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)

Clarification on different packing for Bar code dt.7.9.2011

From: Uday Jadhav <uday.m.jadhav@gsk.com>

Date: Wed, Sep 7, 2011 at 5:35 PM

Subject: Clarification required on barcoding of export packs

To: "rd@pharmexcil.com" <rd@pharmexcil.com>

Cc: Abhijit Kulkarni <abhijit.s.kulkarni@gsk.com>, Siddharth Barve <siddharth.v.barve@gsk.com>

GSK Uday Jadhav Question:  As discussed with you today, kindly refer the attached file in which we have mentioned the various packaging configuration of our representative packs.  As per our understanding we have segregated the primary, secondary and tertiary level packaging which is being mentioned in the attached file. Request you to please confirm whether our understanding is correct and provide your comments & inputs on this so necessary modifications can be done accordingly.

GS1 GOPAL Answered: Your understanding is correct. I require clarity on S.No 6 ( Liquid packing1) where you mentioned bottle goes in one carton, as per my understanding you are  referring to monocarton , if that is so then it is absolutely right. 

GSK Uday Jadhav Question:  Also request you to confirm whether human readable codes are required along with the barcodes on the primary, secondary and tertiary level packaging because as  per the DFGT Notification (Public Notice No. 59 (RE-2010)/2009-2014 by Ministry of Commerce and Industry, GOI) dated 30th June, 2011 nowhere mentions the requirement of human readable code along with the barcode.

GS1 GOPAL Answered: Human readable information is required to be printed with the barcodes at all packaging levels and same has been mentioned in the user manual (uploaded on Pharmexcil website) which is made available as a guidance document to comply with DGFT Notification.

GSK Uday Jadhav Question: Further in the notification is being mentioned that the exporters of the pharmaceutical products will adopt a trace and track system and incorporate its features for exported medicines using barcode technolgogy as per GS1 global standards, however as per our understanding in trace and track system we should have association (a parent child relationship) between the primary, secondary, and tertiary level packaging hence please confirm whether our understanding is correct? if not request you to clarify the term trace and track system for the various level of packaging.

GS1 GOPAL answered: Exporters are required to maintain track and trace systems which would enable them to maintain traceability data related to the product that they export. And as you rightly mentioned that you would need to have parent child relationship which would facilitate you to identify/know which primary went into which secondary pack and which secondary pack went into which tertiary pack. Best Regards,

Sr.No.	Type of packing	Pack Style	Primary  level packaging	Secondary level packaging	Tertiary level packaing
1	Strip Packing	Strips are packed in a cartons, cartons are packed in a Corrugated fiber box	Strip	Carton	Corrugated fiber box
2	Blister Packing	Blisters are packed in a cartons, cartons are packed in a Corrugated fiber box	Blister	Carton	Corrugated fiber box
	Blister Packing	Blister is packed in a monocarton (one blister ina carton). Such monocartons are packed in a outer carton. And outer cartons are then packed in a corrugated fiber box	Monocarton	Outer carton	Corrugated fiber box
3	Ointment Packing	One tube is packed in one carton,10 such cartons are wrapped by a film to form a Bundle. Such Bundles of 10's carton are packed in Corrugated fiber box	carton	Film which forms a bundle of cartons	Corrugated fiber box
4	Tablet packing in bottle	Bottles are labeled, 10 such bottles are shrink wrapped by film, and shrink wrapped bottles are  packed in Corrugated fiber box	Label on the bottle	Shrink wrap	Corrugated fiber box
5	Liquid packing	Bottles are labeled, 10 such bottles are shrink wrapped by film, and shrink wrapped bottles are  packed in Corrugated fiber box	Label on the bottle	Shrink wrap	Corrugated fiber box
6	Liquid Packing 1.	Bottles are labeled, one bottle goes in one carton, cartons are packed in Corrugated fiber box	carton	carton	Corrugated fiber box
7	Injection Packing	5 Ampoules are packed in a single blister pack, such group of blisters are then packed in a carton, and cartons are packed in a Corrugated fiber box	Blister	Carton	Corrugated fiber box
As per the Drugs and Cosmetics Rules 1945 offered by RD
Sr.No.	Type of packing	Pack Style	Primary pack	Secondary pack	Tertiary pack
1	Strip Packing	Strips are packed in a cartons, cartons are packed in a Corrugated fiber box	Strip	Carton	Corrugated fiber box
2	Blister Packing	Blisters are packed in a cartons, cartons are packed in a Corrugated fiber box	Blister	Carton	Corrugated fiber box
	Blister Packing	Blister is packed in a monocarton (one blister ina carton). Such monocartons are packed in a outer carton. And outer cartons are then packed in a corrugated fiber box	Blister	Carton	Corrugated fiber box
3	Ointment Packing	One tube is packed in one carton,10 such cartons are wrapped by a film to form a Bundle. Such Bundles of 10's carton are packed in Corrugated fiber box	Tube	Carton	Corrugated fiber box
4	Tablet packing in bottle	Bottles are labeled, 10 such bottles are shrink wrapped by film, and shrink wrapped bottles are  packed in Corrugated fiber box	bottle	Shrink wrap	Corrugated fiber box
5	Liquid packing	Bottles are labeled, 10 such bottles are shrink wrapped by film, and shrink wrapped bottles are  packed in Corrugated fiber box	bottle	Shrink wrap	Corrugated fiber box
6	Liquid Packing 1.	Bottles are labeled, one bottle goes in one carton, cartons are packed in Corrugated fiber box	bottle	Carton	Corrugated fiber box
7	Injection Packing	5 Ampoules are packed in a single blister pack, such group of blisters are then packed in a carton, and cartons are packed in a Corrugated fiber box	amoule	blister	carton & corrugated fibe box

