Human Bio Samples for Research Purposes
Allowed Subject to WHO/MoEF Norms
[DGFT Notification No. 19 dated 4th
August 2016]
Effect of this Notification: Policy condition for import /export of
human biological samples for commercial purposes is laid down.
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.
In exercise of
powers conferred by Section 3 of FT (D&R) Act, 1992, read with paragraph 1.02 and 2.01of
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”.
*(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