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Government of India
Ministry of Commerce & Industry
Department of Commerce
Directorate General of Foreign Trade
Udyog Bhawan
Notification No. 19/2015-2020
New Delhi, Dated: 4 August, 2016
Subject: Import/export policy for Human Biological Samples for
commercial purposes: amendment Schedule – 1 (Import Policy) and Schedule – 2
(Export Policy) of ITC (HS), 2012.
S.O. (E): - In exercise of powers conferred by Section 3 of FT (D&R) Act,
1992, read with paragraph 1.02 and 2.01 of the Foreign Trade Policy, 2015-2020,
as amended from time to time, the Central Government hereby inserts Import
Policy for Human Biological Samples for commercial purposes under General Notes
17 to Schedule – 1 (Import Policy) and Export Policy for Human Biological
Samples for commercial purposes under General Notes 4 to Schedule – 2 (Export
Policy) of ITC (HS), 2012 as under:
“The import of human biological samples by the Indian diagnostic laboratories
/ Indian Clinical Research Centres for lab analysis / R & D testing or export of
these materials to foreign laboratories should be permitted by Customs
authorities at the port of entry / exit without prior approvals (import licence
/ export permit) from any other Government agency, provided the concerned Indian
company / agency submits an undertaking that they are following and will follow
all the applicable rules, regulations & procedures for safe transfer and
disposal of the biological samples being imported / exported as per the related
norms / regulations set by WHO* / DGFT** [SCOMET items in Export Policy of ITC
(HS), 2012, Schedule – 2 (Export Policy)] / Ministry of Environment, Forests and
Climate Change***, Government of India, to the Customs authorities at the port
of entry / exit along with the details of such samples”.
2. Effect of this Notification: Policy condition for import /export of human
biological samples for commercial purposes is laid down.
* (i) http://apps.who.int/iris/bitstream/10665/149288/1/WHO_HSE_GCR_2015.2_eng.pdf?ua=1)
(ii)
http://www.who.int/csr/resources/publications/biosafety/en/Biosafety7.pdf
** http://dgft.gov.in/exim/2000/scomet/scomet2011.pdf
*** (i) http://envfor.nic.in/legis/env/env1.html
(ii)http://envfor.nic.in/legis/hsm/hsm3.html
(Anup Wadhawan)
Director General of Foreign Trade
E-mail: dgft[at]nic[dot]in
[Issued from F.No.01/89/180/Misc.82/AM-05/PC-2 (A)]
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