Administration (USFDA) approved the first vaccine to prevent HPV virus
3
that is claimed to cause 70% of cervical cancers, under the brand name of Gardasil by a US drug
company namely, Merck.
1.11 In the very same month, an American organization called Program for Appropriate
Technology in Health (PATH) embarked upon a large scale, 5-year long (June 2006 to May 2011)
project with “the main objective …..to generate and disseminate evidence for informed public
sector introduction of HPV vaccines” in four countries, India, Uganda, Peru and Vietnam.
Interestingly these four countries have different ethnic populations: India (Indo-Aryans, Dravidians,
Tribals etc.), Uganda (Negroid), Peru (Hispanics) and Vietnam (Mongoloids). The Committee has
been given to understand that ethnicity is relevant in the determination of safety and efficacy of
some drugs. What would be of further interest, as per World Health Organization (WHO) is that
all these countries have state-funded national vaccine immunization programs, which if expanded
to include Gardasil, would mean tremendous financial benefit to the then sole manufacturer.
1.12 With this background a clinical trial under the title ‘Post-licensure observational study of
Human Papilloma Virus Vaccination – Demonstration Project’ was undertaken by Programme for
Appropriate Technology in Health (PATH), an agency of American origin. The Indian Council of
Medical Research (ICMR), which is the highest body in the Country for medical research and
related matters lent its platform to PATH in an improper and unlawful manner. The State
Governments of Andhra Pradesh and Gujarat swayed by the involvement of ICMR followed suit.
II. NATURE OF PROJECT

2.1 Given the controversy surrounding the project, the Committee was keen to know from the
Government the exact nature of the project. The Committee noticed that there was fundamental
difference between the perceptions of Drugs Controller General of India (DCGI) and Department
of Health Research (DHR)/Indian Council of Medical Research (ICMR) on the actual nature of the
project. The DCGI was of the opinion that since human subjects, as part of the research, were
receiving invasive intervention like vaccines, the clinical trial rules must be enforced. Experts also
upheld these views and were very clear about it. However, PATH described the project as an
“observational study” since “it did not conform to the definition of clinical trial”.
2.2 The Committee found from the information furnished to it that ICMR representative on the
Project Advisory Committee not only opposed DCGI but also argued that the nature of the project
does not require them to follow the clinical trial rules, including reporting of serious adverse effects
within a specific time-frame.
2.3 The Committee in this regard took note of the expert opinion given in the Inquiry
Committee report which questioned the PATH description of the project and observed that since
“the demonstration project is a study of a pharmaceutical product carried out on humans and since
the primary objectives include the study of serious adverse effects, it is clear that clinical trial rules
and guidelines should apply”.
2.4 In fact, the Inquiry Committee in one of its findings very pointedly stated that the
investigators had variously labeled the research project carried out by them as “Observational
Study/Demonstrational Study,” etc. to establish that the study was not a clinical trial. But, since
the project had been carried as research on human participants, it had to follow all the guidelines
and statutory requirements applicable for research on human participants.
2.5 The Committee finds the entire matter very intriguing and fishy. The choice of
countries and population groups; the monopolistic nature, at that point of time, of the
product being pushed; the unlimited market potential and opportunities in the universal
immunization progammes of the respective countries are all pointers to a well planned
scheme to commercially exploit a situation. Had PATH been successful in getting the HPV
4
vaccine included in the universal immunization programme of the concerned countries, this
would have generated windfall profit for the manufacturer(s) by way of automatic sale, year
after year, without any promotional or marketing expenses. It is well known that once
introduced into the immunization programme it becomes politically impossible to stop any
vaccination. To achieve this end effortlessly without going through the arduous and strictly
regulated route of clinical trials, PATH resorted to an element of subterfuge by calling the
clinical trials as “Observational Studies” or “Demonstration Project” and various such
expressions. Thus, the interest, safety and well being of subjects were completely
jeopardized by PATH by using self-determined and self-servicing nomenclature which is not
only highly deplorable but a serious breach of law of the land. The Committee is not aware
about the strategy followed by PATH in the remaining three countries viz. Uganda, Vietnam
and Peru. The Government should take up the matter with the Governments of these
countries through diplomatic channels to know the truth of the matter and take appropriate
necessary action, accordingly. The Committee would also like to be apprised of the
responses of these countries in the matter.
III. ROLE OF DEPARTMENT OF HEALTH RESEARCH/INDIAN COUNCIL OF MEDICAL

RESEARCH
3.1 One of the functions mandated to the Department of Health Research/ICMR is promotion
and coordination of basic, applied, clinical and operational research in medical, health and bio-
medical field through development of infrastructure, manpower and skills. Uniform Ethical
Guidelines for bio-medical Research on human subjects are incorporated in Good Clinical Practice
(GCP) and ICMR documents. These guidelines outline the procedure for Ethics Committees review
of clinical trials in India using the human beings as participants. All institutions and investigators
in the country which carry out any form of biomedical research involving human beings are obliged
to follow these guidelines in letter and spirit to protect participants.
3.2 As per the records made available to the Committee, the first documented contact made by
PATH with ICMR took place, as early as, on 5th October 2006. An employee of PATH India sent
an e-mail to Deputy Director of National AIDS Research Institute, ICMR expressing sorrow that
she could not travel to Seattle, United States for “Formative Research Workshop” (on HPV
vaccine) scheduled for October 24-26, 2006. Apparently, PATH functionaries were in touch with
ICMR officials on an informal basis in the past.
3.3 Within a few days, a meeting took place between PATH and ICMR officials on 13 October,
2006 at PATH office in New Delhi where it was stated that “HPV vaccine, when available (in
India), can prevent HPV and cervical cancer.” The possibility of Global Alliance for Vaccines and
Immunizations (GAVI) subsidizing the cost of vaccine for the first 2 - 4 years was also mentioned.
Evidence (on role, utility of vaccine) made available to Government of India and States would “help
to decide on public sector (State funded) introduction of the vaccine.”
3.4 On 16 November, 2006, a draft Memorandum of Understanding (MoU) between PATH and
ICMR was circulated by PATH which stated that “Parties (PATH and ICMR) desiring to explore
collaboration to support public sector decision regarding HPV vaccine introduction in India and
to generate necessary evidence to allow the possible introduction of HPV vaccine into India’s
Universal Immunization Programme.”
3.5 Thus as early as October-November 2006, it was clear that the main objective of PATH
project was to generate evidence that would facilitate the introduction of HPV vaccine Gardasil into
government-funded immunization program in India. This appears to be a promotional activity for
the benefit of manufacturing company because at that time only one HPV vaccine, Gardasil had
been approved abroad, though not in India. Indeed “the key object of the project activities in India
5
is to gather information and help the government make a decision about the introduction of HPV
vaccine”. The Country Director of PATH in India emphasized that “this needs to be our consistent
message throughout the project.” In the formal proposal submitted by PATH to the ICMR on
Project Proposals involving Foreign Collaboration/Assistance, the applicant clearly stated under Para
9. Objectives of the Project: “……….Introduction of HPV vaccines into Universal Immunization
Program.” The Committee found repeated mention of similar objectives at several places in various
documents submitted by the Ministry. The Memorandum of Understanding (MoU) was signed by
PATH and ICMR on 20 February, 2007. At that time only Gardasil was marketed in some countries
in the world though not approved for use in India. The MoU stated that the purpose of the project
was:
(i) Increasing understanding of HPV vaccine (i.e. Gardasil) introduction.
(ii) To help in decision-making related to the use of HPV (i.e. Gardasil) vaccine in the
public and private sector.
3.6 The Committee enquired from the Secretary of Department of Health Research (DHR) and
DG, ICMR, as to whether the Department or CDSCO, before approving the project had really
reviewed its actual design. The Committee highlighted the observations of the experts of the Inquiry
Committee who have opined that the design of the project itself was faulty. For instance, in the
documents there was no column whatsoever for Serious Adverse Events (SAE) and no diary was
to be maintained as part of the protocol.
3.7 Moreover, much before the trials started, many expected side effects including anaphylaxis
(severe allergic reaction), syncope, convulsions, asthma, central demyelinating diseases, acute
disseminated encephalomyelitis, Idiopathic Thrombopenia Purpura, etc. were known. And
astonishingly, as the records stated, while ICMR functionary was worried of bad publicity in case
of side effects, PATH did not provide for urgent expert medical attention in case of serious adverse
events whether known or unexpected.
3.8 After going through the final report and interactions with the Secretaries of the Department
of Health and Family Welfare and the Department of Health Research/ICMR and DCGI, the
Committee felt that it needs clarification as to under what category, permission was given to PATH
to conduct such study on the Indian people and whether the programme was a clinical trial or
promotional activity. The Committee took note of the fact that the Enquiry Committee meeting held
on September 27, 2010, noted as under (Annexure-A):
“....Besides the factual information about the terms of reference the Committee was greatly
concerned with the aspect of commercial interests of manufacturers influencing the
Government policy on this expensive vaccine. The committee observed that the study was
initiated by PATH on its own …….. without any reference from the National Technical
Advisory Group on Immunization (NTAGI), the official body of the GOI on vaccines.....It
is not clear whether the State expenses were funded by PATH or came from their own
resources. The monetary contributions of ICMR are also not clear. The Committee therefore
felt that it would be in the fitness of the inquiry to document the sources and magnitude
of funding of the study”.
3.9 In this connection, the Committee also noted that one of the roles assigned to ICMR in
the MOU signed by the Director General of the ICMR was “advising on plans for results
dissemination to support decision making for use of the HPV vaccine”.
3.10 The Committee is unable to understand as to how ICMR could commit itself to
support “the use of the HPV vaccine” in an MOU signed in the year 2007 even before the
vaccine was approved for use in the country, which actually happened in 2008. The
6
Committee also questions the decision of ICMR to commit itself to promote the drug for
inclusion in the Universal Immunization Programme (UIP) even before any independent
study about its utility and rationale of inclusion in UIP was undertaken.
3.11 The Committee noted that there were many gaps and missing links in the whole episode and
enquired as to when ICMR came into contact with PATH. First a vaccine should get the approval
from the Government and then only it can be used in UIP. Secretary, Department of Health
Research/DG, ICMR while responding to the queries, informed that the first discussion with the
PATH was held in 2006 followed by signing of agreement in the year 2007. At that time HPV
vaccine had not been approved in India and no study was conducted on it. This was all a
preparatory exercise.
3.12 The Committee was informed that the trial was on the two vaccines approved by DCGI.
It was also stated that these vaccines had been tested abroad and on a limited number of people
in India as per rules following which DCGI had given the approval for their marketing in the
country, and then a post-marketing surveillance trial.
3.13 The Committee in this connection took note of the fact that before any drug is tested
especially on a large population of 25,000-32,000 children between the age of 10 to 14, then
according to the CDSCO guidelines, no such trial can be conducted on children until a similar, prior
trial is conducted on adults to determine efficacy and safety.
3.14 The Secretary, Department of Health Research/DG, ICMR while deposing before the
Committee in its meeting held on 25th July, 2011, stated that the terms of reference of the Enquiry
Committee was to find out any relation between the deaths with the administration of vaccine and
any incidents of irregularities in the implementation of the study. He stated that the Enquiry
Committee concluded that the deaths reported during trial had no uniform pattern to link them to
the administration of vaccines.
3.15 The Committee noted that all the seven deaths were summarily dismissed as unrelated to
vaccinations without in-depth investigations. According to Inquiry Committee report, the speculative
causes were suicides, accidental drowning in well (why not suicide?), maleria, viral infections, sub-
arachnoid haemorrhage (without autopsy) etc. The Committee has been given to understand that
suicidal ideation is caused by many drugs. Since then one more death due to suicide in case of
Gardasil has been reported in addition to 5 deaths reported during 2009-10. Therefore, HPV vaccine
as a possible, if not probable, cause of suicidal ideation cannot be ruled out.
3.16 The Secretary of DHR/DG, ICMR acknowledged that certain irregularities were reported in
the implementation of the project. With regard to Informed Consent, he said that though the
consent was taken properly in Gujarat, there were gross violations of norms in Andhra Pradesh.
He informed the Committee that DCGI, had sought explanation for the incidents of irregularities.
3.17 The Committee took note of Secretary’s comments but sought to know as to how ethical it
was on the part of ICMR to become a party to a project in the name of Public-Private Partnership
(PPP mode). How ICMR, which is mandated to formulate ethical guidelines for researchers, can
become a direct party in such a study. The Secretary, Department of Health Research admitted that
presence of ICMR in the Project’s Advisory Committee-responsible and accountable for various acts
of omissions and commissions-clearly indicates Conflict of Interest. Therefore, ICMR owes full moral
responsibility for numerous irregularities reportedly committed in the study.
3.18 The Committee feels that there was serious dereliction of duty by many of the
Institutions and individuals involved. The Committee observes that ICMR representatives,
instead of ensuring highest levels of ethical standards in research studies, apparently acted
at the behest of the PATH in promoting the interests of manufacturers of the HPV Vaccine.
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3.19 It was unwise on the part of ICMR to go in the PPP mode with PATH, as such an
involvement gives rise to grave Conflict of Interest. The Committee takes a serious view
of the role of ICMR in the entire episode and is constrained to observe that ICMR should
have been more responsible in the matter. The Committee strongly recommends that the
Ministry may review the activities of ICMR functionaries involved in PATH project.
3.20 Secretary of Department of Health Research and DG, ICMR in their defense also claimed
that the ICMR had fulfilled the written role entrusted to it but the irregularities that took place
during the implementation of the study clearly indicate that there were certain micro (ground) level
issues requiring more attention. For instance, it was noticed that States were not even capable of
monitoring the adverse effects. He stated that this all was a learning exercise.
3.21 It maybe pertinent to mention here that the safety, efficacy and introduction of vaccines in
India is handled by National Technical Advisory Group on Immunization (NTAGI). Thus, at the
very outset, ICMR should have either referred PATH to NTAGI or at least taken NTAGI on board.
3.22 The Committee from its examination has found that DHR/ICMR have completely
failed to perform their mandated role and responsibility as the apex body for medical
research in the Country. Rather, in their over-enthusiasm to act as a willing facilitator to
the machinations of PATH they have even transgressed into the domain of other bodies/
agencies which deserves the strongest condemnation and strictest action against them. The
Committee fails to understand as to why ICMR took so much interest and initiative in this
project when the safety, efficacy and introduction of vaccines in India is handled by National
Technical Advisory Group on Immunization (NTAGI). The submissions of the Secretary,
DHR/DG, ICMR before the Committee about the commencement of the project, facts of the
case and the action taken have also failed to stand scrutiny during the Committee’s
examination of the matter. The Committee, therefore, reiterates the recommendation made
in their Forty-first Report that the matter of allowing trial of the vaccine as also the
approval for its marketing in the Country be inquired into by a premier investigating
agency and appropriate action be taken thereafter by the Government in the matter. The
Committee expects the Government not to procrastinate in this matter any further.
IV. ROLE OF DRUG CONTROLLER GENERAL, INDIA (DCGI)

