- Are a major problem for public health;
- Are a threat to the pharmaceutical industry;
- Are a problem for the regulatory organizations, since they have to develop updated regulation to combat this scourge.
These counterfeit products did not appear suddenly. Rather, these counterfeit products appeared gradually.
A half dozen small factories started operating illegally in a place somewhere in the world. These small factories established "strategic partnerships" with firms operating in clandestine distribution sector worldwide.
Initially, when this "innovative activity" was still a novelty, these "entrepreneurs" had room to expand their businesses and prosper. In fact, the "entrepreneurs" who had better "strategic vision" enriched at the expense of innocence, ignorance and poverty of many populations, lack of preparation of authorities and police organizations and absence of regulation, at an early stage.
At a later stage (already more developed) a "new emerging sector" began to take shape. New "challenges" were put to the "sector". These "brilliant entrepreneurs" with greater greed and greater "strategic vision" have applied some of their profits by reinvesting in the expansion of their "highly innovative business" thus becoming owners of small empires within a "new emerging sector".
Meanwhile, since the Internet was in frank expansion, these "visionary entrepreneurs" have taken another step towards the "innovation": they decided to extend their business to the Internet through illegal practices of misleading advertising, email spam and illegal sales.
New generations have placed their eyes on these "brilliant examples to follow". Therefore, these new generations, with studies in accounting, business, management, international trade, economics, macroeconomics, marketing and advertising (and more) gave wings to their "highly refined entrepreneurial spirit" and started their business in this "sector already in consolidation".
In fact, counterfeit medicinal products in general and counterfeit drugs in particular are today a serious challenge to FDA and their similar regulatory organizations.
In addition to this serious problem, FDA and their similar regulatory organizations are now working on regulatory affairs regarding nanotechnology in general, nanotechnology-enabled drugs and nanotechnology-enabled foods & beverages.
However, for a strong and effective regulation in this matter, adapted to real needs of our society, several programs are currently being implemented.
One of these programs is a collaborative platform with several specialized players. Among these several specialized players are R&D institutions, universities and specialized laboratories operating in nanocharacterization.
In fact, I strongly believe that much more laboratories of nanocharacterization are needed urgently. These laboratories are, by excellence, the players that have the capability of characterize all and every existing nanoengineered nanoparticle – a first step for risk monitoring and risk assessment.
However, the highly qualified scientists and staff operating at these nanocharacterization laboratories, as well as their facilities and equipment, are also capable of counterfeit detection. In fact, nanocharacterization laboratories have the capability of determining if unknown, suspect or under investigation samples of drugs or other medicinal products are counterfeit or not.
Ironically, nanotechnology, while putting FDA and similar organizations challenges of unique dimensions throughout History (in what concerns to toxicity), it also provides solutions to solve some of the challenges they are facing: counterfeit medicinal products and drugs.
Therefore, more nanocharacterization laboratories are needed urgently due to the following reasons:
A half dozen small factories started operating illegally in a place somewhere in the world. These small factories established "strategic partnerships" with firms operating in clandestine distribution sector worldwide.
Initially, when this "innovative activity" was still a novelty, these "entrepreneurs" had room to expand their businesses and prosper. In fact, the "entrepreneurs" who had better "strategic vision" enriched at the expense of innocence, ignorance and poverty of many populations, lack of preparation of authorities and police organizations and absence of regulation, at an early stage.
At a later stage (already more developed) a "new emerging sector" began to take shape. New "challenges" were put to the "sector". These "brilliant entrepreneurs" with greater greed and greater "strategic vision" have applied some of their profits by reinvesting in the expansion of their "highly innovative business" thus becoming owners of small empires within a "new emerging sector".
Meanwhile, since the Internet was in frank expansion, these "visionary entrepreneurs" have taken another step towards the "innovation": they decided to extend their business to the Internet through illegal practices of misleading advertising, email spam and illegal sales.
New generations have placed their eyes on these "brilliant examples to follow". Therefore, these new generations, with studies in accounting, business, management, international trade, economics, macroeconomics, marketing and advertising (and more) gave wings to their "highly refined entrepreneurial spirit" and started their business in this "sector already in consolidation".
In fact, counterfeit medicinal products in general and counterfeit drugs in particular are today a serious challenge to FDA and their similar regulatory organizations.
In addition to this serious problem, FDA and their similar regulatory organizations are now working on regulatory affairs regarding nanotechnology in general, nanotechnology-enabled drugs and nanotechnology-enabled foods & beverages.
However, for a strong and effective regulation in this matter, adapted to real needs of our society, several programs are currently being implemented.
One of these programs is a collaborative platform with several specialized players. Among these several specialized players are R&D institutions, universities and specialized laboratories operating in nanocharacterization.
In fact, I strongly believe that much more laboratories of nanocharacterization are needed urgently. These laboratories are, by excellence, the players that have the capability of characterize all and every existing nanoengineered nanoparticle – a first step for risk monitoring and risk assessment.
However, the highly qualified scientists and staff operating at these nanocharacterization laboratories, as well as their facilities and equipment, are also capable of counterfeit detection. In fact, nanocharacterization laboratories have the capability of determining if unknown, suspect or under investigation samples of drugs or other medicinal products are counterfeit or not.
Ironically, nanotechnology, while putting FDA and similar organizations challenges of unique dimensions throughout History (in what concerns to toxicity), it also provides solutions to solve some of the challenges they are facing: counterfeit medicinal products and drugs.
Therefore, more nanocharacterization laboratories are needed urgently due to the following reasons:
- Fight against counterfeiting of everything or almost everything (namely counterfeit medicinal products and counterfeit drugs);
- Operating in tight collaboration with regulatory organizations in the scope of risk assessment and risk monitoring.
Therefore, nanotechnology provides simply the best technological tools to fight against counterfeit medicinal products and drugs.
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