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Government of India
Ministry of Commerce and Industry
Department of Commerce
Directorate General of Foreign Trade
Public Notice No. 4 /2015-2020
New Delhi, Dated the 1 April, 2015
Subject: Implementation of the Track and Trace system for export of
Pharmaceuticals and drug consignments.
In exercise of the powers conferred under Paragraph 1.03 of the Foreign Trade
Policy, 2015-2020, as amended from time to time, the Director General of Foreign
Trade hereby inserts Para 2.89 A in Handbook of Procedure, 2015-2020, as under,
for laying down the procedure for implementation of the Track and Trace system
for export of Pharmaceuticals and drug consignments:
2. “2.89 A
Procedure for Implementation of the Track and Trace system for export of
Pharmaceuticals and drug consignments
(i) The manufacturer of drug for formulations will print the barcode as per
GS1 Global Standard at different packaging levels to facilitate tracking and
tracing of their
products. The details are as follows:
(a) Primary Level:
Incorporation of two dimensional (2D) barcode encoding unique and universal
global product identification code in the format of 14 digits Global Trade Item
Number (GTIN) along with batch number, expiry date and a unique serial number of
the primary pack. The bar code labelling at primary level is exempted till
further notification, however the above mentioned details are required to be
printed in human readable form.
(b) Secondary Level:
Incorporation of one or two dimensional (1D or 2D) barcode encoding unique
and universal global product identification code in the format of 14 digits
Global Trade Item Number (GTIN) along with batch number, expiry date and a
unique serial number of the secondary pack.
(c) Tertiary Level:
Incorporation of one dimensional (1D) barcode encoding unique and universal
global product identification code in the format of 14 digits Global Trade Item
Number (GTIN) along with batch number, expiry date and a unique serial number
[Serial Shipping Container Code (SSCC)] of the Tertiary pack.
(ii) The manufacturer shall maintain the data in the parent-child
relationship for all three level of packaging i.e. Primary, Secondary and
Tertiary and their movement in its supply chain.
(iii) The data mentioned in (ii) above, shall be uploaded on the central
portal of the Government of India by the manufacturer or its designated agency
before release of
the drugs for sale or distribution.
(iv) The responsibility of the correctness, completeness and ensuring timely
upload of data on the central portal shall be with the manufacturer.
The above rules will not be applicable to those drug formulation manufactured
for export purposes, where the government of the importing country has mandated
a specific requirement and the exporter intends to avail the option of printing
the barcodes in their format with the permission of licensing authority
appointed under rule 21. However, the tertiary level of packaging will have
additional printing of barcode as per (i)(c) above in addition to importing
country’s requirement, if any.
(v) The exports of the drugs having manufacturing date prior to 01.04.2015
will be exempted for requirement of barcode labelling and data uploading on
central portal.
(vi) The drugs with manufacturing date on or after 01.04.2015 will
compulsorily carry barcode on tertiary and secondary packages as per the
Notification No. 68 dated 06.08.2014. However the requirement of data uploading
on central portal will be exempted till 30.06.2015.
(vii) With effect from 01.07.2015, all drugs with manufacturing date on or
after 01.04.2015 can be exported only if both the tertiary and secondary
packaging carry
barcoding as applicable and the relevant data as prescribed by DGFT is uploaded
on the central portal.
Explanation:
(a) For the purpose of this rule, primary packaging means the package which
is in direct physical contact with the drug, secondary packaging means the
carton containing multiple primary packs including a mono carton and tertiary
packaging means a shipper containing multiple secondary packs.
(b) Separate guidelines shall be issued for data requirement, maintenance and
upload on central portal.”
3. Effect of this Public Notice:
The procedure for implementation of the Track and Trace system for export of
pharmaceutical and drug consignments has been notified.
(Pravir Kumar)
Director General of Foreign Trade
E-mail:[email protected]
(Issued from F.No. 01/91/180/648/AM 09/Export Cell)
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