Stem Cell Division in Central Drugs Standard Control Organization

The Directorate General of Health Services, Office of Drugs Controller General(India) Ministry of Health and Family Welfare, Government of India has established a Stem Cell Division within Biological Division in Central Drugs Standard Control Organization (HQ) for the internal evaluation of all proposals including stem cell concerning with clinical trial and marketing authorization.

Till recently, there was no mechanism in place to take note of the cases violating these guidelines or take action against the agencies found violating these guidelines. In a step towards this direction, Ministry of Health and Family Welfare (Govt. of India) vide order dated 1st September 2010 constituted a Core Investigational New Drug (IND) Panel of Experts namely “Cellular Biology Based Therapeutic Drug Evaluation Committee (CBBTDEC) under the chairmanship of Director General, ICMR & Secretary, DHR to advice DCGI in matters pertaining to regulatory pathways leading to the approval of clinical trials and market authorization for the “Therapeutic products derived from Stem Cell, human Gene manipulation and Xenotransplantation technology”. CBBTDEC has deliberated on the need for strengthening the regulatory agency (DCGI) by establishing separate wing for Stem Cell Research supported with knowledge and capacity to regulate the activities in the country.

ICMR jointly with Dept. of Biotechnology has formulated Guidelines for Stem Cell Research and Therapy (2007) to help clinicians and scientists working in the field to conduct research in responsible scientific and ethically sensitive manner. Understanding the recent advances in the field, the guidelines are being revised in 2012. The draft guidelines are available on ICMR website (www.icmr.nic.in).

As suggested in the guidelines, all the Institutes working in the field of Stem Cells Research and therapy have to constitute Institutional Committee for Stem Cell Research and Therapy (IC-SCRT) to oversee the activities and proper implementation of all guidelines. The guidelines have also suggested having National Apex Committee for Stem Cell Research and Therapy i.e. (NAC-SCRT) to oversee the activities at National level, where all the IC-SCRTs will be registered. Guidelines do suggest the responsibility of investigator and IC-SCRT to oversee activities at institution level and report to NAC-SCRT in case of violation/unethical practices. So far council has not received any complaints at institutional level.

The above information was laid in the Lok Sabha today by the Union Minister for Health & Family Welfare Shri Ghulam Nabi Azad.

SBS/ls