Steps to be taken to comply with DGFT's Track & Trace Requirements

The below communication which is also attached as doc could be forwarded to all your members to enable them comply with the Track & Trace portal requirements.

For any clarifications you may direct your members to our Implementation team at implementation@gs1india.org

With regards,

S.Swaminathan

General Manager

GS1 India

November 20, 2014

Dear Subscriber,

Sub: Steps to be taken to Comply with DGFT’s Track & Trace Requirements

As you may be aware, The Directorate General of Foreign Trade (DGFT) has notified that all drugs and pharmaceutical products that are exported from India need to implement a track and trace system using barcodes as per GS1 global standards.

As part of this track and trace system, a National Track & Trace Portal is being set up for the purpose of compliance with DGFT’s requirements for exported drugs and pharmaceutical products across various packaging levels.

The following product packaging level indicator digits need to be used by you in the GTIN’s (Global Trade Identification Numbers) for your products. (The indicator digit refers to the first digit of a GTIN-14).

Product Packaging Indicator Number	Packaging Level
Indicator Number 5	Will denote the Tertiary packaging level [i.e. shipper/carton]
Indicator Number 1	Will denote the Secondary packaging level.  In the event of multiple secondary packaging levels, only the first level of secondary packaging requires to incorporate the packaging indicator number.
Indicator Number 0	Will denote the Primary packaging level [strip/vial/bottle, single therapy kits etc.]

To help companies prepare and be compliant with these product marking and coding requirements, GS1 India shall be providing technical guidance through workshops at select locations (as below) and internet based webinar training sessions.

·         The workshops will be held at GS1 India offices in New Delhi, Mumbai and Bangalore. You can view the schedule here:http://gs1india.org/service/education-training/workshop

·         The schedule for the internet based webinar training sessions can be viewed here: http://gs1india.org/service/education-training/webinar

Please register for any one of these upcoming training sessions immediately by emailing us at workshop@gs1india.org. We have limited seating capacity so please reserve your spot today.

At the training workshops, guidance shall also be provided on how to ensure scannability of barcodes in a variety of scanning environments using barcode verification service provided by GS1 India.

For any additional questions or clarifications on these product marking and coding requirements please contact us atimplementation@gs1india.org.

Thanking you,

GS1 India Implementation Team

Amendment to postpone the implementation of bar code on mono carton up to 1st April 2015

DGFT P.N.No.62 (RE-2013)2009-2014 dt. 26th June 2014 - Bar code on Primary level pack - deffered

Government of India
Ministry of Commerce and Industry
Department of Commerce
Directorate General of Foreign Trade
Public Notice No. 62 (RE-2013)/2009-2014
New Delhi, Dated the 26 June, 2014
Sub: 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:
(i) Public Notice No. 21(RE-2011)/2009-2014 dated 10.01.2011
(ii) Public Notice No. 59(RE-2010)/2009-2014 dated 30.06.2011
(iii) Public Notice No. 87(RE-2010)/2009-2014 dated 22.12.2011
(iv) Public Notice No. 10(RE-2012)/2009-2014 dated 11.07.2012
(v) Public Notice No. 54(RE-2012)/2009-2014 dated 05.04.2013
(vi) Public Notice No. 31(RE-2013)/2009-2014 dated 17.10.2013

2. Every exporter of Drugs & Pharmaceuticals at the time of shipment shall submit, alongwith other required documents, the following:
1. A copy of Certificate of Analysis issued by the manufacturer for the subject products; or

2. A copy of Certificate of Analysis issued by approved laboratory of the importing country/ FDA; or

3. A copy of Certificate of Analysis issued by a laboratory approved by Drugs Controller under Drugs & Cosmetics Act, 1940 and the rules made thereunder.

3. (i) 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:
   
   a. 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 Primary pack.
   
   b. 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 Secondary pack. Mono cartons shall be treated as Secondary Level Packaging in line with prevalent global packaging nomenclature.
   
   c. 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).
   
   (ii) The track and trace technology as per serial number 3(i) above will be effective as under:
   
   (a) Primary Level packaging :-             Effective date will be notified later.
   (b) Secondary Level packaging :-         1^st January, 2013 (already given effect to)
   (c) Tertiary Level packaging :-             1^st October, 2011 (already given effect to)
4. 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. Pharmexcil shall dispose of such applications on case to case basis with prior approval of Government.
5. 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.
6. 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.
7. 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.
8. Effect of this Public Notice:
1. 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.

2. 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.

3. 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 Secondary Level Packaging.

(Pravir Kumar)
Director General of Foreign Trade
E-mail: dgft@nic.in

(Issued from F.No. 01/91/180/648/AM 09/Export Cell)

Bar Code Implementation on Primary level Packing for Export Purpose - Deffered

Ref: PXL/H.O./CIR-009/2014-15                                         Date: 13.05.2014
Hyderabad
To,
All the Members of Council,

Dear Sir/Madam, 

 

Sub: Bar Code implementation on Primary Level Packing for Export Purpose - Deferred..

