IMPORTANT INFORMATION –
BAR CODING ON SECONDARY PACKING
TO BE IMPLEMENTED FROM 1ST JANUARY,
2013.
Dear Sir/Madam,
We would like
to bring attention of our members to our circular
dt. 24.12.2012 on the above subject. As
indicated in the earlier circular, Council has been following up with Ministry
of Commerce/DGFT for extension of date of implementation for bar coding on
secondary packing from the stipulated date of 1st January, 2013 by about 6
months. The latest position/additional
clarifications on this subject are given below:
i)
Extension of effective date of
implementation from 1st January, 2013 on secondary packing.
As per the latest discussions with
Government today, it has been informed that Government is not considering to give any extension for implementation of bar
coding on secondary packing.
Accordingly, bar coding on secondary packing would come into effect from 1st January, 2013.
ii)
Clarifications on certain issues sought
by members:
a)
Status of mono
cartons – whether it is primary packing
or secondary packing?
There has been
some confusion from the revised manual published by GSI. Pharmexcil has takenup
the issue with GS1 and brought to their notice that the revised manual has
created some confusion regarding status of mono cartons as secondary packing as
against primary packing indicated in the previous manual. After followup by Pharmexcil, GSI has revised
the manual today and clarified that mono cartons would be considered as primary
packing and therefore would not require bar coding on mono cartons (as requirement
of bar coding from 1st January, 2013 relates to secondary packing only). The revised manual of GSI is uploaded on our web site
b)
Status of products manufactured before January, 2013
The
Government/DGFT vide policy circular No. 43(RE-2010)2009-14, dt. 25.10.2011 has earlier clarified with respect to bar coding on tertiary packing , that
bar coding requirement for pharmaceuticals and drugs would be effective for
products manufactured after effective date of implementation of bar coding .
Accordingly it is indicated that bar coding on secondary packing would
become effective for those products manufactured on or after 1st January 2013 only.
c)
Bar coding for bulk drugs
The Government/DGFT
had already clarified vide policy circular No.48(RE-2010)/2009-14, dt. 28.11.2011 that bar coding requirement is
applicable only in respect of finished pharmaceutical products i.e. medical
formulations and not bulk drugs/APIs/Intermediates.
d)
Bar coding for merchant exporters and
Ayush products.
Pharmexcil has requested GS1 to develop appropriate bar coding
mechanism for merchant exporters for export of heterogenous drugs produced by
varioius manufacteuerers . Pharmexcil has also requested Government for
exempting small merchant exporters and Ayush product manufacturers for
barcoding. Pharmexcil is awaiting for
the decision of the Government
e) Bar coding on
drugs meant for Government and physician’s samples
Pharmexcil has
already taken up this issue with the Government and clarification is
awaited. In the absence of clarification, it would be necessary to meet
the bar coding requirement.
f)
Financial Assistance
Government has
indicated that it would try to consider positively partial cost reimbursement
to small exporters, provided Pharmexcil furnishes adequate data on this
subject. Members are therefore requested
to provide data as per table given below:
a)
Name of the
Company
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b)
Export Turn Over of Formulations
(Rs. In crores)
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c)
No. Of
packing lines required for bar coding system
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d)
Approximate
cost of investment (exclusively for bar coding purpose)
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e)
Remarks ( if
any)
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Members are
requested to kindly note the above position for implementation of bar coding on
secondary packing. Our Council would
extend all possible help with timely representations to Government and early
clalrifications (to the extent possible) to the members on this subject.
Thanking you,
Dr. P.V.APPAJI
Director General
Note: Additional
Clarification:
g)System
already mandated by importing country:
Public notice No. 59(RE-2010) 2009-2014 dated 30th June 2011 of the DGFT states that “ In case the importing country has
mandated a specific requirement, the exporter can adhere to the same and it
would not be necessary to comply with the stipulations”
Accordingly, if any country has already implemented a system
for tract and trace purpose, the Indian exporter need not follow barcode
system. Based on information received from members, Pharmexcil will take up such issues with
Govt. for issuing exemption to such
individual countries. Members are requested to inform council with details of
such countries if any where the track and trace for pharmaceuticals products is mandated.