Authentication Solutions to stop the Scourge of Spurious Medicines

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Authentication Solutions to stop the Scourge

of Spurious Medicines

ASPA Press Event

Lucknow

24th May, 2016


Spurious drugs. –For the purposes of this chapter, a drug shall be deemed to be

spurious, –

(a) If it is manufactured under a name which belongs to another drug; or

(b) If it is an imitation of, or is a substitute for, another drug or resembles another drug

in a manner likely to deceive or bears upon it or upon its label or container the name

of another drug unless it is plainly and conspicuously marked so as to reveal its true

character and its lack of identity with such other drug; or

(c) If the label or container bears the name of an individual or company purporting to

be the manufacturer of the drug, which individual or company is fictitious or does not

exist; or

(d) If it has been substituted wholly or in part by another drug or substance; or

(e) If it purports to be the product of a manufacturer of whom it is not truly a product.

Spurious Medicines: Definition

Drugs and Cosmetics Act, 1940


Scale of the Problem in India

2012 7% of anti-malarials are fake

2014 10.9% of antibiotics and TB

medicines failed basic quality tests

2016 1 in 7 painkillers (diclofenac

sodium) tested found to be

substandard


How Authentication Solutions can Help

Image courtesy: PharmaSecure


Benefits

• Empower patients and increase consumer

confidence

• Give police and drug inspectors a valuable tool to

find counterfeiters

• Increase collection of tax

• Enhance reputation of country’s industry

• Be in line with international standards

• USA, European Union, Turkey, China, South

Korea, etc., all have authentication solution

mandates (“track-and-trace”)


Security Technologies

Authentication

Logical

Cryptographic

Structure analysis

Physical

Printed

Inks/Taggants

OVD / Hologram

Serialization

Identification

Track & Trace

Types of Authentication Solutions

*Use at-least one level of overt authentication *Focus on ethical vendor who provide multi layered security solution instead just one technology *To select technology take help of published standards such as ISO 12931 and NASPO


Case Study: Serialization

Image courtesy: PharmaSecure


By applying an identity to each unit of the

product, the following benefits can be attained:

• Anti-counterfeiting /product authentication

• Loyalty management

• Bundling services with products

• Warranty registration

• Fulfill regulatory serialization mandates

• and many more…

Label on bottle

Code on Rubber (Tyre)

Code printing on medicine blister

Regulatory labelling Label on FMCG product

What is Serialization?


Brand Protection solution to meet the anti-counterfeiting needs

• The solution starts from Coding/Serializing a product right at the manufacturing line to verification of this coded product by the consumer at the time of purchase of medicine.

• The above solution also provides a means of communication with the consumers at a later point of time.

It’s time for

your next

injection of

_________.


How to Serialize

Labels that are pre-printed, branded, with/without added security features (e.g. scratch peel off) which can be applied on the monocartons with available automated industrial grade label applicator systems. Labels will be supplied to brand owners according to his need to be affixed on your consumer packs at your manufacturing / warehousing facility. Depending upon order size, it can be applied manually or with use of industrial grade on-line label application systems.


Direct Printing:

Software can provide encrypted code files directly on printing line which can be decrypted and shared with any printer capable of doing variable printing. The selection of printer is dependent on the parameters like substrate, line speeds, space on the line, any other preferences.

How to Serialize


Regulatory Requirements (DGFT – India)

• A Parent-Child relationship between the Secondary and Tertiary levels be maintained

• Tracking movement of the packages through the supply chain

• The data out of the parent-child relationship shall be uploaded on the central portal of the Government of India by the manufacturer or its designated agency before release of the drugs for sale or distribution


Summary

• Authentication Solutions are a must to curb

spurious medicines

• There are a variety of solutions available, as per

requirement, through member companies of

ASPA

• The Government of India has already taken steps

to protect medicines that are exported

• Now it is time to protect medicines that are being

distributed and consumed within Uttar Pradesh,

and within all of India


Thank You

For more information visit www.aspaglobal.com

Or email at [email protected]

.

Courtesy

http://www.aspaglobal.com/

mailto:[email protected]

Authentication Solutions to stop the Scourge of Spurious Medicines

Health & Medicine

Transcript of Authentication Solutions to stop the Scourge of Spurious Medicines