Application format for IMPORT of human biological material for commercial purposes
1. and /or research for development of commercial products
Purpose of import of biological material. Please specify. i) Bioavailability/Bioequivalence/Pharmacokinetic studies ii) Clinical trials iii) Diagnostic testing iv) Quality Assurance/Calibration for maintaining high standards of Indian laboratories v) Any other purpose
– pl. specify i) Name of Institution/Agency providing the biomaterial (Sending Party): ii) Complete postal address: iii) Contact details : - Telephone no.
Fax No.
E-mail address iv) Brief (one page) write up about the Agency and registration certificate from concerned authority to be enclosed.
2. i) Name of Institution/Agency where biomaterial is proposed to be transferred
(Receiving Party).
3. ii) Complete postal address: iii) Contact details : - Telephone no.
Fax No.
E-mail address iv) Brief (one page) write up about the Agency and registration certificate from concerned authority to be enclosed.
Nature/type of bio-material to be transferred.
Whole blood/Serum/Plasma/Urine/other Body Secretions/Excretions/Body cavity fluid/Tissue/Cell culture/Microbial product/Nucleic acid/ others - Pl. specify the source.
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4.
5.
Number of biological samples to be transferred.
6.
Quantity/ volume of samples to be transferred.
Period/duration (months /years) over which material is to be transferred. (Pl. also indicate the frequency of transfer of material)
7. Purpose and need of transfer of the biological material.
For a) Research purposes
b) Commercial purposes a) If for Research purposes: Type of research/investigations to be carried out using the bio-material (Brief description in 250 words). b) If for Commercial purposes: Details of commercial activity and type of research/investigations to be carried out using the bio-material (Brief description in 250 words).
8. Attach SOP/ Copy of procedure(s) to be followed.
9. Has the approval of CEO/Head of organization obtained for transfer of biological material. In addition, specify if any GoI/State Govt. approval(s) have been obtained. If yes, details thereof.
10. Duly signed Material Transfer Agreement (MTA) in prescribed format enclosed.
(Yes/No).
11. Source of funds through which the transfer of samples will be financed.
12. Expected outcomes/future leads, if any.
13. Implications, if any, on National Health Programmes.
14. Indicate the category under which the biological material proposed to be transferred falls as per UN class specifications in WHO document (2013-14) . In addition, 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 . Accordingly, the ‘category’ in terms of infectious nature/risk group of biological substances to be transferred is required to be assigned and indicated.
15. Specify the safety norms to be observed during transit and while working with the bio-material. ( For transfer of samples, the applicant should follow the ‘Guidance on regulations for the transport of Infectious substances (2013-2014 )’ as published by World Health Organization).
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16. Are there any features in the proposed transfer of samples which involve special / unusual risks (such as radio activity, recombinant DNA/genetic engineering work, toxic compounds, communicable diseases for plants, animals and humans; chemicals with long half life accumulating in the environment, high explosive chemicals etc.)? If yes, appropriate clearances to be enclosed.
17. Specify the Ethical issues involved. A copy of the Institutional Ethics Committee
Clearance certificate along with composition of the Committee to be enclosed (if available in a foreign language should be translated into English version).
18. 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 to be enclosed(if available in a foreign language should be translated into English version).
19. A copy of the Memorandum of Understanding signed between Indian applicant and international agency defining the commercial benefits to each Party to be submitted.
20. A copy of the details of the Intellectual Property Rights (if any) owned in terms of patents, copyright or an MoU/agreement signed by any of the Parties on biological/genetic material being transferred for commercial purposes to be submitted.
21. An undertaking that the material being imported has been tested and free from
HIV, Hepatitis B & C, Malaria and Syphilis.
22. Has the contractual obligation been studied to ensure that there is nothing detrimental or compromising as far as Indian scientific interests are concerned?
Details thereof.
23. Is the information or data to be collected in the course of the research/R&D activity of such a nature as would affect security or the interests of our country?
Details thereof.
24. Will the research/investigations be conducted in accordance not only with the country’s own environmental standards, but with international environmental standards as well? Details thereof.
25. Has 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 submitted ?
26. Is there any plan of storage of biological samples, if yes, suitable need/ justification, plan of utilization and due consent of donor/ patient to be submitted.
27. Has the disposal plan/manual for disposal of biohazardous, potentially infectious leftover samples submitted? Copy to be enclosed.
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28. Has the State pollution Control Board clearance and the contract/agreement with the disposal agency that the hazardous left over bio-material will be collected, treated and disposed off as per current national regulations submitted? Copy to be enclosed.
29. Has the DCGI approval issued to study centre for conducting
Bioavailability/Bioequivalence/Pharmacokinetic analysis obtained? A duly valid copy of approval to be enclosed.
30. A duly valid copy of approval for providing services under relevant discipline such as diagnostics/ physical - chemical studies/toxicity studies /medical / biological testing etc, as applicable, from either of the following to be enclosed. i) National Accreditation Board for Testing and Calibration Laboratories
(NABL) certificate for diagnostic/clinical trial labs or Certificate of GLP compliance /DSIR certification as issued by the Ministry of Science & ii)
Technology, GoI in the relevant discipline as applicable.
Equivalent approval e.g. from College of American Pathologists (CAP or any signatory of International Laboratory Accreditation Cooperation
Arrangement.”
31. If fee for service is being charged by the Indian Agency for analysis of biomaterial in India, a copy of commercial invoice or an MOU to be submitted.
Note w.r.t. 29 & 30 above: For any other kind of analysis/testing, the Committee will consider the approvals from relevant agencies, as submitted, on case to case basis.
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