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Surrogacy industry thrives in India amid regulatory gaps

Surrogacy industry thrives in India amid regulatory gaps

http://www.livemint.com/Politics/1tiGqG9X9ChMt9Tb1pmNpM/Surrogacy-industry-thrives-in-India-amid-regulatory-gaps.html (First Published on THU, OCT 30 2014. 01 13 AM IST)

New Delhi: When Prime Minister Narendra Modi launched the “Make in India” campaign on 25 September, surrogacy would have been last thing on his mind. Now a leading fertility expert in the capital says she has been inviting couples—many of them foreigners—to “make in India” for years. “Our Prime Minister is knocking doors and inviting the world to come ‘Make in India.’ We are giving people a ‘make in India’ family,” said Rita Bakshi, an IVF (in vitro, or artificial, fertilization) expert. A register marked “surrogacy” lies on her desk in her well-appointed South Delhi office. Next to it is an Excel sheet tracking the health parameters of surrogates with Bakshi’s International Fertility Centre in Delhi. At any given time, she says, her clinic handles 100 to 150 surrogacy cases. She spoke as lawmakers prepare to debate a Bill aimed at regulating the commercial surrogacy sector, in the upcoming winter session of Parliament. India has an estimated 20-25 million infertile couples, for many of whom assisted reproductive technology (ART) represents a solution to their problem. For infertile foreigners and non-resident Indians (NRIs), ART in India is a relatively inexpensive proposition. For medical practitioners, it is a market opportunity with the number of IVF cycles creeping up from an estimated 7,000 cycles in 2001 to 85,000 in 2011. The number of clinics offering these services has shot up from 59 in 2001 to close to 600 by 2011. According to Bakshi, nearly 30-40% of couples who come to her are foreigners, 30% foreigners of Indian origin, and the rest Indians. According to Mumbai-based ART consultant Parikshit Tank, “the vast majority of surrogacy cycles are conducted for standard, well-established indications for Indian nationals”. Surrogacy is only one aspect of ART, yet it is the one that seems to get the most publicity—often for the wrong reasons. The shortcomings in India’s legal, yet unaccredited, unsupervised and unregulated commercial surrogacy sector came to light recently when an Australian couple was found to have abandoned one of their twin babies born to an Indian surrogate—apparently because they already had a child of the same sex. The incident came to light in an interview given by the Australian family court chief justice Diana Bryant, who had been informed of it by the Australian high commission in New Delhi. There is no information available about what happened to the child. This has added to an already heated debate about the rights of the child, the role of IVF clinics and the responsibilities of commissioning couples in India’s unregulated landscape of commercial surrogacy. Some rules are hard to fathom. For instance, guidelines allow single Indian parents to commission a surrogate. But single foreigners are excluded for some reason. “This inconsistency leads to a lot of confusion. We should allow couples who are legally allowed to adopt in their home country to commission surrogates here. While the administration is offering lifelong visas for PIOs (persons of Indian origin), we are in the process of shutting doors which were previously wide open,” said Bakshi, referring to surrogacy and the changing guidelines on who is eligible to be a parent and who is not. The government’s July 2012 guidelines say commissioning foreigners are required to have been married for at least two years before seeking a surrogate baby in India, thus shutting out foreign single parents and homosexual couples. In addition, commissioning foreign parents need a letter from their embassy in India or their foreign ministry stating that the country recognizes surrogacy and the baby will be allowed entry in the parents’ country as their biological child.

