Government
of India
Ministry of Commerce and Industry
Department of Commerce
Directorate General of Foreign Trade
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
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:
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.
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.
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:dgft@nic.in
(Issued from F.No. 01/91/180/648/AM 09/Export Cell)
Director General of Foreign Trade
E-mail:dgft@nic.in
(Issued from F.No. 01/91/180/648/AM 09/Export Cell)
The attached notice released by DGFT office states that in the primary level packaging, the details like GTIN number, batch no., expiry date and Serial number is required to be printed in human readable form.
ReplyDeleteCould you please inform us, from which date onwards, the above referred data printing in human readable form is effective? The notice informs that only barcoding at primary level is exempted till further notice but there is no clarity on when onwards the above mentioned details to be printed in human readable form is effective?