 
Our Council members had the unique privilege of interacting with the Commerce Secretary, Shri Rajeev Kher, IAS, during the CEO interactive meeting at Hyderabad on 28th April 2014.

Council had been taking up with the Department of Commerce, Government of India on several occasions regarding the difficulties faced by the members in implementing the Bar Code on Primary Level packaging which is scheduled for commencement from 1st July 2014.

It is with great pleasure, we would like to inform the members that in view of the presentations by the Council as also by members, Commerce Secretary has informed the august gathering that implementation of Bar Coding on Primary Level packing for export purpose has been kept under suspension till further notification. We understand that official notification in this regard is under finalization by Department of Commerce. Members may kindly note the same.

This is for the kind information of our members.

With regards


Raghuveer Kini
Executive Director

Amendment in the date of effect for implementation of Self-certification

PUBLIC NOTICE NO.58(RE-2013)/2009-2014
Dated 15th April, 2014

Amendment in the date of effect for implementation of 

Self-certification regarding compliance of bar-coding 

requirements on secondary and tertiary level packaging 

on 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, Director General of Foreign Trade hereby makes following 

amendments in Public Notice No.56(RE-2013)/2009-14 dated 01.04.2014: 

 

2. Through Public Notice No.56(RE-2013)/2009-14 dated 01.04.2014 it had been notified that 

with effect from 01.04.2014, export of pharmaceuticals and drug consignment would be 

permitted through a self-certification process. 

 

3. Now, it has been decided that the date of effect for implementation of Self-certification 

regarding compliance of bar-coding requirements on secondary and tertiary level packaging on 

export consignment of pharmaceuticals and drugs as mentioned at Para 3 of Public Notice 

No.56(RE-2013)/2009-14 dated 01.04.2014 shall be 15th May, 2014. However, all those 

consignments which have been got cleared as per Public Notice No.56(RE-2013)/ 2009-14 dated 

01.04.2014 till date shall be treated as valid. 

 

4. Effect of this Public Notice: 

 

The effective date of Public Notice No.56(RE-2013)/2009-14 dated 01.04.2014 has been 

amended to 15.05.2014. 

 

 

Sd/- 

(Madhusudan Prasad) 

Director General of Foreign Trade 

 

 

F.No.01/91/180/648/AM 09/Export Cell 

Issued by: 

Ministry of Commerce and Industry 

Department of Commerce 

Directorate General of Foreign Trade 

New Delhi 

 

** ** *

self-certification - P.No. 56 dt. 1.4.2014

Government of India
Ministry of Commerce and Industry
Department of Commerce
Directorate General of Foreign Trade

Public Notice No. 56 (RE-2013)/2009-2014

New Delhi, Dated the 1 April, 2014

Sub: Self-certification regarding compliance of bar-coding requirements on secondary and tertiary level packaging on export consignment of pharmaceuticals and drugs.

In exercise of the powers conferred under Paragraph 2.4 of the Foreign Trade Policy, 2009-14, Director General of Foreign Trade hereby prescribes the procedure for self-certification regarding compliance of bar-coding requirements on secondary and tertiary level packaging on export consignment of pharmaceuticals and drugs.

2. Bar-coding on tertiary level packaging has come into effect from 1^st October, 2011 as per Public Notice No. 59 of 30.06.2011.Similarly on secondary level packaging this has come into effect from 1^st January, 2013 as per Public Notice No. 10 of 11.07.2012. The requirement of bar-coding on primary level packaging will come into effect from 1^st July, 2014.

3. It has been decided that with effect from 01.04.2014, export of pharmaceuticals and drug consignment would be permitted through a self-certification process. In this process, the exporters would be required to furnish a written declaration to the custom authorities at the time of export [as per Annexure to this public notice] regarding compliance of the relevant provisions of bar-coding on secondary and tertiary level packaging on the consignment of pharmaceuticals and drugs being exported.

4. Effect of this Public Notice:

A self-certification process on compliance of bar-coding requirement on secondary and tertiary level packaging of pharmaceuticals and drugs has been introduced. This will be effective from 1^st April, 2014

(Madhusudan Prasad)
Director General of Foreign Trade
E-mail : dgft[at]nic[dot]in

(Issued from F.No. 01/91/180/648/AM09/Export Cell)

Annexure to Public Notice No. 56 (RE-2013)/2009-14 dated 1 April, 2014

(On letter head of Exporter containing details of Company phone numbers, e-mail & website etc)

Exporter’s Declaration to Customs Officer of the relevant port for Pharma Products relating to compliance of track and trace capability and product registration.

(The exporter’s declaration, the text of which is given below, must be made out in accordance with the footnotes. However, the footnotes do not have to be reproduced.)

