The National Consultation on Regulation of Drug Trials

We would like to announce the release of the report on ‘The National Consultation on Regulation of Drug Trials.’ The Consultation held on 26-27^thSeptember, 2011, was an effort towards initiating a dialogue around the existing gaps in policy and its implementation vis-à-vis the regulation of drug trials, towards developing an appropriate framework for future intervention strategies in this regard. The Consultation was organised by Sama –Resource Group for Women and Health, Centre for Studies in Ethics and Rights (CSER); Low Cost Standard Therapeutics (LOCOST), All India People’s Science Network (AIPSN),Drug Action Forum, Karnataka (DAF-K) along with Dr Amar Jesani.

 Recognising the urgent need for furthering transparency in trials, protection of participant rights, and implementation of the highest standards of independent inquiry, this National-level Consultation was attended by nearly 60 participants, who mainly comprised of representatives from health networks, the medical and scientific community, research organisations, media, activists, legal experts, women’s groups and policy makers towards evolving concrete recommendations for policy and regulation on these issues.

 Some of the main themes that were discussed at the Consultation include –

The new division of labour in commercialised research and the CRO industry;

Regulatory standards vis-à-vis the conduct of clinical trials in India;

Pressing dilemmas and Issues with regard to the existing systems of regulation;

Issues of public health vis-à-vis clinical trials;

Role of ethics committees and dilemmas in governance.

The concluding session facilitated a platform for collective strategizing over future interventions towards people-centric clinical research.

The speakers included Amar Jesani, Kaushik Sundar Rajan, Pushpa Bhargava, Brinda Karat, Arun Bhatt, Sandhya Srinivasan, Vasantha Muthuswamy, Sarojini, Anjali, C.M.Gulhati, Deapica, Parsottam Parmar, Rachna, Roli Mathur, Sujith Chandy and many others. The sessions were moderated by Anant Phadke, Amit SenGupta, Vineeta Bal, Satyajit Rath, Chinu Srinivasan, Jacob Puliyel, Samiran Nundy, Nandini Kumar to name a few. Discussions were also held with VM Katoch (DG ICMR), officials from MOHFW and DCGI.

The report in documenting its proceedings closely follows the structure of the Consultation. While presentations have been addressed in verbatim to maintain their authenticity the central concerns and points discussed following the presentations have been highlighted at the end of each session along with the comments from the chairs and discussants.

 If you would like copies, please do write to us at sama.womenshealth@gmail.com .

The HPV Vaccine ‘Demonstration Projects’

Following ethical concerns raised by the people’s health movements, women’s groups, human rights groups, child rights groups, public health networks etc. and Smt Brinda Karat, a Member of Parliament at a press conference on April 7^th, 2010, the HPV vaccine ‘demonstration projects’ were suspended by the Ministry of Health and Family Welfare. The trials were conducted by the American NGO PATH in collaboration with the ICMR and the State Governments of Andhra Pradesh and Gujarat.  Later the Ministry on April 15^th, 2010 constituted an Enquiry Committee. The Committee included, Prof. S.S. Agarwal, former Director Sanjay Gandhi Postgraduate Institute of Medical Sciences; Dr. S.P. Agarwal, Former DGHS and

Dr. Suneeta Mittal, Head of Obstetrics and Gynaecology Department, AIIMS. The brief before the Committee was to look into ‘the alleged irregularities in the conduct of studies using HPV vaccine by PATH in India’. An interim report by the Committee was made available to the media on February 21^st, 2010 at a press conference called for by the campaign. However, the Committee’s final report remains absent in the public domain till today.

The Committee’s final report also follows the trend of the interim report in exonerating the responsible parties despite providing clear evidence of misconduct and violations. The Committee was also assisted by three expert members [Dr. Rani Kumar, Dean, AIIMS; Dr. A.K Dutta, Head of Pediatrics, Kalawati Saran Hospital and Dr. Y.K. Gupta, Head of Pharmacology, AIIMS] to look into various aspects of the projects including the linkages of the deaths with the vaccine and the ethics of the implementation of the projects. While the expert members have raised pertinent questions and ethical concerns, the Committee in its final recommendations and conclusions has in most cases chosen to ignore these findings. Some of the main issues that we would like to highlight here include:

1. Nature of the Projects - Ascertained Clinical Trials Violating the Drugs and Cosmetics Act (DCA)

PATH and ICMR have reiterated several times that the Demonstration Projects could not be classified as clinical trials:  as they did not seek to evaluate the efficacy and safety of the vaccine and as no biomedical outcomes were being researched and no blood or other samples were drawn, and no therapies were tested. However, as Dr. Y. K. Gupta, observes in the Committee’s report, the nature and objectives of these projects, makes it evident that they are in fact clinical trials, wherein the projects were a “study of a pharmaceutical product carried out in human participants” and “4 of 5 primary outcome measures proposed in the study related to evaluation of the safety of the vaccine in population setting.” The very principles used to define a clinical trial by the CDSCO and the Schedule Y of the Drugs and Cosmetics Act, 1954 can be applied to the demonstration projects conducted by PATH.

Moreover, the Committee in the Section 7 of its findings [pg.73] has explicitly stated that it “is of the opinion that by whatever name you call it, the project proposal has been carried out as research on human participants. And as such it had to follow all the guidelines and statutory requirements applicable for research on human participants. Monitoring and management of Adverse Events/ Serious Adverse Events should have been more vigorously pursued.”

If the demonstration projects were indeed clinical trials, the non-compliance of the requirements of Schedule Y of the Drugs and Cosmetics Act raises grave ethical and legal concerns. Several   clauses of the Act have been violated. The Ministry of Health and Family Welfare (MOHFW) therefore needs to take exemplary action on those violating the law of the land: in this case the concerned officials of the ICMR, the DCGI and the NGO PATH.  

2. Selection of Study Area

 

Dr. Y.K. Gupta in his report to the Committee has specifically stated that the study has been carried out on “vulnerable population”. However, the report once again falls short by stating that while the stratification (urban, rural and tribal) “seems appropriate, caution is required”. The Committee in Section 7.5 (Page 75) has further stated that,  “…. for better understanding of the research nature of the study and its impact on cancer prevention a higher strata/ better educated/ better aware population inclusion might have been more desirable. The tribal and more difficult areas could have been chosen in the later round. The standard of medical care in remote areas is generally not of the same level as in the urban areas. It would have been easier to provide proper medical care at urban district level for any SAE, particularly the life threatening SAE. It would have been better investigated to document the cause of the illness even if unrelated. The adequacy of existing AEFI system to measure 4 out of 5 primary endpoints also could have been better tested in the urban area first.“

It has been categorically stressed that “everyone shall desist from research on tribal population, unless of specific benefit to them” (Pg 80:8.5). The Committee’s recommendation to apply caution and safeguards while conducting trials on marginalized populations is a necessary and welcome one. However, the Committee appears to have taken too lenient a view of the violation of this very principle in the context of these demonstration projects, wherein the Committee’s only suggestion is to undertake a review of ethics if the project was to continue.