Regulatory issues

Commercial surrogacy has been allowed in India since 2002 but remains an unregulated grey area. In 2008 the Supreme Court said in a judgment that surrogacy as a medical procedure “is legal in several countries including in India”, without elaborating on what makes surrogacy legal. This was in the “Baby Manji Yamada” case in which the commissioning parents divorced during the pregnancy and the commissioning mother refused to accept the baby. The court finally granted custody to the baby’s grandmother. In 2008, another case, on the citizenship of surrogate babies led the Gujarat high court to state that there is “extreme urgency to push through legislation”, which addresses issues that arise out of surrogacy. A United Nations-backed study conducted two years ago estimates the surrogacy business in India to be worth more than $400 million a year, but civil society activists say the size of the market could well be more than twice that amount. A draft ART Bill has been pending in Parliament since 2010 and is now expected to be taken up in the upcoming winter session beginning 24 November. This too has become a subject of controversy, with civil groups saying they have not been consulted over its drafting. “There are so many people who have done tremendous amount of research who can contribute to the regulation and drafting of a comprehensive Bill but the ICMR (Indian Council of Medical Research) has been very non-transparent. It is difficult to get information about the Bill,” said Deepa Venkatachalam of Sama, a New Delhi-based resource group that works with issues of women and health. The proposed Bill is India’s first attempt at regulating the sector although The National Guidelines for Accreditation, Supervision and Regulation of ART Clinics in India have been around since in 2005 and subsequently amended in 2008, 2010 and 2013. In its current form, the Bill is an impressive document. ART banks, under the Bill, will now be registered and commissioning parents will have to go to these registered banks to identify surrogates, said R.S. Sharma, deputy director general of ICMR and a member of the drafting committee for the Bill. The Bill also seeks to streamline the process of recruiting surrogates, who currently earn anywhere between Rs.1.5 lakh to Rs.4 lakh for their services—with a 25% “bonus” for delivering twins. The Bill will require the commissioning couples to approach registered ART banks and not private IVF clinics, as is currently the case. “This will address a lot of malpractices by private banks. Since a government-approved bank will be involved from the very beginning, the margin of errors is reduced when it comes to the chances of babies being abandoned or the surrogate being treated unfairly,” added Sharma. More importantly, professional surrogates will be registered with these banks and will need an Aadhar card to be eligible. “This will iron out issues about the exploitation of commercial surrogates. Currently, there are so many malpractices when private clinics advertise for surrogates and the money paid is arbitrary. They charge too much from commissioning couples and pay too little (to surrogates). We are hoping the Bill will end these issues,” said V.M. Katoch, director general of ICMR. Moreover, the Bill will continue with home ministry guidelines that stipulate that surrogacy services will be offered only to those foreign nationals who come from countries that legally recognize surrogacy.

Disturbing practices

One problem, however, is the lack of hard data about the sector. As things stand, there is no reliable data even about the number of ART clinics. There is a National ART Registry of India (NARI) but disclosures there by medical practitioners on pregnancy rates, live birth rates, the number of cycles and so on are purely voluntary and do not tell the whole story, said Manish Banker, executive director, Nova IVI Fertility, Ahmedabad and a member of the government board on the Bill. The problems with commercial surrogacy in India are both ethical and legal in nature. The absence of regulation raises the spectre of a surrogacy black market, baby-selling and even questions of legal rights of a surrogate and the baby. For instance, before a pregnancy is commissioned a contract is signed between the parties involved. However, according to a recently published study by the Centre for Social Research (CSR), an NGO dealing with women’s issues, 88% of surrogate mothers in Delhi and 76% in Mumbai who were interviewed for the survey did not know the terms of their contract. In fact, 92% of the surrogates in Delhi did not even have a copy of the contract and only 27% of the clinics in Delhi and 11.4% in Mumbai were party to the contract. The contract is usually signed between the surrogate mother, her husband and the commissioning parents. “What is the legality of these contracts? The few that I have seen consist of a four-line paragraph on a Rs.100 stamp paper simply stating that the woman is entitled to a certain amount of money for being a surrogate and she has no claim on the baby. It’s a mockery of the term (contract),” said Manasi Mishra, who heads the research division of CSR. Clinics refute this claim. According to Inderbir Singh, a Delhi-based lawyer who has drafted several surrogacy contracts, the agreements are comprehensive and address all difficulties that could arise from the business. “An important clause in the contracts is that either party, be it the surrogate mother or the commissioning parents, is free to approach the civil court for enforcement of the contract,” he said. Mishra’s study also threw up some disturbing practices. In some clinics, she claims, up to three embryos are transferred in the womb of the surrogate. “Normally, two mature. There are times when all three mature. Depending on the sex and the gender preference of the commissioning parents, the third embryo is removed,” said Mishra. This process is known as foetal reduction. The study reveals poverty and education of children as the motivating factor for women to become surrogates. Himanshu Bavishi, president of the Indian Society for Third Party Assisted Reproduction (INSTAR), private association of IVF clinics, said most professional surrogates were women with high aspirations and little money. “There is no question of compromising the rights of commercial surrogates. They are not beggars, but women who have aspirations and their usual jobs as domestic helps would not let them meet these aspirations. Being a surrogate gets them the money their regular jobs would not,” added Bavishi. Another issue of concern is the medicalization of the surrogate mother’s bodies. From lack of awareness about the number of cycles they might have to undergo to the side effects of gestational surrogacy—the only kind allowed by India—surrogates, activists say, always end up disadvantaged. Unlike traditional surrogacy which uses the surrogate’s own egg, gestational surrogacy involves suppressing the surrogate’s ovulation cycle and injecting hormones to prepare her uterine lining for the embryos which are made either by the commissioning mother’s own eggs or a third party donor’s eggs. This procedure can later lead to side-effects like mood swings, irritability and depression, facts which activists say are not always shared with the surrogates.

