September 3, 2013
Report points to a serious dereliction of duty by many of the institutions involved
Health activists have appreciated the Parliamentary Standing Committee’s report on the “Alleged Irregularities in the Conduct of Studies Using Human Papilloma Virus (HPV) Vaccine by PATH in India.” They commended “its candid, transparent contents, which reflect the committee’s acknowledgement of the unethical nature of the HPV trials’’ conducted in the country.
In the trials, Program for Appropriate Technology in Health (PATH), with the support of Bill and Melinda Gates Foundation (BMGF), approval from the Western Institutional Review Board (WIRB) [all three private international parties], donations from Merck Sharp and Dohme (MSD) and Glaxo SmithKline (GSK), in partnership with Indian Council of Medical Research (ICMR) and along with the governments of Andhra Pradesh and Gujarat, through the national vaccination programme, delivered and administered HPV vaccines to 10-14-year-old girls in Khammam (A.P.) and Vadodara (Gujarat) districts.
The committee’s findings are wide-ranging: the nature of the project, the role of ICMR, the role of the Drugs Controller General of India (DCGI), the Informed Consent Process, the role of Ethics Committees (EC), the process of inquiry committee formation and function and the role of PATH.
The report points to a serious dereliction of duty by many of the institutions involved. In particular, it questions the role of the ICMR, DCGI, EC members and PATH.
The committee clearly stated that the demonstration project was a clinical trial, no matter what PATH called it.
The report said, “The demonstration project is a study of a pharmaceutical product carried out on humans and since the primary objective includes the study of serious adverse events, it is clear that clinical trial rule should apply.”
A statement issued jointly by Jan Swasthya Abhiyan, Sama – Resource Group for Women and Health, and LOCOST / All India Drug Action Network said PATH, by carrying out clinical trials on the pretext of observation/demonstration project, has violated all laws and regulations laid down for clinical trials by the government.
Though, the committee brought up insurance to the girls, it has not mentioned the compensation in its report from the sponsor or an ex-gratia to the parents of the girls who died after the administration of the trial, the statement said, while demanding that the parents and children be compensated for the grave violations of their rights, as clearly informed consent was not taken from a large number of parents and no assent was taken from the girls who were given the HPV vaccine, and no follow-up or proper management of adverse events and serious adverse events during the trial was done.
“We welcome the recommendations and sincerely hope the contents and recommendations of the 72nd report by the Parliamentary Standing Committee will be acted upon, that there will be concrete early follow-up and outcomes of the committee’s observations and recommendations,” the statement said.
Reacting to the report, PATH said it was troubled by the report’s “inaccurate characterisation of this important work.”
“PATH, a non-profit organisation, is committed to meeting the highest scientific, ethical, and legal standards in our work and to contributing our experience and expertise to address the burden of cervical cancer through transformative innovations such as vaccines, a statement issued by it said.
“The demonstration project in India was part of a four-country project to explore suitable vaccine delivery strategies and help provide evidence for national health authorities to make informed decisions about the potential benefits and challenges of introducing vaccines against HPV, the primary cause of cervical cancer,’’ the statement said.
PATH said ICMR reviewed and approved the protocol for this project, including its design and methodology. At the time of its review, the ICMR determined the project was a post-licensure observational study and not a clinical trial.
“The project did not seek to evaluate the efficacy or long-term safety of the vaccines, which had undergone clinical evaluation in India and had been licensed and approved by the Drugs Controller General of India.’’
ICMR’s view was crucial, as it established the approval processes and protocols for the work that followed. PATH designed the project protocols in compliance with ICMR’s instructions and fully complied with ICMR’s requirements regarding the necessary approval processes and the requirements of the State governments regarding consent processes, according to the statement.
“We believe that by following the guidance provided by ICMR, as well as the two State governments and three ethical review committees, we designed a project that met or exceeded the country’s existing regulatory standards for demonstration projects while providing the greatest health benefit to Indian women,’’ PATH said.
