Implementation of the Track and Trace system for export of Pharmaceuticals and drug consignments. –
Public Notice - Dated 1-4-2015 - DGFT
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.
(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.
Director General of Foreign Trade
(Issued from F.No. 01/91/180/648/AM 09/Export Cell)
DGFT PUBLIC NOTICE
PUBLIC NOTICE NO.68(RE-2013)/2009-2014
Dated 06th August, 2014
As per Public Notice No.62 dated 26.06.2014, Mono cartons are to be treated as part of Secondary Level Packaging and accordingly the requirement of affixing bar-codes on Monocarton as Secondary Level Packaging became effective from 26.06.2014. Now the effective date of affixing bar-codes on Mono-carton as Secondary Level Packaging has been deferred to 1st April, 2015. There shall be no other change in Public Notice No. 62 dated 26.06.2014.Read more...
DGFT PUBLIC NOTICE
PUBLIC NOTICE NO.62(RE-2013)/2009-2014b
Dated 26 th June, 2014
Procedure relating to tracking and tracing of export consignment of pharmaceuticals and drugs.
Every exporter of Drugs & Pharmaceuticals at the time o f shipment shall submit, alongwith other required documents, the following:
All Indian pharmaceuticals are already aware of DGFT notification of implementation of 2d code and UID (unique serialization code) with Track and Trace capability on the primary, secondary and tertiary packing. For detailed DGFT notification please visit the link http://dgft.gov.in/exim/2000/pn/pn10/pn2110.htm
Countries like TURKEY, FRANCE have already started implementing the same on their products and itâ€™s also mandatory for the companies exporting to the countries to have the same on their packing.
It is all read, heard and talked about generating numbers (UID), lot of Companies are trying to sell these numbers (CODEs),providing global server connectivity etc. But nobody seems to be keen in providing solutions of actual implementation of the same onto busy Indian packing lines.
Here is where we play our role in the entire track and trace solutions. We are ready with TRACK and TRACE Solution under ONE -ROOF.
TRACK and TRACE system developed is robust and very easy to use. The single system is compliant to DGFT, TURKEY, FRANCE CIP13, ANVISA Norms and totally capable of upgrading it to California E-pedigree 2015 norms.TRACK and TRACE system developed by Propix is available in 2 types.
TRACK and TRACE system features
" PACK i " is equipped with read decode and verify these code . A standard and configurable user interface paired with innovative and robust image processing tools quickly enable you to design, implement, deploy and test your vision system at a affordable price. Within the pharmaceutical industry the use and application is driven by traceability and the fight against counterfeiting as is the case in this application, and to also conform with the latest EFPIA legislation too.
SOURCE : French Health Products Safety Agency
From 1st January 2011, AFSSAPS (French Agency for Health Safety and Health Products) will introduce new AIDC (Auto Identification and Data Capturing) for traceability regulation for all medicines sold in the French pharmaceuticals market. This program is for companies who wish to protect their products from counterfeiting and diversion problems. December 31, 2010 â€” All the new presentations of drugs would be released with the new CIP 13 codes as well as 2D data matrix bar code (with expiry date and lot) on the external packaging. Also by December 31, 2010, all pharmaceutical industry products distributed in France should have following :