DECLARATION

1A. I, the undersigned, declare that the goods listed for export vide our invoice no. --------------------dated----------------------and Shipping BillNo.--------------------------dated----------------------and No.----------- dated-----------satisfy/comply with the requirements of the Public Notices issued by the Directorate General of Foreign Trade (Department of Commerce) as listed below:

          i.    Public Notice No. 21 (RE-2011)/2009-2014 dated 10.01.2011

         ii.    Public Notice No. 59 (RE-2010)/2009-2014 dated 30.06.2011 (applicable for tertiary level packaging)

        iii.    Public Notice No. 60 (RE-2010)/2009-2014 dated 30.06.2011

        iv.    Public Notice No. 10 (RE-2012)/2009-2014 dated 11.07.2012 (applicable for secondary level packaging)

         v.    Public Notice No. 31 (RE-2013)/2009-2014 dated 17.10.2013

1B. I declare that the Government authority of importing country--------------------(name) has its own legislation/regime regarding track and trace capability and therefore GS1 Data Matrix for the packaging as required under para 3 of Public Notice No. 59 (RE-2010)/2009-2014 dated 30.06.2011, is not applicable in this consignment.

2A. I also declare that the goods in the consignment are being exported to ---------- (name of country) and that the products being exported hold necessary registration/approval issued by the concerned government authorities of importing country.

2B. The product(s) being exported do not require any registration/approval of the Government Authority of the importing country.

I undertake to make available to the customs authorities any further supporting documents they require.

                                                                                                                By

Place:                                                                                 (Name of the Company/Exporter)

Date:                                                                                  (Signature)

Name & Designation of Authorised Officer

(with Company seal)

1. If only some of the goods listed on the document are concerned, they should be clearly indicated or marked and this marking entered in the declaration.

2. The Community, country, group of countries or territory, from which the goods originate to be indicated if the goods are not manufactured in India, in 1 above (if applicable)

3. Declaration at 1B and/or 2A to 2B to be scored out if not applicable for the goods/consignment.

Minutes of meeting with GS1India at Mumbai on 6.2.2014

Summary of discussion for meeting held on 6^th Feb 2014 organized by Pharmexcil between Pharma Industry representatives, GS1 India and Pharmexcil in Mumbai:

GS1 India gave a presentation on the packaging concepts globally followed and a comparison of that with the present packaging definitions as per DGFT   notification dated Oct 2013. Pharmexcil facilitated a discussion with the representatives of the industry on the present issues faced and to have consensus within the industry on definitions of  various levels of packaging seen as primary, secondary and tertiary etc.. The points of discussion are as follows:

Sl No.	Subject	Point of Discussion	Action Plan
1	Mono carton	·   In the meeting the present understanding of primary packaging and mono carton as per the DGFT notification of October 2013 was discussed ·   GS1 presented the Global definition of packaging and its variation with the present definition followed in India (for  primary, secondary and tertiary level packaging) as per the above notification ·   The industry agreed to align with the Global definition of primary and secondary packaging ·    As per the Global definition, any carton, consisting 1 unit or more than 1 unit of vials/strips/bottles including mono carton will be defined as secondary packaging (except shipper level which is tertiary) ·   As per the Global definition, each vial/strip/tube etc. is treated as primary having direct contact with the drug	Facilitate the implementation of the same through notification change by taking it up with DOC and DGFT
2	Implementation on Primary Packaging	·  Industry expressed concern on the implementation of barcoding on the primary packaging such as vial/strip/tube etc. due to ground level challenges faced ·  Industry requested to defer the date of implementation on primary level packaging ·	·  Representatives from the industry were asked to send their concerns and challenges to Pharmexcil with possible solution by 10th of Feb 2014. ·  Pharmexcil to consolidate and take it up with DOC/DGFT
3	Illustration through images in Implementation Manual	·   Industry expressed concern that the understanding of packaging definitions are not uniform across all stakeholders ·   Industry suggested that in the implementation manual, illustrations for different packaging levels to be provided with the help of images to facilitate clear understanding among the stakeholders	GS1 India to prepare the manual after the amendments on the packaging level
4	Stickering on Primary and Secondary level packaging	·   Industry wanted feedback whether stickers are allowed for barcoding on pharma products (primary and secondary) for exports. It is under the purview of DCGI	DCGI is to be  approached for clarification.
5	Barcoding on Small Packaging	·   Challenges for barcoding on small packaging was discussed ·   Industry wanted suggestion for barcoding on small products where there is space constraint	Industry can send the samples to GS1 India for advice. However final decision/approval to be taken from respective authority.
6	Awareness to Customs on DGFT barcoding notification	·   Industry felt the need for creating awareness among custom officials and update them on the DGFT mandate for uniform understanding of packaging level definitions for smooth flow of exports	Pharmexcil to coordinate for creating awareness within custom officials and GS1 India shall assist them
7	Country Specific Requirement	·   Industry wanted a clarity whether barcoding as per DGFT mandate can be over ruled in case there is a specific requirement from the importing country ·   It was pointed out that only if there is a regulation from the importing country regulator it shall be allowed to comply .	·   Industry was asked to provide the mandate/document of the importing country regulator requirement of the importing country  to DGFT / Customs officials for getting exemption
8	Merchant Exporter	·   Merchant exporters requested clarification on complying to the  primary and secondary packaging of the DGFT notification	·      The recommended option is to ask  the   Manufacturer to implement  barcodes as per DGFT notification while supplying to merchant exporters. Incase manufacturer do’s not then merchant exporter has to implement  at their end before exporting  them