DGFT Public Notice No.87 extending Barcode Implimentation

http://164.100.9.245/exim/2000/PN/PN11/pn8710.htm

To be published in the Gazette of India Extraordinary Part-I, Section-I

Government of India

Ministry of Commerce and Industry

Department of Commerce

Directorate General of Foreign Trade

Public Notice No. 87 (RE-2010)/2009-2014

New Delhi, Dated the 22^nd December, 2011

Sub: Deferment in the date of effect for implementation of bar-coding on Primary and Secondary 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. 21 dated 10.01.2011:

2.         The trace and track technology as per serial number 2(i) a and 2(i) b of Public Notice No. 59(RE-2010)/2009-14 dated 30.06.2011 will come into effect as follows:

(a) Primary Level packaging -    With effect from 1^st January, 2013

(b) Secondary Level packaging - With effect from 1^st July, 2012

3. Effect of this Public Notice:

Earlier the requirement of affixing barcodes on Secondary level and Primary level packaging was to come into effect from 01.01.2012 and 01.07.2012 respectively. Now more time is being allowed.

(Anup K.Pujari)

Director General of Foreign Trade

E-mail: dgft@nic.in

(Issued from F.No. 01/91/180/648/AM 09/Export Cell)

Madras HC stays second phase of barcode implementation till Jan-6, 2012

Dear All,
Please see the link for detailed report
http://www.pharmabiz.com/NewsDetails.aspx?aid=66650&sid=1
with regards
K.Subbi Reddy.

GS1India announced Schedule for webinar on Barcode system

Webinar schedule

Sector	Date	Day	Timings
Pharma	Nov 21, 2011	Monday	11:30 AM - 1:00 PM
General	Nov 28, 2011	Monday	10:30 AM - 1:00 PM
Pharma	Dec 5, 2011	Monday	11:30 AM - 1:00 PM
General	Dec 12, 2011	Monday	10:30 AM - 1:00 PM
Pharma	Dec 19, 2011	Monday	11:30 AM - 1:00 PM
General	Dec 26, 2011	Monday	10:30 AM - 1:00 PM

For participating in any one of the webinars, please send a mail to workshop@gs1india.org mentioning the sector,date and time of the webinar.

Pharmexcil submitted Representation to Addl.Secretary, DOC

Dear all,
It is to submit that on receiving many representations from firms like M/s Cadila, Aventis Pharma, Mylan, Ranbaxy etc. ,on organizing an interactive meeting at Hyderabad with Pharma Industry packaging personal and on discussing in the COA meeting, Pharmexcil has submitted a consolidated representation with a request to extend the date of implementation of  Barcode on Secondary Packaging by One year i.e Jan 2013.
with regards
Pharmexcil. 

DGFT circular No.48 dt. 28.11.11

Government of India

Ministry of Commerce & Industry

Department of Commerce

Directorate General of Foreign Trade

Udyog Bhavan, New Delhi.

Policy Circular No. 48 (RE-2010)/2009-14                                                                                                                                                        Dated the 28^th  November, 2011

To

All Customs Authorities / All Regional Authorities / Members of Trade.

Subject:- Implementation of bar coding on  export consignments of pharmaceuticals and drugs  with effect from 01.10.2011- Clarification regarding export of bulk drugs.

 Public Notice No. 59 (RE-2010)/2009-14 dated 30.06.2011 had stipulated incorporation of barcodes (1 D) encoding unique product identification code (GTIN), Batch Number, Expiry Date and Unique Serial Number on export consignments of pharmaceuticals and drugs  with effect from 01.10.2011.

2.       It is clarified that the above barcoding requirement is applicable only in respect of finished pharmaceutical products i.e. medical formulations and not Bulk drugs/APIs/Intermediates. 

3.       This issues with the approval of Commerce Secretary.

(Hardeep Singh)

Joint Director General of Foreign Trade

Email: hardeep.singh@nic.in

(Issued from F.No 01/91/180/648/AM09/Export Cell)

DOC clarification on application of Barcode for Bulkdrugs/APIs dt. 25.11.2011.

From: Mridul Jain
To: Dr Appaji Pv ; appajipv09@gmail.com
Cc: rodelhi@pharmexcil.com
Sent: Friday, November 25, 2011 5:35 PM

No. 15/88/2011-EP(Engg)

Government of IndiaDepartment of Commerce

*****

Udyog Bhawan, New Delhi

Dated: 25th November 2011

OFFICE MEMORANDUM 

Subject :Exemption to APIs from bar coding mandated vide Public Notice No. 21 dated 10th January, 2011 and Public Notice No. 59 dated dated 30th June, 2011

Pharmexcil has informed that Mumbai Customs have withheld all the API/bulk drug  consignments of pharmaceutical products for non implementation of stipulations of bar coding mandated by above Public Notices.  The matter has been considered in Department of Commerce and it has been decided that the mandate in the above Public Notices is applicable for finished pharma products i.e. formulations.  DGFT is requested to issue clarifications that above Public Notices cover only finished pharmaceutical products i.e. medicinal formulations and does not include bulk drugs/APIs/intermediates   This issues with the approval of Commerce Secretary.  

(Mridul Jain)

Joint Secretary

Dr. Anup Pujari

Director General

DGFT  Udyog Bhawan New Delhi

Copy to: 1)    Shri V. Soundarrajan,  Additional Commissioner, Mumbai -  with a request that pending consignments of API/bulk drugs/intermediates be cleared immediately

2)    ED, Pharmexcil. (Mridul Jain)Joint Secretary

USE OF STICKER LABLES FOR BARCODE- GS1INDIA CLARIFICATION

Subject :  Clarification on implementation DGFT Notification on Barcode as per GS1 guidelines for Secondary Level Packaging

Dear Sir

We would like to know  whether Sticker Labels of bar code (either 1D or 2D) are permitted  to paste/stick on the Secondary Level Packaging
(Inner Box/carton/bottle etc) Which has to  be implemented from 1st January 2012.

OR

Barcode 1D or 2D has to be printed directly on the Secondary Level Packaging (Inner Box/carton/bottle etc)
(i.e. Sticker Label of Barcode is not permitted on Secondary Level Packaging)


Your immediate reply on the above would be highly appreciated and useful.

Thanks

Export Manager
BDH Industries Limited
Dear Mr. Reddy,

At tertiary level , stickers can be pasted on the packs but at secondary level & primary level , as there are existing labeling and marking requirements from the  Regulator (DCGI) , so would  suggest you to please  check with DCGI office if stickering is allowed and it is in line with GMP.

As per GS1 standards both options online printing & stickering are OK as long as the data encoded in the barcode is conforming to GS1 standards.

Best Regards,

Gopal Valecha