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

Barcode for OTC drugs

Kindly refer to the PN no. 59(RE-2010)/2009-2014 dtd. 30.06.2011 wherein the implementation date for Affixing Bar Code on Pharmaceuticals and Drugs export Product   was extended .While considering the Implementation, we had discussed the Relevant issue with GS1 global Standard Authority. The concerned Authority of GS1 informed us that the Notification regarding Bar Coding is applicable on Drugs and Medicine under Doctor’s Prescription only. While on this, Kindly note that our  all products fall under the Category “ Herbal Medicaments” and these are OTC medicaments and does not require Doctor’s prescription. In view of above, Your confirmation is solicited that this Bar Code stipulation under above referred notification will not be applicable in our case.
For your clarity of understanding we are furnishing herein below the name of our main  Export Products, which are as follows: -
Himani Boroplus Antiseptic Cream-
Himani Boroplus Skincare Cream-
Menthoplus Balm-
Himani Fast Relief Pain Relief Ointment- Zandu Balm- Zandu Chawanprash Would appreciate your confirmation at an early date.  Thanking You,Yours FaithfullyFor, Emami LimitedB.SARKAR(Sr. Export Manager)

Dear Sir,
It is to submit that the drugs manufactured under any licence under the Drugs and Cosmetics Act, 1940 and Rules 1945 thereunder, they will be treated as Drugs/Medicines which require barcoding as per the DGFT Notifications. As on today, there is no exemption given to Ayush products or any other products under drugs. It is also informed that there is no exemption given for OTC drugs or non-prescription drugs for implimentation of barcode.
Pharmexcil is keeping all the information on barcode system in the form of a Blog with link to the Pharmexcil website. If you visit the website, I am sure you will get some clarification as on this issue as clarification is issued to another member.
Now Pharmexcil is collecting the opinion of exporters on the implimentation of the barcode system and problems faced by them, any solutions or suggestions to submit the same to the Dept of Commerce for their consideration and for issue of directions to over come the problems.
Hence, you are requested to offer your opinion on the implimentation of the barcode system, problems faced, suggetions may be sent to The Executive Director, Pharmexcil for submitting the same to the Govt. for their consideration and a favourable action.
with regards
K.Subbi Reddy.

Barcode for Surgical Dressings

Ref.No : 1345/11                                                            Date : 28.10.2011

Dear Mr. Subbi Reddy,

It was nice talking to you over phone today. Further our
talk, wish to introduce ourselves as one of the leading
Exporter of Surgical Dressings. We are in this field for
65 years and 100% exporting of our products to all over the
world.

In this regard, Kindly inform us the Bar code is applicable
for our Exports. However we are intersted to go for Bar
code system.

Kindly suggest us in detail, to proceed this regard.

Thanks in advance.
                         
Best Regards,
P.R. Vijayaraghavan.

SRI RAM MEDITEX
110, T.P. Mills Road,
Rajapalayam - 626117, India.
Ph : +91 4563 230890
Fax: +91 4563 230894
Email: prvraja@gmail.com, prvraja@dataone.in

Dear Sir,
Thank you for calling and it is nice also for me to speak over phone. I know that your company is the biggest exporter of surgcial Dressings from India. As you are aware, Surgical Dresings are classified as drugs under the Drugs and Cosmetics Act, 1940. Hence they will attract the DGFT public notification No. 59 dated 30.6.2011.
To impliment barcode as per the DGFT notification, please go through the mannual prepared by GS1India which is kept in Pharmexcil website. You can also have access to the blog maintained for this purpose.
Thanking you
with regards
K.Subbi Reddy.

Clarification circular No. 43 of DGFT

http://dgftcom.nic.in/exim/2000/cir/cir11/cir4310.htm

Government of India

Ministry of Commerce & Industry

Department of Commerce

Directorate General of Foreign Trade

Udyog Bhavan, New Delhi.

Policy Circular No. 43 (RE-2010)/2009-14                   Dated the 25^th October, 2011

To

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

Subject:- Implementation of bar coding on tertiary packing of consignments of pharmaceuticals and drugs for export with effect from 01.10.2011.

As per Public Notice No. 59 (RE-2010)/2009-14 dated 30.06.2011, incorporation of barcodes (1 D) encoding unique product identification code (GTIN), Batch Number, Expiry Date and Unique Serial Number of the Tertiary pack (shipper/carton) on export consignments of pharmaceuticals and drugs has come into effect from 01.10.2011.

2.       It is clarified that the above barcoding requirement is compulsory for pharmaceuticals and  drugs manufactured on or after 01.10.2011.

3.       This issues with the approval of Commerce Secretary.

Sd/- 

(Hardeep Singh)

Joint Director General of Foreign Trade

Email: hardeep.singh@nic.in

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

Request letter to issue clarification by DGFT dt. 19.10.2011

19.10.2011

To

Sri J.S.Deepak, IAS

Joint Secretary

Dept of Commerce

Ministry of Commerce and Industry

Govt. of India, New Delhi.

Sir,

                Sub:- DGFT public notification No. 59 dated 30.6.2011 – Clarifications – Requested.

                Ref:- 1. Clarification Letter No. 15/71/2010 EP (Engg) dated 12.8.2011 of the Dept of Commerce.

                         2.  Letter No.15/88/2011-EP (Engg) dated  4.10.2011 of the Dept of Commerce addressed

                             to DGFT.

                Pharmexcil is highly thankful for the timely clarifications on the subject notification to help the members to export the pharmaceutical consignment smoothly. We draw your kind attention on the above referred letters .

                A.  in the 1^st cited reference,  it is clarified that Bulk Drugs / Active Pharmaceutical Ingredients(APIs)   are not  required to have barcode on the labels . Formulations/Medicines  with primary, secondary and tertiary packs are required to be labeled  with barcode as per the notification.  Many of the Pharmexcil members are informing the council that their consignments are stopped at DGFT offices  for not labeling with barcode for the bulk drugs / APIs  and officials are insisting for official clarification and clear guidelines from DGFT   on this issue.

                B. In the 2^nd cited reference, it is clarified that the drugs/medicines manufactured  on and after 1^st oct 2011 are only  required to have barcode for export purpose but some of the council members are informing the council that their drugs manufactured  before 1^st Oct 2011 are stopped at DGFT offices for lack of using barcode on their labels and directing the exporters to submit the clarification from DGFT.

                In view of the above, we   request you to help our  members by advising   DGFT  to issue early clarifications on the above issues at the earliest

                Thanking you

With regards

(Dr.P.V.Appaji)

Executive Director

Copy submitted to Smt Mridul Jain, Director, Dept of Commerce for information.