3. Process of Obtaining Consent

 

In her findings, with respect to the process of obtaining consent and the inspection of the informed consent forms, Dr. Rani Kumar explicitly states “… from the numerical analysis it is obvious that the team involved in conduction (sic) of the study on HPV has been very casual in its approach and has ignored many ethical issues such as signatures of parent/guardian, witness, PI and discrepancy in the date of receiving the vaccine and date of signature (page 49).” Similarly, the Committee in its findings in Section 7.1 [Page-70] has also declared, “the most significant deficiency in the implementation of the project was the obtaining of consent”. The Committee has observed (pg 72:7.1.4) that the ambivalent sentences in the consent form are tantamount to “covert inducement and indirect coercion” especially in the light of the high cost of the vaccine (~ Rs 9000 for three doses). 

 

Also shocking in AP, is the Integrated Tribal Development Authority [ITDA] orders to the hostel wardens, headmasters and teachers to comply with the demands of the project and also facilitate the consent taking processes, particularly in the Ashram Paathshalas where these personnel were ordered to give mass consent (Page 51, Letter to Dr Kishore Chaudhury by Dr Rani Kumar dated 6^th September 2010). 2763 forms (out of a total of 14253) were signed by the Hostel Wardens/ Head Master in AP/.

The Committee, in section 7.1.1 [page 70] also mentions that, “this authorization runs contrary to the basic principles of obtaining consent as students cannot be considered to have full autonomy in front of their teachers/ Head Master. There is no express approval of the Institutional Ethics Committees (Ices) of MNJIO&RCC, Hyderabad for this provision, nor is there any mention of it in the consent document.”

 

It is extremely alarming that despite clear evidence regarding serious lacunae in such a fundamental aspect of any form of research, no action has been recommended against those involved in the designing and implementation of these projects nor against those ethics committees who approved of such a design.

 

4. Issues Related to Safety, Follow-up and Reporting of Adverse Events

 

The lacunae in the adverse event reporting system has been an issue of concern for the experts as well as in the discussions of the Committee. The Committee in its findings in Section 7.2 [page -74] explicitly states, “there has been direct contact with the human participants, they have administered an intervention which is not part of a prescribed prevention, and have expected adverse events.  The Committee is of the view that in all investigational studies (irrespective of being done with non-licensed or licensed products), particularly those that deal with administration of new entities; monitoring, reporting and investigation of all adverse events – non-serious, serious or deaths – should be an integral part of the study and responsibility of the investigator. Adequate insurance cover for participants to include unforeseen/unexpected or even probable morbidity and mortality events should be a part and parcel of such studies.

 

In this context rule 122-e of the Drugs and Cosmetics Rules, 1945 provide that all vaccines shall be new drugs unless certified otherwise by the licensing authorities under Rule 21, and a new drug shall continue to be considered a new drug for the period of 4 years from the date of its first approval or inclusion in the Indian Pharmacopoeia, whichever is earlier.”

 

Moreover, Dr. A.K. Dutta in his observations has mentioned several unacceptable and prolonged delays in the reporting of adverse events and deaths due to a lack of any independent monitoring systems. Further, although his observations state an unlikely link between the deaths of 7 girls and the vaccine, in 3 of these cases no conclusive evidence in this regard could be found. Further it is shocking that the study protocols did not include a separate component for the surveillance of adverse events with solely relying on the existing State run guidelines for the reporting of Adverse Events Following Immunization (AEFI). Particularly surprising is the lack of action taken by the DCGI and ICMR in the light of these delays.

We also welcome the Committee’s recommendation: “…besides issuing directions, an active programme needs to be evolved for training investigators and sensitization of regulatory agencies to specially look for these aspects in any study involving human subjects. There is also need for specific and separate legislation covering all aspects of biomedical and health research involving human participants which should provide statutory status to ICMR ethical guidelines and harmonize separate provisions under GCP guidelines and Schedule Y of the Drugs and Cosmetics Act.” [pg 81]

Although the Committee has quite forcefully condemned the laxity and also made sound recommendations in this regard, in their section on ‘responsibilities’ [pg 81] they once again absolve all the parties involved. Moreover, the Committee does not raise the important questions related to the number of girls who have dropped out of the study and their follow up.

 

5. Lack of Clarity in Finances

 

A lack of clarity regarding the finances and the financial contributions of the different parties involved, in the projects also reflects in the Committees observations and findings. The Committee has raised certain pertinent questions in their remark in section 7.5 [page 75] that states, “On the basis of market price of Rs. 3000 per dose the approximate cost of vaccinating 25000 girls would be aprox. Rs 250 million. What was the financial investment of ICMR and State Governments in the project is not provided. The State clearly provided the cold chain and manpower for immunization. But would it have done so if the vaccine was not free. There is concern about the hidden possibility of a hidden agenda to push this prohibitively expensive vaccine into the Indian Healthcare System. It might have been more prudent if the National Technical Advisory Group on Immunization (NTAGI) has deliberated on the study prior to its implementation and given its recommendations. The Ethics Committees should have looked into this aspect as well before approving the studies and a speaking mention should have been made in their approval.”    

 

6. Need for Insurance Cover for Study Participants

 

Further the Committee states that “concerns over the Insurance No provision has been made of an insurance cover for any unforeseen event or residual, morbidity, related, or unrelated to the intervention; which is a usual practice in trials with NCE/INDs. The Committee is of the view that since the HPV vaccine is a newly developed vaccine, even though licensed, there should have been a provision of insurance coverage for study participants. The need for an Insurance cover is even more since the vaccine is administered to normal healthy individuals that too adolescent girls.” It also goes on to establish that “PATH has taken an insurance cover for itself”. The absence of any mention of such insurance cover for participants in the study protocols raises concerns regarding inadequacies of the approval process and the responsibilities of the approval bodies.

However, once again the Committee has failed to build on these concerns later in the section on ‘conclusions and recommendations’ and ‘responsibilities’.

