Complying with barcoding requirements of DGFT - GS1 India

Complying with barcoding
requirements of DGFT
1

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)
Secondary level – definition
Packaging level containing primary
level packages. There can be more
then one secondary level in a
packaging hierarchy.
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.
Incorporation of barcodes (1D) encoding
unique product identification code (GTIN),
Batch Number, Expiry Date and Unique Serial
Number (SSCC-Serial Shipping container
code) of the Tertiary pack (shipper/carton).
Incorporation of barcodes (1D or 2D)
encoding unique product identification code
(GTIN), Batch Number, Expiry date and
Unique Serial Number on the secondary pack.
Incorporation of 2D (GS1 DataMatrix)
barcodes on medicines at strip/vial/bottle etc
encoding unique product identification code
known as Global Trade Identification Number
(GTIN) and Unique Serial Number on the
primary pack.
Phase 1 – by
1 st Oct 2011
Phase 2 – by
1 st July 2012
Phase 3 – by
1 st January
2013

Implementing barcodes at primary packaging level
Schematic illustration of GS1 Datamatrix (2D barcode) encoding GTIN and serial
number.
(01)
(01)08901107000011(21)abcd12345 - as example only
Application Identifier to be prefixed before the GTIN of the product SKU/variant/
type
08901107000011 GTIN-14 (14 digit) of the primary pack allocated by the company
(21)
abcd12345
Application Identifier to be prefixed before the unique serial number of the product
SKU/variant/type
Unique serial number of each item of the product SKU/variant/type given by the
company
Notes:
• For very small pack size (e.g. vials and ampoules) where there is a space constraint for printing
barcodes , it is mandatory to mention GTIN and serial number in human readable form.
• Detailed technical guidelines for generation and implementation of GS1 Datamatrix are available
at www.pharmexcil.org
3

Implementing barcodes at primary packaging level
Step 1 - Obtaining GCP (GS1 Company Prefix Number)
GCP is the company prefix number allocated by GS1 to a subscriber company to
uniquely identify its products worldwide. It is used in generation of GTIN and SSCC as
per DGFT requirements. To apply for GCP, log in to:
http://www.gs1india.org/Support/GetRegistered
GCP can vary from 7 to 10 digits based on the number (quantity) of stock keeping units
(SKUs)/product variants/product types subscribed by the company.

Implementing barcodes at primary packaging level
Step – 2
Generating GTIN-14 and serial number for primary packs
a) Generating GTIN-14 for the primary pack
GTIN-14 structure
N1 N2 N3 N4 N5 N6 N7 N8 N9 N10 N11 N12 N13 N14
N1
N2 - N13
N14
Package level indicator. Can vary from 0 to 8 to be allocated by the company at its discretion
GS1 Company Prefix Number (GCP) allocated by GS1 India + item reference number (to be
generated as a random number (numeric only) by the company.
Check digit calculated based on preceding 13-digits (calculator available at
http://www.gs1india.org.in/calculator.aspx)
Example: 0 8901107 00001 1 - (GTIN-14)
0 Packaging level indicator
8901107 GCP allocated by GS1 India
00001 Item reference number generated and allocated for each product type/variant/SKU
by the company (numeric only)
1 Check digit

Implementing barcodes at primary packaging level
b) Generating unique serial number for each primary pack item
It is a variable data structure ranging from 1 to 20 characters which can be alpha-numeric to
uniquely identify each item of a product variant/SKU/product type. The same is to be generated by
the company. It is preceded by Application Identifier (AI) 21.
Note: An AI is a prefix code used to identify what kind of information follows it. These identifiers
are standardised and recognised worldwide.
Schematic representation of unique serial number data structure
Application
Identifier
Serial Number
21 mnop09876
In example above, “mnop09876“ is the unique serial number of the
primary pack preceded by AI 21.
6

Implementing barcodes at Primary Packaging level
Notes:
• It is mandatory to use only GTIN-14 data structure at all packaging levels. GTIN-14 would require
to be preceded with Application Identifier (AI) 01 when representing product code alongwith its
serial number at the primary packaging level and other attribute information as required.
• If GTIN-13 (13 digit GS1 product code) already exists for an SKU/product variant/product type, it
can be converted to GTIN-14 by adding 0 as the preceding digit.
Example : If GTIN-13 of an existing primary pack is “8901107000011”, to convert to GTIN-14, it
would become “08901107000011”
• GTIN-14 at primary level will be different from its GTIN-14 at secondary and tertiary levels.
7