Biological vs Genetic

“Much is made of the phrase ‘informed consent’, of the surrogate but it’s a grey area. How much does she know about the process? Emotionally, physically, it’s a very invasive. There is no cap on the number of cycles she might have to go through before the embryo is attached. Also Caesarean are conducted in order to co-ordinate the birth with the arrival of the commissioning parents,” said Sama’s Venkatachalam. Surrogate mothers are often counselled over the importance of separating themselves from any emotional bond with the foetus. They are advised that while they might be carrying the child there is no genetic link. Venkatachalam finds this argument troubling. “What is biological and what is genetic? A woman carrying a child is not seen linked to it if she has not provided her eggs. Would her link be greater if she did so?” The CSR study quotes a paper by Amrita Pande, a senior lecturer in the sociology department of the University of Cape Town as saying, “The surrogate is expected to be disciplined and a willing contract worker who will give away the baby…without creating a fuss. But, simultaneously she is expected to be a virtuous, nurturing mother attached to the baby…”. However, many doctors describe surrogacy in terms of not just empowerment but also compassion. “Yes these women are economically deprived. They are bothered about their children but somewhere their decision to be a surrogate is also motivated by philanthropy. When we counsel them, they meet the intended parents and understand their agony and pain. They understand that they are not doing it for money, it’s but a byproduct. I tell the parents she is doing upkaar (favour) for you,” said Bakshi. All parties concerned hope that the Bill will address issues concerning the health and economic rights of surrogates. Bakshi feels the government could consider introducing a cap for a minimum fee to be paid to the surrogate. Currently there is no provision for post-partum care of the surrogate. “Our research uncovered that clinics hand over a multi-vitamin pack to surrogates after birth in the name of post-partum care,” said CSR’s Mishra. Moreover, what happens if the surrogate miscarries, say, in the seventh month of her pregnancy? Does she get sent home without any pay or is she entitled to some money? In 2012, 36-year-old surrogate mother Premila Vaghela died in childbirth in the eighth month of her pregnancy in Ahmedabad. The baby, however, survived. News reports at that time suggested that thefamily was planning to refuse any compensation offered. This was different from the money promised in lieu of surrogacy. Right now surrogacy works through middlemen and word-of-mouth. According to the CSR report, 73.7% of the surrogates in Delhi were approached by agents whereas in Mumbai the figure was 73.21%. “The agents usually are men with some standing in the community who are respected and trusted. They have observed these women, their needs and recruit accordingly,” said Sama’s Venkatachalam. The recommendation of a family member also acts as a powerful initiative. Several surrogates have also been discovered to have been egg donors in the past, implying familiarity with the networks in place. As the government mulls over the Bill, the sector has lost business to the neighbouring countries where affluent couples can get affordable, hassle-free alternatives to becoming parents. “In 2012, the Indian government passed the directive that we could not cater to single parents and homosexual couples. Then they added conditions like the commissioning couple has to be married for at least two years prior to opting for surrogacy. Such lengthy and tedious government procedures have let to a lot of business moving to Nepal and Thailand,” Bavishi added. And then, there are doctors who believe that except for the rare aberration, the system is working fine with the current ICMR guidelines. “Barring a few considerations, the clinical practice of surrogacy is straight-forward,” says Tank, the Mumbai-based ART consultant. “Most of the Bill’s provisions are already being adopted in practice.”

BMJ
Taming the international commercial surrogacy industry

BMJ 2014; 349 doi: http://dx.doi.org/10.1136/bmj.g6334 (Published 23 October 2014)
Cite this as: BMJ 2014;349:g6334

Sally Howard, freelance journalist, London, UK
admin@sallyhoward.net


The recent case of surrogate baby Gammy, left in Thailand by his commissioning parents after being born with Down’s syndrome and a congenital heart defect, provoked censorious press coverage worldwide. “Surrogate mom vows to take care of abandoned twin,” ran the typical headline when the story broke in August. Outrage grew when it emerged that the father had 22 child sex convictions.1

But behind its sensationalised aspects—taking one healthy child from twins and the questionable background of the Australian father—the case was more legally and ethically nuanced than it might have seemed.