 

7. Public Private Partnerships

Further, while the Committee has pointed out to the, “blurring of the distinction between the National Immunization Programme, as routine service activity versus the research nature of the HPV vaccination project” they have failed to levy any form of responsibility on either the State or PATH in this regard, merely advising caution for such partnerships in the future. Further although the Committee has commented on the role of the NRHM, it has failed to look into the other IEC material that has largely contributed to this blurring of distinction and has also in many ways mislead the parents of participants of the study.

 

Despite these cases of clear violations and foolproof evidence by the experts appointed, the Responsibility section of the report is the weakest with the Committee exonerating all involved in the project. Despite clearly highlighting the aspect of conflict of interest with the involvement of the two pharmaceutical companies, providing the vaccines free of cost, the Committee, fails to build upon these aspect later in the report.

Our Demands

In the light of the above, we demand that:

• The DCGI be held accountable for the approval and licensing of such a study that was severely lacking in several clinical trial protocols as is required by the Drugs and Cosmetics Act and the ICMR’s Ethical Guidelines on Biomedical Research on Human Participants.

• The multi-level violations particularly with regard to the selection of the study area, the lacunae in the research instruments, etc., – reflect the fact that the ICMR and its bioethics committees have been extremely lax in its role as technical supervisors and advisors. Furthermore it also casts doubts on the objectivity, seriousness and thoroughness of the members of the advisory group and ethics committees who gave their approval to these projects without critically examining the protocols. Immediate action should be taken against all members of these committees along with those ICMR officials who were responsible for and associated with these projects.

• Given the active engagement of the State governments and machinery in the implementation of the projects, immediate action must be taken against all those involved and further safeguards be put in place at the policy level to pre-empt such forms of exploitation in the future when similar projects run through public private partnerships.

• These projects should not be restarted and immediate action be taken against the PATH officials involved, with all research findings being treated as null and void.

• Bill and Melinda Gates Foundation the principal donor for these projects and the organization PATH, the principle investigator in this project, also largely responsible for its design and planning, take immediate onus of the various lacunae and provide compensation for all those affected by the vaccination.

• All the participants of the projects for atleast 4 years, as is prescribed by the Drugs and Cosmetics Act, for any adverse event, both serious and non-serious, with the immediate provision of any necessary treatment.

• Given, the earlier concerns raised regarding the safety, efficacy and prohibitive costs of the vaccine, these vaccines must not be introduced under any circumstances in the public universal immunization programme, with increased efforts instead to promote and provide for screening facilities in areas of high incidence of cervical cancer.

• A critical relook at the Drugs and Cosmetics Act and the ICMR’s Ethical Guidelines for Biomedical Research on Human Participants to ensure that such violations do not recur, particularly given the booming clinical trial industry.

Date: 9May 2011

Trial and Error: Ethical Violations of HPV Vaccination Trials in India

On July 9, 2009, the Andhra Pradesh Minister for Health and Family Welfare in association with the Indian Council of Medical Research (ICMR) and PATH (Programme for Appropriate Technology in Health) International a non-profit organization based in USA launched what it described as a ‘demonstration project’ for vaccination against cervical cancer. The vaccine, against the Human Papillomavirus (HPV), which is one of the most common families of viruses and the source of a common sexually transmitted infection, was administered to 14,000 girls between the ages of 10 and 14 in three mandals – Bhadrachalam, Kothagudem and Thirumalayapalem – of Khammam district in Andhra Pradesh. In Andhra Pradesh, the vaccine used was Gardasil, manufactured by Merck Sharpe and Dohme, the Indian subsidiary of Merck and Co. Inc., a US-based pharmaceutical company.

In a similar project, on August 13, 2009, the Gujarat government launched a two-year ‘Demonstration Project for Cancer of the Cervix Vaccine’ in three blocks of Vadodara District – Dabhoi, Kawant and Shinor – to administer three doses of the HPV vaccine to 16,000 girls between 10 and 14 years. There were reports of deaths of four girls from Andhra Pradesh and two girls from Gujarat following the administration of the vaccine.

During March 27-30, 2010, a team of women’s and health activists visited Bhadrachalam mandal, one of the three mandals of Khammam district where the ‘demonstration project’ was undertaken to understand the ground reality; in particular, to look at the nature and procedures of taking consent and providing information to the girls and their parents, and the availability of the health infrastructure required to support cancer screening and prevention.

The children selected to participate in this project were from four social groups with poor economic background – scheduled tribes, scheduled castes, Muslims and other backward communities. Majority were tribal children, whose parents were agricultural labourers. Some girls were from families that have been displaced by the ongoing conflict in the neighbouring state of Chhattisgarh; circumstances that serve only to compound their vulnerability.

Majority of the vaccinated girls in Bhadrachalam were residents of ashram paathshalas (boarding schools). The selection of these girls for the project is striking, given that their parents, living separately, cannot monitor and respond to any adverse developments in their children’s health. Moreover, this has allowed providers to conveniently side-step the provision of parental consent.

The vaccine was administered through a camp approach in the hostels and school campuses. In many instances, the wardens of the residential schools and hostels were asked to provide consent or permission for vaccination, while parents were not informed. The very nature of this project appears to be in violation of all ethical norms as a warden, whether a legal guardian or not, be allowed to provide consent for hundreds of children without consulting their parents, who are their natural guardians;

The ‘consent form’ was used primarily in the case of non-residential schools, and children were asked to get signatures from their parents. This violates the designated protocol for obtaining informed consent, whereby the ‘researcher’ is required to directly provide information mandatory for consent to the person(s), in this case the parents.

Selected girls were given HPV Immunization Cards, which were in English – a language that neither the girls, nor their parents, were familiar with. Further, all involved (the wardens, teachers and students) believed the project to be part of the public immunization program, and had no idea that they were in fact, part of a research study. They were not even aware that they had a choice regarding participation in the study.

Many stated that they were given to understand that the government was providing free of cost an expensive vaccine that would prevent ‘uterine’ or ‘cervical cancer’. This would otherwise be unaffordable for them. Several parents brought their daughters to the vaccination camps themselves when they heard about the project. One mother said, “Since it was a vaccine being given by the government, we all trusted it blindly and considered it reliable, like any other vaccine that is given in the immunization programme”. Participants were verbally informed that the vaccine would provide life-long protection, with no side-effects or impact on fertility. The fact that the vaccine protects against only two types of the HPV virus and that regular pap screening is required even after vaccination was mentioned at all- neither verbally, nor in the written material given to some girls. Since the long term efficacy and protection by the vaccine is unknown, it cannot be claimed that even 60-70% protection will be achieved. Currently is also unclear if, when and how booster shots will be required.

