- Counterfeit medicines cause between 300,000 and one million deaths annually worldwide.
- During 2021, 5,987 incidents of pharmaceutical crime were recorded globally.
- NOM 059-SSA1-2015 refers to good drug manufacturing practices.
Counterfeiting of medicines is a very serious issue with great consequences. But although it is an illegal business, the work of the authorities to end this problem is minimal. In addition, it not only implies economic losses but also puts the integrity of the people who consume them at risk.
First of all, for the development of any drug it is necessary to follow an extensive and complex process. It starts from research and preclinical tests to verify its correct operation. In most cases, at least 10 years and million-dollar investments are required to reach the final stretch.
On the other hand, of each project that begins only a minimum amount reaches a correct conclusion. Most fail at some intermediate stage, and some even work for a different disease than the one they were originally created for.
Counterfeit medicines continue to rise
However, according to the World Health Organization (WHO), 10 percent of the drugs sold globally are bogus. But the most serious thing is everything that this seemingly insignificant action can generate.
Counterfeit medicines cause between 300,000 and one million deaths annually worldwide. The reason is because they do not contain the correct doses or are manufactured with materials of dubious origin. While on the economic level it is estimated that the black market for illicit medicines generates profits of 150 million dollars a year.
For his part, he Institute of Pharmaceutical Safety states that the manufacture of counterfeit medicines continues to increase throughout the world. The nonprofit organization recorded nearly 6,000 pharmaceutical crime incidents in 2021, up 38% from the previous year and the highest number since its records began 20 years ago.
Where is there more counterfeit medicine?
Regarding the geographic distribution of seizures of counterfeit pharmaceutical products, the largest number was recorded in North America (2,442), followed by Asia-Pacific (1,747) and Latin America (770).
This order is largely due to the effectiveness with which countries in these regions identify pharmaceutical crime through police activity and inspections by drug regulatory agencies. As the Institute points out, a lack of funding or inadequate regulatory structures can cause counterfeit medicines to go unnoticed.
Current legal regulation in Mexico
Now, in our country there is Official Mexican Standard (NOM) 059-SSA1-2015 regarding good drug manufacturing practices. The document establishes the guidelines that must be followed by all establishments dedicated to the manufacture of drugs.
In this sense, in order to identify counterfeit medicines, the Federal Commission for the Protection against Sanitary Risks (Cofepris) published an official guide. Therefore, it is a document of great importance for you and your patients.
Characteristics of counterfeit medicines
- Non-existent labeling, of poor quality, superimposed.
- Physical attributes that do not correspond to the original product.
- They have a sanitary registry, alphanumeric key or batch number that does not exist or does not correspond to it.
- The product is in a state of degradation or noticeable deterioration.
- There are erasures, scratches or scratches on the health information.
Also read:
Cofepris publishes a list with 7 counterfeit and illegal drugs: Rivotril, Buscapina and more
Counterfeit drugs against breast cancer and diabetes: So you can identify them
Official Cofepris manual to identify counterfeit medicines