4.1 The Committee noted that as per Rule122-DA and Schedule Y of the Drugs and Cosmetics
Rules, 1945 made under the Drugs and Cosmetics Act, 1940, no clinical trial on a drug can be
conducted except under, and in accordance with the permission in writing, of the Licensing
Authority i.e. DCGI. All vaccines are deemed to be drugs. Clinical trials of pharmaceutical products
are conducted on human subjects in the country to determine or verify safety and/or efficacy.
Every permission for conducting clinical trials also, inter alia, includes a condition that in event of
trial related injury or death, the sponsor will provide complete medical care as well as
compensation. Statement to this effect needs to be incorporated in the Informed Consent Form.
The details of compensation provided are to be intimated to the office of DCGI.
4.2 The Committee noted from the evidence available that the nature of the PATH project made
it Post-marketing Phase IV Clinical Trial under Drugs and Cosmetic Rules. It was on this basis
that DCGI approved the clinical trial on 22 April, 2009 and had earlier issued import licenses on
23 December, 2008 though it was incorrect on the part of DCGI to issue import licences on Form
11 under Rule 33 which states:
Import of drugs for examination, test or analysis: Small quantities of drugs the import of
which is otherwise prohibited under section 10 of the Act may be imported for the purpose
of examination, test or analysis subject to the following conditions:
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(a) No drug shall be imported for such purpose except under a licence in Form 11;
(b) the licensee shall use the substances imported under the license exclusively for
purposes of examination, test or analysis and shall carry on such examination, test or
analysis in the place specified in the license, or in such other places as the licensing
authority may from time to time authorize.
4.3 Since both Gardasil and Cervarix had received marketing approval from CDSCO on 4 July,
2008 and 10 September, 2008 respectively, DCGI should have issued Import Licenses on Form 10
which is applicable to import of drugs already approved.
4.4 The so called Demonstration Project of PATH has the objectives as follows:
Primary Outcomes:
· Number and percentage of vaccinated girls.
· Number and percentage of vaccinated girls experiencing Serious Adverse Events
(SAEs)
· Number and percentage of vaccinated girls experiencing non-Serious Adverse Events.
· Timeliness of reporting SAEs to local, state and national authorities.
· Timeliness of reporting Non-SAEs to local, state and national authorities.
4.5 Thus it is clear that PATH project had two well defined and specific objectives:
(a) The commercial objective of the project was to generate evidence, data and arguments
to support inclusion of HPV vaccines into India’s state-funded Universal Immunization
Program (UIP), and
(b) The scientific purpose was to collect data on serious and non-serious adverse effects.
Given that similar projects were launched in Peru, Uganda and Vietnam, the entire
exercise would have collected side effect profiles of HPV vaccines in all the ethnic
groups that reside in developing countries. Such data would be invaluable to promote
the two branded, patented, single source HPV vaccines as safe all over the world.
4.6 The Committee’s examination has proved that DCGI has also played a very
questionable role in the entire matter. Initially, it took a call that since human subjects,
as part of the studies, were receiving invasive intervention like immunization, clinical trial
rules must be enforced. However, it remained as a silent spectator thereafter, even when
its own rules and regulations were being so flagrantly violated. The approvals of clinical
trials, marketing approval and import licenses by DCGI appear to be irregular. Therefore,
the role of DCGI in this entire matter should also be inquired into.
V. MARKETING APPROVAL TO HPV VACCINES IN INDIA

5.1 Before approving any new drug (including new vaccines), under Drugs and Cosmetics
Rules, it is mandatory to conduct Phase III clinical trials in India to determine any ethnic
differences in the safety and efficacy profiles. As per records made available to the Committee the
following clinical trials, albeit, under various names, were conducted:
Gardasil (Merck): Clinical trials were conducted on 108 subjects (girls in the age
group of 9-15 years). Several violations took place in the trial:
(a) trials should have been conducted in adults first before exposing
children to known and unknown side effects, (b) in adolescents and
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children the trials should have been conducted from “top to bottom”
age groups i.e. first in adolescents (13-15 years) followed by
children (9-12 years). This was not done. Vaccines were
administered to children irrespective of age at the same time.
Cervarix (GSK): Clinical trials were conducted on 162 subjects (adults in the age
group of 18-35 years). Yet permission was given to use the vaccine
in children (10-14 years) in violation of rules.
VI. INQUIRY COMMITTEE
(a) Composition and Terms of Reference

6.1 The Committee was informed that because of the concerns raised at different fora, the
study was suspended and an Enquiry Committee was constituted by the Govt. of India vide
notification No. V.25011/160/2010-HR dated 15th April, 2010, to enquire into “Alleged irregularities”
in the conduct of studies using Human Papilloma Virus (HPV) vaccines by PATH in India.
The inquiry committee consisted of the following:
(1) Dr. S.S. Agarwal, former Director, Advanced Centre for Training, Research, Education
on Cancer,
(2) Dr. S.P. Aggarwal, former DGHS, and
(3) Dr. Sunita Mittal, HoD, Obstetrics and Gynaecology, AIIMS
6.2 The terms of reference of the Committee were to enquire into:
(i) Link between the deaths and vaccine, if any, and
(ii) Ethical Issues of subjecting children of marginalized populations to these studies, and
investigations in children without appropriate Consent.
6.3 The Committee was assisted by the following experts:
(i) Dr. Rani Kumar, Dean, AIIMS
(ii) Dr. A. K. Dutta, Head of Pediatrics, Kalawati Saran Hospital
(iii) Dr. Y. K. Gupta, Head of Pharmacology, AIIMS
(b) Conflict of Interest

6.4 The Committee sought information from the Ministry of Health and Family Welfare
(MoHFW) as to whether members of the Inquiry Committee were asked to file Conflict of Interest
declarations. In response the Ministry replied: “No written Conflict of Interest declarations were
sought from the core members of the Inquiry Committee as well as experts. It was understood
that if there is any conflict, highly learned members will point it out.”
6.5 In order to verify the Ministry’s claim, the Committee picked just one member i.e.,
Professor and HoD of the Department of Obstetrics and Gynaecology (O&G) of All India Institute
of Medical Sciences (AIIMS). It was found that manufacturers of Gardasil, Merck was sponsoring
and funding a trial in the Department of O&G at AIIMS to determine if 2 doses of Gardasil can
be used safely and effectively instead of 3 doses. Documents received by the Committee in
connection with the examination of AIIMS also revealed that the individual in question availed the
hospitality of these very sponsors during the said individual’s visit to Seoul to attend a conference.
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The FCRA application form was, therefore, deliberately left incomplete to hide this truth. All these
speaks of a serious conflict of interest of this member of the Inquiry Committee.
6.6 The Committee also found that the Ministry appointed a senior official of ICMR (described
as Resource Person) to assist the Inquiry Committee. The concerned individual was the main link
between ICMR and PATH, and had participated actively in all discussions, meetings and helped
PATH to carry out the project proactively in every respect right from the beginning in October
2006. As such he had a clear Conflict of Interest and could not be relied upon to give correct
information and unbiased opinion. Indeed he should have been summoned as a witness to answer
questions and not as an official Resource Person attached to the Enquiry Committee.
(c) Adverse Events Reporting

