A draft Bill incorporating all aspects of biomedical research would be brought up for public debate early next month. |
The Biomedical Research Authority Bill is an extension of the present guidelines framed by the Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT). The Bill mainly incorporates 'ethical guidelines for biomedical research on human subjects'. |
Addressing the media at the conclusion of a two-day international symposium on stem cell research, Vasantha Muthuswamy, senior deputy director-general, ICMR said, "a separate legislation will be made to incorporate all aspects and issues pertaining to biomedical research. The draft Bill will be in circulation from the first week of January and brought up for public debate and discussions." |
The need for a holistic legislation has been long felt with India becoming a hot destination for biomedical research. Many companies are showing keenness to set up base here for contract research and ethical issues with regard to human clinical trials and stem cell research taking the front stage. |
Explaining the current position, Muthuswamy said, "the Medical Council of India Act and the Drugs and Cosmetics Act were amended in 2002 to provide an indirect legislative backup and ensure that the ICMR guidelines were followed with respect to biomedical research and good clinical practice guidelines in case of clinical trials." |
One of the key aspects of the draft Bill will be to empower the institutional ethical committees (cleared by the national committee) to look at issues, take decisions and keep the national apex committee informed about its decisions. |
The national apex committee comprising eminent scientists, philosophers and representatives from various scientific institutions would give policy directions, register companies dealing with biomedical research and monitor their activities, Muthuswamy said. |
The present draft Bill also allows embryonic stem cell research except that only spare embryos from in vitro fertilisation (IVF) method could be used for research and that no embryo can be created for research. |
On cord blood banks in India, Lalji Singh, director, Centre for Cellular and Molecular Biology (CCMB), said that the same regulations pertaining to blood banks apply to them too. |
"More breakthroughs need to be achieved before the stem cell research is actually commercialised. Until then, the blood banks will have to store the stem cell lines and keep them from further differentiation, for any future use, which is a costly affair." There are currently four cord blood banks operating in the country. |