We greatly appreciate and welcome the 72nd Parliamentary Standing Committee on Health and Family Welfare’s Report on the “Alleged Irregularities in the Conduct of Studies Using Human Papilloma Virus (HPV) Vaccine by PATH in India” that was presented in the Rajya Sabha and laid on the table in the Lok Sabha on30 August 2013. Indeed it is an extraordinary report and we commend its candid, transparent contents, which reflect the Committee’s acknowledgement of the unethical nature of the HPV trials conducted in the country. According to this 72nd report, the Parliamentary Standing Committee has been looking into the issue of HPV trials on children in Andhra Pradesh (Khammam district) and Gujarat (Vadodara district) since April 2010 following reports of deaths of some of the children.
In the HPV trials, Program for Appropriate Technology in Health (PATH) with the support of Bill and Melinda Gates Foundation (BMGF), with approval from the Western Institutional Review Board (WIRB)[all three private international parties], with donations from Merck Sharp and Dohme (MSD) and Glaxo SmithKline (GSK)and in partnership with Indian Council of Medical Research (ICMR), with the machinery of the State governments of Andhra Pradesh and Gujarat, through the National vaccination programme, delivered and administered HPV vaccines to 10-14 year old girls in Khammam (AP) and Vadodara (Gujarat) districts.
The Committee’s findings, endorsed by MPs from all political parties, are wide-ranging: the nature of the project, the role of ICMR, the role of Drug Controller General of India (DCGI), the Informed Consent Process, the role of Ethics Committees (EC), the process of inquiry Committee formation and function and the role of PATH. The Committee report points to a serious dereliction of duty by many of the institutions involved. In particular, it questions the role of the ICMR, DCGI, EC members and PATH.
Nature of Project: The Parliamentary Committee clearly stated that the demonstration project was a clinical trial, no matter what PATH called it. The report further states, “the demonstration project is a study of a pharmaceutical product carried out on humans and since the primary objective includes the study of serious adverse events, it is clear that clinical trial rule should apply”.
PATH by carrying out the clinical trial on the pretext of observation/demonstration project has violated all laws and regulations laid down for clinical trials by the Government of India.
Role of ICMR: The Committee questions the role of ICMR in the entire trial. Section 3.10. of the report states, “unable to understand as to how ICMR could commit itself to support the use of the HPV vaccines in an MOU signed in 2007 even before the vaccine was approved for use in the country. The Committee questions the decision of ICMR to commit itself to promote the drug for inclusion in the UIP even before any independent study about its utility and rationale of inclusion in the UIP was undertaken.
The Committee observes that ICMR representatives, instead of ensuring highest levels of ethical research standards in research studies, apparently acted at the behest of PATH who was promoting the interest of manufacturers of the HPV vaccine.
The Role of DCGI: Report section 4.3: “The Committee examination has proved that DCGI has played a very questionable role in the entire matter. The DCGI has remained as a silent spectator thereafter even when its own rules and regulation were being so fragrantly violated the approvals of the clinical trials, marketing approvals and import licenses by DCGI. Therefore the role of DCGI in this entire matter should also be enquired into”.
Conflict of Interest: The Committees ought information from the MOHFW as to whether the members of the Inquiry Committee were asked to file a conflict of interest declaration. To this the Ministry had responded that no written conflict of interest declarations were sought from the core members of the inquiry Committee as well as experts. The Committee picked just one member of the Committee from AIIMS and found that MSD, the manufacturer of HPV vaccine Gardasil, was sponsoring and funding the trial in the member’s department. This demonstrates a serious conflict of interest of this member of the inquiry Committee. The Committee has strongly deprecated the government for appointing the 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 have any conflict of interest with the subject matter of inquiry.
The report also observes that ICMR representative “instead of ensuring highest levels of ethical standards in research studies, apparently acted at the behest of PATH in promoting the interest of the manufacturers of the HPV vaccine”.
The Committee report 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.”
The Committee takes a serious view of the violations and strongly recommends that on the basis of the facts, PATH should be made accountable and the Ministry should initiate appropriate action in the matter including taking legal action against PATH for breach of various laws of the land and possible violation of laws of the country of its origin.
The Committee, therefore, recommends that every effort should be made to expedite the report Committee so that real facts about the HPV vaccine trial are made known without any further delay and collective measures, not only in respect to this trial, 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 foolproof system for pre-empting unethical research studies. The Committee has taken serious note of the fact that both the Ethics Committees were registered only as a formality and they did not play their designated role, a clear dereliction of their duty.
