07/06/2026  |  Brazilian Ministry of Health

https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/canetas-do-paraguai-nao-demonstraram-equivalencia-com-medicamentos-registrados-no-brasil 

To ensure that one drug is equivalent to another, specific tests are required to verify identical concentrations and characteristics

The Brazilian Health Regulatory Agency (Anvisa) states that the claim that laboratory tests have proven the equivalence of smuggled pens to products registered in Brazil is FALSE.

To ensure that one drug is equivalent to another, specific tests are required to verify identical concentrations and characteristics. In addition, the tests must assess whether the drug works the same way when administered to a person. To do this, it is necessary to evaluate how the product is absorbed by the body, what concentration it reaches in the bloodstream, and how long it takes to be eliminated.

To prove equivalence, the study must be conducted at an accredited bioequivalence center, which is responsible for evaluating the clinical, analytical, and statistical phases of the study.

What is the fact?

The Center for Toxicological Information and Assistance at Unicamp (CIATox) conducted only tests to detect the presence, concentration, and molecular structure of the active ingredient tirzepatide in contraband medications.

CIATox is NOT an accredited bioequivalence center in Brazil and did not conduct equivalence studies. The center is also not part of the Brazilian Network of Analytical Laboratories in Health.

The tests conducted by Unicamp confirm the presence of the active ingredient in the vials. However, it is not possible to state that they are equivalent, since no analyses were performed for impurities, contaminants, product degradation, sterility, or the presence of heavy metals, among other factors.

Most importantly: the test did NOT evaluate bioavailability. This is the most relevant data for determining whether one drug works the same way as another.

Want to learn more?

The drug registration process is complex and requires the submission of complete qualitative and quantitative information about the product, including its characterization, formulation, impurities, specifications, quality control, validation of analytical methods, and manufacturing process, as well as data demonstrating its clinical efficacy and safety.

A laboratory analysis, without knowledge of information that only the manufacturer possesses about the product (such as the synthesis process, possible impurities, degradation profile, etc.), does not provide reliable information, especially regarding the drug’s content and impurities.

An analytical method does not automatically detect every impurity. Even methods described in pharmacopoeias are not automatically considered adequate and must undergo a validation process.

First, it is necessary to understand which impurities may be present (potential impurities) in order to then develop a method capable of detecting and monitoring these impurities.

The manufacturers of the products analyzed by Unicamp were NOT evaluated on the production line, which directly affects the quality of the final product. Nor were they evaluated by Anvisa, which did not have access to the reports or methodologies regarding Good Manufacturing Practice (GMP) certification—an essential step in ensuring the quality of drug manufacturing.