It is vital for the pharma manufacturers to invest in anti-counterfeit and anti-tampering measures. It increases customer trust in their products and results in increased market share. Additionally it also results in regulatory compliances.

Tamper evident packaging indicates and alerts the user if a drug has been tampered with in any form and stage before the drug has reached the end-user. The tampering can take form any shape and include:

· Opened container.

· Adulteration of a pharma product.

· Any damage caused to its packaging.

To prevent tampering with the medicine, the packaging is designed in a way that cannot be corrected or converted to the default form. It also enables the user to detect tampering as the tampering evidence cannot be hidden. Restoring packaging can only be carried out in the manufacturer’s facility. 

Anti-counterfeit packaging is also specialized packaging that prevents the manufacturing of unauthorized products of the drugs. These products contain specialized safety features that can only be created or applied at the manufacturing facility. These unauthorized productions are sub-standard products manufactured with the intent of earning money or damaging the manufacturer’s reputation. 

Commonly counterfeit products involve labels with wrong information showing incorrect drug ingredients. Anti-counterfeit packaging includes unique features and uses the latest technology that cannot be copied or reproduced in any facility except in the manufacturer’s facility.             

Consequences of Tamper and Counterfeit Products

There are various consequences of tampering and counterfeit pharma products that can affect both the manufacturers and the users. It only benefits the producer of these tampered with and fake products.

There are un-limited hazards and harmful effects of these tampered with and counterfeit products. Some of them are briefed below.

Punishment by Regulatory Bodies

It is the responsibility of the drug manufacturers to adopt effective measures that prevent tampering and counterfeit of its medicines and products. Medical supplies manufacturers are also responsible for developing resources to implement these features.

If the manufacturer fails to implement Tamper evident and anti-counterfeit features for its products, regulatory bodies can issue a warning letter, impose a fine, or shut down its operations. Regulatory bodies impose these types of strictness because they have failed to implement such safety measures for their medicines in their respective markets.

Damage to manufacturer’s reputation

Tampered and Counterfeit products significantly damage the manufacturer’s reputation, which costs them to lose valuable market share against their competitors. The user loses confidence in the manufacturer’s ability to produce quality medicines, and its effect can be felt for a more extended period. It also establishes a wrong impression in the mind of its customers about poor quality processes and equipment being used in the manufacturing facility.

Once the manufacturer is affected by all these factors and loses its position in the market, it is quickly replaced by its competitors. It can take days, sometimes months, to take back its market share if the manufacturer loses its share.

Adverse effects on end user and patients

The end-user is the most affected party due to tampering with counterfeit products. These medicines can result in severe effects on the patients' health and even cause life-threatening consequences. Some treatments and drugs are used as life-saving, and they are vital for the patients for their health and even life. It can also delay their healing or recovery process by taking longer than usual.

Packaging to prevent tampering and counterfeiting

The latest innovation, research, and technology have greatly helped the pharmaceutical industry players produce products that qualify for the patient health and regulatory requirements. Additionally, it has also helped the pharma products manufacturers to add security and reliability to their products, and one of the fields is anti-tampering and anti-counterfeiting.

There are various ways for the manufacturers to choose from to prevent tampering and counterfeiting. However, we will only focus on packaging and what different packaging solutions are available to avoid these issues and problems.

Tamper Evident Labeling

Tamper evident labels are specialized labels showing visible proof that the label had been tried to remove, change, or be disturbed. They are pasted to make it difficult for anybody to remove or open. They can only be open by self-damaging, simultaneously showing visible signs.

The label cannot be converted into its default condition, nor can its tampering be made hidden.  

The end-user or patient must remove or damage the label before opening the container or pack.

A properly intact label indicates that the product packaging has not been open, showing the product’s authenticity inside the pack. The product inside the pack can be utilized for human consumption.

 On the contrary, if the label is not intact or is damaged in any form, it indicates that the product packaging has been opened, and there is a chance that there has been something wrong with the product inside. The product inside the pack can be dangerous for human consumption.

There are different types of tamper-evident labels; some of them are mentioned below.

Hidden Message: In this type, when the label is removed, a secret message shows up. The warning message indicates that the product has been tempered and alerts the user not to use it. A typical example of a hidden warning message is “Void,” which appears when removed.

Fragile Labels: These labels are made up of fragile materials that can be destroyed when tried to remove. Fragile materials prevent the removal of labels in the whole piece, so they cannot be applied again after tampering with the product.

Destructive Labels: these labels destroy the upper part of the packaging material or mark when the label is removed. These marks are difficult to remove from the packaging, or the packaging material cannot be replaced or corrected.

Serialization and Track & Trace

Serialization is the method of providing a unique identity to each packed pharma product. The unique Identity cannot be duplicated or produced except at the manufacturing facility. The unique Identity can only be allocated or created at the manufacturer’s site to track the pharma product throughout the supply chain life cycle until it reaches its intended user or the patient.

The advantage of serialization is that since the unique Identity can only be generated at the manufacturer site, it requires specialized software and machinery. For this reason, it is not possible to generate fake Identity

 The unique Identity is associated with each product produced and contains vital information such as the date of manufacturing and the product's Expiry Date. The data associated with the unique Identity cannot be erased, deleted, or changed. Additionally, the unique Identity can only be read by specialized readers called Scanners. These scanners display the information associated with unique identifiers.

Serialization allows the manufacturer to track every activity of product produced by them. It records every point that a product has passed before it reaches the patient or the end-user. The data is stored in a database system with access to the authorized personnel to analyze and derive the results.

Tamper Evident Tape

Tamper evident tapes are applied to the sealed packs or boxes. These tapes prevent the opening of the pack or box. Otherwise, it clearly indicates if it is attempted to change or alter. These tapes are designed with specialized design or features so that the tapes cannot be reproduced and prevents replacement. When the pack or box is open, the tape must be broken or damaged.

These tapes are commonly used during moving pharma product cartons or boxes from one section to another. This is also helpful during the transportation of pharma products.

Tamper evident tapes can withstand different temperature ranges, which the pharma product often faces, such as Hot and Cold temperatures. These tapes cannot be removed automatically due to any temperature change. Another important feature is that these tapes also show evidence of tampering if attempted to break by any means such as heating or freezing.

Shrink Wraps

Shrink wraps decrease in size when heat is applied to them and take the shape of the applied surface. Shrink wraps are one of the effective anti-tampering methods for the pharmaceutical industry.

The shrink wrap is wrapped around the cap and the part of the body container. When heat is applied, it seals the surface. The sealed surface cannot be used, opened, or tampered with without removing and damaging the seal. The seal material consists of a distinctive design that cannot be reproduced or replaced.

If the seal is damaged or not present, the product has been tampered with, and it is not safe to use it.

Breakable Caps

Breakable caps are specialized caps that break away a portion of the cap to open to use the container. A broken cap indicates the tampering of the pharma product and alerts the user before using it.

Breaking away does not put the cap away. Instead, the cap remains on the container neck, and the container can be easily opened and closed through the cap after it is first opened for usage.

When the cap is broken, it cannot be changed back to its original condition, nor can the cap be corrected. Additionally, breakable caps require specialized machinery to apply them, making them impossible to duplicate.

About the Author:

Muhammad Asim Niazi has a vast experience of about 11 years in a Pharmaceutical company. During his tenure he worked in their different departments and had been part of many initiatives within the company. He now uses his experience and skill to write interested content for audiences at PharmaSources.com.