BAR-CODING REGULATIONS FOR HEALTHCARE PRODUCTS IN INDIA

Presented by NERAJA REDDI

Do you know …..

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.

anti-malarial drugs - 'Made In India' - from China

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

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.

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.

Types of barcodes

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.

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-14ITF-14 bar codes can only carry GTINs, can be printed

directly on corrugated cartons, but cannot be used to identify items crossing POS

“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

GLOBAL ROBUST MULTI-SECTOR USER-GENERATED SCALABLE REDUCE COST AND

COMPLEXITY

WHY GS1 SYSTEM

implementation of Barcoding using gs1 global standards

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

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

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

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

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

Primary packaging

(01)08901107000011-GTIN “8901107”- company prefix

number “00001”-item reference number “1”- check digit (21)abcd12345-serial number(1 to

20 digits)

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

Tertiary level packaging

homogeneous

GTIN

SSCC

heterogeneous

SSCC

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

Tertiary level packagingHomogeneous packaging 1st barcode- (01)- GTIN identifier

(17) -YYMMDD

(10)-batch/lot number identifier 2nd barcode- (00) SSCC(Serial Shipping Container

Code)

Heterogeneous packaging

SSCC STRUCTUREExtension 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.

TEN STEPS TO BAR CODE IMPLEMENTATION

1. Get A GS1 Company Prefix2. Assign Numbers3. Select A Bar Code Printing Company4. Select A “Primary” Scanning

Environment5. Select A Bar Code

cont….

6. Pick A Bar Code Size7. Format The Bar Code Text8. Pick A Bar Code Colour9. Pick The Bar Code Placement10. Build A Bar Code Quality Plan

POINTS TO REMEMBER WHILE PRINTING

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