6.7 The Committee examined the final Report of the Inquiry Committee constituted to enquire
into the alleged irregularities in the conduct of studies using HPV vaccines by PATH in India. In
its first meeting held on 21-4-2010, the Inquiry Committee sought details on the following core
issues:
1. When did PATH approach ICMR for trial runs?
2. With whose permission was MOU signed?
3. Did President of ICMR approve?
4. Whether it had approval of the Screening Committee?
5. Approval of DCGI.
6. Details of reimbursements provided so far by PATH to ICMR
7. Names of beneficiaries.
8. Expenditure incurred by ICMR so far on all items including travel expenses.
6.8 However in its second meeting on 30 April, 2010, no discussion took place on the above
crucial issues since the Inquiry Committee wished “to restrict itself to the terms of reference.”
6.9 Inexplicably, however, as the records placed before the Committee proved, this decision did
not prevent the Inquiry Committee from going into and recommending actions on other matters far
beyond the terms of reference.
6.10 The Committee notes that once this matter was taken up by it, the Government
appointed an Inquiry Committee on 15 April, 2010 to inquire into ‘alleged irregularities in
the conduct of the studies using HPV vaccines by PATH in India’. The Committee has noted
the serious conflict of interest of members of this Inquiry Committee with the subject
matter. The Committee, therefore, strongly deprecates the Government for appointing a
committee to inquire into such a serious matter in such a casual manner even without
ascertaining as to whether any of the members of the said Inquiry Committee were having
any conflict of interest with the subject matter of inquiry.
6.11 The Committee finds it very intriguing as to when the Inquiry Committee after
having sought details of some core issues in the very first meeting of the Committee on
21 April, 2007 subsequently chose not to pursue them purportedly because ‘it wanted to
restrict itself to its terms of reference’. These core issues raised by the Inquiry Committee
earlier, if pursued to their logical end, would not only have provided the Inquiry Committee
a lot more clarity in unraveling the truth but also the Country would have known the exact
details as to what transpired in this sordid incident.
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(d) Informed Consent

6.12 Obtaining Informed Consent from study subjects is a core requirement in the conduct of
clinical trials and protection of human rights. In case of minors, the Consent has to be signed by
parents/guardians. In the case of uneducated signatories, an independent person has to explain and
witness the consent process. The Informed Consent document approved by various Ethics
Committees on PATH project included the sentence: “I have read the information in this consent
form (or it has been read to me). I consent to allow my daughter to receive three doses of HPV
vaccines.” In the case of Andhra Pradesh 9,543 forms were signed, 1,948 had thumb impressions
while hostel warden had signed 2,763 forms. In the case of Gujarat 6,217 forms were signed,
3,944 had thumb impressions and 545 were either signed or carried thumb impression of guardians.
The data shows that a very large number of parents/guardians were illiterate and could not even
sign in their local language i.e. Telugu or Gujarati.
6.13 One of the experts, while going into the question of Informed consent in great detail, in
two reports, has pointed out glaring discrepancies. Out of 100 consent forms for AP Project taken
for study, it was found that signatures of witnesses were missing in 69 forms. In many forms
there were no dates while in others the signature of just one person appeared in seven forms The
legality of the Andhra Pradesh State Government circular directing all Headmasters/Wardens in all
private/government/ashram schools to sign the consent forms on behalf of parents/guardians was
also questionable.
6.14 The Inquiry Committee, while going through the above report, noticed the following
irregularities and discrepancies in the study:
(i) The warden/teachers/headmasters were not given written permission by the parents/
guardians to sign on behalf of their girls.
(ii) On many forms witness had not signed and of the forms which are signed, it is not
clear whether they are signed by full time government employees, as per rules.
(iii) Neither the photograph nor the photo ID card of parents/guardians/wardens is pasted
in consent form.
(iv) On many forms investigator has not signed.
(v) On some forms signature of parents/guardians is not matching with their names.
(vi) The date of vaccination is much earlier than the date of signature of parents/guardian
in the consent forms. Apparently they were obtained post-facto.
(vii) In some forms, the name is of the father but signature is of probably mother (lady’s
name).
6.15 Secretary, DHR and DG, ICMR while deposing before the Committee, reiterated that the
regulatory approvals given to the project were in proper order and due attention was paid to the
guidelines and formats for seeking consent. However, during the implementation of the project
certain irregularities took place. He admitted there were cases of discrepancies in A.P. He admitted
that many consent forms were filled up by the Principal on behalf of the students. He admitted
to gross violation in the recording of SAEs also. He informed the Committee that keeping all these
observations in view the DCGI, besides issuing immediate instructions to stop the study, had sought
explanations for irregularities committed during the study.
6.16 The Committee observes that obtaining informed consent from study subjects is a
fundamental requirement in the conduct of clinical trials to ensure that the human rights
of the study subjects are ensured. In case of minors it is mandatory that the consent be
12
signed by parents/guardians. For the uneducated subjects, the law requires an independent
person to explain and witness the consent process. The Committee is however, deeply
shocked to find that in Andhra Pradesh out of the 9543 forms, 1948 forms have thumb
impressions while hostel wardens have signed 2763 forms. In Gujarat, out of the 6217 forms
3944 have thumb impressions and 5454 either signed or carried thumb impressions of
guardians. The data also revealed that a very large number of parents/guardians are
illiterate and could not even write in their local languages viz. Telugu or Gujarati. The
Committee is further shocked to find from one of the reports that out of 100 consent forms
for Andhra Pradesh project signatures of witnesses were missing in 69 forms. In many
forms there were no dates. One particular person had signed seven forms. In fact the
legality of Andhra Pradesh State Government directing headmasters in all private/
Government/ashram/schools to sign the consent form on behalf of parents/guardians is
highly questionable. The absence of photographs of parents/guardians/wardens on consent
forms, the absence of signatures of investigators; the signatures of parents/guardians not
matching with their names; the date of vaccination being much earlier than the date of
signature of parents/guardian in the consent forms, etc. all speak of grave irregularities.
6.17 The Committee, accordingly, concludes that most, if not all consent forms, were
carelessly filled-up and were incomplete and inaccurate. The full explanation, role,
usefulness and pros and cons of vaccination had not been properly communicated to the
parents/guardians. The Committee observes that there is a gross violation of the consent
and legal requirement of consent which had been substantiated by the experts. The
Committee takes a serious view of the violations and strongly recommends that on the
basis of the above facts, PATH should be made accountable and the Ministry should take
appropriate action in the matter including taking legal action against it for breach of
various laws of the land and possible violations of laws of the Country of its origin.
6.18 The Committee was informed that the basic aim of the study was to evaluate strategies
for introduction and delivery of the vaccines in the public sector. Strangely four of the five primary
outcome measures proposed in the study related to evaluation and determination of safety of the
vaccines.
6.19 One of the experts has stated that there was lack of rigour in the design regarding
reporting and dealing with serious adverse events. He has pointed out absence of preparedness in
the event of any such occurrence that would put children at grave risk. The side effects mentioned
by the manufacturers themselves were revised several times and now include serious health issues.
Since there were contra-indications to the use of the vaccines, the reasons for not ascertaining
contra-indications before the girls were vaccinated is clearly an act of willful negligence.. The
design of the project neither took the possibility of Serious Adverse Event (SAE) seriously nor was
there any attention paid to the need for an independent monitoring agency. Consequently action on
investigations into the causes of deaths took an unacceptably long time. A number of discrepancies
and gaps in the investigations of the deaths have also been pointed out. There was no diary card
based reporting of adverse events for recording minor or major adverse events in the study
protocol in such a large study. This resulted in gross under reporting of the adverse events.
6.20 Another expert, while analyzing deaths and Adverse Events Following Immunizations
(AEFI) has observed after reviewing all seven deaths (five deaths from AP in the Gardasil group
and two deaths in Gujarat from Cervarix group), that there was no common pattern to the deaths
that would suggest that these were caused by the vaccine. However, the reporting system as per
Government of India surveillance of vaccine preventable disease guidelines notification was not
done within time limit in two cases in AP and both the cases in Gujarat. There was no uniformity
in the reporting system of AEFI in both the States. The primary end point of the study was to
13
find out the number of girls having serious and non serious adverse events following vaccination
through routine UIP system. He has opined that in this regard first of all routine system of
reporting should have been verified in both States.
6.21 Another expert has stated that the reporting of non-serious AEs was grossly under reported
and hence the accuracy of SAEs is doubtful as well. It has been observed that delay in reporting
and investigations of deaths could have been due to sole dependence on routine UIP protocol. It
was a significant lapse in the protocol and execution of the study. While reporting on safety
aspects in the study, it has been pointed out that there was absence of preparedness to handle
Serious Adverse Events (SAE) like anaphylaxis, cardiac arrest, seizures, etc. occurring at the sites
of vaccine administration. Though such serious adverse events might be rare but it was advisable
to be well prepared for such an eventuality through adequate training of health workers.
Assessment of the immune status of the participants by the ANM, ASHA or the health workers was
virtually non-existent. These issues needed to be addressed as prescribing information of the HPV
vaccines specifically contra-indicates administration in immune-compromised subjects (such as
HIV/AIDS etc.).
6.22 The Committee, in the light of the observations made by experts, feels that the
methodology and implementation of the study at both the places was full of flaws. The
Committee is of the view that since the population under study was vulnerable, utmost
caution should have been exercised in the implementation of the study. The Committee also
recommends that there should be an independent monitoring mechanism in such a study
involving human participants so that the accurate recording of AEs and SAEs could be made.
The findings of the experts clearly indicate that the safety and rights of the children in this
vaccination project were highly compromised and violated. The Committee is also concerned
over the fact that there was no insurance cover for the children. The Committee strongly
recommends that while allowing any such trial in future, all the lapses pointed out by the
experts should be addressed effectively. ICMR and DCGI should ensure strict adherence to
the guidelines, methodology and monitoring.
(e) Role of Ethics Committees

6.23 While examining the role of the Ethics Committees in both the States, one of the experts
pointed out that Ethics Committees were supposed to meet periodically to evaluate and monitor
the progress of the project and review SAE reports. No such meetings were held by the
Committees. Only after reports of deaths appeared in the media, the meetings of these
Committees were held.
6.24 The Committee takes a serious note of the fact that both the Ethics Committees
existed only as a formality and they did not play the role they were designated for. This
is a clear dereliction of duty on the part of the Ethics Committees. The Committee apart
from recommending suitable action in the matter, strongly recommends that there should
be a mechanism in place to take appropriate action against such dereliction of duty on the
part of the Ethics Committees. There should be specific guidelines for Ethics Committees
and the Ethics Committees should strictly follow them. The functioning of Ethics
Committees should be regularly monitored.
(f) Use of Official Machinery

