The Department of Biotechnology (DBT) will take the lead to formulate a comprehensive Human Tissue Act with codes and guidance for regenerative medicine soon. As a first step, the DBT and Indian Council for Medical Research (ICMR) has set up a joint committee to prepare a National Guideline on stem cell research. The joint committee is looking into the existing guidelines that have been brought out by ICMR and DBT separately and is to recommend a single guideline soon. The committee is to meet on April 28th, Dr M K Bhan, secretary, DBT informed.
According to Dr Bhan, gone are the days when there were duplication of efforts due to the absence of proper coordination between various scientific bodies like ICMR and DBT. He said that the department and ICMR is planning to have a joint committee of permanent nature to take up all issues of joint concern and formulate single rules and guidelines in medical research in future.
The draft National Biotechnology Development Strategy prepared by DBT has called for the formulation of Human Tissue Act by 2005 end. It has proposed the creation of DNA and stem cell banking facilities. It has also recommended clearer laws on animal testing, emphasize on IPR and regulation for human tissue engineered products.
The strategy paper also underlined the need for an inter-ministerial group to address the anomalies and issues that arise in regulation from time to time. The proposed group is to be chaired by a reputed scientist and is to be established during the current year itself. While the administrative support for the committee has been proposed to be through DBT, the committee would be mandated to vet any changes in policies, procedures and protocols by departments dealing with regulation in biotech products and processes. It will be empowered to resolve issues emanating from the overlapping / conflicting rules in various acts related to regulation of biotechnology activities in R&D, import, export, releases etc and to review guidelines, protocols, standard operating procedures and ensure their dissemination to all stakeholders from time to time.