US Track and trace plans signed into law w.e.f. 27.11.2013

The US FDA has started work on a national track and trace system for pharmaceuticals after President Barack Obama signed the Drug Quality and Safety Act into law on 27/11/2013. The Drug quality and security Act of USA is available at the following link which enable  USFDA to formulate the track and trace system . 
 https://www.govtrack.us/congress/bills/113/hr3204/text
Source:
http://www.in-pharmatechnologist.com/Regulatory-Safety/Happy-Thanksgiving-US-track-and-trace-plans-signed-into-law?utm_source=copyright&utm_medium=OnSite&utm_campaign=copyright

Monocarton is declared as primary pack by DGFT dt. 17.10.2013

-COPY OF
PUBLIC NOTICE NO.31(RE-2013)/2009-2014  Dated 17th October, 2013

Mono cartons to be treated as primary level packaging of 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 amends the Public Notice No.21 dated 10.01.2011 as
under.

2. Sub-para (a) of Para 3 of Public Notice No.21 dated 10.01.2011 is amended by adding a new
sentence at the end of the existing para. The amended para would read as under:

“3a. Incorporation of 2D (GS 1 Data Matrix) barcodes on medicines at strip/vials/bottle level
encoding unique product identification code (GTIN), Batch Number, Expiry Date and
Serial Number of the Primary pack. Mono cartons containing stripes/vials/bottle shall be
treated as part of primary level packaging”

3. Effect of this Public Notice:
Mono cartons containing strips/vials/bottles shall be treated as Primary level packaging.

Sd/-
(Anup K. Pujari)
Director General of Foreign Trade

F.No.01/91/180/648/AM09/Export Cell
Issued by:
Ministry of Commerce and Industry
Department of Commerce
Directorate G

P.Notice No.54 dt. 5.4.2013 extending the date of implementation to 1.7.14

Public Notice No. 54 (RE-2012)/2009-2014
New Delhi, Dated the 5th April, 2013
Sub: Deferment in the date of effect for implementation of bar-coding on Primary level
packaging on export consignment of pharmaceuticals and drugs for tracing and
tracking purpose.
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. 59(RE-2010)/2009-14 dated 30.06.2011 read
with Public Notice No. 10 (RE-2010)/2009-2014 dated 11.07.2012:
2. The date of effect for implementation of bar coding on Primary Level packaging as
mentioned at serial number 2(i) a of Public Notice No. 59(RE-2010)/2009-14 dated
30.06.2011 will now come into effect from 1st July, 2014.
3. Effect of this Public Notice:
Earlier the requirement of affixing barcodes on Primary Level packaging was to take
effect from 01.07.2013. Now this date has been deferred to 01.07.2014.
(Anup K.Pujari)
Director General of Foreign Trade
E-mail: dgft[at]nic[dot]in
(Issued from F.No. 01/91/180/648/AM 09/Export Cell)

list of importing countries wherein bar coding is already mandated

Country	Importing Country Requirement - Pre-Printed Bar Code	Status
USA	Linear Bar Code	Implemented
France	2D Bar code	Implemented
Baltics	Linear Bar Code	Implemented
Bulgaria	Linear Bar Code	Implemented
Czech Republic	Linear Bar Code	Implemented
Germany	Linear Bar Code	Implemented
Hungary	Linear Bar Code	Implemented
Italy	Linear Bar Code	Implemented
Kosovo	Linear Bar Code	Implemented

Pharmexcil's circular on Status of Barcode dt.31.12.12.

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
b)       Export Turn Over of Formulations (Rs. In crores)	Yr 2009-10 Yr2010-11 Yr 2011-12
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.

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. 

representation submitted by Pharmexcil for Merchant Exporters

Clarification by GS1 India on Mono carton

S Swaminathan	3:13 PM (2 hours ago)
to DG, Ravi, Rajeev, Mridul, E, me, Amit, info, Gopal

Dear  Dr. Appaji,

Season’s greetings and best wishes for a happy and prosperous New Year!

As per our discussion with your officers, considering Indian export  packaging processes and practices and to facilitate the compliance on barcode requirements stipulated by DGFT , the primary level barcode  requirements  shall be applicable on mono carton.

The attached manual could be hosted on your website and made available to your members to clarify the same.

We have been regularly conducting awareness workshops  and webinars for Pharmaceutical exporters and  shall continue to undertake the same in future as well. Schedule for workshop and webinar for 2013 ( Jan – Mar) is available at:

http://www.gs1india.org/service/education-training/workshop

http://www.gs1india.org/service/education-training/online-training    and the same  could be communicated to your members.

Should any further technical clarification is desired your members they may approach our implementation team for support.

Thanking you.

With regards,

S.Swaminathan

General Manager.

GS1 India.