6.25 The Committee has noted that the information/publicity material displayed/distributed at trial
sites implied that the Government had started a vaccination programme. Thus, the credibility of the
Universal Immunization Programme (UIP) was used to promote private, foreign interests. It has
14
been found that the funds meant for the NRHM were used, without authorization for monitoring
and transportation of the vaccines to the fields for use in the project.
6.26 The Committee observes that the wrongful use of the NRHM logo for a project
implemented by a private, foreign agency as well as the identification of this project with
the UIP has adversely affected and damaged the credibility of the programme as well as that
of the NRHM. The Committee, therefore, recommends that such practices of diverting
public funds for advancing interests of a private agency should never be allowed in future.
The Committee strongly recommends that strict action should be taken against those
officials responsible for such lapses.
6.27 Besides, the Committee notes that no information had been provided to Indian authorities
about funding of the project except that it was reportedly funded by Bill and Melinda Gates
Foundation and that the vaccines had been donated by the manufacturers. The information
regarding financial investments of ICMR and State Governments in the project was not provided,
though the States clearly provided cold chain and manpower for immunization. The Committee,
accordingly, observes that it might have been more prudent if the National Technical
Advisory group on Immunization (NTAGI) had been brought into the picture right in the
beginning to review and give its views on the study prior to its approval and
implementation.
6.28 No information is available on the total outlay on the project spent by PATH, ICMR, state
governments of Andhra Pradesh and Gujarat (immunization staff, cold chain system, equipment,
transportation etc.). According to the documents submitted by PATH to ICMR/Health Ministry
Screening Committee, the total outlay by PATH for expenses in India was Rs. 29,76,000. However
Centre for Operations Research and Training (CORT), a sub-contractor of PATH had quoted US$
83,889 (first year) and US$ 96,472 (second year), which is not included in the figure submitted
to ICMR/HMSC.
6.29 Considering the above lapses and irregularities committed by PATH during the course
of conducting the trials on hapless tribal children in Andhra Pradesh and Gujarat, the
Committee is convinced that the authorities concerned did not exercise due diligence in
scrutinizing the publicity material of PATH. Blurring the distinction between the UIP and
PATH project due to the involvement of the State Governments in the project and ignoring
the financial contribution of ICMR and the State Governments are very serious issues. The
Committee, therefore, recommends that the Ministry should investigate into the above acts
of omissions and commissions and take necessary action against those who are found
responsible for breach of rules and regulations.
(g) Action taken on the Inquiry Committee Report

6.30 With a view to find out the action taken by the Government on the findings of the Inquiry
Committee, the Committee again heard the Secretary, Department of Health Research/DG, ICMR
along with DCGI at its meeting held on 24th May, 2013. The Secretary informed the Committee
that after the submission of Report by the Inquiry Committee, they were formally called to give
explanation in the year 2011. In addition, clarifications were also sought from them in between
which were formally answered to. The Committee in the said meeting desired to know whether
criminal inquiry, if any, has been initiated against PATH on account of the following irregularities
in the conduct of trial as pointed out by the Inquiry Committee:
(i) Irregularities in obtaining consent forms and actual implementation of the consent
process;
(ii) Lack of monitoring and preparedness to deal with serious adverse events;
15
(iii) Inclusion of vulnerable and tribal population groups;

(iv) Blurring of distinction between Universal Immunization Programme and PATH study;
(v) Absence of insurance coverage for the study participants; and
(vi) Inclusion of the statement in the consent form that “you will not be charged for your
daughter to receive the vaccine” that could be construed as covert inducement.
6.31 The Committee also sought to know as to whether any compensation was awarded to the
families of children for suppression of material information before administering vaccines.
6.32 The Committee also took note of the Action Taken Note submitted by Department of Health
Research wherein it was informed that subsequent to findings of the Inquiry Committee following
action was taken:
(i) PATH was informed about suggestions made by the Committee;
(ii) Principal Investigators of other suspended studies on HPV vaccines were informed to
get their studies re-examined from respective Ethics Committees after addressing the
concerns raised by the Inquiry Committee;
(iii) DCG(I) was informed of the suggestions of the Committee for necessary action; and
(iv) Suggestions were forwarded to the relevant authority for inclusion in the Draft bill on
Biomedical Research on Human Subjects.
6.33 DCG(I) informed the Committee that subsequent to findings of the Inquiry Committee; the
following action was taken:
(i) Both the manufacturers of HPV vaccines have been asked to submit additional data for
4 years on PSURs (Periodic Safety Update Reports), every 6 months for first 2 years,
and annually during the subsequent 2 years, and to submit protocol for approval for
conducting post marketing surveillance study;
(ii) Proposal to amend the definition of “New Drug” under rule 122-E would be taken up
for consideration; and,
(iii) In future the following steps would be ensured before approving a clinical trial by
DCG(I): (a) every clinical trial is to be registered at ICMR’s clinical trial registry of
India; (b) every approval would include a condition for provision of complete medical
care in case of study related injury/death and the statement to this effect is to be
included in the informed consent: (c) DCG(I) should be informed about death/injury:
(d) Schedule ‘Y’ would be amended to expand the responsibilities of sponsors,
investigators and Ethics Committees; and (e) the consent forms are to be amended to
include details of address and occupations of subject giving socio-economic
background.
6.34 The Committee is amazed at the audacity of DCGI to merely repeat various steps
which it proposes to take as if they are new, additional measures. All these are already part
of the written rules and are supposed to be followed by all sponsors. Except for slight
amendment in the Informed Consent Form, there is nothing new in the ATN submitted by
DCGI.
6.35 The Committee observes that the Department has nothing fresh to offer in the status note
as the same information was furnished by it in December, 2012 vide its updated note on Action
Taken after availability of Report of enquiry Committee.
16
6.36 The Committee not being convinced with the action taken by the Department or
DCGI, feels that the whole issue has been diluted and no accountability has been fixed on
the erring Officials/Departments for the gross violations committed in the conduct of Study.
The Committee also feels that a very casual approach has been taken by the Department
in the matter and their replies lack any concrete action to protect and safeguard the health
of our people.
6.37 The Committee also noticed lack of firm action on the part of DCGI, to avoid such
irregularities in future. One of the actions proposed by the DCGI to check any recurrence
of such gross violations was ‘proposal to amend the definition of New Drug during the next
meeting’. The same assurance was given by DCGI in December, 2012. The Committee,
accordingly, observes that response of the Department and DCGI is very casual,
bureaucratic and lacks any sense of urgency. The Committee feels that DCGI is not very
serious in bringing improvements in the system. It, therefore, desires the Ministry to
ensure compliance by DCGI.
VII. PROGRAMME FOR APPROPRIATE TECHNOLOGY IN HEALTH (PATH)

7.1 The Committee during the course of its present examination sought information from the
Government about PATH in order have a better understanding of its legal status and its locus standi
in carrying out various activities on the Indian soil including the project in question where
apparently several laws of India and possibly of its country of origin had been violated.
7.2 The information furnished to the Committee reveals that PATH describes itself as an
“International nonprofit, non-government organization based in the United States.” Legally, it is a
Public Benefit Corporation (PBC) registered (No. 600588751 dated 28th August, 1981) by the
Corporation and Charities Division in the State of Washington. For all practical purposes its legal
status in US is equivalent to a Registered Society in the Indian context. It is certainly not a
commercial company and hence would not be subject to the jurisdiction of Company Law Board
or Registrar of Companies in India. Incidentally, Ford Foundation is also a PBC (Registration
number 768093 dated 15th January, 1936). Under American laws organizations such as Trusts,
Fraternal Societies, Savings and Loan Associations, Municipal Utility Services etc. are all registered
as PBCs.
7.3 Under Indian rules, foreign non-commercial organizations such as PATH wanting to set up
an office in India are required to obtain (a) permission from the Ministry of External Affairs (MEA)
from “political angle” (Annexure B) and (b) permission from Ministry of Home Affairs (MHA)
from “security angle” (Annexure C). In the latter case, application needs to be forwarded through
proper channel such as Ministry of Health and Family Welfare for health-related activities, Ministry
of Human Resources for education related activities, Ministry of Labour for trade union or workers
related activities etc. Once such an approval is accorded, then an office can be setup which should
naturally abide by all other laws of the land such as income tax, shop and establishment act,
municipal and other applicable laws, just to mention a few.
7.4 The Committee asked the Department to direct PATH to provide details of various
mandatory permissions required by foreign agencies, including charities, for and in connection with
opening office in India and the date of opening of its office in India. Unbelievably, the exact date
of opening the office is not even known to its functionaries in New Delhi. To begin with vide its
letter dated 5-3-2012, PATH claimed that “it has a Liaison Office status under Income Tax Rules.”
Since no such provision exists, after prolonged correspondence it settled for 19th April, 1999 as the
date of opening office based on the fact that its PAN card (No. AAFCP2249G) is dated
19th April, 1999. The Committee was intrigued because PAN card is issued just for income tax
17
purposes and nothing else. Income Tax Department does not go about permitting foreign entities
to open offices in India. In any case PAN card is not a replacement for Ministry of External Affairs
and Ministry of Home Affairs approvals. Besides, the application for issuance of PAN card must
have been made much before 19th April 1999 there being no online system of obtaining PAN card
instantaneously. It can be safely assumed that the date of opening office has to be much earlier
than 19th April, 1999.
7.5 PATH also produced copy of a letter dated 16-3-1999 from PATH office in US to the
Exchange Control Department of the Reserve Bank of India along with reply dated 19-4-1999
received by PATH in US on 29-4-1999. It merely stated that since PATH is “not engaged in any
commercial, trading or industrial activity,” it does not need “RBI permission from foreign exchange
angle. However you may seek necessary approval from the Government of India or other statutory/
regulatory bodies as applicable.” Apparently PATH paid no attention to RBI’s sane advice. Even
before the letter reached PATH office in the United States on 29-4-1999, it had already opened its
office in India.
7.6 The Foreign Exchange Regulation Act (FERA) was replaced with Foreign Exchange
Management Act (FEMA) on 1-6-2000. PATH produced post-facto permission from the Reserve
Bank of India dated 25-5-2009 which clearly stated:
“RBI permission (is) granted from the foreign exchange angle….and should not be
construed to convey the approval of any other statutory authority or Government under any
other laws/regulations.” Moreover, the Liaison Office is permitted to undertake “solely
liaison work for the head office” as mentioned below:
1. Representing in India the parent company/group companies
2. Promoting export, import from/to India.
3. Promoting technical/financial collaborations between parent/group companies and
companies in India.
4. Acting as a communication channel between the parent company and Indian
companies.
“The office in India will not render any consultancy or any other services directly/indirectly
with or without any consideration.”
In addition “Permission granted by RBI is limited to and for the purpose of the provisions
of FEMA-2000 and shall not be construed in any way as regularizing, condoning or in any
manner validating any irregularities, contraventions and other lapses, if any, under the
provisions of any other law.”
7.7 It is clear that the back dated permission obtained after 10 years of having opened its
office in India was merely and exclusively from foreign exchange angle and not a substitute for
approval from MEA and MHA.
7.8 Finally and belatedly PATH produced a certificate from the Registrar of Companies (RoC)
dated 23-9-2009 stating that PATH, a company originally incorporated in US, had filed documents
on 10-09-2009 notifying establishment of place of business in India w.e.f. 19.4.1999. The
Certificate was apparently issued in violation of its own rules that states that documents must be
submitted within 30 days of the establishment of “place of business.” In any case such a certificate
cannot and does not obviate the need to obtain baseline, mandatory permission from MEA and
MHA. Moreover RoC deals with commercial companies, not foreign trusts, foundations and
charities.
18
7.9 PATH also claimed that it had received “permission” from the Ministry of Health and Family
Welfare to set up an office in India. The post-facto letter dated 27-4-2001 (two years after PATH
admits having opened the office in India) is not a permission at all but a vague, non-specific
statement to say that PATH was “engaged in health care related activities”.
7.10 According to the published Annual Report of PATH for the year 2008, it received funding
in “excess of US $ 1,000” from many governmental sources including the Ministry of Health and
Family Welfare, Government of India. However, in response to Rajya Sabha Question Number 952
on 3.8.2010, the Health Minister denied any Ministry funding to PATH.
7.11 The Committee is concerned that if PATH can set up an office in India so easily
without getting the required mandatory approvals/permissions, then individuals and entities
inimical to the interest of the country can do the same. The Committee expresses its
concern that paper and shell companies can be easily registered in many jurisdictions and
then set up a place of business in India as “Liaison offices” with no questions being asked.
It is surprising that security and intelligence agencies did not raise an eyebrow on the way
a foreign entity entered India virtually incognito through the backdoor. The Committee
desires that such incidents should not be allowed in future. The Government should tighten
the rules lest one day foreign citizens, with deep roots in organizations/nations inimical to
India, set up offices in the country to engage in anti-national and/or unlawful activities.
7.12 It is apparent the PATH has exploited with impunity the loopholes in our system as
also the absence of a nodal point or a single window for maintaining a data bank of foreign
entities entering the Country for setting up their offices. Given the multiplicity of agencies
involved in processing such requests there is a definite need for a nodal agency which would
keep a tab on all such existing and aspiring agencies from the point of view of having
obtained all necessary clearances/permissions before commencing their operations in India.
The Committee strongly recommends that government set up one such umbrella agency
which should be linked to all the agencies that are involved in processing such requests.
The Committee desires that within three months such an agency should be put in place and
start functioning. The proposed nodal agency should be a part of MHA with a well
established coordination mechanism with the MEA so that undeserving cases are dealt
forthwith through diplomatic channels. All ministries/departments/agencies/state
governments/other entities should be required to share details of all requests/proposals from
foreign entities for setting up offices in any form with this nodal agency.
7.13 Coming to the instant case, it is established that PATH by carrying out the clinical
trials for HPV vaccines in Andhra Pradesh and Gujarat under the pretext of observation/
demonstration project has violated all laws and regulations laid down for clinical trials by
the Government. While doing so, its sole aim has been to promote the commercial interests
of HPV vaccine manufacturers who would have reaped windfall profits had PATH been
successful in getting the HPV vaccine included in the UIP of the Country. This is a serious
breach of trust by any entity as the project involved life and safety of girl children and
adolescents who were mostly unaware of the implications of vaccination. The violation is
also a serious breach of medical ethics. This act of PATH is a clear cut violation of the
human rights of these girl children and adolescents. It also deems it an established case of
child abuse. The Committee, therefore, recommends action by the Government against
PATH. The Committee also desires that the National Human Rights Commission and
National Commission for Protection of Children Rights may take up this matter from the
point of view of the violation of human rights and child abuse. The National Commission
for Women should also suo motu take cognizance of this case as all the poor and hapless
subjects are females.
19
7.14 The Ministry of Health and Family Welfare should without wasting time report the
violations indulged in by PATH to international bodies like WHO and UNICEF so as to
ensure that appropriate remedial action is initiated by these agencies worldwide.
7.15 The Committee also desires that the Ministry of Health and Family Welfare may
take up the matter through the Ministry of External Affairs with the US Government so
as to ensure that appropriate action is taken against PATH under the laws of its country
of origin in case of any violations of laws there.
20
OBSERVATIONS/RECOMMENDATIONS — AT A GLANCE
II. NATURE OF PROJECT

