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

Wednesday, September 7, 2011

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.

Tuesday, September 6, 2011

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

Sunday, September 4, 2011

DGFT Notification No.59 dt.30.6.2011


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. 59(RE-2010)/2009-2014
New Delhi, Dated the 30th June, 2011

Sub: Deferment in the date of effect for implementation of bar-coding 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 amends Public Notice No. 21 dated 10th January, 2011 and prescribes the following procedure for tracing and tracking of export consignments of pharmaceutical products.

2. (i)     Exporters of pharmaceutical products will adopt a trace and track system and incorporate its features for exported medicines using barcode technology as per GS 1 global standards as detailed below:

a.    Primary Level packaging requirement:
Incorporation of 2D (GS1 Data matrix) barcodes on medicines at strip/vial/bottle, etc. encoding unique product identification code (GTIN) and Unique Serial Number of the Primary pack.

b.    Secondary Level packaging requirement :
             Incorporation of barcodes (1D or 2 D) encoding unique product identification code (GTIN), Batch Number, Expiry Date and Unique Serial Number of the Secondary pack.

c.    Tertiary Level packaging requirement:
            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).

   (ii)     The trace and track technology as per serial number 2(i) above will come into effect as follows:

(a)     Primary Level packaging              - With effect from  1st July, 2012
(b)   Secondary Level packaging                       - With effect from  1st January, 2012
(c)    Tertiary Level packaging               - With effect from  1st October, 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.

4.         Under the track and trace system, manufacturers would be required to maintain serialized record of exported pharmaceutical products for a minimum period of six months after the expiry date of the product.

5.         Authentication features will be added in due course and integrated with the trace and track system.

6.         Government will set up a Central Portal for tracing and tracking exported pharmaceutical products.

7.         Effect of this Public Notice:

Earlier the requirement of affixing barcodes was to come into effect from 01.07.2011. 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)

Pharmexcil representation dt.8.4.2011


Pharmaceuticals Export Promotion Council
(Setup by Ministry of Commerce & Industry, Govt. of India)

Dt:08.April.2011

To
Shri Rajeev Kher,IAS
Additional Secretary
Department of Commerce
Ministry of Commerce & Industry
Govt. of India
New Delhi

Dear Sir,

Sub: Comments of Pharmexcil on DGFT Notification Dt.10.01.2011 on Trace & Track Technology

This has reference to the discussions in the meeting held on 10.March.2011 under the Chairmanship of your goodself on the above subject. In this regard, we have invited comments from all members.A final report consisting of various constraints & suggestions/recommendations by the Council is enclosed for your kind information.

With regards,

Dr.P.V.Appaji
Executive Director

Comments of Pharmexcil on DGFT Notification Dt.10.01.2011 on Trace & Track Technology

Sub.:    Public notice dated 10th January 2011 issued by DGFT relating to tracing and tracking of exported consignment of medicines- Comments by Pharmexcil submitted

A.        Para-wise comments of the above notification given below:

Para 3 (or Serial Number 3) – ‘Exporter of Pharmaceutical products will build track and trace capability for their exported medicines using barcode technology as per GS 1 global standards. The same will need to be done at Primary, Secondary & Tertiary level packaging labels as per details below –

3.a. Primary Level packaging – Incorporation of 2D (GS 1 Data matrix) barcodes on medicines at strip/vial/bottle level encoding unique product identification code (GTIN), Batch Number, Expiry Date and Serial Number of the Primary pack

Concerns:

a.1. For Export of medicines, “Text matter” on the ‘Label’ (ampoule, vial or bottle) or ‘Strip’ is approved by each individual country (according to the regulations in that country). To change the approved label (or to add extra text / bar code) will require permission from respective country. Manufacturer will have to apply for each product in each individual country separately to obtain such permission – Changes in the ‘Label’ can be implemented ONLY after receiving approval from regulatory authority of respective country.

a.2. Many times, the size of Label / Strip is small and space is not enough for mentioning the basic details such as “Brand name, generic name, composition, manufacturer’s name, batch no., exp. date, size, etc.” In addition to this basic requirement, incorporation of additional Bar Code will be difficult / may not be possible.

a.3. Bar code is required with ‘Serial Number of the primary pack’ – To include Serial number in the bar code, sophisticated on line bar code generating machine (equipment) will be required. Also such machine will be required for each packaging line separately.