Many of the vaccinated girls continue to suffer from stomachaches, headaches, giddiness and exhaustion. There have been reports of early onset of menstruation, heavy bleeding and severe menstrual cramps, extreme mood swings, irritability, and uneasiness following the vaccination. No systematic follow up or monitoring has been carried out by the vaccine providers.

While the project was being carried out under the banner of the National Rural Health Mission (NRHM) shockingly enough the Mission’s mandate does not extend to or mention any such research project. Further, the existing health infrastructure in the region is woefully inadequate. Pap smear facilities are conspicuous by their absence in all government facilities in the area. The entire tribal mandal of Bhadrachalam does not have a single gynaecologist.

The vulnerability of this these communities are thus further compounded by of the lack of access to health care, lack of access to information and absence of mechanisms for reporting adverse effects.

The state government has claimed that the deaths of the four girls post-vaccination were unrelated to the ‘project’. However, parents of Kudumula Sarita, who died in January 2010, believe that their daughter died due to the vaccination, and not by consuming pesticide, as has been officially declared by the authorities.

The trial has been suspended temporarily by the government after a strong campaign by health networks, women’s groups and by parliamentarians. A committee has been set up by the government to conduct an inquiry, the composition of the committee leaves much to be desired and is far from representative.

The Ministry of Health and Family Welfare, on 22^nd April 2010, finally conceded that the HPV vaccination project was in fact, a “post-licensure operational research study”, which on further clarification, was confirmed to be a Phase IV, post marketing, clinical trial.

On 29^th April, the ICMR admitted that their ethical guidelines had been flouted in the course of this trial.

Meeting Health Rights by Free Treatment to All Indians: Requirements and Challenges

A day long consultation on the subject ‘Meeting Health Rights by Free Treatment to All Indians – Requirements and Challenges’ is being jointly organized by Jan Swasthya Abhiyan, Centre for Budget and Governance, Oxfam India, Centre for Legislative Research & Action, Sama, and Prayas at Dy. Speaker’s Hall, Constitution Club, New Delhi on 4^th May 2010 from 10:00 AM to 5:00 PM.

The objective of this consultation is to orient and sensitize members of parliament and other important segments of policy planners about this very vital issue and evolve an economical and social model to ensure free treatment to all citizens of India.

Background

The total health spending in India is one of the lowest in the world, and most of it is private expenditure in the form of out of pocket payments. The majority of this payment is on the purchase of drugs and diagnostics, which are priced exorbitantly when bought individually by patients from chemist shops or pharmacies of private doctors, nursing homes, and hospitals. The same medicines are available in one tenth of the cost if bought in bulk.  It is a huge challenge that these medicines at reduced costs, which are essentially the actual prices, will reach citizens. Purchase of medicines individually:

1. Causes significant rise in the overall cost of treatment
2. Increases the load of unreasonable and unnecessary drugs, which are the causes of rising drug resistance and iatrogenic morbidities
3. Leads to higher occurrence of catastrophic illnesses, which require hospitalization because large numbers of patients do not seek treatment until it gets very serious for reasons of non-availability of money
4. Causes continuing high maternal mortality ratio and child death rates because of lesser use rate of health care services

Participation is only by invitation.

Press Conference on HPV Vaccines

On the occasion of World Health Day, Jan Swasthya Abhiyaan (JSA), All India Democratic Women’s Association (AIDWA), Sama – Resource Group for Women and Health and Saheli Women’s Resource Centre organised a Press Conference to highlight our concerns regarding the HPV vaccines and to voice our opposition to the unethical nature of the ongoing HPV vaccination ‘projects’ being conducted in Andhra Pradesh and Gujarat by PATH International, in collaboration with ICMR and the State Governments.

The safety and the efficacy of the two HPV vaccines Gardasil and Cervarix is highly suspect and a number of very serious side effects, including deaths have been observed across the world, in vaccinated girls.

As per the extensive documentation by a fact finding carried out by local groups in Khammam district in Andhra Pradesh (where 14000 girls in the age group if 10 – 14 years have been vaccinated with the three doses of HPV vaccine), the adverse reactions faced by over 120 girls include epileptic seizures, severe stomach aches, headaches and mood disorders. The matter has further gained grave urgency with the deaths of four girls in the area. Moreover, the very basis of the project is in direct violation of both, the Governments own Ethical Guidelines of Research on Human Subjects and the rights of children as secured by national law as well as international conventions that India is a signatory to.

Other serious issues include the unethical licensing of the two vaccines for marketing as so-called preventives against cervical cancer, and the aggressive promotion by the manufacturers in schools, residential localities and so on through pediatricians and gynaecologists.

The key findings from a fact-finding visit to Khammam district in Andhra Pradesh were also shared at the conference.

The speakers at the conference included:

Brinda Karat – Member of Parliament

Amit Sen Gupta – Jan Swasthya Abhiyaan

Sarojini N. -  Sama Resource Group for Women and Health

Kalpana Mehta -  Saheli Women’s Resource Centre

Sudha Sundararaman – All India Democratic Women’s Association

Venue: Indian Women’s Press Corps (IWPC), 5 Windsor Place, Ashoka Road, New Delhi
Date:  April 7^th, 2010
Time: 1:30 – 3:30 pm

Visit http://www.hindu.com/2010/04/08/stories/2010040857390100.htm and http://www.dnaindia.com/india/report_cancer-vaccine-programme-suspended-after-4-girls-die_1368681 to view some of the news coverage.

Press Release

April 7^th, 2010 – World Health Day

Unethical Medical Intervention to prevent HPV infection by the government in collusion with drug company and foreign NGO renders poor tribal girls dead and debilitated

Protests, representations and extensive coverage in the media against PATH-ICMR project being carried out in AP and Gujarat seem to have fallen on deaf ears and the government has gone ahead with a vaccination programme with Gardasil (HPV vaccine manufactured by Merck) leading to four deaths and 120 girls suffering from debilitating new illnesses like epilepsy, headaches, stomach disorders and early menarche.

The girls, 10-14 years old, belonging to poor families, were enrolled in a study being carried out jointly by PATH (an International NGO), Indian Council of Medical Research and the respective state governments funded by Bill and Melinda Gates Foundation. The objective of this two year study is to look into acceptability and service delivery issues of Gardasil, marketed in India by MSD Pharmaceuticals Pvt. Ltd, being misleadingly promoted as a preventive for cervical cancer.

