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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 bar coding 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: [email protected]
(Issued from F. No. 01/91/180/648/AM 09/Export Cell)
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