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

Querry on Para 3 of the Notification No. 59

Query  No. 1Currently  we are using shipper i.e. tertiary pack for shipping the export consignment and on that we are affixing the Shipper label on it which is having bar code on it.This bar code is being provided by our export customer as per their country rule and is specific to a pack style. Refer  Attachment No. 1However the current shipper label ( tertiary pack label) is unable to meet the requirement of DGFT.  REPLY  FROM REGIONAL DIRECTOR as followsWith reference to your mail, please see the para 3 of the notification no. 59 dt. 30.6.2011. 3.  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 at serial number a, b & c of para 2 above.If you are using the barcode as per the importing country's requirements, you have to get the importing country's endorsement on the label and obtain exemption under the above clause from DGFT for export of your goods without any alterations.
What we understand  on above reply  is ---------- 
We will affix  the current label only on  shipper which is having customer provided bar code. We will get endorsed copy ( Importing country)  of shipper label  from our export customer for us and we will submit the same to DGFT  to get the exemption from the clause mentioned.If you have any comment Pl. reply
Query  No. 2 
Currently  we are using shipper i.e. tertiary pack for shipping the export consignment and on that we are affixing the Shipper label on it which is without bar code,  The  shipper label design is  provided & approved by our export customer and is specific to a pack style –  .  However inner carton i.e. secondary pack  is having barcode on it which was  also provided by our export customer— The current shipper label ( tertiary pack label--   is unable to meet the requirement of DGFT,  if we will get the  endorsement on this label from our customer i.e. from importing country.  Pl. advise is it will serve the purpose or not. 
Regional Director says that If importing country endorsement is required to get exemption under above notificatiion and it will solve your problem.

Large Scale Exporters doubts on barcode dt.21.9.2011

We would like to understand which of the following case we should consider for compliance:
Case 1 - All goods manufactured on and after 1st October should carry the label following GS1 guidelines OR
Case 2 - All Shippers / Pallets packed on and after 1st October should carry the label following GS1 guidelines OR
Case 3 - All Shippers / Pallets dispatched from factory on and after 1st October should carry the label following GS1 guidelines OR
Case 4 - All Shippers / Pallets reached customs on and after 1st October should carry the label following GS1 guidelines

Forwarding letter of Pharmexcil for Merchant Exporter Representation

Dt:19.09.2011

Shri J.S.Deepak, IAS
Joint Secretary
Dept. of Commerce
Ministry of Commerce & Industry
New Delhi
 Dear Sir, I am herewith forwarding the representation(copy enclosed) received from one of our member (merchant exporter) and we request you to kindly attend to their representation on Barcode issue. Several merchant exporters are likely to face this issue. At present, there are about 1300 merchant exporters with Pharmexcil. As the date of implementation is nearing, they are apprehending total loss of their export business. For your attention and kind consideration. Thanking you, Yours faithfully, Dr.P.V.AppajiExecutive Director CC: Shri Rajeev Kher, IAS,Additional Secretary, Department of Commerce,Ministry of Commerce & Industry,Govt. of India.       Ms.Mridul Jain,Director,Department of Commerce,Ministry of Commerce & Industry, Govt. of India
       Shri Smitesh Shah,Chairman,Pharmexcil
       Shri N.R.Munjal,Vice Chairman, Pharmexcil
       Shri Devang Shah,COA Member,Pharmexcil representing Merchant Exporters

Copy of Representation:

To

The Jt. DGFT                                                                                                       September 14, 2011

Mumbai.

Dear Sir,

Ref : Barcoding – Tracing & Tracking of Pharma Export Consignments

We as Merchant Exporters  would like to have clarification on some points in the Captioned matter.

As you are aware, the new system proposed to be introduced from 1.10.2011 ,vide Public Notice No. 59(RE-2010)/2009-2014   is primarily applicable to Pharmaceutical  manufacturers.

Indeed, as Merchant Exporters, we also get certain products manufactured , through Supporting manufacturers, wherein the new system would be followed by us as well through the supporting manufacturers. However, quite often, we also buy goods from local markets (through dealers/authorized agents/ retailers/etc..). Many of those Goods DO NOT have Barcodes since the local law does not require them. It is with reference to such local packs that this letter deals.

1)      Having bought such goods from traders, we / our suppliers  do not have any locus standi to tamper with the pack so as to put the Barcodes. Further, there is no local rule requiring such Barcoding.

2)      While exporting goods, many a times, we have to pack 8 to 10 products in one shipper since each item is of very small quantity & size so that sending them separately would mean very small shippers in big numbers. There is a threat of pilferage / Loss. So having packed multiple items in one bigger Shipper, how can one bar code that Shipper ?

In the foregoing circumstances, it is requested that until the time Barcode rule is locally made applicable, Merchant exporters be permitted to export the local packs even if they do not bear the Barcodes. Indeed, there is a very good system in place for easy tracing & tracking of local packs since , as per law, those packs inter alia  carry the following :

Batch No., Mfg. dt., Expiry date, manufacturers name & address & Mfg. Licence Nos.

Further, all the Pharma consignments are checked by the office of Asst. Drug Controller both at the Air as well as Sea Ports. There ,therefore, is adequate control in place over such exports.

Should you not still be convinced, we request you to grant us personal hearing.

Thanking You,

Yours Sincerely,

Kamlesh Shah

M/s M.T.Madon Exports

Email: mtmexp@gmail.com,

clarification by DOC dt.12.8.2011

From: Dilip Peswani
To: info@pharmexcil.com
Sent: Monday, July 18, 2011 11:32 AM
Subject: Clarification for bar coding of exports.

Dear Sir, This is in relation to the notification of Bar Coding for all export medicines. We seek to clarify whether this ‘export products’ would include APIs which are exported for Pharma formulations abroad?We are not sure about the classification of products whether it means only formulations or it also includes APIs. Please suggest.
Thanks.Regards,
Dilip Peswani
Manager - Business DevelopmentFermenta Biotech Ltd 'DIL Complex', Ghodbunder Road, Thane (W) - 400 610. Maharashtra. India.

Mail forwarded to DOC for clarification by Pharmexcil:

Dear Madam
I am herewith forwarding the mail received with a request to clarify whether Bar Coding is applicable to Bulk drugs or APIs . Pharmexcil is of the opinion that it is applicable to medicines which are formulations having primary, secondary and tertiary packings. We request you to give your opinion on this issue for the benefit of Council members.
Thanking you
with regards
 Dr.P.V.Appaji,
Executive Director

Reply letter from DOC

N o.15 / 71/ 2010- E P( E ngg) dt. 12.8.2011

To

Dr. P.V. APPaji,

Executive Director,

Pharmexcil,

Hyderabad.

Subject : Ctarification with regard to bar coding of exports'

Sir,

Please refer to Pharmexcil's e-mail dated the 18ff July' 2011

forwarding therewith a copy of e-mail received frorn Business

Fermenta Biotech Ltd', Thane on the subject mentioned above'

It is confirmed that bar coding is applicable to medicines

which are formulations having primary, secondary and tertiary

packings.

Yours faithfully,

Director(MridulJain)