The literature circulated in the project makes outright false statements about its safety, efficacy and duration of effectiveness. The girls and their parents have been told through the project documents that the vaccine will give life long immunity, has no side effects other than minor ones like fever and rash and will not affect future fertility of the young girls.

When deaths started getting reported local groups in Andhra Pradesh were alarmed by and carried out a fact finding to discover that no consent was taken from parents and the girls and their families have been left uncared for. Post mortem reports were also not easily accessible, and in cases of death cover up was the general dictum.

We question:

1. Why are poor girls and their families being actively misled? Who is liable for the debilitating effects of the vaccine and who will medically look after these girls and pay compensation for the damages suffered by these people?
2. How has the government embarked on this study of giving three injections to the girls when it is also planning a massive multi-centric dose determination study to see if two doses will suffice?
3. How has the Drugs Controller General granted approval to the vaccine without proper research in India? For a drug to be administered to children, it has to go through stages of clinical trial, including Phase 3 adult clinical trials. So far with Gardasil only one trial has been carried out with just a small sample of 110 girls which has followed them up for just one month after the completion of vaccination and that too only to look at the immune response post vaccination. The vaccine has also been approved for adult women till 27 years of age without doing any trials with them at all.
4. Why are these studies being carried out when at various times the concerned government officials have gone on record to say that it is not feasible for the vaccine to be introduced in the Indian Public Health system given its costs? Is it not then using these poor girls as guinea pigs for a vaccine which can be used only in the private market by well to do families? Why is a two year study being carried out with no future guarantee even for the subjects of this study to keep them protected with boosters when they actually get married by when the effect of this vaccination will wear off? The effect of the vaccine seems to wear off after 4-5 years, and will require periodic booster injections to retain claimed effectiveness.

The path of licensing of the vaccine in India raises many serious questions as time and again scientific logic and the ethical guidelines have been violated at each step. Our law clearly states that no trials of drugs can be conducted among children before trials are conducted on adults. While the other HPV vaccine, Cervarix, made by GlaxoSmithKline has also been licensed in India it has been approved for use for children without any trials among them at all. It should be remembered that last year the two drug companies had engaged in massive advertisement of these vaccines in the media and are continuing with giving incentives to doctors and holding promotional camps in schools among the paying segment of the market.

All this is being done for products which have no proven value. Even the license given by US FDA has asked Merck to actually study whether there is a reduction in the incidence of cervical cancer due to vaccination.

Even as their effectiveness and usefulness remains unproven information on the adverse effects of these vaccines are pouring in from all quarters. The tally in US alone crossed the mark of 17000 adverse effects (as reported under the voluntary adverse effects reporting system); and even the US FDA gave a hearing to health advocates to present the case against the vaccines on March 12, 2010. The adverse effects include heart, immune, blood clotting, respiratory, nervous, digestive and musculoskeletal systems and occur with far greater frequency than those observed with any other vaccines. Many experts and established medical journals have already termed it the biggest public health experiment.

In the public health system of India this vaccination will prove to be an expensive and hazardous exercise. These vaccines at best protect against two sub types among 15 which are associated with cervical cancer and hence ideally women will have to undergo pap smear tests for an effective cancer control strategy along with various hygiene and nutrition related strategies. Unfortunately, there is no investment in screening which can help the adult population today.

We demand:

1. Complete suspension of all studies and trials with Gardasil and Cervarix and suspension of their licence for marketing in India till such time that a public enquiry is held on their licensing in violation to the India law.

1. Proper enquiry in the deaths in Khammam that have been dubbed as suicides. Unless it becomes clear that the vaccine has no impact on the mental health of girls the project authorities cannot be absolved of the blame.
2. Each vaccinated girl be examined by independent authority to assess the range and incidence of side effects. While this will provide the much needed information about vaccine safety it will also detail the care that these girls require and the compensation they and their families deserve for having been actively misled.

4. Proper long term follow up of the vaccinated girls till they get married and have children and booster doses at the right time free of cost, with full informed consent for those girls who wish to continue vaccine protection.

Unless the government details a plan for cervical cancer control, with full compliment of boosters, screening and treatment this project is sheer experimentation with innocent, vulnerable and poor people of the society who can not afford this expensive vaccine. According to us the government is constitutionally bound to take care of the life of all citizens and not subject them to new medical problems at the behest of foreign NGOs.

Sama                      All India Democratic Women’s Association                   Saheli

All India People’s Science Network                  Jan Swasthya Abhiyan

The Problematics of Cervical Cancer Advertisements

The recently launched (and extremely aggressive) marketing campaign against Cervical Cancer has caught Sama’s attention. This GlaxoSmithKline (GSK) sponsored “public awareness campaign” bears distinct resemblance to a previous campaign by MSD (Merck Sharp & Dohme Corp.) with the caption ‘Guard Yourself’. Interestingly, both the advertisements do not disclose the name of the vaccine. Moreover, there is no mention of contraindications or side effects.

The print ads for these campaigns invariably feature a smiling (and presumably loving) mother-daughter pair. The latest cervical cancer ad by GSK carries sub-headings giving information and prompting action. This campaign is much more aggressive than MSD’s previous one, and is running full-page ads in leading national dailies and sending smses through country-wide networks. The ad supplies a sobering statistic on cervical cancer, putting it ahead of breast cancer as a leading killer for women. It announces the ‘Good News’ that vaccination can protect ‘our daughters’ from Cervical Cancer. The dosage required is mentioned, along with urgent slogans and affirmations such as ‘Act today!’ and ‘It’s true!’ What is missing again is the name of the vaccine, contraindications, side effects etc.

The MSD advertisements would carry on in a similar vein, asking you to know, do and give, as much as you can, to protect your loved ones from cervical cancer. The ad provided information under headings like ‘It can happen to you’, ‘Know the relation between HPV and cervical cancer’ and ‘How is HPV contracted?’ The ad concluded with a message imploring the reader to consult her doctor for protection. These also appeared on TV channels. Throughout, the name of the vaccine being so obviously promoted, was conspicuous by its absence.

