Thursday, December 22, 2011

DOC letter dt. 21.12.2011 in response to Pharmexcil representation

DGFT Public Notice No.87 extending Barcode Implimentation



To be published in the Gazette of India Extraordinary Part-I, Section-I
Government of India
Ministry of Commerce and Industry
Department of Commerce
Directorate General of Foreign Trade

Public Notice No. 87 (RE-2010)/2009-2014
New Delhi, Dated the 22nd December, 2011

Sub: Deferment in the date of effect for implementation of bar-coding on Primary and Secondary level packaging on export consignment of pharmaceuticals and drugs for tracing and tracking purpose.

In exercise of the powers conferred under Paragraph 2.4 of the Foreign Trade Policy, 2009-14, as amended from time to time, Director General of Foreign Trade hereby makes following amendments in Public Notice No. 59(RE-2010)/2009-14 dated 30.06.2011 read with Public Notice No. 21 dated 10.01.2011:

2.         The trace and track technology as per serial number 2(i) a and 2(i) b of Public Notice No. 59(RE-2010)/2009-14 dated 30.06.2011 will come into effect as follows:

(a) Primary Level packaging -    With effect from 1st January, 2013
(b) Secondary Level packaging - With effect from 1st July, 2012

3. Effect of this Public Notice:
Earlier the requirement of affixing barcodes on Secondary level and Primary level packaging was to come into effect from 01.01.2012 and 01.07.2012 respectively. Now more time is being allowed.


(Anup K.Pujari)
Director General of Foreign Trade
E-mail: dgft@nic.in
(Issued from F.No. 01/91/180/648/AM 09/Export Cell)

Tuesday, December 13, 2011

GS1India announced Schedule for webinar on Barcode system

Webinar schedule


Sector
Date
Day
Timings
Pharma
Nov 21, 2011
Monday
11:30 AM - 1:00 PM
General
Nov 28, 2011
Monday
10:30 AM - 1:00 PM
Pharma
Dec 5, 2011
Monday
11:30 AM - 1:00 PM
General
Dec 12, 2011
Monday
10:30 AM - 1:00 PM
Pharma
Dec 19, 2011
Monday
11:30 AM - 1:00 PM
General
Dec 26, 2011
Monday
10:30 AM - 1:00 PM

For participating in any one of the webinars, please send a mail to workshop@gs1india.org mentioning the sector,date and time of the webinar.

Pharmexcil submitted Representation to Addl.Secretary, DOC

Dear all,
It is to submit that on receiving many representations from firms like M/s Cadila, Aventis Pharma, Mylan, Ranbaxy etc. ,on organizing an interactive meeting at Hyderabad with Pharma Industry packaging personal and on discussing in the COA meeting, Pharmexcil has submitted a consolidated representation with a request to extend the date of implementation of  Barcode on Secondary Packaging by One year i.e Jan 2013.
with regards
Pharmexcil. 

Monday, November 28, 2011

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 28th  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)

Friday, November 25, 2011

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

Thursday, November 10, 2011

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

Thursday, November 3, 2011

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.

Friday, October 28, 2011

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 25th 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 1st 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 2nd cited reference, it is clarified that the drugs/medicines manufactured  on and after 1st 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 1st 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.

Monday, October 10, 2011

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,

Sunday, October 9, 2011

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. 


Wednesday, October 5, 2011

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 .

Monday, October 3, 2011

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

Monday, September 26, 2011

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.

Tuesday, September 20, 2011

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

Friday, September 9, 2011

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)

Thursday, September 8, 2011

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 packingPack StylePrimary  level packagingSecondary level packagingTertiary level packaing
1Strip PackingStrips are packed in a cartons, cartons are packed in a Corrugated fiber box StripCartonCorrugated fiber box 
2Blister PackingBlisters are packed in a cartons, cartons are packed in a Corrugated fiber box BlisterCartonCorrugated fiber box 
 Blister PackingBlister 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 boxMonocartonOuter cartonCorrugated fiber box 
3Ointment PackingOne 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 cartonFilm which forms a
bundle of cartons
Corrugated fiber box 
4Tablet packing in bottleBottles are labeled, 10 such bottles are shrink wrapped by film, and shrink wrapped bottles are  packed in Corrugated fiber box Label on the bottleShrink wrapCorrugated fiber box 
5Liquid packingBottles are labeled, 10 such bottles are shrink wrapped by film, and shrink wrapped bottles are  packed in Corrugated fiber box Label on the bottleShrink wrapCorrugated fiber box 
6Liquid Packing 1.Bottles are labeled, one bottle goes in one carton, cartons are packed in Corrugated fiber box cartoncartonCorrugated fiber box 
7Injection Packing5 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 BlisterCartonCorrugated fiber box 
As per the Drugs and Cosmetics Rules 1945 offered by RD
Sr.No.Type of packingPack StylePrimary packSecondary packTertiary pack
1Strip PackingStrips are packed in a cartons, cartons are packed in a Corrugated fiber box StripCartonCorrugated fiber box 
2Blister PackingBlisters are packed in a cartons, cartons are packed in a Corrugated fiber box BlisterCartonCorrugated fiber box 
 Blister PackingBlister 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 boxBlisterCartonCorrugated fiber box 
3Ointment PackingOne 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 TubeCartonCorrugated fiber box 
4Tablet packing in bottleBottles are labeled, 10 such bottles are shrink wrapped by film, and shrink wrapped bottles are  packed in Corrugated fiber box bottleShrink wrapCorrugated fiber box 
5Liquid packingBottles are labeled, 10 such bottles are shrink wrapped by film, and shrink wrapped bottles are  packed in Corrugated fiber box bottleShrink wrapCorrugated fiber box 
6Liquid Packing 1.Bottles are labeled, one bottle goes in one carton, cartons are packed in Corrugated fiber box bottleCartonCorrugated fiber box 
7Injection Packing5 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 amouleblistercarton & corrugated fibe box