DGFT guidelines for Barcoding as per

GS1 Standards: Pharmaceuticals

rm/iib/hyd/050214
 About GS1

Global not- for- profit Organisation

111 Member Organisations / 150 Countries

2 Million Member Companies

24 Industry Sectors

5 billion barcodes scanned everyday

Administer the GS1 System of Standards

2 2014
 GS1 Standards – Building Blocks

1 3
Unique identification Links management
Products Physical flow
Information flow
Logistics units
 Locations & legal entities
 Etc.

Traceability

Data capture Data communication

Bar codes Share data
EPC/RFID Retrieve data

2 4
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 Benefits of Barcoding in Healthcare
Supply Chain
Unit /
Unit dose

Primary
Complexity

Secondary

Case Gradually expand management

of supply chain data and improve
patient safety
Pallet

Interdependence

Automatic Identification Electronic Product Electronic Data Point of Care

Interchange Traceability Applications
4 & Data Capture Catalogue
 Initial DGFT Circular on adoption of GS1
Standards

5
 Summary of DGFT requirements

Packaging level

Tertiary level – definition

Comprises highest level of packaging containing

secondary and other intermediate packages meant for
transport/logistics(cartons/pallets/ shipments)

Secondary level – definition

•Implemented
•Implemented
Packaging level containing primary level packages. •Jan 2013
•April 2015
•Implemented
•October 2011

Primary level – definition

Comprises first level of packaging in direct contact with

the product e.g. medicine strip, vial, single therapy kit,
or items packed in mono carton for sale to consumers.
Primary Secondary Case / Shipper
(Tertiary)

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 Current Packaging Definitions - India

Ambiguity

Primary Secondary Tertiary

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 Recommended Packaging Definition - India

For aligning with global standards, Mono Carton should be treated as Secondary pack

Primary Secondary Tertiary

Primary Secondary Level 1 Secondary Level 2 Tertiary

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 Identification & Capturing at Different packaging levels:

Packaging Level Requirement Illustration

Human Readable Form
Primary • GTIN 14 • GTIN: (01)08901296909652
• Exp. Date: (17)13/06/00
• Exp. date • Batch No.(10)2257258
• Batch no • S. No.: (21)123456
• Serial number

GS1 DataMatrix Symbology for • GTIN: (01)18901296909659

Capturing • Exp. Date: (17)13/06/00
Secondary • Batch No.(10)2257258
• GTIN 14
• S. No.: (21)987456
• Exp. date
• Batch no
• Serial number
OR
GS1 128 Symbology

GS1-128 symbology
• GTIN 14
Homogenous • Exp. Date
• Batch no
Tertiary +
Unique Carton Number (SSCC)

Heterogeneo
us Unique Carton Number (SSCC)
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 Illustration: GTIN-14 Construction at Different
level of packaging

Packaging Data Structure

Level

GTIN - 14 : 0 8901296 90965 2

Indicator Digit Company Prefix Product Codes Check Digit

0 8901296 90965 2
As per the requirement of Assigned By GS1 Product Codes assigned Check Digit generated based
Primary DGFT portal, only “0” can be India by the company on Modulo-10 algorithm
used as an indicator digit

GTIN - 14 : 1 8901296 90965 9

Indicator Digit Company Prefix Product Codes Check Digit
Secondary
1 8901296 90965 9
As per the requirement of Assigned By GS1 Product Codes assigned Check Digit generated based
DGFT portal, only “1” can be India by the company on Modulo-10 algorithm
used as an indicator digit

Tertiary GTIN - 14 : 5 8901296 90965 7

Indicator Digit Company Prefix Product Codes Check Digit

5 8901296 90965 7
As per the requirement of Assigned By GS1 Product Codes assigned Check Digit generated based
DGFT portal, only “5” can be India by the company on Modulo-10 algorithm
used as an indicator digit

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 Data Structure - Primary Packaging Level

Packaging Information Data Structure

Level

(01) Indicates the data following it is GTIN-14

0890129690 GTIN-14 of the Secondary Pack

9652

(17) Expiry Date of the Drug

130600 Expiry date of the drug in YYMMDD format

Primary • GTIN 14
(10) Indicates the data following it is Batch No.
• Expiry Date
Batch Number
2257258 Batch No. of the drug. Alphanumeric 20 digit long
•
• Serial Number
(21) Indicates the data following it is serial number

987456 Serial number of the Drug. Alphanumeric and 20 digit

long

AI GTIN-14 AI Exp.D AI Batch AI Serial No

ate No.
(01) 18901296909659 (17) 130600 (10) 2257258 (21) 987456

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 Data Structure – Secondary Packaging Level

Packaging Information Data Structure

Level

(01) Indicates the data following it is GTIN-14

1890129690 GTIN-14 of the Secondary Pack

9659

(17) Expiry Date of the Drug

Secondary • GTIN 14 130600 Expiry date of the drug in YYMMDD format

• Expiry Date (10) Indicates the data following it is Batch No.

• Batch Number 2257258 Batch No. of the drug. Alphanumeric 20 digit long

• Serial Number
(21) Indicates the data following it is serial number

987456 Serial number of the Drug. Alphanumeric and 20 digit

long

AI GTIN-14 AI Exp.D AI Batch AI Serial No

ate No.
(01) 18901296909659 (17) 130600 (10) 2257258 (21) 987456

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 Data Structure – Tertiary Packaging Level

Packaging Information Data Structure

Level

First Barcode: AI GTIN-14 AI Exp.Date AI Batch No.