Concerns around HPV vaccine: A Memorandum to the Health Minister

In a Memorandum to the Ministry of Health and Family Welfare, public health activists, along with several health networks and organisations, voiced concerns around the introduction of the Human Papilloma Virus (HPV) vaccine Gardasil. The Memorandum is as follows:

To

Shri Ghulam Nabi Azad,
Union Minister for Health and Family Welfare,
Ministry of Health and Family Welfare,
Nirman Bhavan,

Maulana Azad Road,
New Delhi 110 011

Date: October 1, 2009
Subject: Concerns around Human Papilloma Virus (HPV) vaccine
Sir,

We, the undersigned, public health organizations, health networks, medical professionals and women’s groups, write to express our concern with regard to the introduction of Human Papilloma Virus (HPV) vaccine, Gardasil, to young girls in the country.

On July 9^th, 2009 under the demonstration project being implemented by the Union Ministry of Health and Family Welfare in association with Indian Council of Medical Research (ICMR), PATH International and State government, the Andhra Pradesh Minister for Health and Family welfare launched a pilot program for vaccination against cervical cancer. The three doses of HPV vaccine are to be administered to 16,000 girls between 10 and 14 years in the mandals of Bhadrachalam, Kothagudem and Thirumalayapalem in Khammam district in Andhra Pradesh.[1] The vaccine will be administered in 3 doses at the interval of 0, 2 and 6 months.

Similarly, on August 13, 2009, the Gujarat government launched a two-year ‘Demonstration Project for Cancer of the Cervix Vaccine’ in three blocks of Vadodara District – Dabhoi, Kawant and Shinor – to immunize 16000 girls between 10 and 14 years with three doses of Gardasil. The Gujarat State Minister for Health and Family Welfare claimed that this demonstration project will help the Centre to examine the possibility to introduce the vaccination project across the country [2]

We are alarmed by this decision by State and Union Governments and we oppose the introduction of the vaccine on the following grounds:

Efficacy of the Vaccine

• Information about the efficacy of Gardasil remains uncertain. The current HPV vaccine prevents infections, resulting from just two of the HPV subtypes (16 and 18) that may cause cervical cancer, and also HPV subtypes 6 and 11 that can lead to genital warts. The subtypes 16 and 18 account for 70% of the cases of invasive cervical cancer globally.[3] But there are over 100 HPV subtypes and one of the main concerns is that if the vaccine was to work and indeed ‘block’ subtypes 16 and 18 then the other carcinogenic subtypes may become dominant.
• There is lack of conclusive data regarding the length of immunologic protection the vaccine confers against HPV subtypes 16 and 18.[4] Studies so far have followed up with the vaccinated ‘subjects’ for 5 years and have shown that it offers protection only for 5 years. Thus it is not clear whether protection lasts longer than this time period. Since the long term efficacy and protection by the vaccine is unknown we can not claim that even 60-70% protection will be achieved. Moreover, since the highest incidence of cancer of the cervix in India is in women above 35years of age, it is not clear whether a 3-dose schedule will provide long lasting immunity or if boosters will be required.
• If booster doses are needed, and it is not known how frequently, what will be the impact of the booster doses on the safety of the vaccine? Moreover, booster doses would certainly increase the cost of vaccination per woman as many times as the booster would be given.
• HPV vaccination is not a substitute for cervical cancer screening. All women, including those who are vaccinated, should continue to have regular Pap test screening and also HPV test as the preventive effect of the vaccine on cervical cancer has not yet been demonstrated.
• HPV Infection rarely leads to progression to cancer. Only a minority of infections persist for several years, and only about 10% of low-grade lesions progress to a higher grade. About 5%of high-grade lesions progress to invasive cancer.[5]

Side-effects

1. The Federal Vaccine Adverse Event Reporting System (VAERS) in the US has logged a total of 12,424 of adverse events following HPV vaccination, according to the US Centre for Disease Control and Prevention. Between June 2006 through December 2008, more than 23 million doses were administered in the US alone. Of these, 772 were reports of serious events (6.2 % of the reports) including 32 deaths and the remaining 11652 (93.2%) were classified as non-serious.[6]

The most common events reported were, Syncope, Local reactions at the site of immunization (pain and redness), Dizziness, Nausea and Headache.[7] Venous thromboembolic events, autoimmune disorders, Guillian Barre Syndrome, motor neuron disease, anaphylaxis, transverse myelitis, pancreatitis and death were amongst the serious adverse events reported. Amongst reports of autoimmune disorders to the VAERS system, 88% were associated with the HPV vaccine alone.[8]

1. In Australia, the rate of anaphylaxis shock after Gardasil injection has been reported as 2.6 per 100.000 doses[9].
2. The official Gardasil website itself clearly mentions, “GARDASIL may not fully protect everyone, and does not prevent all types of cervical cancer, so it’s important to continue routine cervical cancer screenings. GARDASIL does not treat cervical cancer or genital warts”.[10] The side effects listed include, pain, swelling, itching, bruising, and redness at the injection site, headache, fever, nausea, dizziness, vomiting, and fainting. Sometimes fainting is accompanied by falling with injury, as well as shaking or stiffening and other seizure-like activity.[11]
3. The Indian Academy of Pediatrics Committee on Immunization (IAPCOI) in their recommendations mentions that, the vaccine is contraindicated in those with history of previous hypersensitivity to any vaccine and should be avoided during pregnancy.[12] Moreover, there have been no adequate and well-controlled studies in pregnant women, and animal reproduction studies are not always predictive of human response.[13]

Moreover, while this data is mostly sourced from US based research and trials conducted in other countries, the adverse reactions in the Indian context are unknown. Thus, the approval of a vaccine that claims to prevent a sexually acquired infection that sometimes causes cancer of cervix, and that too only if vaccination is completed before exposure, is highly questionable.

