Press Releases

Implementation of the Track and Trace system for export of Pharmaceuticals and drug consignments. 1st April, 2015

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.

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)

Deferment in the date of effect of implementation of bar-coding on Monocarton as Secondary Level Packaging on export consignment of pharmaceuticals and drugs for tracing and tracking purpose. 07th August, 2014

DGFT PUBLIC NOTICE

-COPY OF-
PUBLIC NOTICE NO.68(RE-2013)/2009-2014
Dated 06th August, 2014

  • In exercise of the powers conferred under Paragraph 2.4 of the Foreign Trade Policy, 2009-14, as amended from time to time, Director General of Foreign Trade hereby makes the following amendment in Public Notice No.62(RE-2013)/2009-2014 dated 26.06.2014.
  • The date of implementation of bar-coding on Mono-carton packaging as mentioned at Sl.No.3(i) b of Public Notice No. 62(RE-2013)/2009-2014 dated 26.06.2014 will come into effect from 1st April, 2015.
  • Effect of this Public Notice:

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.

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Procedure relating to tracking and tracing of export consignment of pharmaceuticals and drugs. 07th July, 2014

DGFT PUBLIC NOTICE
-COPY OF-
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.

  • In exercise of the powers conferred under Paragraph 2.4 of the Foreign Trade Policy, 2009- 14, as amended from time to time, and in supersession of the following Public Notices, Director General of Foreign Trade hereby prescribes the following procedure for tracking and tracing of export consignments of drugs and pharmaceutical products:
    • Public Notice No. 21(RE-2011)/2009-2014 dated 10.01.2011
    • Public Notice No. 59(RE-2010)/2009-2014 dated 30.06.2011
    • Public Notice No. 87(RE-2010)/2009-2014 dated 22.12.2011
    • Public Notice No. 10(RE-2012)/2009-2014 dated 11.07.2012
    • Public Notice No. 54(RE-2012)/2009-2014 dated 05.04.2013
    • Public Notice No. 31(RE-2013)/2009-2014 dated 17.10.2013
  • Every exporter of Drugs & Pharmaceuticals at the time o f shipment shall submit, alongwith other required documents, the following:

    • A copy of Certificate of Analysis issued by the manufacturer for the subject products; or
    • A copy of C ertificate of Analysis issued by approved laboratory of the importing country/FDA; or
    • A copy of C ertificate of Analysis issued by a laboratory approved by Drugs Controller under Drugs & Cosmetics Act, 1940 and the rules made thereunder.
    • Exporters of pharmaceutical products will adopt a track and trace system and incorporate its features for exported medicines using barcode technology as per GS 1 global standards. The following is needed to be done as detailed below:
      • Primary Level packaging requirement:
        Incorporation of 2D (GS1 Data matrix) barcodes on medicines at strip/ vial/bottle, etc. encoding unique product identification code (GTIN) and Unique Serial Number of the P rimary pack.
      • Secondary Level packaging requirement :
        Incorporation of barcodes (1D or 2 D) encoding unique product identification code (GTIN), Batch Number, Expiry Date and Unique Serial Number of the Seconda ry pack. Mono cartons shall be treated as Secondary Level Packaging in line with prevalent global packaging nomenclature.
      • Tertiary Level packaging requirement:
        Incorporation of barcodes (1 D) encoding unique product identification code (GTIN), Batch Number, Expiry Date and Unique Serial Number of the Tertiary pack (shipper/carton).
    • The track and t race technology as per serial number 3(i) above will be effective a s under:
      • Primary Level packaging :- Effective dat e will be notified later.
      • Secondary Level packaging :- 1 st January, 2013 (already given effect to)
      • Tertiary Level packaging :- 1 st October, 2011 (already given effect to)
  • In case, the Government of the importing country has mandated a specific requirement, the exporter has the option of adhering to the same and in such a case, it would not be necessary to comply with the stipulations at serial number a, b & c of para 3(i) above and if an exporter is seeking to avail exemption from bar coding prescribed by the Government of India as above, the exporter is given the option to move an application to the Pharmaceuticals Export Promotion Council of India (Pharmexcil) for this purpose, clearly specifying the nature of such an exemption in the interest of the exports from the country. Pha rmexcil shall dispose of such applications on case to case basis with prior approval of Government.
  • Under the track and trace system, manufacturers would be required to maintain serialized record of exported pharmaceutical products for a minimum period of six months after the expiry date of the product.
  • Authentication features will be added in due course and integrated with the track and trace system and Government will set up a Central Portal for tracking and tracing exported pharmaceutical products.
  • A self-certification process has been mandated effective 15.05.2014, vide Public Notice No.56 (RE-2013)/2009-2014 dated 01.04.2014 read with Public Notice No.58(RE-2013)/2009-2014 dated 15.04.2014. This shall continue to be applicable without any change.
  • Effect of this Public Notice:
    • The requirement of affixing bar codes on Tertiary Level and Secondary Level Packaging already implemented w.e.f. 01.10.2011 and 01.01.2013 respectively continue to be in force.
    • The requirement of affixing barcodes on Primary Level Packaging was to be effective from 01.07.2014. Now this date has been deferred till a new date is notified.
    • Earlier through Public Notice No. 31 dated 17.10.2013, mono cartons were to be treated as part of Primary Level Packaging. Now this has been modified to treat mono cartons as Seconda ry Level Packaging.
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Total Track and trace solution under one roof 15th Jan, 2011