Gammy’s gestational mother, 21 year old Thai food vendor Pattaramon Chanbua, told news agency Agence France Presse that she had found out that one of the twins had a chromosomal disorder four months into the pregnancy.1The commissioning parents, David and Wendy Farnell, told Australia’s Channel Nine television (60 Minutes, 9 August) that they had then urged Chanbua to selectively abort the abnormal fetus.

Abortion is illegal in Thailand, except in cases of rape or incest or endangerment to the mother’s life or mental or physical health.2 It is unclear whether abortion for a birth defect was stipulated in the surrogacy contract between Chanbua and the Farnells. However, Chanbua claimed that she refused to abort the child because it was against her Buddhist faith. She also complained that she has been promised $9300 (£5800; €7300) to carry the children but had not been paid in full.3

Gammy remained in Thailand under the care of Chanbua who, under Thai law, was considered the child’s mother. After the case gained media attention, pressure grew to repatriate the 7 month old to Australia, where he was also offered citizenship and where he would be entitled to free healthcare for his complicated birth conditions.

“A bodge job or worse”

The family law barrister Barbara Connolly QC says that the labyrinthine tangles of family, immigration, and contract law exposed by Gammy’s case are typical of international commercial surrogacy.

“When it comes to commercial surrogacy our laws are a bodge job or worse,” she told The BMJ. “Unlike international child abduction and adoption, there are no international conventions and agreements in this area. Legal issues relating to parentage and immigration vary so widely that the process can result in dramatic outcomes, such as a child born via surrogacy who is both legally orphaned and stateless.”

The legal status of commercial surrogacy varies from country to country. In some countries, including Georgia, Ukraine, and South Africa, all surrogacy agreements are legal and enforceable. Other nations, such as the United States and Australia, regulate or criminalise commercial surrogacy with a patchwork of common law and case legislation that is enforced at state level. France, Italy, and Switzerland ban all forms of surrogacy and will not recognise children born through commercial surrogacy abroad as legal citizens. In the United Kingdom and Denmark altruistic surrogacy (when the mother can receive only reasonable expenses) is permitted but agreements are unenforceable and commercial surrogacy is banned. However, when couples have sought commercial surrogacy abroad, the courts may retrospectively sanction payments that have already been made in the interests of the child.

Asia legislates

The call for a unified legal framework around commercial surrogacy is loudest in the “fertility tourism” destinations of the global south. In Thailand, where the commercial surrogacy industry is worth $125m according to the Thai Department of Health Service Support, the military government responded trenchantly to the baby Gammy case by approving a draft law to criminalise commercial surrogacy. If the law is approved by Thailand’s National Legislative Assembly in early 2015, it will criminalise both commercial surrogacy agencies and commissioning parents, allowing only altruistic surrogacy for infertile, married Thai nationals.

Reverberations are being felt most keenly in India, the world’s largest destination for fertility tourism. (The Indian commercial industry, legalised in 2002, was valued at $449m in 2006.) Last month the Indian government introduced into parliament the 2010 Assisted Reproductive Technologies Regulation (ART) Bill, which has been grinding on to the statute book since 2008.4 The bill, in its current draft, includes a chapter that considers oocyte donors, gestational surrogates, and surrogate born children in altruistic and commercial surrogacy agreements. When the bill is enacted, surrogacy agreements will become legally enforceable, and the age and background of surrogate mothers will be restricted. All foreign surrogacy arrangements will require the appointment of a local guardian who is legally responsible for the surrogate mother throughout the pregnancy as well as the resulting child if the commissioning parents fail to claim him or her.

Indian wombs for hire

This law change comes after the Indian Ministry of Home Affairs issued new guidelines on surrogacy in January 2013. These included a visa requirement for foreign nationals commissioning surrogacy in India, with such visas being restricted to married couples from countries where surrogacy is legal.5 N B Sarojini, founder of the non-profit making Delhi based women’s health advocacy and research organisation Sama, thinks that these regulations have done little to curb what the Indian press has derisively referred to as the trade in “Indian wombs for hire.” Sarojini, who has lobbied for amendments to the ART bill, hopes that the new legislation will check the untrammelled commercialisation of India’s assisted reproduction industry but fears that the bill will be “hugely lacking” in its reach.

“The ART bill has been led by the ART industry—that is, by commercial clinics and gynaecologists, largely for the purpose of validating this lucrative business,” she says. “It fails to regulate big players in the industry, such as surrogacy agents. And it provides little support, or legal recourse, for the gestational surrogate. It seems the free trade mandate brushes aside all ethical questions.”