M/s Nakoda Chemicals Limited querry

marketing nakodachemical@nakodachemical.com to me, info
show details 12:43 PM (1 hour ago)
Kind Attn. : Mr. SubbiReddy

Good Morning Sir,

Dear Sir,

This is reference to our telephonic discussion just few moments ago regarding implemntation of Bar Coding w.e.f  01.10.2011

We have below querries to be addressed/clarified

1.    Whether we being Bulk Drugs & Intermediates/API's manufacturer are mandatory for BAR Coding.

2.    If yes then as per the circular issued by DGFT that what ever product exported should be bar coded.

3.    We normally have almost 12 to 15 products which are regularly exported all over the world.

3.    Our Products normally packed as per the requirement in sizes ranging from 1 Kg to 50 Kgs HDPE/Fibre Drum for commercial shipments both by Air/Sea
       (For eg. : A Shipment of 105 Kgs can be packed in 25 Kgs x 4 drums & 5 Kgs x 1 drum)

4.    Some times we send Trade samples/impurities ( Free of cost) to our customers ranges from 200mg to 1 Kg. Is this also covered under Bar Coding.

Kindly help how to go ahead about it as there is no clear clarity about Barcoding mandatory Yes or No.

Awaiting for your feebdback for doing the needful.

Thanks & Regards
Pramod
Manager
Nakoda Chemicals Limited

Dear Sir,
With reference to your mail dated 7.9.2011, it is to submit that Bar code is not  required for API's /Bulk drugs/Intermediates as per the clarification received from the Dept of Commerce while exporting
with regards
K.Subbi Reddy.

Webinars on Barcodes by GS1

Gopal Valecha gopal@gs1india.org
toRegional Director <rd@pharmexcil.com>
cc"mridulj@nic.in" <mridulj@nic.in>,
"js1tpd-doc@nic.in" <js1tpd-doc@nic.in>,
ED <ed@pharmexcil.com>
dateTue, Sep 6, 2011 at 4:03 PM
subjectWebinars
 Dear Sir,
As you may be aware that GS1 India is conducting physical workshops at our office every week since July ’11 and from Aug’11 onwards we also started conducting Webinars for pharma companies to facilitate them complying with the barcode requirements as stipulated under DGFT Public Notice. We are also providing them our support for registration and implementation.  The pharma companies who are unable to participate in physical workshops due to various constraints , Webinars  enable these companies to  gain required knowledge on implementation of barcoding , sitting at their respective offices. They just require internet connection and a microphone to get access to Webinar . A webinar is of one and half hours duration and 20 participants can participate at a time.   Should you wish to arrange such webinars for your members ,please let us know. We shall be happy to provide our support for the same and organize webinars exclusively for Pharmexcil members.  For the same you may send us list of interested participants with their contact details (Name, Organisation, email id & phone number ) to enable us send them invite to participate in Webinars.  Best Regards,  
Gopal Valecha
Sr. Manager
Business Development
GS1 India(Under Ministry of Commerce, Govt. of India)