Manufacturer will have to procure number of such sophisticated barcode generating and printing machines and will have to modify the packaging lines – which involve cost & will require time for such modifications.

Many times the primary units are produced in a large quantity (based on the batch size – generally in few lakhs quantity) and then primary packing is carried out using number of primary packaging lines (machines). In such case, serial numbering of primary pack will not be possible (since the primary packs are produced on number of packaging lines simultaneously).

a.4. Any wear and tear of the primary pack (either the container/strip or the packaging material) after packaging & bar coding is complete will mean missing out of that serial number in the final export consignment. This can not be tracked without additional stress on the schedule and additional equipment usage / man power wastage to note down such details.
        
3.b. Secondary Level packaging – Incorporation of barcodes (1D or 2D) encoding unique product identification code (GTIN), Batch Number, Expiry Date and Serial Number of the Secondary pack.

Concerns:

b.1. As mentioned in the point no. 1 of primary level packaging, the text on secondary level packaging is also approved by each individual country. To change the approved label (or to add extra text / bar code) will require permission from respective country. Manufacturer will have to apply for each product in each individual country separately to obtain such permission. – Changes can be implemented ONLY after receiving approval from regulatory authority of respective country.

b.2. Normally the secondary packaging is done manually by multiple personnel. Hence the serial numbers on the barcodes will be difficult to incorporate. This also will need a sophisticated barcode generating and printing machine in addition to the one required for primary packaging, specially designed for such packaging.

b.3. Even in case of automatic secondary packaging, multiple lines are used and the same numbers of barcode machines will be required.

b.4. Any wear and tear of the secondary pack (either the primary pack or the packaging material) after packaging & bar coding is complete will mean missing out of that serial number in the final export consignment. This can not be tracked without additional stress on the schedule and additional equipment usage / man power wastage to note down such details.

3.c. Tertiary Level packaging – Incorporation of barcodes (1D) encoding unique product identification code (GTIN), Batch Number, Expiry Date and Serial Number of the Tertiary pack (shipper / carton).

Concerns:

c.1. The carton / shipper may not be labeled, the details are many times stenciled or printed on the tertiary packaging as the tertiary packaging material is mostly of corrugated cardboards from which the sticker labels get peeled off.

c.2. To generate bar codes with the serial numbers for the tertiary packaging separate barcode generating and printing machines will be required. This too adds to the cost and work load.

General Concerns:

This entire exercise will require huge investment in machinery and technology.
Such sophisticated machines are not available locally and require to be imported in a large quantity to cater the needs of about 3500 exporters.
The work load, man-hours for each operation will increase considerably
The efficiency of production will reduce significantly
This will lead to higher manufacturing cost and is against industry’s interest for competing against the competitors in international markets.
SMEs will not be able to cope up with the additional investment cost.
Such system is not followed even by the International manufacturers.  
Above everything, there is no justifiable significant advantage of implementing such procedures as the main goal of tracking the individual pack is not ensured.
Moreover, not all products or drugs need to be monitored so strictly or stringently at the packaged levels as the finished goods are well monitored and documented otherwise.
              



                                                                                            
Additional Points:

1.            Along with small ‘Label and Strip’, the space constraint is also applicable for small tubes.

2.            Export of Pharmaceutical products is very high (about 10 billion US$) – this entire Export will be at stake.  

3.            Fast moving products are manufactured with proper forecasting. There will be a huge stock of finished goods which will be manufactured before 1st July 2011. Permission shall be given for export of goods manufactured before 1st July 2011.

4.            Approval for incorporation of such code on Primary & Secondary pack will be required in many importing countries. Such approval will require about 9 to 12 months.

5.            Primary packs shall be exempted from these requirements.

6.            Such system of bar coding is not implemented in any other country. 

7.            Bar coding for Export products must comply with the requirements and the system adopted by the Importing country.

8.            The proposed Bar code system may not be acceptable to the Importing country.  

9.            As per the Report published by CDSCO, the percentage of Spurious Drugs is only 0.046%.

10.        Such notification should be simultaneously published / issued by Ministry of Health & Family Welfare.

11.        Many Indian companies are manufacturing products of Foreign companies on Contract manufacturing (neutral labeling) and such requirements of bar code are not asked by these companies.