The Committee states that the act of PATH is a clear cut violation of the human rights of these girl children and adolescents and is a serious breach of medical ethics. The Committee recommends that “the National Human Rights Commission (NHRC) and National Commission for Protection of Children Rights (NCPCR) may take up this matter further from the point of view of violation of human rights and child abuse”.
Though, the Committee brought up the Insurance to the girls it has not mentioned the compensation in its report from the sponsor or an ex gratia to the parents of the girls who died following the administration of the trial. We demand that the parents of the girls who died and the children must be compensated for the grave violations of their rights, as clearly informed consent was not taken from a large number of parents of the girls and no assent was taken from the girls who were given the HPV vaccine, and no follow up or proper management of adverse events and serious adverse events during the trial was done. The Committee report also does not mention on the funding from Gates and other sources; and money spent by ICMR and state governments.
We welcome the recommendations and sincerely hope that the contents and recommendations of the 72nd report by the Parliamentary Standing Committee will be acted upon, that there will be concrete early follow up and outcomes of the Committee’s observations and recommendations. We also hope that the extremely critical insights and recommendations by the Committee will not be sidelined, only to set up further committees without substantive, concrete action.
Sama Resource Group for Women & Health
Jan Swasthya Abhiyan
All India Drug Action Network
Drug Action Forum Karnataka
Date: 2 September 2013
Please find below the link to the SEVENTY-SECOND PARLIAMENTARY STANDING COMMITTEE REPORT ON “ALLEGED IRREGULARITIES IN THE CONDUCT OF STUDIES USING HUMAN PAPILLOMA VIRUS (HPV) VACCINE BY PATH IN INDIA”
Tuesday, 13 August, 2013, 10:37am
Western celebrities such as Elton John and Nicole Kidman have used surrogates to fulfil their desire for parenthood. Now with two of Bollywood’s biggest stars, Shah Rukh Khan and Aamir Khan, and their wives having taken the same route, surrogacy has gained some respectability, if not a hint of trendiness, in India.
While it still carries considerable stigma in the country, the celebrities’ choice has eased the way for other couples to do the same.
Even so, critics say the practice is prone to abuse because of the lack of regulation and the severe wealth gap there.
Aamir Khan surprised India when he and his wife, film director Kiran Rao, announced in 2011 that their baby son, Azad, was born to a surrogate. The actor already had children from his first marriage, but Rao opted for surrogacy as a “last resort” after suffering a miscarriage.
“The publicity around their case helped to clear up a lot of misconceptions. They made it seem like a perfectly acceptable way of bringing a baby home. That’s the power of celebrity,” says Dr Kaberi Banerjee, a fertility specialist in New Delhi.
Then, in May this year, Shah Rukh Khan and his wife, Gauri, announced that after trying to have a child for two years, their baby son, AbRam, had been born in Mumbai to a surrogate. The couple have two other children.
Surrogacy is a US$2.3 billion business in India. Its established medical infrastructure, coupled with a surfeit of poor women desperate to earn some money by renting their wombs, have turned the country into a preferred destination for childless couples from around the world looking for a low-cost, straightforward way of becoming parents.
But because the procedure is unregulated, it’s open to malpractice. A study by the Centre for Social Research in New Delhi last year found that most of the 100 surrogate mothers interviewed did not understand the procedure or the contract they signed with commissioning parents and fertility doctors.
While awaiting the births, they are often forced to live in guarded homes and given only limited access to their families.
“We found that 60 per cent were illiterate. That means they are easy to exploit because they won’t understand the possible medical complications,” says the centre’s director, Dr Ranjana Kumari.
Other controversies surround the process, including issues of gender selection and caste.
A survey last year by the Delhi women’s group Sama showed Indian couples were prepared to pay more for a light-skinned surrogate from the right caste.
The survey said couples often used the same adjectives to describe the kind of surrogates they wanted as those used in matrimonial ads – fair, beautiful, high caste.
