Complying with barcoding reqmts of DGFT and Min. of Health, Govt. of India
Summary of DGFT requirements
Packaging level | Barcoding requirements | Timeline |
Tertiary level–definition Comprises highest level of packaging containing secondary and other intermediate packages meant for transport/logistics(cartons/pallets/shipments) | Incorporation of barcodes (1D) encoding unique product identification code (GTIN), Batch Number, Expiry Date and Unique Serial Number of the Tertiary pack (shipper/carton). | Phase 1 –by 1stOct 2011 |
Secondary level–definition Packaging level containing primary level packages. | Incorporation of barcodes (1Dor2D) encoding unique product identification code (GTIN), Batch Number, Expiry date and Unique Serial Number of the secondary pack. | Phase 2 –by 1stJan 2012 |
Primary level–definition Comprises first level of packaging indirect contact with the product e.g. medicine strip, vial, single therapy kit, or items packed in mono carton for sale to consumers. | Incorporation of2D (GS1DataMatrix) barcodes on medicines at strip/vial/bottle encoding unique product identification code Global Trade Identification Number (GTIN) and Unique Serial Number of the primary pack. | Phase 3 –by 1stJuly 2012 |
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Summary of Min of Health, Govt. of India requirements Phase 1
Phase 2
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Procedure for generation of GTIN as per DGFT and Min of Health, Govt. of India requirements
· Obtain GS1 Company Prefix (GCP) through registration with GS1India. For registration procedure, logon to: http://www.gs1india.org/Support/Get Registered
· Use GCP to generate GTIN as per steps below:
· Assign item reference number of applicant company’s choice to each product type/variant
· Calculate check digit using online Check Digit Calculator available at the URL http://www.gs1india.org.in/calculater.aspx
· Generate GTIN using GCP, item reference number and check digit. Find more about how to generate GTIN at the URL
· http://www.gs1india.org.in/gs1barcodes/number_development_guide.htm
Implementing barcodes at primary level as per DGFT and Min of Health, Govt. of India reqmnts
Generate GTIN-14 for primary pack.
a) GTIN (Global Trade Item Number) is the GS1 identification key used to uniquely identify each product type/variant.
b) GTIN-14 is generated from GTIN-13,using prefix of “0” to convert to14digitcode.
c)Generating GTIN-13
GTIN-13 structure (e.g.8901107000011)
8901107 00001 1
Company ItemRef. Check
Prefix No. No. digit
8901107-Company prefix no. allocated by GS1India
00001- item Ref.No. allocated for each product type/variant/SKU by manufacturer/brand owner
1- check digit calculated based on preceding digits(calculator availableatwww.gs1india.org)
d) Generating GTIN-14from GTIN-13 by prefixing “0”
GTIN-14 structure (from GTIN-13 illustrated above)
0 8901107000011
GTIN-14structure evolved out of GTIN-13 structure as above
Encoding product information in 2D (GS1 DataMatrix) barcode symbology as per DGFT reqmnts for primary level
UseGS1generalspecsavailableat:
Schematic representation of GS1
DataMatrix at primary level
(01)08901107000011(21)abcd12345
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Implementation as per DGFT mandate –Secondary Pack
Unique identification of secondary pack.
· GTIN using application identifier (01)
· Expiry Date in YYMMDD format using application identifier (17)
· Batch/Lot Number using application identifier (10)
· Serial No. of the secondary package using application identifier (21) Points to be noted:
· GTIN of secondary level packaging should be different from GTIN of primary and shipper package.
· The above barcoding requirements shall be in addition to existing statutory labeling & marking requirements.
· The parentheses (brackets) are not encoded in the barcode and they are represented in human readable form only for highlighting the application identifier number within the brackets.
· Fixed length data fields will always precede variable length fields.
· It is mandatory to print data encoded in barcodes as human readable information.
· 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 above requirement
Implementation as per DGFT mandate –secondary Pack
Generation of (GTIN)
Refer to steps mentioned in the previous slides on implementation at primary pack
Encoding of GTIN, Expiry Date, Batch number and serial number
GS1 DataMatrix(2D):
(01)08901107000028 (17)090400
(10)ab12345 (21)mnop09876 OR
GS1-128 barcode symbology(1D):
Not more than 48 characters can been coded inasingleGS1–128barcode.If the total number of character sexceeds48,it should be split in two barcode sonasingle label.
