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.

DGFT to indicate procedure for getting exemption u/p 3 of the notification 59.

Your kind support is required to have feedback from DGFT.

APL Query to GS1/ Pharmexcil: If importing country do not required implementation of DGFT norms.
What to do?
Reply from GS1/ Pharmexcil - In case importing country has regulation/requirement on barcoding then only you don’t require complying with DGFT notification and for that also you need to get approval from DGFT after showing all the required endorsements from importing country. Rest in all other case you shall be required to comply with DGFT requirements.               
APL Query to DGFT- What documents/ endorsement letter (from customer or importing country) require to submit to DGFT to get exceptions?                

APL Query to GS1/ Pharmexcil: In case, if importing country having their own EAN code on secondary pack, same can be converted into GTIN?

Reply from GS1/ Pharmexcil: EAN product code is also a GTIN.   If you are already using EAN/GTIN at secondary pack as per the requirement of importing country then you would require to only providing information on tertiary/shipper/logistic pack in line with the requirement stipulated by DGFT.

APL Query to DGFT- In that case, only SSCC code to print on shipper label, as it is already regulated by importing country/ customer. What documents require submitting to DGFT to get exceptions?                                                                    

APL Query to GS1/ Pharmexcil: Can we convert importing country MA (Marketing Authorization) number allocated by respective country regulatory agency into GTIN?.         Example:                                                                                                                                                     France: 3400959252995                        Germany: PZN-5116210                       
Italy: 039044045/M                        Portugal: *5248000*

Reply from GS1/ Pharmexcil: This point is answered above in point no 1 & 2 .

APL Query to DGFT- In that case, only SSCC code to print on shipper label, as it is already regulated by importing country/ customer. What documents require submitting to DGFT to get exceptions?

Thanks for your support,

How to verify Barcode by DGFT officials

Hello Mr. Subbi Reddy

Greetings from Bartech Data Systems

                      Myself Sunny Jain and we just had a chat on phone. I am representing Bartech Data Systems, and we provide Auto ID Solutions (Barcoding & RFID).

                      I am having 1 query, which even the GS1 People were unable to handle, which I will be sharing with you. I will be obliged if you can throw some light on my below mentioned query:

#) Tertiary Level Packaging: The Shipper Boxes will be packed in containers having 3 to 4 locks. So, how will DGFT be able to know that the Pharmaceutical companies have followed the mandates for Tertiary Packs or not. Secondly, even at the receiving country's Dock, the officials normally don't open the containers and check the entire contents (shipper boxes), as the containers will be in lakhs. So, how the DGFT Mandates be scrutinized against the set standards?

Thank you

Awaiting your response.....

-- 

With Regards,

 

Sunny Ashok Jain

Dear Sir,

Govt. authorities,  on the declaration of the consignee and also on production of labels used, they will clear the goods. As and when they got doubt, they will verify and proper action will be initiated against the offenders.

with regards

K.Subbi Reddy.

Hello Mr. Subbi Reddy

Greetings from Bartech Data Systems

                  It was my pleasure talking to you yesterday. Thanks a lot for solving my query.

Thank you

Sunny Jain       

Clarification for cosmetics and food items

Dear Sir,
Good Day,
this is on the recommendation of GS1INDIA we are in front of you for some clarification.

looking to the new rules from DGFT we would like to have your advise on the following---
as we are exporter of food...cosmetics...and ayurvedic products...and being member of yours.
will the Bar Code latest requirement from 1st oct on the master case pack is compulsory in these three category products ?
can you clarify the stand on these three categories of Govt ?
as we are ready with export consignment ...please be quick on your guideline...
in anticipation of early reply....
thanks 
Rakesh Hathi
Manager-Export
PRINCE CARE PHARMA PVT LTD,
5, City Center, Kalanala,
Bhavnagar-364001
Gujarat, India.
Dear Sir,

As per Notification no. 59 dated 30.6.2011, barcode is required for medicines for export purpose and this notification is not applicable to cosmetics, food items. If Ayurvedic products are manufactured under Drug licence, they will be treated as Medicines and they require barcode. Please visit the website of Pharmexcil and visit the Blog maintained for this purpose for latest updates. 

with regards

K.subbi reddy. 

Ministry clarification on Date of Mfg for use of Barcode