Bioequivalence and Bioavailability Forum

Dear Mr Vivek Badoni,

Indian Guidance on transfer of human biological material such as Plasma samples for research purposes are as follows.

As per the guidelines issued by the Ministry of Health & F.W; Govt. of India (vide O.M.No.19015/53/1997-IH Pt.) dated 19th November, 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;

Ten sets of the application including copies of the following documents are required to be submitted by the applicants to ICMR for obtaining permission to import plasma samples from USA to India:

1. Duly filled in application form for transfer of samples. Download format
   
   
2. A copy of the duly signed Material Transfer Agreement (MTA). Download format
   
   
3. A copy of the Institutional/Independent Ethics Committee (IEC) clearance along with the composition of Ethics committee.
   
   
4. A copy of 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.
   
   
5. A copy of 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.
   
   
6. A copy of the import certificate as issued by the relevant foreign regulatory authority to the foreign laboratory receiving the Indian biological samples.
   
   
7. A copy of the Memorandum of Understanding signed between Indian laboratory and international agency defining the commercial benefits to each party.
   
   
8. A copy of safety or operations manual being followed/adopted as safety procedures by your laboratory for the workers involved in activities involving possible exposure to pathogens through blood or other body fluids is to be submitted.
   
   
9. A copy of the National Accreditation Board for Testing and Calibration Laboratories (NABL) certificate as issued by the Department of Science & Technology, Government of India/or equivalent is to be submitted.
   
   
10. The disposal plan and necessary clearances for disposal of biohazardous, potentially infectious leftover samples is to be submitted. An Undertaking that GoI guidelines on biomedical disposal will be followed to be submitted.
    
    
11. A copy of 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).

For more information, see here .