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pramodbatkhal ☆ 2014-03-12 16:46 (4487 d 05:30 ago) Posting: # 12608 Views: 2,736 |
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Dear all, Please let me know the procedure to obtaine Noc from DCGI or respective authority in India for Export of Stem Cell. I think same procedure have to followed as Biological sample export like plasma Please clarify. |
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drgunasakaran1 ★★  2014-03-14 19:35 (4485 d 02:42 ago) @ pramodbatkhal Posting: # 12630 Views: 2,251 |
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❝ 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 — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
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