1. The Committee finds the entire matter very intriguing and fishy. The choice of
countries and population groups; the monopolistic nature, at that point of time, of the
product being pushed; the unlimited market potential and opportunities in the universal
immunization progammes of the respective countries are all pointers to a well planned
scheme to commercially exploit a situation. Had PATH been successful in getting the HPV
vaccine included in the universal immunization programme of the concerned countries, this
would have generated windfall profit for the manufacturer(s) by way of automatic sale, year
after year, without any promotional or marketing expenses. It is well known that once
introduced into the immunization programme it becomes politically impossible to stop any
vaccination. To achieve this end effortlessly without going through the arduous and strictly
regulated route of clinical trials, PATH resorted to an element of subterfuge by calling the
clinical trials as “Observational Studies” or “Demonstration Project” and various such
expressions. Thus, the interest, safety and well being of subjects were completely
jeopardized by PATH by using self-determined and self-servicing nomenclature which is not
only highly deplorable but a serious breach of law of the land. The Committee is not aware
about the strategy followed by PATH in the remaining three countries viz. Uganda, Vietnam
and Peru. The Government should take up the matter with the Governments of these
countries through diplomatic channels to know the truth of the matter and take appropriate
necessary action, accordingly. The Committee would also like to be apprised of the
responses of these countries in the matter. (Para 2.5)
III. ROLE OF DEPARTMENT OF HEALTH RESEARCH/INDIAN COUNCIL OF MEDICAL

RESEARCH
2. The Committee is unable to understand as to how ICMR could commit itself to
support “the use of the HPV vaccine” in an MOU signed in the year 2007 even before the
vaccine was approved for use in the country, which actually happened in 2008. The
Committee also questions the decision of ICMR to commit itself to promote the drug for
inclusion in the Universal Immunization Programme (UIP) even before any independent
study about its utility and rationale of inclusion in UIP was undertaken. (Para 3.10)
3. The Committee feels that there was serious dereliction of duty by many of the
Institutions and individuals involved. The Committee observes that ICMR representatives,
instead of ensuring highest levels of ethical standards in research studies, apparently acted
at the behest of the PATH in promoting the interests of manufacturers of the HPV Vaccine.
(Para 3.18)
4. It was unwise on the part of ICMR to go in the PPP mode with PATH, as such an
involvement gives rise to grave Conflict of Interest. The Committee takes a serious view
of the role of ICMR in the entire episode and is constrained to observe that ICMR should
have been more responsible in the matter. The Committee strongly recommends that the
Ministry may review the activities of ICMR functionaries involved in PATH project.
(Para 3.19)
20
21
5. The Committee from its examination has found that DHR/ICMR have completely
failed to perform their mandated role and responsibility as the apex body for medical
research in the Country. Rather, in their over-enthusiasm to act as a willing facilitator to
the machinations of PATH they have even transgressed into the domain of other bodies/
agencies which deserves the strongest condemnation and strictest action against them. The
Committee fails to understand as to why ICMR took so much interest and initiative in this
project when the safety, efficacy and introduction of vaccines in India is handled by National
Technical Advisory Group on Immunization (NTAGI). The submissions of the Secretary,
DHR/DG, ICMR before the Committee about the commencement of the project, facts of the
case and the action taken have also failed to stand scrutiny during the Committee’s
examination of the matter. The Committee, therefore, reiterates the recommendation made
in their Forty-first Report that the matter of allowing trial of the vaccine as also the
approval for its marketing in the Country be inquired into by a premier investigating
agency and appropriate action be taken thereafter by the Government in the matter. The
Committee expects the Government not to procrastinate in this matter any further.
(Para 3.22)
IV. ROLE OF DRUG CONTROLLER GENERAL, INDIA (DCGI)

6. The Committee’s examination has proved that DCGI has also played a very
questionable role in the entire matter. Initially, it took a call that since human subjects,
as part of the studies, were receiving invasive intervention like immunization, clinical trial
rules must be enforced. However, it remained as a silent spectator thereafter, even when
its own rules and regulations were being so flagrantly violated. The approvals of clinical
trials, marketing approval and import licenses by DCGI appear to be irregular. Therefore,
the role of DCGI in this entire matter should also be inquired into. (Para 4.6)
VI. INQUIRY COMMITTEE
(c) Adverse Events Reporting

7. The Committee notes that once this matter was taken up by it, the Government
appointed an Inquiry Committee on 15 April, 2010 to inquire into ‘alleged irregularities in
the conduct of the studies using HPV vaccines by PATH in India’. The Committee has noted
the serious conflict of interest of members of this Inquiry Committee with the subject
matter. The Committee, therefore, strongly deprecates the Government for appointing a
committee to inquire into such a serious matter in such a casual manner even without
ascertaining as to whether any of the members of the said Inquiry Committee were having
any conflict of interest with the subject matter of inquiry. (Para 6.10)
8. The Committee finds it very intriguing as to when the Inquiry Committee after
having sought details of some core issues in the very first meeting of the Committee on
21 April, 2007 subsequently chose not to pursue them purportedly because ‘it wanted to
restrict itself to its terms of reference’. These core issues raised by the Inquiry Committee
earlier, if pursued to their logical end, would not only have provided the Inquiry Committee
a lot more clarity in unraveling the truth but also the Country would have known the exact
details as to what transpired in this sordid incident. (Para 6.11)
(d) Informed Consent

