IMPORTANT INFORMATION –
BAR CODING ON SECONDARY PACKING
TO BE IMPLEMENTED FROM 1ST JANUARY, 2013.
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
b) Export Turn Over of Formulations
(Rs. In crores)
c) No. Of packing lines required for bar coding system
d) Approximate cost of investment (exclusively for bar coding purpose)
e) Remarks ( if any)
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.
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.