Bioequivalence and Bioavailability Forum

❝ Please let me know the procedure to obtaine Noc from DCGI or respective authority in India for Export of Stem Cell.

Dear Mr Pramodbatkhal,
All proposals for import/export of stem cells and their derivatives required for research and development including for clinical trials shall be examined by the IC- SCR, and if felt necessary by the NAC-SCRT. After satisfying the scientific and ethical considerations, the statutory requirements of approval from DCGI and the Govt. of India’s guidelines (Circular No. L/950/53/97-H1 (Pt.) dated November 19th, 1997 of the Ministry of Health) on import/export of biological materials should be followed.

A critical limitation of the use of stem cells for research and development is to maintain them in a viable state. Since their viability can be affected by X ray – irradiation, appropriate international guidelines need to be followed for their packaging, labelling, handling and transport at ports without compromising their quality.

Reference: http://icmr.nic.in/guidelines/NGSCR%202013.pdf