Cost Effectiveness

• The current cost of the vaccine is Rs. 3000/- per dose (approximately USD 60) per dose. So for every 10-year old girl, 3 shots initially, and 8 shots (assuming the need for a booster shot every 5 years) over the next 40 years [until she becomes 50].  This would amount to Rs. 33,000/- by present estimate. Can the Ministry afford an injection that costs Rs 9,000 for every woman in a country where we cannot give DPT (costing Rs. 3) to 50% of children of the country?
• In a recent study from India, published in the New England Journal of Medicine (NEJM), 31,488 women (30 to 59 years old), were followed up over 8 years with no intervention (in the control group). 64 died of cervical cancer. The absolute risk of cervical cancer was 2.5/10,000/year. If we optimistically assume that every case of cervical cancer will be prevented by the vaccine, the absolute risk reduction is 0.00025 and the numbers of women needed to be vaccinated to prevent one death is 4000. So the cost per life saved is Rs. 75 million.[14]
• A cost effectiveness study published in the NEJM in 2008 concluded that if the vaccine provided protection against HPV for only ten years, then vaccinating preadolescent girls would only provide a “2% marginal improvement in the reduction in the risk of cervical cancer as compared with screening alone.” Moreover, it would cost $144,100 for each healthy year of Life Saved, instead of the $ 43,600 estimated for a vaccine providing life-long protection. Most researchers believe that even in the US, interventions costing more than $50,000 per quality-adjusted year of life (QALY) saved, are not cost-effective, while others use a higher ceiling of $100,000.[15]
• Looking at our public health system, no government in India can afford this expense. The average per capita annual income in India in 2009 is Rs.38 000 and, while the current per capita annual public health expenditure in India is about USD 10.
• Given this totally unfavorable cost-efficacy in the Indian context, we see no chance that this vaccine can be included in the Indian National Immunization program. Hence conducting such a demonstration project in India would mean using Indian people as mere guinea pigs.

Aggressive Marketing

• Merck Sharp & Dohme (MSD) India Pharmaceuticals Private Limited, which is the Indian subsidiary of Merck & Co. Inc., the manufacturers of Gardasil, has also recently started a Cervical Cancer Prevention Program that informs Indian Women to help protect them against cervical cancer and related HPV infections. The program’s tagline, “What will I do to save my daughter from cervical cancer? – Everything that I can!”[16] is uncannily similar to Gardasil’s tag line – “We chose to help protect ourselves against cervical cancer and other HPV infections: Now the choice is yours.”[17] Similarly, PATH, that supported the formative research for the HPV vaccine Gardasil in India, highlights the demand for the vaccine through quotes like “Our granddaughters’ generation should be a generation without cancer.”[18] In this way a false signal is sent out that claims that the vaccine can prevent cancer although Gardasil prevents cancer of cervix associated with just 2 types of HPV.
• These advertisements induce fear with regard to HPV and cervical cancer and thus create an inaccurate impression of a “public health emergency”.
• A 15-second commercial on Indian television urges parents to get their young girls inoculated with the vaccine Gardasil to protect against cervical cancer, Advertising prescription drugs on television is unethical enough, but using fear and inaccurate claims to sell them is worse.[19]

We urge that

1. The Government should review the decision to conduct a demonstration project of HPV vaccine in the mass immunization programs in the absence of sufficient long-term evidence of its effectiveness complete and unbiased information, and without any prior public debate. The huge cost incurred in this mass immunisation even if the current price of the vaccine is reduced substantially should be seriously considered.

1. The state initiates comprehensive access to reproductive and sexual health programs / services for adolescents, women and men.

v      The focus should be on increasing access to preventive health care services such as pap screenings, visual screening of the cervix with acetic acid (VIA) and Visual Inspection of cervix with Lugol’s Iodine (VILI).

v      Screening programs should be augmented with newer technologies such as the use of liquid based pap testing in women, who have abnormal pap test results.

v      Provide population-based outreach pap screening services for Cancer of cervix, particularly for women from the tribal and rural areas.

v      Undertake special measures towards promoting awareness among women and community so that they come forward without any inhibitions to undergo such screening tests.

v      Instead of an expensive vaccination strategy, monitoring measures should be made available to detect Cervical Cancer at a very early stage. Treatment of all women with the diagnosis of Cervical Cancer in situ is likely to cost the public health care system much less, than buying the vaccine.

v      Public health services be made available to all, with special emphasis on women’s health, by filling in the vacancies of the gynaeocologists and para- medical workers, by providing basic screening facilities.

1. As mentioned earlier the current vaccines target only 2 oncogenic types: HPV-16 and HPV-18. Secondly, the relationship between infection at a young age and development of cancer 20-40 years later is not known. So how should a parent, physician, politician, or anyone else decide whether it is a good thing to give young girls the vaccine that partly prevents infection caused by a sexually transmitted disease that in a few cases will cause cancer 20-40 years from now?[20]

1. It is learnt that the Union Health Ministry has signed a memorandum of understanding (MoU) with the US Company Merck, covering the entire gamut of the trial and the launch in the country. As per the MoU, the pre introductory trial will be carried out at several centres in the country, including Institute of Cytology and Preventive Oncology (ICPO) (www.icpo.org.in) for a duration of 6 months. What is the status of these trials and if they have been completed, what are the results / findings?

1. Financial support from industry or from an international organization should not be the criteria to introduce any vaccine in pilot phase or in universal immunization program.

1. The role of PATH is not very clear. It appears that PATH is trying to find ways of influencing policy makers through its formative research.

Our Demands;

1. All trials and studies to be immediately brought to a halt till in an open forum questions relating to safety, efficacy and cost effectiveness of the planned intervention can be justified.

1. To place before the public:

• All the documents pertaining to the agreement with vaccine manufacturers and all other bodies regarding the government’s plan to introduce the HPV vaccine. The list of all trials planned, proposed, approved and completed, the agencies involved, the donors involved and proposed locations and all the results of the pilot phase trials as well as clinical trials.
• The status of approval accorded to the vaccine and the data which has been submitted by the company (vaccine manufacturer) for the purpose.
• The estimated total cost, as per the government’s assessment, of purchase of the vaccine and its administration.

1. A vaccine policy to be formulated based on public health needs.

1. Open up the issue for public debate and the opinion of health groups, women’s groups and other civil society members to be actively sought.

We urge you to consider these demands very seriously and act upon this matter in the larger interest of the health and well-being of the women and adolescent girls of this country. We ask you to provide the information and documents that we have requested within a month of the receipt of this letter.