“Indians are obsessed with religion, caste and fair skin. Even when they are told that the baby won’t have any of the surrogate’s characteristics, they still feel that some mingling of blood and tissue in the womb will affect the outcome,” says Deepa Venkatachalam, Sama’s programme co-ordinator.
But Dr Naina Patel, who runs a fertility clinic in Ahmedabad, says most commissioning parents simply want the surrogate to be healthy.
“They sometimes ask about the caste, but their main concern is that she be healthy and follow a healthy diet while carrying the baby,” Patel says.
But in what is manifestly an unequal relationship, it is the commissioning parents who call the shots and set the conditions. Surrogate mothers are usually too poor and powerless even to demand the right to be with their families during the pregnancy.
Women’s groups point out that this inequality extends to the spousal relationship. When the fee is paid, it is usually the husband who decides how to spend it.
“In some cases, he uses it to pay off a loan, just fritters it away or starts some ill-conceived business which fails. The woman often has no say,” says Brinda Karat, a Communist Party politician and women’s activist.
That is why many surrogates, such as Sangita Rana, offer their wombs a second or third time.
“My husband started a business selling packed meals to office workers. It failed, and he lost the money I made from having a baby. So I’m here to do it again,” Rana says while awaiting a check-up at the Delhi Research Centre.
Fearing being ostracised, they carefully hide this arrangement. “My husband tells our relatives that we are moving for a year because of his job. They would refuse to speak to us if they knew what I do,” Rana says.
So, while becoming a parent by surrogacy is losing its stigma for celebrities, earning money this way is still a disgrace.
This article appeared in the South China Morning Post print edition as Womb service
August 1, 2013 10:19 IST
Against concerns of lack of clarity and sufficient protection for surrogate mothers in the draft ART Bill, 2010, the Planning Commission is set to appoint a committee for wider consultations
The Centre will set up an expert committee for wider consultations on the draft Assisted Reproductive Technologies (ART) Bill, 2010. The committee will deliberate upon very “grave and critical” concerns raised by stakeholders and explore possible ways to address these issues.
The decision was taken after the Planning Commission recommended substantive changes in the legislation and advised the Indian Council for Medical Research (ICMR) against pushing the draft Bill till the process of consultations was satisfactorily concluded.
The Planning Commission will coordinate the process of forming and facilitating this committee towards developing an efficient regulatory framework and legislation. This comes after a meeting convened by the plan panel with stakeholders in the Capital earlier this week who made a pitched demand for setting up an expert committee to look into some of the provisions of the Bill, according to Sama, a non-governmental organisation working on women’s health.
Sama has been engaged in Assisted Reproductive Technologies and commercial surrogacy, through research, advocacy, and creation of resources (including a recent film on surrogacy) over the past eight years.
The outfit was invited by the Planning Commission as part of their Civil Society Window initiative to present its views on commercial surrogacy in India. The meet, chaired by Dr. Syeda Hameed, Member, Planning Commission, was attended by representatives from the Planning Commission, Union Ministry of Health and Family Welfare, ICMR, Union Ministry of Law and Justice, the National Commission for Protection of Child Rights (NCPCR), and Office of the Registrar General of India, amongst others.
The discussion flagged concerns with regard to the unregulated industry, unethical practices, especially lack of protection of the surrogate women’s health and rights, sex selection, lack of employment opportunities, and other health and rights issues of children born through surrogacy arrangements, and issues related to their citizenship.
Given the presence of Dr R.S. Sharma (member secretary Drafting Committee of the Draft ART Bills 2008 and 2010), the deliberations focused on the content and provisions of the Bill. The “short-sightedness” of some of the provisions, the absence of sufficient protection for surrogate women and in general the lack of transparency, consultative processes involving domain experts, including organisations in the drafting of the Bill, and lack of clarity on nodal authority, were issues raised by the members.
The ART Bill has been hanging fire since 2008 when the first draft was prepared. It was revised in 2010 but is yet to get a final approval from the Union Law Ministry following which it will go to the Cabinet for clearance.
Commercial surrogacy is a multi-million dollar industry in India but there is no legislation to regulate surrogacy which is resulting in exploitation of poor women who offer their wombs for a price without realising the adverse health impacts.
