Fighting Counterfeit Drugs - Pharmaceutical Solutions
Counterfeit drugs became a nuisance for pharma companies causing
drug recalls, liability suits, and jeopardizing brand loyalty as consumers
perceive added risks while employing a company’s product. the most important risk is for consumers as most of those fake medicines contain either
adulterated active ingredients which will put the patient’s lives in peril or entirely inert materials like chalk or cornstarch rendering the
medicines completely inactive. Further, these fake drugs are reprocessed in an
unhygienic environment and stored at temperatures without considering the
drug’s stability which again threatens the well-being of patients.
To circumvent the risks along side ensuring patient safety, pharma
manufacturers are arising with numerous proficient anti-counterfeit strategies.
The contemporary methods to combat counterfeiting include legal actions on
illicit traders, countermeasures using technologies, consumer education and
awareness, private investigations, and cooperation with enforcement agencies.
Current global approaches for tackling counterfeit
drugs
Counterfeiters pay special attention to the
packaging of faux drugs to facilitate their insertion into the legitimate drug
supply chain. that's why a majority of the present anti-counterfeit measures are aimed toward drug
packaging. a number of these are described here:
• Tamper-evident/tamper-resistant packaging
– it's used as an indicator to supply visible or audible proof to consumers
that interference with the merchandise has occurred.
• Product Authentication – Unique features like overt (holograms, colour-shift inks) or
covert (embedded images, digital watermarks, invisible printing), or forensic
(chemical and biological tag, micro-taggants) are embedded either on the dose
or on the packaging of the medicines. Holograms can combine 3-layer security measures . one hologram provides overt first-line
authentication while covert features like scrambled images, microtext,
UV-sensitive, or other specialised inks provide second-line authentication. The
serialisation of holograms (e.g. binary encrypted holograms, light diffraction
hologram elements during a product label, or a mixture of a hologram, 2D data-matrix, and
thermal monitoring) offers authentication with traceability.
• Track & Trace (T&T) technology –
T&T is currently leading the battle against the rising menace of the
counterfeit drug market and has been made a compulsory requirement by several regulatory bodies
across the planet . It assigns a singular identification code to every stock unit during manufacturing which is
maintained throughout the availability chain until its consumption and may be accessed easily on a secure database.
This technology includes pedigree (paper document or electronic file that
records the small print of the distribution of a prescription from its manufacture through wholesale
transactions), mass serialisation (uniquely identifies every entity and ensures
the absence of counterfeits), Global Trade Item Number (GTIN), serialised
Global Trade Item Number (sGTIN) and data carriers. With the help of those technologies, the drugs within the supply chain are often certified as legitimate by the govt authorities.
A glimpse of the various anti-counterfeit initiatives worldwide
• Following 2016, signature DNA marker packaging
materials are to be adopted over digital coding, to deliver efficient
anti-counterfeiting for pharmaceutical tablets as they supply more encryption. Four years
post-enactment, the USA Drug Supply Chain Security Act (DSCSA) imposes that the
drugs must be serialised by manufacturers at the sealable unit and case level.
• Mobile Authentication Service may be a NAFDAC (National Agency for Food, Drug,
Administration, and Control) program in Nigeria supported by BIOFEM
pharmaceuticals where Sproxil technology enables any consumer to verify the
authenticity of a medicine with an easy text message. GSK together with NAFDAC applies this service for the
authentication of antibiotic Ampiclox™.
• The Malaysian Ministry of Health introduced
the “Meditag” holographic authentication sticker in 2005 to ensure the authenticity of registered
medicines.
• The French Health Products Safety Agency
notified the distributors mandating replacement of ‘13 character CIP (Club
Inter Pharmaceutique) code with the batch number, expiry date, and Simplex
linear barcode’ with 2D data matrix marking.
• As archived within the Canadian Consensus Statement, 2009, 2D
bar codes on the first package and 2D or linear barcodes on the secondary package,
both including GTIN and therefore the lot number were made mandatory. As of
2017, the Universal Product Code project is in Phase 4 of development.
• The Directorate General of Foreign Trade,
India issued a public notice in 2011, stating that exported pharmaceutical
products must be equipped with T&T capability using barcode technology as
per GS1 global standards. A 2D barcode must be maintained at the first level packaging, 1D or 2D on the
secondary level and 1D at the tertiary level encoding the GTIN code, batch
number, expiry date, and serial number of respective packaging.
Country-wise details
of measures undertaken to combat counterfeit products
|
Country |
Legal framework
involved |
Border measures (detention by customs) |
Criminal
prosecution (duration of
imprisonment and fine) |
|
India |
·
Trademarks Act 1999 ·
Indian Penal Code 1860 ·
Drugs & Cosmetics Act 1940 |
Not
defined |
6
months-3 years; $765-$3,060 |
|
USA |
·
Lanham Act (codified at 15 USC § 1051) ·
Trademark Counterfeiting Act 1984 (codified at 18 USC § 2320) |
5-7
business days |
10-20
years; $2-$5 million |
|
Canada |
·
Trademarks Act (RSC 1985, c T-13) ·
Copyright Act (RSC 1985, c C-42, as amended) ·
Criminal Code (RSC 1985, c C-46) |
10
working days |
5
years; C$1 million |
|
UK |
·
Trademarks Act 1994 ·
The Frauds Act 2006 and the Proceeds of Crime Act 2002 |
10
days and 3 days for perishable goods |
Not
defined |
|
China |
·
Civil code ·
Tort law ·
Criminal Law ·
Product Quality Law and the Anti-unfair Competition Law |
3
working days |
$7250 |
|
France |
·
EU Customs Regulation 608/2013 (amended by IP Code) |
4
business days |
3
years (or 7); €300,000 |
|
Brazil |
·
Industrial Property Law (9,279/96) ·
Copyright law (9,610/98) ·
Software law (9,609/98) ·
Internet law (12,965/14) |
10
working days |
3
months -1 year or 2-4 years + fine |
Conclusion
As the technologies are becoming smarter, counterfeiters also are devising new ways to beat the
anti-counterfeit techniques employed by the regulatory bodies and therefore the pharma companies. However, with the
increasing use of T&T and serialisation systems along side the implementation of other counterfeit
detection methods, we will certainly hope to curb the threat of faux medicines.
References
Comments
Post a Comment