Sarojini argues that, although the new bill imposes restrictions on the number of embryo transfers a surrogate can accept for a commissioning couple (three) and the number of children a surrogate can bear (five, including her own children), the bill makes no provision for the health of the surrogate beyond the bounds of the nine month gestational contract. In a climate where the public healthcare sector is under-resourced, says Sarojini, such omissions are unethical.

An early draft of the bill said that the health risks to the surrogate mother were small. But Deepa Venkatachalam, who also works for Sama, says the organisation’s research shows that surrogacy “can have grave effects on women’s health. The surrogate is subjected to repeated hormonal injections in preparation for implantation, putting her at risk of ovarian hyperstimulation syndrome, and most surrogates undergo non-indicated caesarean sections to time the birth for the commissioning parents’ convenience.”

Human trafficking

Anil Malhotra, a lawyer based in the north Indian city Chandigarh, is also a critic of the upcoming legislation. At a conference on surrogacy organised by the Centre for Social Research, a New Delhi non-governmental organisation, in September he raised concerns that the bill fails to consider the background and credentials of commissioning parents, a problem that emerged in the baby Gammy case.

“As the bill stands, there is no requirement to verify the background of commissioning parents,” Malhotra told The BMJ. “At the minimum, the home study reports mandated under CARA [India’s Central Adoption Resource Authority] guidelines on inter-country adoptions should be applied, under the bill, to cross-border surrogacy arrangements.”6

Malhotra also noted the absence of a clause pertaining to human trafficking for surrogacy. In 2009 the United Nations Development Programme warned that trafficking of women for commercial surrogacy would eventually develop.7 Just two years later, 13 Vietnamese women, seven of whom were pregnant, were rescued from a surrogate “baby breeding ring” in Bangkok.8

“You cannot just close your eyes and hope that baby breeding cartels won’t develop,” Malhotra said. “With such financial incentives involved, it’s a false hope.”

Malhotra argued that India is losing its opportunity to set a legislative standard for surrogate source nations: “To have any hope of keeping pace with socioeconomic conditions and technological advancements, we need a one-stop-shop piece of surrogacy legislation that covers both domestic and international surrogacy arrangements,” he said. “Scattered pieces of legislation won’t do.”

China’s ban

China is one of the few Asian nations to have taken a firm stance on commercial surrogacy from the outset. In 1994, as gestational surrogacy was emerging, the Chinese government banned commercial surrogacy on the grounds of its implications for defining true parenthood. However, by the early 2000s an unregulated market was flourishing. In 2009 the Chinese government strengthened the criminal enforcement of the surrogacy ban, and reports emerged of surrogates having forced abortions.

Health and human rights campaigners say there is a pressing need for an international legal framework to regulate the commercial surrogacy industry. But such agreements will be a long time coming. The Hague Conference on Private International Law convened to consider international surrogacy arrangements in March 2012 and April 2014. It will reconvene in early 2015. To Connolly, the conferences’ preliminary reports make for sober reading.9 10

“The reports highlighted the huge problems in these cross border arrangements,” she said. “But they also pointed to the real obstacles in the way of reaching any kind of international consensus, let alone a convention, on the issue. As an indication of how long these conventions can take, Japan only signed up to the Hague Convention on International Adoption, which was drafted in 1993, earlier this year.”

Meanwhile there is pressure for affluent nations to legalise the commercial surrogacy market within their own borders. Connolly agrees that the argument is attractive. “But you have to be realistic about market forces,” she said.

“If you liberalise commercial surrogacy in the UK you won’t prevent UK nationals from seeking a cheaper surrogate abroad. For example, as India and Thailand impose restrictions there are signs that an unregulated commercial surrogacy industry is emerging in Mexico.”

For baby Gammy the future is bright. He will soon live with his surrogate mother in a new three bedroom apartment paid for with funds from the reported $AU240 000 (£130 000; €165 000; $210 000) donated to a charitable endowment established for his long term care.11 For the industry that brought Gammy into being, the future is less certain.

Modern surrogacy: the birth of an industry

·         In 1980, two years after the birth of the first baby conceived in vitro, Louise Brown, the US lawyer Noel Keane wrote the first legally binding surrogacy contract through his own infertility centre, a business that sought to connect couples to willing surrogates.