Health activists feel that the ART draft Bill is designed to regularise and promote the interest of the providers (mainly the private sector) of these technologies rather than regulate and monitor the current practices. The Bill is also inadequate in protecting and safeguarding the rights and health of the women who undergo these ART procedures, surrogates, egg donors and of the children born through these techniques.
In the context of surrogacy, the draft Bill at present constructs surrogacy as an isolated problem and proceeds to resolve conflicts engendered by the practice, a perspective that is in favour of the industry. The surrogacy industry, in effect, seeks to open up the market by removing any legal impediments in its smooth functioning. It is also decidedly in favour of commissioning parents, Sama points out.
“Lack of transparency from ICMR on this ART Bill is quite known to us for many years. We were appalled to learn that ICMR has again revised the draft Bill 2010 which we came to know only at the Planning Commission (the 2012 ART Bill is not on the ICMR website). The Ministry and ICMR have never made an effort to have any consultation on this Bill with women’s rights, child rights, health rights and legal rights organisations,” activists said while hoping that the Planning Commission meeting would lead to some positive outcome towards greater civil society participation.
Abantika Ghosh : New Delhi, Thu Aug 08 2013, 09:09 hrs
The directorate general of health services (DGHS) has proposed that the option of surrogacy should be available only to married, infertile couples of Indian origin.
The suggestions forwarded by DGHS Dr Jagdish Prasad to the department of health research rule out surrogacy options for foreigners, unless they are married to a person of Indian origin. The suggestions also say that a woman may become a surrogate mother only once in her lifetime.
The health ministry, which is engaged in a tussle with the Planning Commission on NGO consultations over a law to regulate the “infertility” industry, has circulated a cabinet note on the Assisted Reproductive Technologies (ART) Bill. The DGHS is an arm of the ministry.
According to a recent survey on surrogacy done by a Delhi-based NGO, foreigners made up 40 per cent of the clientele, and were inevitably those who paid the most. It is estimated that approximately 2,000 babies are born every year in India through commercial surrogacy. According to CII figures, surrogacy is a $ 2.3 billion industry in the country.
According to the NGO’s survey, surrogate women were forced to live in hostels away from their families for a few lakhs, a sum that they forfeited in case of complications or a miscarriage.
There were allegedly cases where more than one woman were made pregnant with a couple’s children to increase the chances of success. After a certain cut-off period, all but one were forced into a miscarriage without telling them.
The DGHS suggestions, coming on top of the health ministry’s disagreements with the Plan panel on whether and to what extent NGOs should be consulted, have further dimmed the chances of a Bill that has been in the works for over five years, making it to the cabinet anytime soon.
Planning Commission member Syeda Hameed said, “Organisations like SAMA have worked extensively in the field and have domain expertise.
We have decided to make a small core group of the commission to see how we can use that field knowledge to make valuable additions to the Bill.”
Sources said the ministry has been less than forthcoming in accepting the panel’s insistence on wider stakeholder consultations.
DGHS Prasad has also suggested that the potential surrogate mother would have to be aged between 25 and 35 years, and may not have more than two children of her own. The original note made surrogacy services available to individuals, which by extrapolation meant gay/lesbian couples could opt for it, but Prasad has suggested a far more narrow band of eligibility in which only married couples qualify.
ICMR deputy director general Dr R S Sharma, who is dealing with the ART Bill, said he had not received Prasad’s suggestions. “He has spoken to me on the issue but his written suggestions will come to me through the department of health research,” Sharma said.
Prasad declined to elaborate on his suggestions but said they were important to regulate the industry. “There is a lot of corruption right now, from the way women are exploited to how the babies are treated by the foreigners who take them. There is a need to make a foolproof law,” he said.
A paper by Sama, Health Insurance: Evaluating the Impact on the Right to Health (Working paper) based on a recently concluded study / review of CHI / SHI schemes in India, was disseminated. The findings of the study suggest the paucity of systematic reviews and comparative assessments undertaken to either test the assumptions underlying the expansion of health insurance across India or to examine the core contents of the right to health; they challenge claims of insurance as impacting equity, access, utilization, financial protection and quality. (Authors: Dr Anuj Kapilashrami and Deepa Venkatachalam).
