Wednesday, February 26, 2014

Minutes of meeting with GS1India at Mumbai on 6.2.2014

Summary of discussion for meeting held on 6th 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.
Point of Discussion
Action Plan

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
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 
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 

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.
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.
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
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
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