9. The Committee observes that obtaining informed consent from study subjects is a
fundamental requirement in the conduct of clinical trials to ensure that the human rights
22
of the study subjects are ensured. In case of minors it is mandatory that the consent be
signed by parents/guardians. For the uneducated subjects, the law requires an independent
person to explain and witness the consent process. The Committee is however, deeply
shocked to find that in Andhra Pradesh out of the 9543 forms, 1948 forms have thumb
impressions while hostel wardens have signed 2763 forms. In Gujarat, out of the 6217 forms
3944 have thumb impressions and 5454 either signed or carried thumb impressions of
guardians. The data also revealed that a very large number of parents/guardians are
illiterate and could not even write in their local languages viz. Telugu or Gujarati. The
Committee is further shocked to find from one of the reports that out of 100 consent forms
for Andhra Pradesh project signatures of witnesses were missing in 69 forms. In many
forms there were no dates. One particular person had signed seven forms. In fact the
legality of Andhra Pradesh State Government directing headmasters in all private/
Government/ashram/schools to sign the consent form on behalf of parents/guardians is
highly questionable. The absence of photographs of parents/guardians/wardens on consent
forms, the absence of signatures of investigators; the signatures of parents/guardians not
matching with their names; the date of vaccination being much earlier than the date of
signature of parents/guardian in the consent forms, etc. all speak of grave irregularities.
(Para 6.16)
10. The Committee, accordingly, concludes that most, if not all consent forms, were
carelessly filled-up and were incomplete and inaccurate. The full explanation, role,
usefulness and pros and cons of vaccination had not been properly communicated to the
parents/guardians. The Committee observes that there is a gross violation of the concept
and legal requirement of consent which had been substantiated by the experts. The
Committee takes a serious view of the violations and strongly recommends that on the
basis of the above facts, PATH should be made accountable and the Ministry should take
appropriate action in the matter including taking legal action against it for breach of
various laws of the land and possible violations of laws of the Country of its origin.
(Para 6.17)
11. The Committee, in the light of the observations made by experts, feels that the
methodology and implementation of the study at both the places was full of flaws. The
Committee is of the view that since the population under study was vulnerable, utmost
caution should have been exercised in the implementation of the study. The Committee also
recommends that there should be an independent monitoring mechanism in such a study
involving human participants so that the accurate recording of AEs and SAEs could be made.
The findings of the experts clearly indicate that the safety and rights of the children in this
vaccination project were highly compromised and violated. The Committee is also concerned
over the fact that there was no insurance cover for the children. The Committee strongly
recommends that while allowing any such trial in future, all the lapses pointed out by the
experts should be addressed effectively. ICMR and DCGI should ensure strict adherence to
the guidelines, methodology and monitoring. (Para 6.22)
12. The Committee takes a serious note of the fact that both the Ethics Committees
existed only as a formality and they did not play the role they were designated for. This
is a clear dereliction of duty on the part of the Ethics Committees. The Committee apart
from recommending suitable action in the matter, strongly recommends that there should
be a mechanism in place to take appropriate action against such dereliction of duty on the
part of the Ethics Committees. There should be specific guidelines for Ethics Committees
and the Ethics Committees should strictly follow them. The functioning of Ethics
Committees should be regularly monitored. (Para 6.24)
23
13. The Committee observes that the wrongful use of the NRHM logo for a project
implemented by a private, foreign agency as well as the identification of this project with
the UIP has adversely affected and damaged the credibility of the programme as well as that
of the NRHM. The Committee, therefore, recommends that such practices of diverting
public funds for advancing interests of a private agency should never be allowed in future.
The Committee strongly recommends that strict action should be taken against those
officials responsible for such lapses. (Para 6.26)
14. Besides, the Committee notes that no information had been provided to Indian
authorities about funding of the project except that it was reportedly funded by Bill and
Melinda Gates Foundation and that the vaccines had been donated by the manufacturers.
The information regarding financial investments of ICMR and State Governments in the
project was not provided, though the States clearly provided cold chain and manpower for
immunization. The Committee, accordingly, observes that it might have been more prudent
if the National Technical Advisory group on Immunization (NTAGI) had been brought into
the picture right in the beginning to review and give its views on the study prior to its
approval and implementation. (Para 6.27)
15. Considering the above lapses and irregularities committed by PATH during the course
of conducting the trials on hapless tribal children in Andhra Pradesh and Gujarat, the
Committee is convinced that the authorities concerned did not exercise due diligence in
scrutinizing the publicity material of PATH. Blurring the distinction between the UIP and
PATH project due to the involvement of the State Governments in the project and ignoring
the financial contribution of ICMR and the State Governments are very serious issues. The
Committee, therefore, recommends that the Ministry should investigate into the above acts
of omissions and commissions and take necessary action against those who are found
responsible for breach of rules and regulations. (Para 6.29)
16. The Committee is amazed at the audacity of DCGI to merely repeat various steps
which it proposes to take as if they are new, additional measures. All these are already part
of the written rules and are supposed to be followed by all sponsors. Except for slight
amendment in the Informed Consent Form, there is nothing new in the ATN submitted by
DCGI. (Para 6.34)
17. The Committee not being convinced with the action taken by the Department or
DCGI, feels that the whole issue has been diluted and no accountability has been fixed on
the erring Officials/Departments for the gross violations committed in the conduct of Study.
The Committee also feels that a very casual approach has been taken by the Department
in the matter and their replies lack any concrete action to protect and safeguard the health
of our people. (Para 6.36)
18. The Committee also noticed lack of firm action on the part of DCGI, to avoid such
irregularities in future. One of the actions proposed by the DCGI to check any recurrence
of such gross violations was ‘proposal to amend the definition of New Drug during the next
meeting’. The same assurance was given by DCGI in December, 2012. The Committee,
accordingly, observes that response of the Department and DCGI is very casual,
bureaucratic and lacks any sense of urgency. The Committee feels that DCGI is not very
serious in bringing improvements in the system. It, therefore, desires the Ministry to
ensure compliance by DCGI. (Para 6.37)
VII. PROGRAMME FOR APPROPRIATE TECHNOLOGY IN HEALTH (PATH)

19. The Committee is concerned that if PATH can set up an office in India so easily
24
without getting the required mandatory approvals/permissions, then individuals and entities
inimical to the interest of the country can do the same. The Committee expresses its
concern that paper and shell companies can be easily registered in many jurisdictions and
then set up a place of business in India as “Liaison offices” with no questions being asked.
It is surprising that security and intelligence agencies did not raise an eyebrow on the way
a foreign entity entered India virtually incognito through the backdoor. The Committee
desires that such incidents should not be allowed in future. The Government should tighten
the rules lest one day foreign citizens, with deep roots in organizations/nations inimical to
India, set up offices in the country to engage in anti-national and/or unlawful activities.
(Para 7.11)
20. It is apparent the PATH has exploited with impunity the loopholes in our system as
also the absence of a nodal point or a single window for maintaining a data bank of foreign
entities entering the Country for setting up their offices. Given the multiplicity of agencies
involved in processing such requests there is a definite need for a nodal agency which would
keep a tab on all such existing and aspiring agencies from the point of view of having
obtained all necessary clearances/permissions before commencing their operations in India.
The Committee strongly recommends that government set up one such umbrella agency
which should be linked to all the agencies that are involved in processing such requests.
The Committee desires that within three months such an agency should be put in place and
start functioning. The proposed nodal agency should be a part of MHA with a well
established coordination mechanism with the MEA so that undeserving cases are dealt
forthwith through diplomatic channels. All ministries/departments/agencies/state
governments/other entities should be required to share details of all requests/proposals from
foreign entities for setting up offices in any form with this nodal agency. (Para 7.12)
21. Coming to the instant case, it is established that PATH by carrying out the clinical
trials for HPV vaccines in Andhra Pradesh and Gujarat under the pretext of observation/
demonstration project has violated all laws and regulations laid down for clinical trials by
the Government. While doing so, its sole aim has been to promote the commercial interests
of HPV vaccine manufacturers who would have reaped windfall profits had PATH been
successful in getting the HPV vaccine included in the UIP of the Country. This is a serious
breach of trust by any entity as the project involved life and safety of girl children and
adolescents who were mostly unaware of the implications of vaccination. The violation is
also a serious breach of medical ethics. This act of PATH is a clear cut violation of the
human rights of these girl children and adolescents. It also deems it an established case of
child abuse. The Committee, therefore, recommends action by the Government against
PATH. The Committee also desires that the National Human Rights Commission and
National Commission for Protection of Children Rights may take up this matter from the
point of view of the violation of human rights and child abuse. The National Commission
for Women should also suo motu take cognizance of this case as all the poor and hapless
subjects are females. (Para 7.13)
22. The Ministry of Health and Family Welfare should without wasting time report
the violations indulged in by PATH to international bodies like WHO and UNICEF so
as to ensure that appropriate remedial action is initiated by these agencies worldwide.
(Para 7.14)
23. The Committee also desires that the Ministry of Health and Family Welfare may
take up the matter through the Ministry of External Affairs with the US Government so
as to ensure that appropriate action is taken against PATH under the laws of its country
of origin in case of any violations of laws there. (Para 7.15)
25
MINUTES
VIII
EIGHTH MEETING
(2009-10)
The Committee met at 11.00 A.M. on Tuesday, the 6th April, 2010 in Room No. 139, First
Floor, Parliament House Annexe, New Delhi.
MEMBERS PRESENT
RAJYA SABHA
1. Shri Amar Singh — Chairman
3. Dr. Radhakant Nayak
LOK SABHA
7. Shri Ashok Argal
9. Dr. Chinta Mohan
11. Shri S.R. Jeyadurai
12. Dr. (Shrimati) Kruparani Killi
SECRETARIAT
27
28
WITNESSES
* * *
Representatives from the Department of Health Research
1. Dr.Vishwa Mohan Katoch, Secretary
2. Ms. Shalini Prasad, Joint Secretary
3. Dr. Vijay Kumar, Scientist
4. Dr. Bela Shah, Head NCD Division
5. Dr. K. Satyanarayana, Head P&I Division
6. Shri Sanjiv Datta, Financial Adviser
* * *
2. At the outset, the Chairman welcomed Members to the meeting and informed them about
the agenda of the meeting, i.e., examination of Demands for Grants (2010-11) of the Ministry of
Health and Family Welfare and taking oral evidence of the Secretaries * * *, Health Research
* * * in connection therewith.
3. * * *
4. * * *
5. * * *
6. * * *
7. The Committee then adjourned at 1.30 P.M. for lunch to meet again at 2.30 P.M.
8. * * *
9. During the course of the meeting, Shrimati Brinda Karat, Member of the Committee raised
the issue about the trial of HPV vaccine on the children in Khammam district of Andhra Pradesh
and reported deaths of the children therefrom and sought exact status in this regard from the
Secretary. The Secretary, Department of Health Research informed the Committee that the Drug
Controller General of India had given approval for marketing of HPV vaccine in India as per
schedule ‘Y’ of the Drugs and Cosmetics Act and then a post-marketing surveillance. The
Committee was informed that the proposal for trial came two years back before the ICMR through
PATH, an American NGO. Attention of the Secretary was drawn to DCGI guidelines whereunder
third phase trial cannot be conducted on children until a similar trial was conducted on adults. It
was admitted by the Secretary that the DCGI guidelines were not adhered to in the present case.
The Committee was assured that State Governments of Andhra Pradesh and Gujarat would be
asked to get the ongoing clinical trial stopped immediately. Taking serious view of procedural and
ethical lapses on the part of the Ministry, the Committee sought the matter of allowing trial of the
vaccine as also the approval for its marketing in the country to be enquired into by a premier
investigating agency and to take further appropriate action in the matter. It also asked that findings
of the investigating agency and the follow-up action taken in this regard may be furnished to the
Committee at the earliest.
10. * * *
11. * * *
12. A verbatim record of the proceedings of the meeting was kept.
13. The Committee then adjourned at 5.15 P.M.
* Relate to other matters.