Note: Suppliers may chose either 2D or 1D symbology
as illustrated below:
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Implementation as per DGFT mandate -at carton/shipper level
Allocation of Serial Shipping Container Code(SSCC)
SSCC Is used for the unique identification of each Shipper/Carton/Tertiary level package as a logistic unit.
Steps to generate, SSCC (18 digits shipper identification code):-
•Assign the Extension digit ranging from 0-9 to increase the capacity of the Serial Reference within the SSCC
•Use GCP issued by GS1 India or any other GS1 member organizations in other countries
•Generated unique serial reference number to identify each Shipper/Carton/Tertiary level package..
•Calculate check digit using online Check Digit Calculator available at http://www.gs1india.org.in/calculateeer.aspx
Implementation at carton/shipper level -Homogeneous pack
Homogeneous Packs contain same type of secondary packs
Requirement for homogeneous packs
Two GS1-128 barcodes The first barcode contains:
•Product Identification code (Unique GTIN- 14 product code of the Shipper/Carton/Tertiary level packaging) using application identifier (01)
•Expiry Date in YYMMDD format using application identifier (17)
•Batch/Lot Number using application identifier (10)
The second barcode:
•SSCC to identify individual Shipper/Carton/Tertiary level packaging uniquely using application identifier (00)
Note: GTIN of shipper level packaging should be different from GTIN of primary and secondary package. Refer to steps mentioned in the ‘Implementation at primary pack’ section for generation of GTIN in 14 digit format.
(01) | The Application Identifier to indicate that the data following it is the GTIN-14 data format. |
08901107000035 | The GTIN of Shipper/Carton/Tertiary level packaging. |
(17) | The Application Identifier to indicate that the data following it is the expiration date of the product in YYMMDD format. |
090400 | The expiration date of the product in YYMMDD format(April2009thiscase) |
(10) | The Application Identifier to indicate that the data following it is batch or lot number of the product. |
ab12345 | The batch/lot number of the product. |
The second barcode represents: | |
(00) | The Application Identifier to indicate that the data following it is the numeric serial number of the Shipper/Carton/Tertiary level packaging. |
189011070000000018 | The18digit numeric serial no. of the Shipper/Carton/Tertiary level packaging. |
Implementation as per DGFT: carton/shipper level-Heterogeneous pack
Homogeneous Packs contain different types of secondary packs
Requirement for homogeneous packs
A GS1-128 barcode encoding
SSCC (Serial Shipping Container Code) to
Identify individual Shipper/Carton/Tertiary
Level packaging uniquely using application
identifier(00)
In the above example
(00) | Is the Application Identifier to indicate that the data following it is the numeric serial number of the Shipper/Carton/Tertiary level packaging. |
189011070000000018 | Is the 18 digit numeric serial no. of the Shipper/Carton/Tertiary level packaging. |
Points to be noted
• Allocate different GTIN for different pack level, i.e.-primary , secondary and shipper package.
• The above barcoding requirements shall be in addition to existing statutory labeling & marking requirements.
• The parentheses (brackets) are not encoded in the barcode and they are represented in human readable form only for highlighting the application identifier number with in the brackets.
• Fixed length data fields will always precede variable length fields.
• It is mandatory to print data encoded in barcodes as human readable information.
• 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 above requirement.
Summary of MoHFW Mandate
Phase I
Packaging level | Requirements | Timeline |
Primary: The first level of packaging indirect contact with the product. Example: a single item such as a medicine strip, a vial etc or group of items for a single therapy such as a Kit. | Incorporation of GS1 barcodes encoding unique product identification code, i.e.-Global Trade Identification Number (GTIN). | (Phase1)– 1st October 2011 onwards |
Secondary: A group of primary packages containing a single item. | Incorporation of barcodes (GS1–128 i. e .1D or GS1 Data Matrix i .e.2D) encoding unique product identification code (GTIN), Expiry Date ,Batch Number | (Phase1)–1stOctober2011onwards |
Tertiary: Shipper/Carton level packaging meant for transport & logistics purpose | Incorporation of GS1- 128 barcode symbology (1D) encoding GTIN of the Shipper/Carton/Tertiary level packaging package, expiry date, batch number of the product and Serial Shipping containers code (SSCC) of the Shipper/Carton/Tertiary level packaging | (Phase1)–1stOctober2011onwards |
Primary & Secondary | Serial isation through the (check previous presentation) | (Phase2)–Not yet decided |
Note: There may be additional intermediate packaging levels between secondary and Shipper/Carton/Tertiary level packaging. These intermediate packaging levels are not required to be barcode at this time. Examples of these exclusions include:
•Inner packs (bundles)
•Intermediate packs (inner case).
