To be published in the Gazette of India Extraordinary Part-I, Section-I
Government of India
Ministry of Commerce and Industry
Department of Commerce
Directorate General of Foreign Trade
Public Notice No. 13 /2015-2020
New Delhi, Dated the 22 May, 2015
Subject: Implementation of the Track and Trace system for export of drug formulations.
In exercise of the powers conferred under Paragraph 2.04 of the Foreign Trade Policy, 2015-
20, as amended from time to time, the Director General of Foreign Trade hereby amends Para 2.89 A
of Handbook of Procedure, 2015-20, as notified vide Public Notice No. 4/2015-20 dated 01.04.2015,
as under, for laying down the procedure for implementation of the Track and Trace system for export
consignments of drug formulations:
2. “2.89 A
Procedure for Implementation of the Track and Trace system for export of drug
formulations
(i) The manufacturer or the exporter of drug 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 on optional basis till further notification.
(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. However, manufacturer or exporter shall affix bar
code on mono carton containing one primary pack on optional basis till further
notification.
(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 of the
tertiary pack i.e. Serial Shipping Container Code (SSCC).
(ii) The manufacturer or exporter shall maintain the data in the parent-child relationship
for three levels of packaging i.e. Primary, Secondary and Tertiary packaging and their
movement in its supply chain. However, maintenance of parent-child relationship
between primary and secondary packaging is optional till further notification.
(iii) The data mentioned in (ii) above shall be uploaded on the central portal of the
Government of India by the manufacturer or exporter or its designated agency before
release of the drug formulations 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 or exporter.
(v) The above rules (i) to (iv) will not be applicable to those drug formulations
manufactured for export purposes, where the government of the importing country
has mandated or formally notified its intention to mandate a specific requirement and
the exporter intends to avail the option of printing the barcodes in their format after
duly obtaining the permission of DCGI or its nominee. 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.
(vi) The exports of the drugs having manufacturing date prior to 01.10.2015 will be
exempted from requirement of data uploading on central portal.
(vii) With effect from 01.10.2015, all drugs with manufacturing date on or after
01.10.2015 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,
(i) Drug formulation means a formulation manufactured with a license
from Drug Control Authority under the provisions of Drugs &
Cosmetics Act and Rules made there under.
(ii) Primary packaging means the package which is in direct physical
contact with the active ingredient. Secondary packaging means a
carton containing one or more primary packs and includes a mono
carton containing one primary pack. The tertiary packaging means a
shipper containing one or more secondary packs.
(b) Separate guidelines shall be issued for grant of exemption (s), data
requirement, maintenance and upload on central portal.”
3. Effect of this Public Notice:
In supersession of the earlier Public Notice No. 4/2015-20 dated 1st April, 2015, the procedure
for implementation of the Track and Trace system for export of drug formulations has been
modified.
(Pravir Kumar)
Director General of Foreign Trade
E-mail:dgft@nic.in
(Issued from F.No. 01/91/180/648/AM 09/Export Cell)
