1. that methodology and implementation of the study

1. The debate triggered by reports of controversial medical (clinical) research being conducted in India, has questioned the robustness and credibility of Indian regulatory system. Parliamentary Standing Committee on Health and Family Welfare in its 72nd report on Alleged Irregularities in the Conduct of Studies using Human Papilloma Virus (HPV) Vaccine by PATH in India, 2013 reported that methodology and implementation of the study was full of flaws. This projected the use of Indian population by multinationals as ‘guinea pigs’, which was addressed later in revised regulations.2. The revised regulations were result of petition before Hon’ble Supreme Court of India in 2012 by Swasthya Adhikar Manch (SAM), Indore wherein the petitioner proclaimed   inadequacies and lack of transparency in current regulations. It was through the intervention of the Court, the Indian government proposed additional measures to strengthen the protection for clinical trial participants and advanced regulatory framework on clinical trials came into existence. 3. When compared to compensation regime in United States and Australia, the Indian compensation model and formula is very unique. As per Australian guidelines, the sponsor is required to provide compensation for trial participants in the event of trial-related injuries or death. The sponsor must explain to participants the compensation and/or treatment available to them in the event of trial-related injuries. Compensation or payment to participants must not be disproportionate to the time involved, or include other incentives that encourage them to take risks. Further, compensation decisions should consider customs and practices of the community in which the trial will be conducted. In USA, the sponsor is responsible for providing compensation to research participants and/or their legal heirs in the event of trial-related injuries or death. Compensation for participation is considered to be a recruitment incentive and not a benefit, and it is often offered when the participant’s health benefits are remote or non-existent. Basically in USA the compensation policy is quite limited and a mix of both private and public responsibility (as many institutions have their own compensation plan). According to Indian regulations, the sponsor shall be responsible for paying compensation to clinical trial participant in case of clinical trial related injury or death, if the same has occurred due to any of the following reasons:h. adverse effects of investigational product(s);i. violation of the approved protocol, scientific misconduct or negligence by the sponsor or his representative or the investigator;j. failure of investigational product to provide intended therapeutic effect where, the standard care, though available, was not provided to the subject as per clinical trial protocol;k. use of placebo in a placebo-controlled trial where, the standard care, though available, was not provided to the subject as per clinical trial protocol;  l. adverse effect due to concomitant medication, excluding standard care, necessitated as part of approved protocol;m. for injury to a child in-utero because of a parent’s participation in a clinical trial;n. any clinical trial procedures involved in the study. The Indian formula is based on no-fault liability, is a mathematical formula. No such formula for compensating the clinical trial participant is available across the world. USA lacks national standards for either no-fault procedures or compensation guidelines for research-related injuries.     4. Though the advanced regulatory regime of compensation guidelines has apparently impacted clinical research industry in India. Inspite, India remains a hotspot for conducting global clinical trial and will keep on attracting global clinical trial(s). The government acted swiftly and improved regulations as per direction of the Court to ultimately benefit the clinical research participant. Doing so may make it less attractive to foreign sponsors, who can simply shift their activities to more industry-friendly jurisdictions. It is necessary to emphasize here that these economic pressures unlikely affected Indian strategy to revamp the regulations and regulatory ‘race to the bottom’ is only an inaccurate representation of facts.