Replying to a question in Lok Sabha on mechanism put in place for violations in this regard, Health Minister Ghulam Nabi Azad said the new stem cell division will evaluate all proposals in this regard, including issues concerning clinical trial and marketing authorisation.
Government has on September 1, 2010, set up a Cellular Biology Based Therapeutic Drug Evaluation Committee, a core new drug panel of experts to advice the Drug Controller General in matters pertaining to regulatory pathways leading to approval of clinical trials and market authorisation for "therapeutic products derived from stem cells, human gene manipulation and xenotransplantation technology".
Azad said since there was no mechanism in place to take note of violations of guidelines for stem cell research and therapy till recently, the Indian Council for Medical Research has not received any complaints at institutional level.
He said 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 such activities in the country.
The ICMR jointly with Department of Biotechnology has formulated Guidelines for Stem Cell Research and Therapy (2007) to help clinicians and scientists in responsible scientific and ethically sensitive manner, Azad said.
Understanding the recent advances in the field, the guidelines are being revised in 2012, he said.
Azad said as per the guidelines, all institutes working in 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. PTI SKC