Implementing barcodes at secondary packaging level
Schematic illustration of GS1-128 linear (1D) barcode and GS1 Datamatrix (2D) barcode encoding
GTIN, expiry date, batch number and serial number as per DGFT requirements. Companies can opt
for either the 1D or 2D barcode depending on space availability.
2D- GS1 Datamatrix
1D- linear barcode
(01)08901107000028
(17)090400
(10)ab12345
(21)mnop09876
or
(01) Application Identifier (AI)to indicate that the data following it is GTIN-14
08901107000028 GTIN-14 to be allocated by the company
(17)
AI to indicate that the data following it is the expiration date of the product in
YYMMDD format
090400 Expiration date of the product in YYMMDD format (April 2009 in this case)
(10) AI to indicate that the data following it is batch or lot number of the product.
ab12345
(21)
mnop09876
Batch / lot number of the product generated by the company
AI to indicate that the data following it is the unique serial number of the
secondary pack.
Serial number of secondary pack generated by the company which should be
alpha-numeric and of variable length field varying from 1 to 20 characters
8

Implementing barcodes at secondary packaging level
Notes:
a. Generate GTIN-14 as explained in slide no 5. GTIN-14 at secondary level will be different from
the one at primary and tertiary level. GTIN-14 is preceded by application identifier (01).
b. Expiry date is to be represented after GTIN-14 of the secondary pack. AI (17) is to be used to
denote expiry date. There are two alternative ways of providing expiry date, depending on
whether only the month and year is used or whether date, month and year is used. Examples
of how to represent these two options are as below:
Example:
“090419” - where expiry date is required to be represented with date, month and
year. In this case it is for representing 19 th April 2009.
“090400” - where the expiry date is required to be represented with month and year
only. In this case it is for representing April 2009.
c. It is mandatory to print information in human readable form along with the barcode.
9

Implementing barcodes at tertiary packaging level for homogenous packs
Homogeneous pack contains multiple units of the same SKU/product variant/product type
DGFT requirement: Two separate linear barcodes on the label as per details below:
1. First barcode - with GTIN-14, expiry date and batch number following GS1-128 symbology
2. Second barcode – with serial shipping container code (SSCC) following GS1-128 symbology
.
Label for tertiary
packaging
First barcode
First barcode
(01) Application Identifier (AI) to indicate that the data following it is the GTIN-14 of the tertiary pack
08901107000035 GTIN of the tertiary pack generated by the company using the GCP allocated to it
(17) AI to indicate that the data following it is the expiry date of the product in YYMMDD format
090400 Expiry date of the product in YYMMDD format (April 2009 this case)
(10) AI to indicate that the data following it is batch or lot number of the product.
ab12345
Batch/lot number of the product allocated by the company (1 to 20 digits in alpha-numeric format)
Second barcode
(00) AI to indicate that the data following it is the SSCC of the tertiary pack.
189011070000000018
Second barcode
SSCC number of the tertiary pack (18 digit numeric) generated by the company using the GCP
allocated to it.
10

Implementing barcodes at tertiary packaging level for heterogeneous packs
Heterogeneous pack contains multiple units of the different SKUs/product variants/product types
DGFT requirement:
One linear barcode representing SSCC of the tertiary pack on the
label as below:
(00)
189011070000000018
AI to indicate that the data following it is the unique serial
number of the tertiary pack in SSCC format.
SSCC (18 digit numeric number) of the tertiary pack generated
by the company using the GCP allocated to it
11

Implementing barcodes at tertiary packaging level
Generating SSCC for both homogenous and heterogeneous packs using “89011070000000018” as
an example:
Extension digit Global company prefix (GCP) number Serial number Check digit
1 8901107 000000001 8
Notes:
1 Extension digit - can be any number ranging from 0-9. It provides flexibility to increase
the serialisation capacity of the SSCC. With each extension digit, a company can
generate a fresh set of serial numbers.
8901107 GCP of the company allocated by GS1 India or by any other GS1 organisation
worldwide.
000000001 Serial number of the tertiary pack generated by a company.
8 Check digit calculated using check digit calculator available at
http://www.gs1india.org.in/calculator.aspx
12

Important general notes
• Each packaging level (primary, secondary and tertiary) requires generation of different GTIN for it.
• DGFT requirements on barcoding are 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 as well.
• Detailed technical specifications for generation of barcodes and GS1 numbers using are available at
http://www.pharmexcil.org.
• DGFT notification allows exemption from the stipulated barcoding requirements in the event of specific
requirement of the Government/Regulator only in the importing country. Such exemption is not
available for importer/buyer requirements.
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