Implementation as per MoHFW mandate –
Primary pack
• Get registered with GS1 India to obtain your GS1 Company Prefix (GCP)
• Generate unique GTIN in 14 digit format using your GS1 Company Prefix (GCP) as per the procedure explained in the DGFT section if you are using GS1 Data Matrix.
OR
GTIN-13 format can been coded as EAN-13 barcode
•Encode data in suitable GS1 barcodes (1D: EAN-13,2D:GS1DataMatrix)
GS1 Data Matrix symbology encoding GTIN-14 using
Application Identifier (01)
Acceptable till 31stMarch,2012
Implementation at secondary pack level
Generation of (GTIN) at Secondary Level Packaging:
Refer to steps mentioned in the Implementation at primary pack section’ for generation of GTIN and in 14 digit format
Encoding of GTIN, Expiry Date, Batch number and serial number
A) In GS1 Data Matrix (2D):
(01)08901107000028 (17)090400(10)ab12345
Not more than 48 characters can be encoded In a single GS1–128 barcode. If the total number of characters exceeds 48, it should be split in two barcodes on a single label. |
B) In GS1-128 barcode symbology (1D):
(01) | The Application Identifier to indicate that the data following it is the GTIN |
08901107000028 | GTIN |
(17) | The Application Identifier to indicate that the data following it is the expiration date of the product in YYMMDD format |
090400 | The expiration date of the product in YYMMDD format (April 2009 in this case) |
(10) | The Application Identifier to indicate that the data following it is batch or lot number of product. |
ab12345 | The batch/lot number of the product |
Implementation at carton/shipper level
Allocation of Serial Shipping Container Code (SSCC)
SSCC is used for the unique identification of each Shipper/Carton/ Tertiary level package as a logistic unit.
Steps to generate, SSCC (18 digits shipper identification code):-
• Assign the Extension digit ranging from0-9 to increase the capacity of the Serial Reference within the SSCC
• Use GCP issued by GS1 India or any other GS1 member organizations in other countries
• Generated unique serial reference number to identify each Shipper/Carton/Tertiary level package.
• Calculate check digit using on line Check Digit Calculator available at http://www.gs1india.org.in/calculater.aspx
Implementation at carton/shipper level-Homogeneous pack
Homogeneous Packs contain same type of secondary packs Requirement for homogeneous packs Two GS1-128 barcodes The first barcode contains:
• Product Identification code (UniqueGTIN-14 product code of the Shipper/Carton/Tertiary level packaging) using application identifier (01)
• Expiry Date in YYMMDD format using application identifier (17)
• Batch/Lot Number using application identifier (10)
The second barcode:
•SSCC to identify individual Shipper/Carton/Tertiary level packaging uniquely using application identifier (00)
Note: GTIN of shipper level packaging should be different from GTIN of primary and secondary package. Refer to steps mentioned in the Implementation at primary pack’ section for generation of GTIN in 14 digit format
(01) | The Application Identifier to indicate that the data following it is the GTIN-14 data format |
08901107000035 | The GTIN of Shipper/Carton/Tertiary level packaging. |
(17) | The Application Identifier to indicate that the data following it is the expiration date of the product in YYMMDD format |
090400 | The expiration date of the product in YYMMDD format (April2009thiscase) |
(10) | The Application Identifier to indicate that the data following it is batch or lot number of the product. |
ab12345 | The batch/lot number of the product. |
The second barcode represents: | |
(00) | TheApplicationIdentifiertoindicatethatthedatafollowingitisthenumericserialnumberoftheShipper/Carton/Tertiarylevelpackaging. |
189011070000000018 | The18digitnumericserialno.oftheShipper/Carton/Tertiarylevelpackaging. |
Implementation at carton/shipper level-Heterogeneous pack
Homogeneous Packs contain different types of secondary packs
Requirement for homogeneous packs
A GS1-128 barcode encoding
• SSCC (Serial Shipping Container Code) to identify individual Shipper/Carton/Tertiary level packaging uniquely using application identifier (00)
In the above example
(00) | Is the Application Identifier to indicate that the data following it is the numeric serial number of the Shipper/Carton/Tertiary level packaging. |
189011070000000018 | Is the 18 digit numeric serial no. of the Shipper/Carton/Tertiary level packaging. |
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