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.
|
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
|