·         In 1986 Keane wrote the contract pertaining to Baby M, a controversial case in which surrogate Mary Beth Whitehead refused to cede custody of the resultant child, Melissa, to the couple with whom she made the surrogacy agreement. The case led many US states to ban commercial surrogacy arrangements.

·         In traditional surrogacy the egg of the surrogate mother and the sperm of either the intended father or a sperm donor are used. From the 1990s advances in in vitro and implantation methods enabled gestational surrogacy, in which the surrogate carries a child she is not genetically related to, created from eggs and sperm of the intended parents or donors.

·         The arrival of gestational surrogacy led to a boom in commercial surrogacy worldwide. The global industry is now estimated to be worth $6bn12

References

For references, please click on the following link

http://www.bmj.com/content/349/bmj.g6334

National Seminar on Compensation in Drug Trials, 14th and 15th July 2014 Delhi, Organized by Sama, LOCOST, PHFI and TWN

Compensation is a widely debated issue globally in the context of clinical trials and the regulations concerning compensation vary across countries. In India, Compensation in the context of clinical trial related adverse events, ranging from relatively minor harm to major injuries or even disastrous injuries (leading to permanent disability or even death) are some of the issues being raised consistently. In January, 2013, Government devised a formula to determine compensation for serious adverse events of death occurring during the clinical trial and in May, 2014 a set of formulae has been devised to determine compensation for clinical trial related injury (other than death).

Sama has been engaged with issues related to clinical trials and has worked towards a constructive dialogue between various stakeholders to deliberate on various ethics and regulation issues related to clinical trials. In this context, a two day national seminar is being organised by Sama Resource Group for Women and Health along with LOCOST Therapeutics, Public Health Foundation of India (PHFI) and Third World Network (TWN). The seminar will be attended by multiple stakeholders such as Principle Investigators, Civil Society Members, Ethics Committee Members, Pharma representatives, CRO representatives, bioethics experts, and academicians. The seminar aims to discuss the mechanisms for compensation including the recent formulae.

Sama’s New Relaeases

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Sama Resource Group for women and Health in collaboration with Bern Declaration (BD), a Switzerland based NGO carried out to a Study to explore the conduct of clinical trials sponsored by Swiss pharmaceutical companies in India. The main objective is to verify if these companies comply with the relevant ethical standards and with the regulatory environment in India from the perspective of various constituencies and stakeholders. The study was conducted across four states of India and 17 clinical trial participants were interviewed.  The study focused on informed consent, sourcing and recruitment of participants and the issues related to compensation vis-à-vis clinical trials. 

 

The research study is priced towards the cost of postage etc. If you would like to place an order please contact Sama directly at sama.genderhealth@gmail.com

 

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This multi-site study was conducted by Sama during 2011-2013 exploring the perspectives of the clinical trial participants with regards to various aspects of clinical trials. The study was conducted across 37 institutions located in seven cities from four states of India. During the study, total 67 interviews were conducted which included 36 clinical trial participants and 31 other key informants. This study examined the perspectives of the clinical trial participants with respect to the various components of the clinical trials such as recruitment, reasons for participation, informed consent, adverse events, compensation and post trial access. In the process of recruitment, various pathways through which the participants reach the clinical trial have been explored along with the most common places for recruitment of the participants. 

The study elaborates various push and pull factors such as economic status, free health services, trust on the doctor etc. which influence the decision of participant of enrolling in the clinical trial. Informed consent has been discussed in its conceptual paradigm in detail dealing with comprehension of the information in consent form and voluntariness of the consent. The issues related to adverse events and compensation including the recent regulatory developments in the area of compensation and issues related to them are discussed from the perspective of the participants. The complex issue of post trial access and current obligations under the law have been explored in the report. The report provides recommendations and future research agenda in the area of clinical trials.

 

The research study is priced towards the cost of postage etc. If you would like to place an order please contact Sama directly at sama.genderhealth@gmail.com

Exploratory study on clinical trials conducted by Swiss Pharmaceuticals companies in India: Issues concerns and challenges (September, 2013)

Sama Resource Group for women and Health in collaboration with Bern Declaration (BD), a Switzerland based NGO carried out to a Study to explore the conduct of clinical trials sponsored by Swiss pharmaceutical companies in India. The main objective  is to verify if these companies comply with the relevant ethical standards and with the regulatory environment in India from the perspective of various constituencies and stakeholders. The study was conducted across four states of India and 17 clinical trial participants were interviewed.  The study focused on informed consent, sourcing and recruitment of participants and the issues related to compensation vis-a-vis clinical trials.Image