New weapons in the battle against fake drugs

By Abhai Pandey,Lex Orbis
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C ounterfeiting has become an enigma for the world pharmaceutical trade. Estimated rates of counterfeiting keep varying with the investment and ease to produce counterfeit goods, although it is certain that counterfeiting accounts for a significant component of the global trade.

Abhai Pandey, Partner, Lex Orbis IP Practice
Abhai Pandey
Partner
Lex Orbis

The most obvious effect for a company whose products are being counterfeited is the loss of sales along with the dilution of the brand in the case of niche products. Loss of goodwill is also a factor as consumers generally blame the legitimate manufacturer for lack of quality when they unwittingly buy a counterfeit thinking it to be genuine.

Seizures by customs, law enforcement and test purchases are some ways in which companies become aware that their products are being counterfeited and whether a continuing problem is getting worse.

One of several measures companies can use to reduce the problem is anti-counterfeiting technology. Incorporating anti-counterfeiting technology in the product, packaging or both makes the task of producing a sophisticated counterfeit harder and more expensive.

Overt anti-counterfeit technologies enable consumers to recognize, avoid and report fakes. Covert technologies (undetectable without special equipment) alert companies to counterfeiting activity and also provide essential evidential support before the law enforcement authorities.

Drug counterfeiting

A counterfeit drug has a deceptive representation with regard to its origin, authenticity or effectiveness.

A counterfeit drug may be one which does not contain active ingredients, or a sufficient quantity of active ingredients or contains entirely incorrect ingredients. It is typically sold with inaccurate, incorrect or fake packaging.

The difficulty in detecting, investigating and quantifying counterfeiting has led to technologies that help combat the problem.

Radio frequency identification uses electronic devices to track and identify pharmaceutical products by assigning individual serial numbers to the containers holding each product. Techniques like Raman spectroscopy and energy dispersive X-ray diffraction can be used to discover counterfeit drugs while still inside their packaging.

Bilcare Research, a Pune-based pharma packaging company has done some pioneering work in this area. It lately launched a product to help check the menace of counterfeit drugs. The product has a label with a unique bar code made with nano and fingerprinting technology. The customer can swipe the drug packet in the scanner or at select ATMs to verify the authenticity of the drug. Bilcare has a dedicated R&D section for packaging research, material research, analytical research, drug sensitivity studies and package design and is regularly granted patents.

One of the company’s recently published patent applications – Interactive Smart Package-associated Device for Anti-Counterfeit and Compliance Measures – facilitates detection of the presence or absence of products in the package through a synergistic combination of the product package with the means to generate a signal and an associated device.

In effect, removing a product from the package generates or alters a signal detected by a sensor, thus ensuring user registration and identification, authentication and registration of the package. Interactive capabilities for real time feedback to and by the user and an integrated system linking various user entities ensure effective and secure user compliance.

Loss of value

Counterfeit drugs are a big value destroyer for pharma companies. They also put patient safety at risk.

Pharma companies are using overt measures, such as embedded holograms, and covert measures, like excipients, to fight the problem. The question is whether technology alone is enough.

Secure business practices coupled with technology can be the solution.

Active participation of the people involved in distribution can ensure the integrity of the supply chain by authenticating and tracking products.

Consumer awareness can also prevent counterfeiting. While purchasing a medicine, patients should look for abnormalities in the packaging such as illegible labels and the absence of details such as the manufacturer name, address and licence number, manufacturing and expiry date, improper sealing and difference in colour.

The Organisation of Pharmaceutical Producers of India (OPPI), a premier association of research-based international and large pharmaceutical companies in India, has developed anti-counterfeiting guidelines.

These guidelines establish requirements that facilitate authentication and discourage counterfeiting and recycling of original manufacturer’s packs. OPPI is lobbying the government to form dedicated cells in state Food and Drug Administrations and law enforcement agencies to fight drug counterfeiting.

Abhai Pandey is a lawyer with LEX ORBIS IP Practice, a law firm specializing in intellectual property issues

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