Yours Sincerely,

1. Dr. Gopal Dabade, All India Drug Action Network (AIDAN)
2. Medico Friend Circle (MFC)
3. Jan Swasthya Abhiyan (JSA)
4. All India Peoples Science Network (AIPSN)
5. Centre of Social Medicine and Community Health, Jawaharlal Nehru university (JNU), Delhi
6. Sama Resource Group for Women and Health, Delhi
7. Dr. Y. Madhavi, National Institue of Science Technology And Development Studies (NISTADS), Delhi
8. Jagori, Delhi
9. Dr. Imrana Qadeer, Delhi
10. Dr. N. Raghuram, Guru Gobind Indraprastha University, Delhi
11. All India Democratic Women’s Association(AIDWA), Delhi
12. Action India, Delhi
13. Human Rights Law Network (HRLN), Delhi
14. Delhi Forum, Delhi
15. Centre for Women’s Development Studies (CWDS), Delhi
16. The Other Media, Delhi
17. TARSHI, Delhi
18. Partners in Law and Development (PLD), Delhi
19. MATRIKA, Delhi
20. Indira Chakravarthy, Public Health Researcher Delhi
21. Ranjan De, Film maker, Delhi
22. KRITI, Delhi
23. Dr Veena Shatrugna, Hyderabad, Andhra Pradesh
24. Dr. Sagari Ramdas, ANTHRA, Andhra Pradesh
25. Andhra Pradesh Adivasi Aikya Vedika, Andhra Pradesh
26. Dr. Rukmini Rao, President, Gramya Resource Centre for Women, Hyderabad, Andhra Pradesh
27. Yakshi, Hyderabad, Andhra Pradesh
28. Locost, Baroda, Gujarat
29. SAHAJ, Baroda, Gujarat
30. Utthan, Ahmedabad, Gujarat
31. Sahiyar, Baroda, Gujarat
32. Dr. Hanif Lakdawala, Ahmedabad, Gujarat
33. Dr. Hemant Shah, Deputy Director, Bhansali Trust, Radhanpur, Gujarat
34. Mahila Sarvangeen Utkarsha Mandal(MASUM) Pune, Maharashtra
35. Dr. Anant Phadke, Sathi-Cehat, AIDAN, Pune, Maharashtra
36. SATHI-CEHAT, Pune, Maharashtra
37. CEHAT, Mumbai, Maharashtra
38. LABIA, Mumbai, Maharashtra
39. Forum Against Oppression of Women, Mumbai, Maharashtra
40. Ravi Duggal, Mumbai, Maharashtra
41. Dr. Amar Jesani, Independent Consultant on Bioethics and Public Health, Mumbai, Maharashtra
42. Dr. Lakshmi Lingam, Professor, Women’s Studies, Mumbai, Maharashtra
43. Dr. Dhruv Mankad, Hon. Director, Vachan, Nasik, Maharashtra
44. Amitava Guha, FMRAI, Kolkata, West Bengal
45. Dr. Narendra Gupta, Chittorgarh, Rajasthan
46. Drug Action Forum, Karnataka
47. Community Health Cell (CHC), Bangalore, Karnataka
48. Dr. Daisy Dharmaraj, TEST Foundation, Chennai, Tamilnadu
49. Dr. Subhashri, Chennai, Tamilnadu
50. North East Network, Assam
51. Dr. Ajay Khare, Madhya Pradesh Vigyan Sabha, Bhopal, Madhya Pradesh
52. Jagannath Chatterjee, Bhubaneswar, Orissa

Contact address:

Anjali and Sarojini

C/o Sama, B-45, 2^nd Floor, Shivalik Main,

Malviya Nagar, New Delhi –110017.

Ph: 26692730

---

[1] The Hindu, (July 10, 2009), “Pilot Program for Vaccination against Cervical Cancer launched”

[2] Press Trust of India (August 13, 2009), “Gujarat Launches Cervical Cancer Vaccine.”

[3]Schiffman M, Castle PE, Jeronim J, Rodrigue AC, Wacholde S. (2007) “Human Papillomavirus and Cervical Cancer” Lancet; 310

[4] Lippman A, Melynk R et. Al (2007),”Human papillomavirus, vaccines and women’s health: questions and cautions” Canadian Medical Association Journal (CMAJ) 177

[5] Jun 2007 “Human papillomavirus: often harmless but in some cases carcinogenic.” Prescrire International, (Vol. 16, Issue 89, Pages 115-119)

[6] Centre for Disease Control and Prevention, USA, “Summary of HPV adverse events reports published by JAMA” http://www.cdc.gov/vaccinesafety/vaers/HPV_JAMA.htm Accessed on: September 10, 2009.

[7] Centre for Disease Control and Prevention, USA, “Summary of HPV adverse events reports published by JAMA” http://www.cdc.gov/vaccinesafety/vaers/HPV_JAMA.htm Accessed on: September 10, 2009.

[8] Slade B., Leidel L, et al (2009)”Post Licensure Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine” JAMA, Vol.302, No.7

[9] Brotherton, J.M, Gold. M.s., Kemp, A.S.et al. (2008). “New South Wales Health HPV Adverse Events Panel. Anaphylaxis following quadrivalent human papillomavirus vaccination” Canadian Medical Association Journal, 179(6), 525-33

[10] http://www.gardasil.com/ Accessed on September 11, 2009

[11] Ibid

[12]Indian Academy of Pediatrics Committee on Immunization(IAPCOI) (2008), “Consensus Recommendations on Immunization” Indian Pediatrics; Volume 45

[13]Slade B., Leidel L, et al (2009)”Post Licensure Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine” JAMA, Vol.302, No.7

[14] Aneja H and Pulliyel, J (2009) “Selling Vaccines: Deciding on who can afford HPV” Indian Pediatrics:

[15] Kim J and Goldie S. ( August 21, 2008) “Health and Economic Implications of HPV Vaccination in United States”, New England Journal of Medicine Volume 359:821-832

[16] Guard your self brochure by MSD

[17] http://www.gardasil.com Accessed on September 11,2009

[18] PATH, “Shaping a strategy to introduce HPV Vaccines in India”

[19] IANS December 13, 2008 “Cancer vaccine Kicks up Controversy in India”,

[20] Haug C.(2009) “The Risks and Benefits of HPV Vaccination” JAMA; 302(7):795-796.

Draft National Health Bill – A Public health and Gender Analysis

A Workshop

12th and 13th December 2009, New Delhi

Sama is organizing a two-day workshop on the draft National Health Bill, which is a critical first step towards legal recognition of the right to health and health care in India and its operationalisation, and therefore necessitates an in-depth understanding and analysis of its provisions. This workshop follows several requests that we have received from organisations and provides an opportunity to develop a comprehensive understanding of the Draft Bill based on a public health and gender analysis.

The workshop will address the following:

• * the salient features of the bill
• * the key thematic areas
• * role and regulation of the private health care sector
• * centre / state relationship under the mandate for a central law on health

The resource persons for the workshop are – Shruti Pandey [an advocate & senior consultant with the National Health Systems Resource Centre (NHSRC)], Renu Khanna (SAHAJ, Baroda) and Abhay Shukla (SATHI, Pune). This workshop will be in English and is designed primarily for Programme Co-ordinators.

Participation is only by invitation from Sama.