Clinical trials and vaccine trials in India have become an important issue of policy level discussions. The report of the parliamentary panel severely indicts the premier government body on public health research – Indian Council for Medical Research – for colluding with the international agencies and for flouting all established ethical and public health norms. The journey to this level of policy discussion began with some civil society organisations critically looking at the administering of Human Papillomavirus (HPV) on tribal girls in Andhra Pradesh, resulting in couple of deaths of tribal adolescent girls. Civil society organisations too led a fact finding team and it also became a national issue due to which a parliamentary panel was formed.
Beginning from 2009, the fact findings by SAMA Resource Centre (Delhi), Smt Brinda Karat (parliamentarian and also leader of All India Democratic Women’s Association – AIDWA) and other women’s groups, in Bhadrachalam (one of the sites where the HPV trial was conducted in Andhra Pradesh), visibilised the unethical conduct of the HPV trials by PATH (international organisation) in collaboration with Government of Andhra Pradesh and Gujarat, with financial support from BMGF and donation of the vaccines for the trial by Merck, Glaxo (GSK) and technical support from ICMR. This was followed by a consistent campaign, parliamentary debates, that led to the eventual suspension of the trials. The critiques of the interim and final reports of the enquiry committee set up to examine the irregularities, filing of RTIs, etc. strengthened the campaign.
According to this 72nd report, the Committee has been looking into the issue of HPV trials on children in Andhra Pradesh – India (Khammam district) and Gujarat – India (Vadodara district) since April 2010 following reports of deaths of some of the children. The report states that PATH by carrying out the clinical trial on the pretext of observation/demonstration project has violated all laws and regulations laid down for clinical trials by the Government of India.
This process of civil society monitoring of the human rights and ethical violations in health interventions leading to a policy and parliamentary discussion is a significant illustration of the process of monitoring by the grass roots and policy community. The issue of HPV along with the unethical clinical trials have led to new policy formulations on clinical trials and a draft bill is now being proposed to regulate clinical trials.
Read The Hindu’s coverage of the issue below:
It’s a PATH of violations, all the way, to vaccine trials: parliamentary panel– Committee questions roles of ICMR, Drug Controller-General of India in the “intriguing” 2010 episode (The Hindu, 2nd September, 2013.)
By: E. Premdas Pinto