Another paper, The Rashtriya Swasthya Bima Yojana (RSBY) experience in Chhattisgarh: What does it mean for Health for All? authored by Dr Madhurima Nundy (PHRN), Dr Rajib Dasgupta (JNU), Kanica Kanungo (PHRN), Sulakshana Nandi (PHRN and Chaupal) and Dr Ganapathy Murugan (PHRN) is being published by Sama.
The paper based on six studies of RSBY in Chhattisgarh questions the ‘tendency to pass off health insurance as Health for All’ and highlights the shortcomings in the design, constraints faced by public and private providers, and a range of beneficiary related issues. It discusses how the reach of RSBY is unfulfilled as a large proportion of the vulnerable population still remains out of its ambit due to low enrolment rates even as evidence of experience among those enrolled points to high out-of-pocket expenditures. Discussed in the frame the Right to Health, these issues gain further significance.
Notwithstanding the various issues that have emerged in the context of health insurance from different States of India, there are several questions to be asked What are the implications of RSBY like schemes for the health sector? Do they improve access and quality of care? What are the concerns about insurance schemes that are emerging from the country? Is health insurance, health for all?
The discussions will be in a mix of Hindi and English language. We look forward to your confirmation.
Workshop for Media Students in Delhi/ NCR
Sunday, 30th June 2013
10:00 am to 2:00 pm
Conference Room No. 2,
India Islamic Cultural Centre, Lodi Road, New Delhi
Issue in Focus: Come and participate in an interactive session on some key, topical issues vis-à-vis gender, health and rights with specific reference to gender based violence and and the role of the health system ( consent, care and medico legal issues), and Assisted Reproductive Technologies (IVF, etc.) commercial surrogacy (social, ethical and regarding regulation).
Duration and Format: This session is planned as a short introduction to these issues that we hope will contribute to your understanding and work their course of your study, research and practice or as future media professionals. It will be divided into two sessions which will include a documentary film screening, participatory exercises and discussion as the tools of learning and sharing.
For Whom: This workshop is primarily open for students of Media Studies, who are studying journalism, film making, and use of other kinds of media to tell stories, report on issues and make/ change public opinion through their work. There are some slots for other interested students also, especially students of sociology, gender studies, law, medicine, etc. Certificates of Participation will be given to all those who attend this workshop.
Please send us a paragraph expressing why this issue is important for you and how this workshop will help you. Registrations will close once we have a full house, so do send in your mails soon! We will send a confirmation of participation to selected students only due to space constraints.
Who we are: Sama has been working on issues of women’s health and rights for more than a decade, through action research, policy monitoring and advocacy, capacity building and knowledge creation and dissemination. To know more about our work please visit
Sama Resource Group for Women and Health, Delhi is happy to announce the release of,
1.‘Birthing a Market’, a report on the study on commercial surrogacy undertaken by Sama. The study analyses the perspectives of various actors, surrogates, agents, doctors and commissioning parent, involved in the industry and the arrangements to establish the position of the surrogate in the arrangement as well as the logics driving the industry. The research was conducted in Delhi and Punjab and captures the variations in the industry across the regions. The study does a careful analysis of the medical practice and the interests that influence it.
The context in which women are increasingly choosing to enter the industry as well as the various accompanying ideological tropes in practice are highlighted to better understand their choices and unearth the ways in which the arrangements embody both relations of domination as well as possible subversion. The study brings to fore a critique of the practice by raising questions regarding women’s work, the public health system in India and medical ethics in private health care. This critique is situated within the debates of women’s autonomy and organization of care in the current political economy of a transnational industry.
2.“CAN WE SEE THE BABY BUMP PLEASE?” is a 43 minutefilm on commercial surrogacy in India, that explores questions and concerns through the experiences of surrogate women. The film’s narrative traces the ethical challenges, medical malpractice, and potential exploitation that can occur when surrogacy is practiced in a legal vacuum, while also highlighting and understanding the interplay of surrogate women’s choices, contexts and compulsions.
Directed by Surabhi Sharma
Produced by Sama – Resource Group for Women and Health
Executive Producer- Magic Lantern Foundation
Funded by- UNFPA, India
For more details contact: