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

Clarity on Importing Country requirements

Querry No. 1: If importing country do not required implementation of DGFT norms. What to do?

As per our understanding, we adhere existing system and not necessary to comply DFGT requirement. Only SSCC barcode shall be given as per manufactures GS1 Company prefix.          
    
Ans by GS1India: In case importing country has regulation/requirement on barcoding then only you don’t require to comply 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.

Querry No. 2: In case, if importing country having their own EAN code on secondary pack, same can be converted into GTIN?

As per our understanding, it can be converted into GTIN. But, if we get endorsement copy from customer, there is no need to create GTIN barcode. Only, SSCC code to be a part of shipper label as per manufactures GS1 Company prefix.              

Ans by GS1India: 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 provide information on tertiary/shipper/logistic  pack in line with the requirement stipulated by DGFT.

Querry No. 3: 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*

As per our understanding, we should be adhering to existing system and not necessarily to comply DFGT requirement. Only SSCC barcode label to be generated.

Ans by GS1India: This point is answered above in point no 1 & 2 .  

Querry No. 4: In case of SSCC code company prefix should be of manufacturer or Brand owner (Importing country)?.

As per our understanding, always prefer to have manufacturer company prefix to create SSCC code. 

Ans by GS1India: It is always recommended to use company prefix of brand owner as it is his responsibility for that particular brand . Having said that it is the mutual agreement between trading partners ( manufacturer & brand owner) whosoever wishes to use his company prefix .

Bar code is appicable for products manufactured after 1st oct 2011

As clarified over phone, we confirm that Bar coding is applicable only for batches produced from 1st oct 2011. This has been confirmed to us by senior officials from DoC

Best regards,

Dr.Appaji PV.
Executive Director
Pharmexcil