2013 | Berne Declaration, Sama
This research report is based on a study that Sama along with Berne Declaration, an independent Swiss NGO, undertook in 2012- 2013 to explore the conduct of clinical trials sponsored by Swiss pharmaceutical companies in India. The study aimed to look into whether these companies comply with the relevant ethical standards and the regulatory environment in India.
Qualitative Research methods were employed while exploring the perspectives of various constituencies and stakeholders who were relevant to the study context. These included clinical trial participants, Principal Investigators, Clinical Research Coordinators (CRCs) and representatives of Contract Research Organisations (CROs).The study site included six states, Gujarat, Maharashtra, Rajasthan, Delhi, Andhra Pradesh and Uttar Pradesh. A large number of clinical trials were conducted in these states as per 2011 Clinical Trial Registry of India (CTRI) data, including those by Swiss pharmaceutical companies.
The study looked at aspects and procedures related to the recruitment process, the securing of informed consent, the reporting of serious adverse events (SAE), post trial access (PTA), insurance and compensation. A critical analysis of the relevant bills, laws and guidelines was also undertaken to gain an understanding of the status of the relevant legislation, regulations and policies that affect the clinical trial industry, and the reports produced by the Parliamentary Committee to identify the issues that needed public debate and discussion.
The study findings raised concerns regarding legal and ethical issues that impinge on clinical trials conducted by various institutions and professionals: the informed consent- taking process; the assessment and award of compensation; the reporting of Adverse Events, Serious Adverse Events, and deaths; Post Trial Access; and the role of Ethics Committees and Institutional Review Boards. The report also makes recommendations addressing these issues.