1. BAR-CODING REGULATIONS FOR HEALTHCARE
PRODUCTS IN INDIA
Presented by
NERAJA REDDI

2. Doyouknow…..
Several studies, in different countries, indicate that adverse effects from
medication errors represent a significant problem for Healthcare
worldwide.
 Spain - a study indicated that 9.3% of hospital stays incurred a serious
adverse event, with medication errors being the main cause (37.4% of
such events).
 New Zealand - the Ministry of Health found that each year about 5,000
patients are subject to medication errors. As a result, about 150 patients
die, over 400 are permanently disabled and nearly 3,500 are disabled for
less than one year.
 USA - medical errors in hospitals result in preventable adverse events
with up to 98,000 patients dying each year, which costs the sector
US$138 to 192 billion annually. Medication errors account for 7,000 of
these deaths.

3.  anti-malarial drugs - 'Made In India' - from
China

4. solution
 maintaining the supply chain data right from
the production until it reaches to the patient
 Track and Trace
objective
 increasing supply chain efficiency and, more
importantly, ensuring patient safety

5. BARCODE
 serialization is the process of translating data structures or
object state into a format that can be stored and
resurrected later in the same or another computer
environment
 A barcode is an optical machine readable representation
of data relating to the object to which it is attached.
Originally barcodes systematically represented data by
varying the widths and spacings of parallel lines, and may
be referred to as linear or one-dimensional (1D). Later
they evolved into rectangles, dots, hexagons and other
geometric patterns in two dimensions (2D).
 Barcodes originally were scanned by special optical
scanners called barcode readers.

6. DGFT GS1
 GS1 is an international not-for-profit
association with Member Organisations in
over 100 countries.
 GS1 is dedicated to the design and
implementation of global standards and
solutions to improve the efficiency and
visibility of supply and demand chains
globally and across sectors. The GS1 system
of standards is the most widely used supply
chain standards system in the world.

7. Typesofbarcodes
 EAN/UPC: European Article Number/
Universal Product Code
• Used at POS and in logistics must be printed
larger than the "target" size to accommodate
logistics scanning
 GS1 DataBar
• smaller than EAN/UPC and can carry additional
information such as serial numbers, lot numbers of expiry
dates.

8.  GS1-128 (previously referred to as EAN-128)
GS1-128 (UCC/EAN-128) bar codes can carry
all GS1 Keys and attributes but cannot be used to identify
items crossing PO
 ITF-14
ITF-14 bar codes can only carry GTINs, can be printed
directly on corrugated cartons, but cannot be used to
identify items crossing POS

9. “2D MATRIX”
 GS1 DataMatrix
 symbol of choice for many in healthcare
Because GS1 DataMatrix requires camera based scanners it is
currently specified for healthcare items not crossing POS and
direct part marking
 GS1 QR Code
 restricted for use with applications that will involve imaging
scanners within mobile devices and not for Point Of Sale
(POS) processin

10.  GLOBAL
 ROBUST
 MULTI-SECTOR
 USER-GENERATED
 SCALABLE
REDUCE COST AND COMPLEXITY
WHYGS1SYSTEM

11. implementationofBarcodingusinggs1globalstandards
 Section A : Primary Level Packaging
 Requirement: GS1 DATAMatrix(2D)
GTIN(01) and Unique serial number(21)
 Section B : Secondary Level Packaging
 Requirement: GS1 128(1D)
GTIN, expiry date, batch number & serial number
 Section C : Tertiary Level Packaging
 Reruirements: GS1-128(1D)
 GTIN, expiry date , batch number & SSCC

12. GTIN
GCP(GS1 Company Prefix
Number)
Allocated by GS1 India to
applicant company
ITEM REFERENCE
NUMBER
Assigned by
manufacturer/ brand
owner
CHECK DIGIT
Calculated based on
preceding digits

13. GTIN-STRUCTURE
 The Global Trade Item Number™ (GTIN™) is used for the
unique identification of trade items worldwide. GTINs may be
8, 12, 13 or 14-digits in length. Their data structures require up
to 14-digit fields, and all GTIN processing software should
allow for 14 digits

14. GS1 Company prefix (GCP) number
 The GS1 Company Prefix consists of a GS1 Prefix and
the Company Number both of which are allocated by
GS1 Member Organisations and form the GS1
Company Prefix. In general it comprises six to ten digits
depending on the capacity needs of the company.
 REGISTRATION FORM dully filled and signed along
with the “product classification sheet”.
 Request letter/ forwarding letter
 Copy of audited balance
 PAN card copy of proprietor
 Proof of status of applicant company

15.  Item reference
component of the Global Trade Item Number (GTIN) assigned
by the owner of the GS1 Company Prefix to create a unique
GTIN and is a non-significant number, which means that the
individual digits in the number do not relate to any
classification or convey any specific information. The
simplest way to allocate ItemReferences is sequentially, that is
000, 001, 002, 003, etc.
 Check digit
The Check Digit is the last digit. It is calculated from all
other digits in the GTIN

16. Primary packaging
 (01)08901107000011-GTIN
“8901107”- company prefix number
“00001”-item reference number
“1”- check digit
 (21)abcd12345-serial number(1 to 20 digits)

17. Secondary packaging
 (01) GTIN
 (17) expiry date – format YYMMDD
 (10) BATCH /LOT NUMBER
 (21) serial number of secondary package
(01)08901107000028
(17)090400(10)ab12345
(21)mnop09876
GS1-128 BARCODE
GS1 DataMatrix

18. Tertiary level
packaging
homogeneous
GTIN
SSCC
heterogeneous SSCC

19.  Location and orientation
definite shaped Cylindrical Pouches
 Printer’s devils
 Smudged , crooked or curved bars , bubbles , flecks ,
scratches , etc – reduce scanability
 Modulation and bar width- common errors

20. Tertiary level packaging
Homogeneous packaging
 1st barcode- (01)- GTIN identifier
(17) -YYMMDD
(10)-batch/lot number identifier
 2nd barcode- (00) SSCC(Serial Shipping Container Code)
 Heterogeneous packaging

21. SSCC STRUCTURE
 Extension digit : used to increase the capacity of
the Serial Reference within the SSCC. It is assigned
by the company that constructs the SSCC. The
Extension digit ranges from 0-9.
 GS1 Company prefix : A globally unique number
assigned to a GS1 member company
 Serial reference number : The ‘serial’ part of the
number assigned one-by-one by the member
company to create a globally unique SSCC.
Check digit : A modulo-10 number calculated
across the preceding digits to ensure data integrity.

22. TENSTEPSTOBARCODEIMPLEMENTATION
1. Get A GS1 Company Prefix
2. Assign Numbers
3. Select A Bar Code Printing Company
4. Select A “Primary” Scanning Environment
5. Select A Bar Code

23. cont….
6. Pick A Bar Code Size
7. Format The Bar Code Text
8. Pick A Bar Code Colour
9. Pick The Bar Code Placement
10. Build A Bar Code Quality Plan

24. POINTSTOREMEMBERWHILEPRINTING
 GTIN Colour
13-digit
 Size – reduction of height not advisable
 Print contrast – higher contrast, better scan rate
 Spectral reflectance -
 Quiet zones – space surrounding barcode
minimum space