Counterfeit: An imitation of a document, product or its packaging that is made with the intent to deceptively represent the item as the genuine article.

According to the trade related aspects of the Intellectual Property Rights (The trips agreement), "counterfeit trademark goods" shall mean any goods, including packaging, bearing without authorization a trademark which is identical to the trademark validly registered in respect of such goods, or which cannot be distinguished in its essential aspects from such a trademark, and which thereby infringes the rights of the owner of the trademark in question under the law of the country of importation”

In pharma industry, counterfeit drugs include any fake or substandard medicine that is below the FDA’s established standards of quality but hide this fact. Counterfeit drugs can be any, or all, of the following things:

Fact: Counterfeit drugs are not limited to brand-name prescription drugs. Counterfeiters also create fake versions of generic and over-the-counter (OTC) drugs.

  • Too strong or too weak
  • Missing key ingredients
  • Made with dangerous ingredients
  • Contaminated with foreign, even toxic, materials
  • Made in unsanitary or unsterile conditions
  • Created using unsafe standards
  • Improperly labeled, stored or handled
  • Expired (out-of-date)

From https://www.safemedicines.org/frequently-asked-questions

Ans: In layman language, the making of an imitation, copy of forgery of a genuine document, card, product, label or package with the intention to deceive or defraud is counterfeiting

A: According to the Indian Penal Code, a person is called a counterfeiter when he is she causes one thing to resemble another, intending by means of their resemblance to practice deception or knowing it to be likely that the deception will be practical.

A: It is important to identify the type of counterfeiting threat prior to selecting or developing effective countermeasures.

Types of counterfeiting (Adapted from (Spink, 2009b , Spink, 2007 ))
Term Definition
Adulterate A component of the legitimate finished product is fraudulent
Tamper Legitimate product and package are used in a fraudulent way
Over-run Legitimate product is made in excess of production agreements
Theft Legitimate product is stolen and passed off as legitimately procured
Diversion The sale or distribution of legitimate product outside of intended markets
Simulation Illegitimate product is designed to look like but not exactly copy the legitimate product
Counterfeit All aspects of the fraudulent product and package are fully replicated

Note: In each case, fraudsters may not be following the regulatory definitions of Good Manufacturing Practices (GMPs), Good Agricultural Practices (GAPs), or Good Hygiene Practices (GHPs).

Another important distinction for each type of product counterfeiting is that products could be deceptive or non-deceptive. Deceptive counterfeit products are presented in the marketplace as being genuine with the intent to deceive the purchaser. Non-deceptive counterfeit products are presented in the marketplace as counterfeit or fraudulent with no intent to deceive the purchaser (for more information see (OECD, 2007a) or (Spink, 2011)). Non-deceptive counterfeit products are marketed to consumers who seek counterfeit products such as apparel and luxury goods. Effective countermeasures must evaluate whether consumers are intending to buy genuine or counterfeit products. From https://crimesciencejournal.springeropen.com/articles/10.1186/2193-7680-2-8

A: The spread of counterfeiting is far and wide, and ranges from counterfeit automobile and aerospace parts to fake luxury items. The trade in counterfeited goods is worth a whopping $462 billion (£321bn) a year, according to the most recent figures from the OECD and the EU’s Intellectual Property Office, with a 2017 report predicting it could hit an astonishing $2.3 trillion (£1.7 trillion) by 2022. As per OECD, the top 10 most counterfeited goods in 2016 include;

  • Footwear
  • Clothing
  • Electrical Machinery
  • Leather Articles
  • Watches
  • Instruments, optical and medicals
  • Perfumes and cosmetics
  • Toys
  • Pharmaceutical
  • Jewellery

In past, luxury items tend to be the most counterfeited products because they are more valuable, but, today the list is not limited to any specific products as its is available in almost all sectors including most of the day to day items used such as automotive components, tobacco, FMCG products etc. etc.

A: Counterfeiting activities are heavenly bleeding all the sectors. While many counterfeit products only cause economic losses to brands and authorities, there are many reported cases of counterfeit goods causing health and safety problems, which, in some cases, have led to serious injuries and / or death – especially in products related to baby food, pharmaceuticals and automotive parts.

A: While some counterfeit are nearly indistinguishable to the legitimate product, many counterfeit leave visual clues or have physical traits that can help you judge whether or not the product are real. When ever you buy a product, it is advisable to take care of basic characteristics, including its appearance, texture, reactions and packaging. In case of pharmaceutical products, you can also check the expiry date, compare the medicine you receive with what it is supposed to look, taste and feel like. When comparing packaging, look for differences in paper, printing, color, and fonts (i.e., is it the same size, raised print, embossed, etc.).

A: There are a wide variety of technologies available today that support brand protection strategies. These technologies are applied in the three main areas of anti-counterfeiting, anti-tampering, and tracking and tracing.

  • Anti-Counterfeiting: The common feature of anti-counterfeiting technologies is that they assist in identifying a product as suspect. Some anti-counterfeiting technologies go further, however, and allow a product to be verified as genuine.
  • Anti-Tampering: Found more in the food and pharmaceutical industry that in the electrical industry, anti-tampering technologies are used to protect a product from adulteration or replacement. An anti-tampering device that is intact a product is a sign that the product is likely to be genuine.
  • Tracking and Tracing: Tracking and tracing technologies are used to determine where and when a product (taking its components into account) was manufactured, when it has been and when, and its current status in the supply chain. Some technologies allow for determining where a product is supposed to go. Thus, tracking and tracing technologies are used to fight unauthorized distribution, which is frequently linked to counterfeiting.

A: Many countries have regulations requiring anti-counterfeiting and serialization which needs to be addressed by Brand Owners, e.g. India, USA, EU, Turkey and Russia. For example, the global pharmaceutical industry is moving towards a serialized world, the program will help in evaluating all the available options required to ensure regulatory compliance, protecting supply chain and keep track of their products. We have designed our program in a such a manner that it will help delegates in understanding the entire eco-systems in-depth. Secondly, ISO is going to published new standards on tamper verification features for medicinal product packaging. Our members and expert speakers can help delegates in understanding all these requirements.

The new EU Customs Regulation (608/2013) came into force on January 1 2014. In a careful and evolutionary approach, the new regime aims to: • establish a mandatory procedure for the destruction of infringing goods without the need for a court order; • stem the rising flood of postal and courier traffic of counterfeit goods which has resulted from the increase in online sales; and • expand the range of IP rights which rights holders can invoke in customs enforcement procedures