Pharmaceuticals


 


SDI’s SpectraSure™ technology has a vast array of applications. It is safe for pharmaceuticals, supplements, foods, and cosmetics. With SpectraSure™, you can feel confident knowing your product is impossible to counterfeit.

The Problem

A counterfeit medicine is one that has been deliberately and fraudulently produced and/or mislabeled with respect to identity and/or source to make it appear to be a genuine product. Counterfeit products include drugs with no active ingredient, drugs that are super potent, and drugs with dangerousimpurities. (Source: Pharmaceutical Security Institute)

 

Pills
Harmful ingredients found In counterfeit medicines have included boric acid, leaded highway paint, floor polish, heavy metals, nickel, arsenic, and brick dust.

 

Counterfeit pharmaceuticals represent a violation of intellectual property rights and a serious public health risk. The World Health Organization (WHO) estimates that roughly 10 percent of the worlds’ pharmaceuticals may be counterfeit or substandard, with some regions of the developing world with far higher rates. Even in Europe and the United States, counterfeit drugs are increasingly entering the supply chain, particularly via internet sales. These drugs at best will not deliver the therapy they promise and at worst can endanger patients’ lives. Thousands of people, many of them young children, have lost their lives because they failed to receive needed treatment when they unknowingly took counterfeit drugs.

 

The Solution

 

The World Health Organization (WHO) has issued the following guidelines for governments of each country to show political will/commitment for evolving and implementing programs for combating counterfeit medicines. Political will and commitment should be demonstrated by:

 

  1. Enacting new drug laws or updating existing drug laws for prohibiting counterfeit medicines;
  2. Establishing institutions for the regulation of medicines and clearly setting out in the drug laws, the power, duties and responsibilities of the institution(s);
  3. Training of personnel, including enforcement officers, for national drug control;
  4. Making available necessary financial and other resources;
  5. Ensuring that the drug laws are enforced; and
  6. Fostering international cooperation in the control of pharmaceuticals and entering into bilateral and multilateral agreements with other governments and with international organizations such as WHO, Interpol, and the World Customs Organization (WCO).

 

While these are noble goals, the fact remains that the responsibility lies at the manufacturers’ doorstep, along with their chosen supply chain and distribution systems. Efforts to combat counterfeit pharmaceuticals to date have largely focused on making the product packaging difficult to copy. However, in many places, drugs are not sold in their original packaging, and counterfeiters have become very adept at imitating even the most sophisticated packaging.

 

Pharma Mfg
What is needed is a solution that becomes a part of the drug itself, making it impossible to separate the authentication process from the end product. SpectraSure™ is a non-organic taggant unique among covert and overt security markers in that it is impossible to reverse-engineer due to the underlying physics and the proprietary manufacturing processes. Even using sophisticated mass-spectrometry or nuclear magnetic resonance spectroscopy, counterfeiters cannot discern and duplicate the mark. Unlike many other taggants, SpectraSure™ can be incorporated into the product, applied to the product (and its packaging) and can be authenticated in real time, on-site, and on-demand. There is no need for long lead-time and costly laboratory analysis. The SpectraSure™ readers authenticate the mark in milliseconds.

The SpectraSure™ taggant does not decay over time, can be encoded for specific and targeted tracking activities, and can withstand environmental extremes far in excess of the item marked.  It is consumable

 

Implementation

 

The pharmaceutical production process involves a wide variety of sophisticated and costly equipment. No two fabrication lines will be identical. However, there are common themes within the manufacturing and supply chain. The SpectraSure™ system can be integrated into:

 

  • The manufacturing process by directly incorporating the SpectraSure™ taggant
    into the drug itself;
  • The supply chain anywhere pharmaceuticals are inspected and tested, includingdistributors and authorized sources;

 

Integration of SpectraSure™ is performed without disruption or down-time to manufacturers or distributors.


Whether you require complete operation and maintenance of your SpectraSure™ system, supply of SpectraSure™ taggant and readers, or a tailored approach, the SDI team can help. For more information and to initiate the SpectraSure™ process, contact us directly using any of our convenient methods.