The Indian Council of Medical Research (ICMR) has issued Guidance on the submission of papers and documents for the purpose of transfer of human biological material for commercial purposes and /or research for development of commercial products.

Senior ICMR officials said that the evaluation of cases will be a continuous process and the ICMR will process the applications four times in a year.

Officials said that as per the guidelines issued by the union health ministry on November 19, 1997, a committee has been constituted by DG, ICMR to consider the cases related to transfer of human biological material for commercial purposes. The evaluation of cases where infectious biological material/samples are proposed to be transferred from foreign research centers to Indian diagnostic laboratories/research centers or vice versa for analysis; transfer of human biological waste material or any other cases for commercial purposes will be considered by this committee.

Officials also said that for transfer of samples, the Indian applicants should follow the ‘Guidance on regulations for the transport of Infectious substances (2009-2010)’ as published by World Health Organization (WHO). There are specific packing instructions as per United Nations class (6.2) specifications to be followed during transport of infectious substances. Unless otherwise declared the biological materials such as blood and/or blood components; dried blood spots and faecal occult blood; medical or clinical wastes are to be considered under the ‘infectious substance category’.

The documents which are required to be submitted by the applicants to ICMR include: application form for transfer of samples; Material Transfer Agreement (MTA); the Institutional/Independent Ethics Committee (IEC) clearance along with the composition of Ethics committee; and the patient information sheet and informed consent form (as approved by IEC) giving details on the utilization of samples of the patient for a particular research/R&D study and the kind of benefit (direct/indirect or no benefit - as applicable) for appropriate decision making by the patient.

Besides, the applicants should also submit the documents like the informed consent/undertaking of individual patient(s) agreeing to the utilization of his/her said biological samples for a particular study/purpose. The undertaking should also clearly state that the patient is willing /not willing (as agreeable to patient) to claim any commercial benefit on the product developed as a result of work carried out on his/her biological samples.

The applicants should also submit the import certificate as issued by the relevant foreign regulatory authority to the foreign laboratory receiving the Indian biological samples; the Memorandum of Understanding (MoU) signed between Indian laboratory and international agency defining the commercial benefits to each party; and safety or operations manual being followed/adopted as safety procedures by the laboratory for the workers involved in activities involving possible exposure to pathogens through blood or other body fluids.

Other documents to be submitted to the IMCR include the National Accreditation Board for Testing and Calibration Laboratories (NABL) certificate as issued by the Department of Science & Technology, or equivalent; the disposal plan and necessary clearances for disposal of biohazardous, potentially infectious leftover samples; an Undertaking that GoI guidelines on biomedical disposal will be followed; and the valid recognition letter as issued by office of DCGI for approval as Bioavailability/Bioequivalence study centre (for laboratories where biological samples are being received for BA/BE studies).