Note: Who ever is interested, they are requested to furnish the details for conducting the program for 20 members at a time. Pharmexicl members are requested to utlize the oppurtunity at the earliest.

Clarification on 3rd party products

mtmexp@gmail.com
tord@pharmexcil.com
ccinfo@pharmexcil.com
dateFri, Aug 26, 2011 at 4:36 PM
subjectBarcoding
mailed-bygmail.com
signed-bygmail.com
Important mainly because of the words in the message.
hide details Aug 26 (11 days ago)
Dear Sir,

We are merchant Exporters and we would like some clarifications for Bar Coding.

Can we get Bar Coding for Products from other Manufacturers (Like.... Can we get barcode for Neurobion Tablet manufactured by Merck India)... if not then how can we export the same ?

If we pack 15 different products per shipper, then are we supposed to put Bar Code of Each Product on the Shipper ?

Kindly give us the contact details of the concerned person, who can explain us how can we proceed or go ahead with the same.

Regards,

Kamlesh Shah

Mob : 9821110829
Off : 022-66336214 / 15
 Reply Reply to all Forward Invite M.T.MADON EXPORTS to chat

 Reply |Regional Director to Gopal, mridulj, ED, romumbai, mtmexp
show details Aug 26 (11 days ago)
DearMr.Gopal
I am herewith forwarding the mail received from one our member for your kind clarification. Please give clarification under copy to the council.
with regards
K.Subbi Reddy.

- Show quoted text -
On Fri, Aug 26, 2011 at 4:36 PM, M.T.MADON EXPORTS <mtmexp@gmail.com> wrote:
Dear Sir, We are merchant Exporters and we would like some clarifications for Bar Coding. Can we get Bar Coding for Products from other Manufacturers (Like.... Can we get barcode for Neurobion Tablet manufactured by Merck India)... if not then how can we export the same ? If we pack 15 different products per shipper, then are we supposed to put Bar Code of Each Product on the Shipper ? Kindly give us the contact details of the concerned person, who can explain us how can we proceed or go ahead with the same. Regards, Kamlesh Shah Mob : 9821110829Off : 022-66336214 / 15

--
Mr.K.Subbi Reddy,M.Pharm.LL.B.
Regional Director
Pharmceutical Export Promotion Council
(Set up by Ministry of Commerce, Govt. of India), 101, Adithya Trade Center, Ameerpet, Hyderabad 500038 Cell No 08008135757 Tel.No.040-23756255 Fax:040-23735464

 Reply Reply to all Forward

 Reply |Gopal Valecha to mtmexp, mridulj, ED, romumbai, me
show details Aug 26 (11 days ago)
Dear Mr. Shah, As you are a merchant exporter so you should get the barcoding done on the products from Manufacturer as they are the brand owners . Having said that this can also be a mutual agreement between you and the manufacturer on who would own the responsibility to put barcode at tertiary level packaging but in any case barcoding at primary & secondary level packaging has to be done by manufacturer only as it would require to print variable data during production runs. Also to maintain parent child relationship at all packaging levels ,barcoding should be done by manufacturers. Hope this answers your query. Best Regards, Gopal Valecha Sr. Manager Business DevelopmentGS1 India(Under Ministry of Commerce, Govt. of India) ……………………………………………………………330,2nd Floor, “C” Wing , August Kranti BhawanBhikaji  Cama Place, New Delhi-110066,IndiaT  +91-11 – 26168720/721/725M +91- 99 103 50 103F  +91-11 – 26168730   gopal@gs1india.orghttp://www.gs1india.org