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INDIAN
COUNCIL OF MEDICAL RESEARCH International Health Division Guidance
on transfer of human biological material for commercial purposes and /or
research for development of commercial products Announcement for submission of applications 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; transfer of human biological waste material or any other
cases for commercial purposes will be considered by this committee. This
will be a continuous process and ICMR will process the applications four
times in a year. Ten sets of the application including copies of the following documents are
required to be submitted by the applicants to ICMR: 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). Note:
Applications complete in all respect should be submitted at
the following address: International
Health Division (Attn: Dr. Harpreet Sandhu) Indian
Council of Medical Research, V. Ramalingaswami Bhawan, Ansari Nagar, New
Delhi – 110029, Tele fax: 011-26589492 Last
date for this call for submission of applications : 31st
January, 2012 (Future
deadlines for submission of
applications would be 31st January; 31st April; 31st
July and 31st October in each calendar year)
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