1. Developing Guidelines for HIV- AIDS in India Concerns,Needs,Bottlenecks, Solutions Dr.Vasantha Muthuswamy Senior Deputy Director General, Indian Council of Medical Research New Delhi,India

2. HIV/ AIDS in INDIA 2nd most populous nation in the world More than 1 billion people 0.7% of Indian population are HIV+ IN actual number ----- 3.9 million + cases > 1% of general population in 6 states ----- Maharashtra,A.P.,Tamil Nadu, Karnataka,Manipur,Nagaland Rest of the country < 1% of general population

3. Concerns Moved from high risk to general population Men are victims in > 75% cases Transmission route is sexual in > 85% cases Significant variations among and within states Based on annual surveillance data collected from 232 sites

4. Modes of transmission Sexual contact ------------- 84.53% Blood and Blood products – 3.37% IDUs -------------------------- 3.36% Perinatal transmission ------ 2.14% Others ------------------------- 6.70%

5. NEEDS Continuous surveillance Awareness programmes Increased health care allocations Identification of high risk groups Access to treatment for all Removal of stigma and discrimination Developing appropriate guidelines

6. Development of guidelines NACO ----- Treatment Guidelines, Blood safety guidelines,Awareness programmes,Traininbg module for Blood bank,STD clinics,ANC clinics ICMR ------ Ethical guidelines for Biomedical research, 1980,2000,Ethical guidelines for HIV/AIDS research,2001 NACO- IAVI-Lawyer ’ s collective ---- HIV/AIDS legislation,HIV vaccine trial guidelines

7. Ethical guidelines for HIV/AIDS Research Research in HIV/AIDS Epidemiological studies Clinical trials ---- IRBs,Investigator ’ s responsibilities,Sponsor ’ s responsibilities,Vaccine trials,microbicidal trials,MTCT studies Vulnerable populations Sociobehavioural studies International collaboration Guidelines for healthcare providers

8. Challenges Dissemination of national and international guidelines Training workshops for different stakeholders Appropriate legislations for compliance as guidelines are not mandatory- will be ready by end of 2003.Draft legislation of ethical guidelines is with the MOH & FW. Behavioural studies for risk reduction Promotion of access to drugs as all ARVs are available in the open market but not in the National programme on AIDS control. Large number of claims from traditional practioners – there are 6 recognised TRM practices

9. Major issues Illiteracy,Gender discrimination,imbalanced globalisation Stigma and discrimination Informed consent – an enigma - how « informed »,who informs Human rights-Privacy and Confidentiality Clinical trials- Post trial benefits – who determines and how No regulation of traditional medical practice trials International collaboration – whose interests

10. Ethical Principles Beneficence - ‘ Do no Harm ’ - Public health concerns are not placed over individual rights Justice - Vulnerables to be identified and protected Autonomy – Informed consent in difficult settings – illiteracy,overcrowding,muti linguistic society,family and community consultation Ensure ethical review – training of IEC/IRB members- FERCI/ FERCAP/ SIDCER

11. Existing Legislations Drugs and Cosmetics Act 1940,2002 GCP India guidelines,2001 MCI guidelines, 1956,2002(only applicable to modern medicine practioners) Social science research guidelines,2000 National AIDS policy,National Health policy,National health research policy, 2002 Draft bill for biomedical research authority,2002

12. Some thoughts Uniform ethical guidelines are ideal as all are born equal and are guided by the basic human rights. –Is it feasible in a world of unequals –Is it possible where Govt. Policies are different –Is it acievable where no capacity exists Is it right to impose stricter standards ?

13. « Protection of human subjects in HIV/AIDS research entails a clear demarcation of responsibilities and liability in the conduct of research.Issues such as Informed consent,provision of insurance,medical care,availabity of followup care and medication,compensation and methods of determining the same require legislation before research can be permitted.Participants should be aware of the legal liability for harm and compensation »

14. Case study Clinical trial of ATT with ART drugs in HIV+ cases who are also positive for Tuberculosis –First time trial –Single dose ART with DOT therapy- also first time –ART for 2 years and then National policy –Who decides, how long,who bears the cost –Counselling for HIV as well as ATT trial –Privacy and confidentiality issues

15. THANK YOU