12.        In many CIS countries (Russia, Ukraine, Kazakhstan), sample of each batch is tested as per the approved documents including checking of Text, Colour, Design  of Primary & Secondary pack as per the approved art works.  

13.        Present  GS1 13 digit (1D) Bar Code used in almost all Importing  countries, contains details of the country of manufacture, name of manufacturer, product name and unit pack Batch no., Mfg. Date, Expiry Date and Mfg. Lic. No. is in any case printed on both the primary and secondary packs as per the requirements of Drugs & Cosmetics Act and Rules. This is adequate to track and trace the product right up to the manufacturer.

14.        There is no guarantee that the proposed 2D bar coding system cannot be counterfeited and duplicated.

15.        Efforts shall be made to evolve a  “Global Track and Traceability” programme using a harmonized bar coding system which will be acceptable to all countries across the globe rather than impose a Unilateral Standard which is sure to create problems and will not be acceptable to the Importing countries.

16.        Joseph Ringwood, COO - Systech International (NJ, US) had this to say regarding the Foreign Trade Ministry Serialization announcement:

We serve the global serialization market. This emerging regulation from India is  than that being implemented in Turkey and actually resembles California legislation. A key point to be made is that the track and trace requirements do not specify infrastructure or the need to capture data and maintain it in any type of database for queries. This type of serialization is useless unless the product can at the very least be authenticated.”

17.        The cost of the equipment for implementing the trace and track technology per line is Rs.35.79 lacs.In addition to this, annual maintenance costs towards software, about 15% of the software costs has to be incurred. Small and medium drug companies will find it extremely difficult to implement it from the cost point of view.

18.        Observations:

1)      In overseas markets also variable barcodings are not printed. Only specific product linear barcodes are specified as mandatory requirement in some of the markets

2)      Barcoding on tertiary packs would serve no purpose as the same boxes are not always used. Further in the distribution channel/and are often repacked.

3)      In most of the countries Secondary packaging is the unit for sale, therefore there is no need for barcoding on primary packs


B. Current International Status:

1)      No other country is following the systems prescribed by DGFT.

2)      France has notified about 2D coding in March 2007 and provided four years time frame for implementation.

3)      Developed markets in EU and America do not insist on 2D barcodes on export packs with variable data.

4)      The coding and serialization requirements have just begun from 2010 only. About 10 countries have started/announced implementation of this solution. Adequate time is provided by several countries. The position is explained below,


C. List of Remarks/Problems & Constraints as received from various members:

1)      Majority of the Ayurvedic formulations are exported as food/food supplements and personal care products. The counterfeit/misbranded/spurious drugs are not an occurrence in traditional medicines. Keeping traditional medicine which are covered under the purview of Drugs & Cosmetics Act to sophisticated tracking technology is totally unnecessary

2)      To revise printed components involving several labels of exported medicines to accommodate barcodes. This will have impact on timelines

3)      To write off existing old inventories and to create new inventories

4)      Regulatory approvals from importing country would take considerable time

5)      Need to build infrastructure, serialisation, printing of 2D barcode etc

6)      New installations are required

7)      Cartons are saleable packs in International markets

8)      Serialization on primary packs is not done internationally

9)      There are no added guidelines provided on implementation of trace & track 2D code for the pharmaceutical manufacturers

10)  Barcode generating and printing machines to be purchased for each packaging lines involving huge investments

11)  Separate machines will be required from primary, secondary, tertiary packaging sections again contributing to high costs

12)  It is important  to decide the agency who will allot the codes(UPIC) to the companies for printing barcodes

13)  Due to exorbitant capital and recurring costs, most of the exports from SME sector will become unremunerative rendering them out of export business

14)  The Commerce Ministry in Russia has reportedly denied permission to print the barcoding on primary packaging(labels)

15)  Several problems are involved with barcoding incorporation on primary packs

16)  Changes in the label can be implemented only after receiving approval from the regulatory authority of respective country

17)  Many times sufficient space is not available for incorporation of complete information on primary labels