29
XV
FIFTEENTH MEETING
(2010-11)
The Committee met at 11.00 A.M. on Monday, the 25th July, 2011 in Committee Room ‘A’,
Ground Floor, Parliament House Annexe, New Delhi.
MEMBERS PRESENT
RAJYA SABHA
LOK SABHA
8. Shri Ashok Argal
12. Shri S.R. Jeyadurai
SECRETARIAT
WITNESSES
* * *
Department of Health Research
1. Dr. V.M. Katoch, Secretary, Health Research
2. Ms. Shalini Prasad, Joint Secretary
3. Shri S.K. Rao, Joint Secretary
29
30
2. The Chairman welcomed the Members of the Committee and apprised them of the agenda
of the meeting, i.e. to hear oral evidence on (i) * * *(ii) * * * and (iii) issues arising out of the
final report of the Committee to enquire into “Alleged irregularities in the conduct of studies using
Human Papilloma Virus (HPV)” by PATH in the country.
3. * * *
4. * * *
(The Committee adjourned at 12.20 P. M . to meet again at 2.30 P.M.)
5. In the second half of the meeting, the Committee heard the views of Secretaries of
Departments of Health Research and Health and Family Welfare on the issues arising out of the
final report of the Committee appointed to enquire into “Alleged irregularities in the conduct of
studies using Human Papilloma Virus (HPV) by PATH in the country”. The Secretary, Department
of Health Research, in his deposition, admitted before the Committee that the trials of the vaccine
were not conducted by PATH according to the required protocol/guidelines in Andhra Pradesh. He
admitted flaws in ethical procedure in conducting the tests such as lack of proper consent from
the parents etc. He further stated that new guidelines are being issued and a moratorium has been
imposed on further trials till guidelines are issued. The Members raised some queries like how far
it was ethically correct for ICMR to go into Private Public Partnership (PPP) mode, faulty design
of project; differences between ICMR and DCGI with respect to the project, action taken against
the person involved; sale of this vaccine even before it was tested. The Members also enquired
as to why the said enquiry report has not been posted on the website of the Ministry. The
Secretary, Department of Health and Family Welfare submitted before the Committee that show
cause notice of 15 days has been issued to PATH to seek its written views on the issue and action
will be taken within three months after the reply of PATH is received. Members also raised queries
like sources and magnitude of funding of this project, compensation to the affected parties and
blacklisting of PATH, etc. which were partly answered. The Committee directed the witnesses to
furnish written replies to queries which remained unanswered.
7. The Committee then adjourned at 3.30 P.M.

31
XII
TWELFTH MEETING
(2012-13)
The Committee met at 12.00 (NOON) on Friday, the 24th May, 2013 in Committee Room ‘A’,
Ground Floor, Parliament House Annexe, New Delhi.
MEMBERS PRESENT
RAJYA SABHA
5. Shri D. Raja
6. Shri H.K. Dua
LOK SABHA
8. Shri Kirti Azad
9. Shri Mohd. Azharuddin
14. Shri Tarun Mandal
16. Shri Harin Pathak
18. Dr. Raghuvansh Prasad Singh
SECRETARIAT
WITNESSES
Department of Health Research
1. Dr. V. M. Katoch, Secretary
2. Dr. D. K. Shukla, Scientist-F
3. Dr. Tanveer Kaur, Scientist-D
31
32
Department of Health and Family Welfare

Dr. G. N. Singh, Drug Controller General of India
I. Opening Remarks
2. At the outset, the Chairman welcomed Members of the Committee and apprised them of the
agenda of the meeting, i.e., to hear the Secretary, Department of Health Research along with the
Drug Controller General of India (DCGI) on the Action Taken on the final report of the Committee
appointed by the Government of India to enquire into “Alleged irregularities in the conduct of
studies using Human Papilloma Virus (HPV) vaccine” by PATH in India. * * *
II. Oral Evidence of the Secretary, Department of Health Research and DCGI on the
final report of the Committee appointed by the Government of India to enquire
into”Alleged irregularities in the conduct of studies using Human Papilloma Virus (HPV)
vaccine” by PATH in India
3. Thereafter, the Committee heard the Secretary, Department of Health Research on the
Action Taken on the final report of the Committee appointed by the Government of India to enquire
into”Alleged irregularities in the conduct of studies using Human Papilloma Virus (HPV) vaccine”
by PATH in India. In his deposition, the Secretary, stated that in the year 2007, PATH had applied
for licence for trials which was approved in the year 2008 and trails were started on the tribal and
non tribal girls of Andhra Pradesh and Gujarat in the year 2009 to see the acceptance of the
vaccines. In the year 2010, five deaths in Andhra Pradesh and two deaths in Gujarat were reported.
Subsequent to the reported deaths an expert Committee was set up under the Chairmanship of Prof.
S.S. Aggarwal, PGIMER, Chandigarh, which in its Report submitted in February, 2011, found the
discrepancies in respect of: (i) consent forms and actual implementation of the consent process;
(ii) methods of monitoring of adverse effects/serious adverse effects and remedial measure for
such events; (iii) inclusion of vulnerable and tribal population groups; (iv) blurring of distinction
between National Immunization Programme and Path study; (v) insurance coverage for the study
participants; and (vi) convert inducement and indirect coercion etc. The Secretary, apprised the
Committee about the remedial action taken pursuant to the findings of the expert Committee.
However, members were not satisfied with the action taken by the Department.
4. The Drug Controller General of India, in his deposition, inter alia stated that during the
future trials for any vaccination, the following safeguards would be adopted: (i) consent form
would be transparent; (ii) consent would be in audiovisual format; (iii) clear guidelines have been
framed. He also informed the Committee that these guidelines are available on the website of the
Ministry. Further, he informed the Committee that in future strict emphasis would be laid on
enforcement and patient safety.
5. Thereafter, members raised queries on some issues including conduct of trail without
guardian’s approval; details of action taken, if any, against officials who had given approval to these
trials; absence of complete details of postmortem conducted on the subjects who had died during
the said trials; details of use of machinery of State Governments by PATH during the conduct of
the trials; whether the said trials were classified as ‘clinical trial’; non action on the findings of
the Expert Committee, etc. The Chairman directed the witnesses to send comprehensive written
replies to queries which remained unanswered, within a week’s time.
7. The Committee adjourned at 12.56 P.M.

33
XV
FIFTEENTH MEETING
(2012-13)
The Committee met at 4.00 P.M. on Thursday, the 29th August, 2013 in Committee Room
‘A’, Ground Floor, Parliament House Annexe, New Delhi.
MEMBERS PRESENT
RAJYA SABHA
3. Shri Mohd. Ali Khan
4. Shri H.K. Dua
LOK SABHA
5. Shri Kuvarjibhai M. Bavalia
7. Mohd. Asrarul Haque
11. Shri P. T. Thomas
SECRETARIAT
* * *
I. Opening Remarks
2. At the outset, the Chairman welcomed the Members of the Committee and apprised them
of the agenda of the meeting, i.e., * * * and consider and adopt draft Seventy-second Report on
“Alleged irregularities in the conduct of studies using Human Papilloma Virus (HPV) vaccine by
PATH in India.”
* Relates to other matters.
33
34
II. Adoption of the Draft Report on “Alleged irregularities in the conduct of studies
using Human Papilloma Virus (HPV) vaccine by PATH in India.”
3. The Committee then considered and discussed the draft Seventy-second Report on “Alleged
irregularities in the conduct of studies using Human Papilloma Virus (HPV) vaccine by PATH in
India.” The Chairman invited Members to share their specific suggestions for incorporation in the
Draft Report. After some discussion, the Committee adopted the Report with some modifications.
4. The Committee, thereafter, decided that the Report may be presented to the Rajya Sabha
and laid on the Table of the Lok Sabha on Friday, the 30th August, 2013. The Committee authorized
its Chairman and in his absence, Shri Shri H.K. Dua and Shri Jagat Prasad Nadda to present the
Report in Rajya Sabha, and Shri Sanjay Jaiswal, and in his absence, Dr. Anup Kumar Saha to lay
the Report on the Table of the Lok Sabha.
II. * * *
3. * * *
4. * * *
6. The Committee adjourned at 5.00 P.M.
35
ANNEXURES
ANNEXURE-A
Committee to investigate “Alleged irregularities in conduct of