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 it’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.
  1. Online implementation (Total modular system i.e. separate modules available for primary, secondary and tertiary level as per user needs)
  2. Offline implementation i.e. conveyor based system.

TRACK and TRACE system features

  1. Generation of serial numbers (UID) at multiple levels as per GS1 standards i.e. Primary, secondary and Tertiary level. The numbers generated are alphanumeric and randomized.
  2. Integration with many available Printers. E.g. Wolke m600, HSAJET, Alfa Jet, Image, Domino, etc.
  3. High resolution machine vision Cameras
  4. High Speed Vision inspection system to perform {Multi camera (@4-6 camera) supported system}.
  5. Online 2D code inspection with ISO Standard grading analysis.
  6. Checking of UID (for its uniqueness and printability)
  7. Optical Character Recognization (OCR) for human readable text
  8. Data handling / Storage ( Encrypted form)
  9. Total Aggregation ( Child Parent Relationship)
  10. Global server connectivity & Management
  11. SMS gateway.
  12. Customized conveyors.
  13. Report generation.
  14. 21 CFR part 11 Compliance.
Please feel free to contact us for more details
Propix introduced high speed 2 data matrix decoding 13th Feb, 2011

" 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.

Benefits:

  • Compliance with regulatory requirements
  • Multi-camera vision in single screen .
  • Advanced image processing software.
  • Easy Installation.
  • Significant reduction in wastage.
  • Offering various customized solutions like “blissâ€? pre and post sealing Blister Inspection system for value addition to pharma manufacturing process .

SOURCE : French Health Products Safety Agency

Auto Identification and Data Capturing 1st Jan, 2011

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 — 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 :

  • ECC200 Data Matrix barcode made up of Code CIP13, batch number, expiration date and human readable text. (used for reimbursements) consisting of CIP 13, the reimbursement rate and the price as well as the barcode.
  • New CIP 13 [13 digits] codes as well as 2D data-matrix bar code (with expiry date and lot number – non serialized and non randomized) on the external packaging.
  • ECC200 Data Matrix barcode made up of Code CIP13, batch number, expiration date and human readable text. (used for reimbursements) consisting of CIP 13, the reimbursement rate and the price as well as the barcode.
  • Provide insight into demand patterns,
  • Easier detection of expired products,
  • More efficient recalls,
  • Reduce opportunities for fraudulent activity,
  • Enhanced patient safety.