(01) 58901296909657 (17) 130600 (10) 2257258
• GTIN 14
• Exp. date (01) Indicates the data following it is GTIN-14
• Batch no 5890129690 GTIN-14 of the Secondary Pack
9657
(17) Expiry Date of the Drug
Tertiary 130600 Expiry date of the drug in YYMMDD format
(10) Indicates the data following it is Batch No.
2257258 Batch No. of the drug. Alphanumeric 20 digit long

Second Barcode: AI SSCC

• Unique Carton
(00) 089012960200000012
Number (SSCC)

(00) Indicates the data following is SSCC

08901296020000 Unique serial number(SSCC) of the number of
0012 the Carton. Numeric 18 digit code

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 Generation of SSCC

SSCC (18 digits shipper identification code ) is used for the unique identification of each Tertiary / logistic level
package.

Steps to generate, SSCC:-

• Extension digit can be any number ranging from 0-9. It provides flexibility to increase the serialization capacity
of the Serial Reference within the SSCC. With each extension digit, you can generate a fresh set of serial
reference numbers.
• Use GCP issued by GS1 India or any other GS1 member organizations in other countries
• Generated unique serial reference number to identify each Tertiary/logistic level package.
• Calculate check digit using online Check Digit Calculator available at http://www.gs1india.org.in/calculater.aspx

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 GS1 Application Identifiers……

• GS1 application identifiers (AI’s) are used to identify the type /

structure of the data following it.
• AI’s related to healthcare sector are as below:-
00 SSCC (Serial Shipping Container Code)
01 GTIN (Global Trade Item Number)
10 Lot / Batch
17 Expiry Date
21 Serial Number

Over 100 AI’s are available as a part of GS1 standards.

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 Data Mapping in Internal Application - Parent
Child Relationship

Tertiary-SSCC Secondary GTIN Secondary Primary GTIN Primary Serial

Serial No No* (As per
future
requirement)

58901296909657 18901296909659 987456 08901296909652 0001

08901296909652 0002

18901296909659 987457 08901296909652 0003

08901296909652 0004

18901296909659 987458 08901296909652 0005

08901296909652 0006

18901296909659 987459 08901296909652 0007

08901296909652 0008

58901296909664 18901296909727 522142 08901296909720 XBI589

18901296909727 522143 08901296909720 XBI595

18901296909727 522144 08901296909720 XBI599

18901296909727 522145 08901296909720 XBI605

16 ©2005 GS1
Barcode Quality
Compliance
 Quality Parameters’: 2D Barcode

Use only GS1 Datamatrix Symbology

X-dimension (mm)
Quiet Zone
Minimum Target Maximum
1X on all
0.255 0.3 0.615
four sides

L shaped Square
finder Symbol
pattern

Human Readable
Format

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 Quality Parameters’: 1D Barcode

 Dimension, GS1-128 Barcode (All Measurements are in mm)

X-Dimension
 Color, (Recommended)
Height Quiet Zones

 Location and 0.250 (Minimum) 12.70 2.5

 Quiet Zones 0.495 (Maximum) 12.70 4.95

X-Dimension: This is width of the narrowest bar or

space in the barcode

Quiet Zone: Quiet Zone refers to the blank margin

on either side (left and right) of barcode

• All measurements mentioned is maximum allowed (mm) considering maximum recommended X dimension
• Please note GS1-128 is different from Code-128 symbology. In case of any questions with regards to generating GS1-128 barcode.

*All dimensions are in mm

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 Barcode Verification

• GS1 provides barcode verification service for 2D and 1D barcodes

• Barcode verification service helps subscribers by verifying the following:

 The format of data encoded

 The order of the data encoded
 The correctness of the data encoded
 Barcode symbology check and scannability

• Will support the Self certification process of subscribers

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 Points to be noted

 Each packaging level, i.e.- primary, secondary and tertiary requires assignment of different
GTIN’s.
 DGFT requirements on barcoding shall be in addition to existing statutory labeling &
marking requirements.
 The parentheses (brackets) of AI’s should not be encoded in the barcode and are meant to
be represented only in human readable form.
 It is mandatory to print data encoded in barcodes as human readable information.
 Please refer to GS1 specifications for further details.
 List of solution providers is available at : http://www.gs1india.org/Support/SolutionProvider

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 Notifications for Supply to Domestic Market

From Madhya Pradesh State Government:

http://www.health.mp.gov.in/tender/mproc-2014/126-ARC-
256%20drugs-14.pdf

From Maharashtra State Government:

https://phd.maharashtra.etenders.in/tpoimages/phd/tender/Tender1147.
pdf

From MoHFW, Government of India:

http://mohfw.nic.in/WriteReadData/l892s/GS1%20barcode%20requirem
ents%20for%20medicines-drugs-49916377.pdf

From National AIDC Control Organisation (NACO), Government of

India:
http://naco.gov.in/upload/Procument/Sept%202012/Amendment_No._2-
Single_Blood_Bags-08-2012.pdf

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Questions?
 Thanks
GS1® India
http://www.gs1india.org
[email protected]