studies in India using Human Papilloma Virus (HPV) vaccine”
Minutes of the 5th Meeting held on September 27th at the Indian Red Cross Society, (NHO), New Delhi
1. All members of the committee were present. In addition the Experts nominated to assist the
committee vide GO no. V.250II/160/20IO-HR dated June 30th, 2010 were also invited to
attend the meeting.
2. The minutes of the meeting dated June 22nd, 2010 as circulated were adopted.
3. The Experts were requested to present salient findings of their reports and the members
discussed with them their findings. A summary of the discussions is as follows:
(a) Dr. Rani Kumar, Dean, AIIMS –
(i) She was requested to carry out numerical analysis of the consent forms – under
headings already identified – separately for the AP and Gujarat. (Action: Dr. Rani
Kumar)
(ii) She requested the list of members of the two ethics committees at AP and
Gujarat. In particular she asked about the membership of a lawyer in the
committee. She also asked about the functioning of these committees – the
number and dates of meetings, and any monitoring of the PATH study prior to
repots in the Press. (Action: Dr. Kishore Chaudhry)
(iii) Opined that the trial in adolescent girls was justified as this is the target group
to benefit, but authorization of school authorities by the AP Govt. to give consent
on behalf of the girls was not correct. Also, implementation of the procedure of
taking consent lacked rigor.
(b) Dr. Y.K. Gupta, HOD Pharmacology, AIIMS – made the following points:
(i) Bridging trials in India, as required under Schedule Y for drugs/vaccines already
approved and in use abroad, for licensing in India were carried out as required.
One of the studies was in Adults and the other one was in adolescent girls.
(ii) The DCGI has licensed the GSK HPV vaccine Cervarix for “ .... females from
10-45 years of age for prevention of cervical cancer. ... ”, and MSD vaccine
Gardasil for “ .. girls and women 9-26 years of age for prevention of cervical
cancer ...”
(iii) There is wide international experience, including that in India, regarding use of
HPV vaccines in adolescent girls.
(iv) HPV vaccines are quite safe. Millions of doses of HPV vaccines of both types
have been used abroad. By the end of May, 2010, there were 16, 410 VARES
reports of AE following Gardasil vaccination licensed in the US in 2006. 8% of
these have been considered serious, including syncope, GB syndrome, blood clots,
and anaphylaxis. A total of 53 deaths have been recorded following vaccination
37
38
but they do not seem to be related to the vaccine. The use of the vaccine
continues all over the world. Several countries have incorporated it in their
national programmes.
(v) Both the GSK and MSD have submitted the required Periodic Safety Update
Reports to the DCGl. These are international reports, and not India specific.
There has been some delay in submission of these reports. The last six monthly
report for 18th November to 17 th May, 2010 which should have covered the
reports the deaths from India has not been submitted yet.
(vi) A critical analysis of the First Information Reports of SAE/Deaths, Medical
records related to these events and the Post-mortem reports do not support the
possibility of deaths to be related to vaccine but it can not be ruled out with
certainty. This was mainly because the alternate cause of death as listed can not
be fully substantiated on the basis of medical records in all the cases. The quality
of the medical records was not adequate. The capability of the local staff and
preparedness to deal with SAEs/Critical illnesses leading to death is also suspect.
Most of the deaths were detected when the ANMs were mobilizing the recipients
for the next vaccination. These events were not reported and investigated timely.
In most cases the treatment was provided by private medical practitioners and the
subjects had to be shifted to a better facility while they died on the way. There
was no plan to deal with the crisis as it emerged.
(vii) There is a strong need to strengthen the post-licensing surveillance.
(c) Dr. A.K. Dutta, Head of Pediatrics, Kalavati Saran Hospital, New Delhi –
(i) Dr. Dutta focused on analysis of Deaths and AE, both serious and minor, under
the HPV vaccination project carried out in AP and Gujarat, by PATH in
collaboration with the respective State Governments.
(ii) Dr. Dutta highlighted that the Primary Outcome measures of the project were:
– Number and percent of eligible girls fully vaccinated, partially vaccinated or
not vaccinated at all according to vaccine delivery strategy
– Number and percent of vaccinated girls experiencing serious adverse events,
as reported spontaneously through routine mechanisms of UIP programme
– Number and percent of vaccinated girls experiencing non-serious adverse
events, as reported spontaneously through routine mechanisms of UIP
programme
– Timelines of reporting serious adverse events to local, state and National
authorities, as per the usual UIP protocol and
– Timelines of reporting non-serious adverse events to local, state and National
authorities, as per the usual UIP protocol
(iii) Since 4 out of the 5 outcome measures related to monitoring and reporting of AE
the project should not have totally relied on the existing UIP AEFI reporting
system. There should have been a parallel research based monitoring system for
AEFI to compare with the State system. Alternatively the effectiveness of the
State system should have been pre-verified before initiating the study.
(iv) Dr. Dutta found that 3 of the 7 deaths have occurred within 30 days of last
vaccine dose (one in AP and 2 in Gujarat, on days 18,20 and 23), while 4 were
after this period (45,49,96,97 days after the vaccine).
39
The ones within 30 days have been attributed to Fever of unknown origin - ?
Viral, Malaria and Snake bite. Two of the 4 later deaths were attributed to
Pesticide poisoning. In both cases post-mortem has been done and chemical
report on record has confirmed presence of the poison in stomach.
In one case there was history of drowning in a pond. The fourth case has died
after a brief illness of few hours, probably neurological ? Intracranial hemorrhage/
Intracranial space occupying lesion.
Dr. Dutta’s observation was that – 1. There was no specific pattern of illness
leading to death, 2. The illnesses can not be explained by expected adverse
responses to vaccine, and 3. There was an alternate plausible diagnosis in most
cases. Therefore, the deaths were unlikely to be related to the vaccine. However,
post-mortem has been carried out only in 2 cases. And the alternate diagnosis is
not confirmed in all the cases.
(v) Further a critical analysis of the reporting of other AE and SAE shows the
inadequacies of the AEFI reporting system. Dr. Dutta was of the opinion whether
it was an observational study or otherwise the vaccine was administered to the
subjects and data collected for enerating knowledge. It should have followed all
the rigors of the research.
4. The committee deliberated on the reports of the Experts and pertinent data received under
various queries raised during previous meetings of the committee. Besides the factual
information about the terms of reference the committee was greatly concerned with the
aspect of commercial interests of manufacturers influencing the Government policy on this
expensive vaccine. The committee observed that the study was initiated by PATH on its
own having obtained funds from the Bill and Melinda Gates Foundation and supply of
vaccine from the manufacturers – without any reference from the NTAGI, the official body
of the GOI on vaccines. It is not clear whether the State expenses were funded by PATH
or came from their own resources. The monetary contribution of ICMR is also not clear.
The committee therefore felt that it would be in the fitness of the inquiry to document the
sources and magnitude of funding of the study. It desired to obtain the following
information from the PI, i.e. PATH in this case:
(i) Letter of Sanction of grant form Bill and Melinda Gates foundation for Indian
study
(ii) Letter of donation of vaccine by the manufacturers and the invoice indicating the
cost of the vaccine for trial in India
(iii) Copies of the letters of PATH to ICMR and State Government, including the terms
and conditions of collaboration
(iv) Financial contribution of the 3 parties to the study, viz., the PA TH, ICMR and
the State Governments from beginning till date
Action: Dr. Kishore Chaudhry
5. The committee noted the urgency to submit the report. Since most of the facts have been
gathered and analyzed, including the critical input of the experts, it decided to expedite the
finalization of the report. Since there was consensus on all issues among the members, the
committee authorized the chairman to prepare the draft report which may be circulated to
all the members and then finalized in a meeting called for the purpose. In the meantime the
additional information as identified above may also be collected. The next meeting could be
held in about 2 week time. (Action: Chairman)
40
ANNEXURE-B
Government of India Hkkjr ljdkj

Ministry of External Affairs fons’k ea=ky;] ubZ fnYyh
New Delhi the_____________200
No.AA/551/1/2011 Dt. 11th June, 2012.
OFFICE MEMORANDUM
Sub: Clinical Trial of HPV Vaccine – regarding
Reference O.M. No. RS.10/2(ii)/2011-Com. (H&FW) dated 4th June, 2012 from the
Parliament of India, Rajya Sabha Secretariat, New Delhi, on the subject mentioned above.
2 As per the existing procedure, the clearance of the Ministry of External Affairs
from Political angle is required before any foreign organisation/charity/foundation etc. sets
up an office/branch in India. The concerned foreign entity may approach this Ministry
with a detailed proposal, to be routed through the concerned nodal Ministry in India, for
processing and issue of above Political clearance.
Sd/-
(R.K. Nagpal)
Deputy Secretary (Coord)
Parliament of India
Rajya Sabha Secretariat,
[Kind Attn: Ms. Arpana Mendiratta, Joint Director],
Parliament House/Annexe,
New Delhi. Telefax: 23035428
23012007
40
41
ANNEXURE-C
No.II/20034/280/2012-IS-II
Government of India
Ministry of Home Affairs
IS-I Division, (IS-II Desk)
New Delhi, the 5th July, 2012
Office Memorandum
Subject:– Parliamentary Standing Committee on Health and Family Welfare –

clinical trial of HPV Vaccine and related matters – furnishing of
information to the Committee.
The undersigned is direacted to enclose a copy of Rajya Sabha Secretariat O.M

No.RS.10/2(ii)/2011-Com.(H&FW) dated 21st June, 2012 along with a copy of earlier D.O.
letter dated 4th June, 2012 regarding clinical trial of HPV Vaccine on the subject noted
above and to state that Department of Economic Affairs is the concerned Administrative
Ministry for “setting up of the Liaison Offices/Branch Offices/Project Offices in India by
foreign entities”. As such, laying down the procedure/rules/guidelines etc. for setting up
of such offices falls within the ambit of DEA.
2. Department of Economic Affairs seeks MHA’s comments from security angle on the
applications received from various firms for setting up of the Liaison Offices/Branch
Offices/Project Offices in India by foreign entities. As such, Ministry of Home Affairs
assesses the suitability of the applicant company from security angle.
3. Further, a draft Circular proposed by RBI and forwarded by DEA containing

additional reporting feature by foreign entities for implementing additional security
safeguards is under consideration in this Ministry.
4. In view of foregoing, the above Rajya Sabha Secretariat O.M. dated 21st June, 2012
along with its enclosures is transferred to Department of Economic Affairs for giving a
suitable reply to Rajya Sabha Secretariat, under intimation to this Ministry.
Sd/-
(Rakesh Mittal)
Director (IS-I)
Department of Economic Affairs,

(Shri R.K. Sinha, Under Secretary),
North Block, New Delhi.
Copy for information to: Rajya Sabha Secretatiat (Ms. Arpana Mendiratta, Joint
Director), Parliament House Annexe, New Delhi-110001.
41
Printed at : Bengal Offset Works, 335, Khajoor Road, Karol Bagh, New Delhi-110005.

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REPORT NO.

DEPARTMENT-RELATED PARLIAMENTARY STANDING COMMITTEE

SEVENTY SECOND REPORT

Alleged Irregularities in the Conduct of Studies using Human

Rajya Sabha Secretariat, New Delhi

DEPARTMENT-RELATED PARLIAMENTARY STANDING COMMITTEE

SEVENTY SECOND REPORT

Alleged Irregularities in the Conduct of Studies using Human

(Presented to the Rajya Sabha on 30th August, 2013)

Rajya Sabha Secretariat, New Delhi

1. COMPOSITION OF THE C OMMITTEE ......................................................................................... (i)-(vi)

Composition of the Committee (2009-10) .................................................................. (i)

2. PREFACE .................................................................................................................................. (vii)-(viii)

3. ACRONYMS .............................................................................................................................. (ix)-(x)

4. R EPORT ................................................................................................................................... 1—19

(I) Background ................................................................................................................ 1—3

(II) Nature of Project ...................................................................................................... 3—4

(III) Role of Department of Health Research/ICMR .................................................... 4—7

(IV) Role of Drug Controller General of India ............................................................. 7—8

(V) Marketing Approval to HPV Vaccine in India ....................................................... 8—9

(VI) Inquiry Committee ..................................................................................................... 9—16

(a) Composition and Terms of Reference ....................................................... 9

(b) Conflict of Interest ....................................................................................... 9—10

(c) Adverse Events Reporting ............................................................................ 10

(d) Informed Consent ......................................................................................... 11—13

(e) Role of Ethics Committees .......................................................................... 13

(f) Use of Official Machinery ........................................................................... 13—14

(g) Action taken on the Inquiry Committee Report ....................................... 14—16

(VII) Programmes for Appropriate Technology in Health (PATH) .............................. 16—19

5. OBSERVATIONS/RECOMMENDATIONS — AT A GLANCE .......................................................... 20—24

6. MINUTES ................................................................................................................................. 25—34

7. ANNEXURES ............................................................................................................................. 35—41

I, the Chairman of the Department-related Parliamentary Standing Committee on Health and

(i) Background note received from the Ministry;

7. For facility of reference and convenience, observations and recommendations of the

30. NTAGI – National Technical Advisory Group on Immunization

II. NATURE OF PROJECT

III. ROLE OF DEPARTMENT OF HEALTH RESEARCH/INDIAN COUNCIL OF MEDICAL

IV. ROLE OF DRUG CONTROLLER GENERAL, INDIA (DCGI)

V. MARKETING APPROVAL TO HPV VACCINES IN INDIA

VI. INQUIRY COMMITTEE

(a) Composition and Terms of Reference

(b) Conflict of Interest

(c) Adverse Events Reporting

(d) Informed Consent

(e) Role of Ethics Committees

(f) Use of Official Machinery

(g) Action taken on the Inquiry Committee Report

(iii) Inclusion of vulnerable and tribal population groups;

VII. PROGRAMME FOR APPROPRIATE TECHNOLOGY IN HEALTH (PATH)

II. NATURE OF PROJECT

III. ROLE OF DEPARTMENT OF HEALTH RESEARCH/INDIAN COUNCIL OF MEDICAL

IV. ROLE OF DRUG CONTROLLER GENERAL, INDIA (DCGI)

VI. INQUIRY COMMITTEE

(c) Adverse Events Reporting

(d) Informed Consent

VII. PROGRAMME FOR APPROPRIATE TECHNOLOGY IN HEALTH (PATH)

* Relate to other matters.

* Relate to other matters.