ICMR for human biologics committee

A committee has been formed by the director general of the Indian Council for Medical Research (ICMR) in order to consider the cases related to the transfer of human biological material for commercial purposes.

The committee has been set up in accordance with the guidelines issued by the Ministry of Health, Government of India (vide O.M.No.19015/53/1997-IH Pt.) dated November 19, 1997.

For transfer of samples, the Indian applicant should follow the ‘Guidance on regulations for the transport of Infectious substances (2009-10)’ as published by the WHO. There are specific packing instructions as per United Nations class (6.2) specifications that are to be followed during transport of infectious substances. Unless declared otherwise, the biological materials such as blood and/or other blood components; dried blood spots and faecal occult blood and medical or clinical wastes are to be considered under the ‘infectious substance category’.

The applicants are required to indicate the category under which the infectious substances or organism falls. In addition to categories indicated as per UN class specifications in the WHO guidelines (2009-10), the applicant should also refer to the relevant categories mentioned under SCOMET items in schedule of India’s Foreign Trade Policy classification as well as Animal and Human pathogens scheduled as risk groups in the Ministry of Environment and Forests Notification, GoI,1989.