18)  The agency who will handle track & trace data is not notified

19)  There should be a vendors list approved by DGFT/GS1 for providing Unique Identification Code
                                  
20)  Very difficult to comply by traders/merchant exporters

21)  Difficult to have more than one code on the pack if the receiving market legislation also requires its own mechanism

22)  Compliance with the rigid requirements specified in the notification in terms of realistic implementation time

D. Suggestion received from various members:

  1. Hidden hologram which can be pre-printed on the carton would be advantageous as no extra cost and time is involved at the manufacturers end

  1. 2D Barcoding may be implemented for secondary packaging instead on primary packaging

  1. Requirement for serial number on cartons may be waived off

  1. System required to be introduced in a phased manner and may be made applicable,to start with trading/export houses having highest rankings

  1. Procedure for barcoding in case of medicines exported for neutral label/for repackaging purposes 

  1. Serialisation need not be insisted.

  1. Serial number may not be insisted for tertiary packaging

  1. The cost incurred by SMEs may be reimbursed by Commerce Ministry and, may be under Brand India fund

  1. Prior education/training of the small scale sector to make them ready for compliance is required. The Govt. needs to organise awareness programmes/workshops with sufficient time gap.

  1. To provide timelines for implementation due to cost implications

  1. Clear guidelines for implementation are required

  1. Barcoding for primary packaging not advisable as it is nowhere done globally

  1. Incorporating trace and track system by printing random code on each unit pack would help industry as the end user. End user verification is convenient if a toll free SMS contact number is provided

E. Summary of Major Constraints observed from the Notification:

In view of the difficulties faced by the industry to implement the recommendation of the DGFT at a short notice on the following parameters:
a)      Time lines required to adopt to technology which has to be adopted for all levels of packing
b)      Time to change the pack art works at all levels of packing with different importing countries across the world where the Indian companies export to.
c)      Huge investment cost involved in the changes to be brought in at the packing lines level for primary/secondary packing.
d)      Importing countries having specific requirements in the primary and secondary packing for bar coding which is different than the requirements of the GS1.
e)      All regulatory countries have the site approval and product dossiers mechanism in place to implement track & traceability in the existing forum is not possible and not required at all.

F. Suggestions by Pharmexcil for Amendments to the Notification:

1.    Primary pack which is a blister/strip/ vial shall be exempted since it requires huge investment and regulatory approvals. Also cost of pack will increase since the blister size needs to be increased to accommodate space for barcode. Also it has  a cascading effect on cartons / shippers
2.    Track & Trace is to be implemented without serialization at carton level at marketable unit pack. {E.g. for blisters in a carton; then carton is marketable pack}.Track & Trace to be implemented at carton level (Marketable pack) which is internationally a saleable pack. This can be implemented from July 2016.
3.    Implementation of Track & Trace can be done at tertiary level from December 2012 which gives the manufacturer’s origin and identification.
4.    Countries which have implemented or recommended to implement Track and Trace (which differ from our standards e.g. sNDC for US, CIP for France etc), country specific Track & Trace should be adopted as per the requirements of the importing countries.
5.    Countries which either don't have existing Track and Trace requirement or have requirements matching to our standards should be considered for INDIAN Track and Trace guidelines, before implementation these countries should give acceptance to Indian track & trace guidelines.

6.    Traditional medicines may be exempted from the requirements. Majority of the Ayurvedic formulations are exported as food/food supplements and personal care products. The counterfeit/misbranded/spurious drugs are not an occurrence in traditional medicines. Keeping traditional medicine which are covered under the purview of Drugs & Cosmetics Act to sophisticated tracking technology is totally unnecessary

7.    In no case Indian Drug Industries are in a position to implement serial number correlation of Primary and Secondary Packaging i.e., mother-child co-relation. As majority of our Units are manual based packaging lines whereas to implement serialization, one requires to have fully automatic & computerized packaging lines. Hence serialization be exempted from the requirements.

Timelines are proposed considering high level of investment associated with line and plant layout modification, complexity associated with modified line /new equipment qualification, validation, training period etc

G. Assistance:

1)       Appropriate awareness/technical assistance may be provided to SME sector by conducting workshops
2)      Financial assistance to SME sector may be provided