Clinical trials in India sponsored by the pharmaceutical industry: a proposal for reforms
Pai, M.; Colford, J.M.
National Medical Journal of India 15(2): 93-96
2002
ISSN/ISBN: 0970-258X PMID: 12044124 Document Number: 543787
An article is presented discussing the need to re-examine issues related to industry sponsorship of clinical trials in India, due to recent allegations of unethical trials and human experimentation. On 16 May 2001, the Ministry of Health and Family Welfare proposed new rules to rationalize the system of approval of new drugs, and conduction of clinical trials and post-marketing surveillance. It is proposed that all institutions that conduct biomedical research adhere to the revised Indian Council of Medical Research guidelines on ethics.