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Anvisa contesta Fantastic and guarantees: generic is safe

02/01/2017

This article was translated by an automatic translation system, and was therefore not reviewed by people.

 

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About the article "Fantastic tests the quality of the most sold generics in Brazil", shown by the program on TV Globo this Sunday (29/01), in which fifteen generic drugs with the active principles dipirone sodium, losartan potassium and sildenafil, Anvisa clarifies:

The Center for Studies and Pharmaceutical Analytical Development (CEDAFAR) of the Federal University of Minas Gerais, contracted for the production of Fantástico for the studies, was never authorized by Anvisa to carry out drug tests for the purpose of fiscal analysis. The tax analysis, which is carried out on drugs, medicines, pharmaceutical inputs and related documents, to verify compliance with the formula that gave rise to the registration, follows rules defined by the Agency, always guaranteeing the collection of three sets of samples of the Drug to be tested; The possibility of the test being accompanied by an expert appointed by the company; And its realization exclusively in laboratory enabled for this purpose. This rigor is necessary to avoid unfair competition between manufacturers, who could order tests in laboratories not only enabled to raise questions about competing products.

CEDAFAR is authorized by the Agency, as well as other laboratories, only to carry out pharmaceutical equivalence tests in order to register the medicine. These tests are, after being carried out, analyzed technically by Anvisa, which verifies its technical consistency, along with other parameters, and decides to grant the registration. CEDAFAR has already been authorized to carry out these tests suspended by the Agency on two occasions, the last of them in the period from 09/12/2015 to 03/02/2016, since none of its equipment, in the inspection carried out by Anvisa, was calibrated The information that CEDAFAR is not qualified to carry out fiscal analysis tests was passed on to the report, but was banished by Fantástico to its viewers, giving the false impression that the laboratory is accredited for all types of tests.

The report's claim that the bioequivalence test for medicines, which is the most important and conclusive test in the world to define whether a generic is actually equivalent to the reference medicine, was also astonished, was not made by "Ethical issues". This is not true. There would be no ethical impediment for these tests to be carried out, as long as they comply with the current ethical standards to be submitted and approved by a Research Ethics Committee (CEP) accredited by the National Research Ethics Committee (CONEP) Of the National Health Council / MS. On the contrary, once such tests were carried out, they could provide conclusive information.

Bioequivalence tests are performed on healthy volunteers and measure the concentration of the product in the blood, making possible, without any doubt, the definitive evaluation of the actual action of the drug in the human organism. The tests that were carried out by the laboratory contracted by Fantástico - of content and dissolution of the active principle - are important, but not sufficient. That is, they are not able to assure the pharmaceutical equivalence of the generic medicines with the reference medicines, which is done by the bioequivalence test, which was not done for the reportage.

This rule of taking the bioequivalence test as the definitive one to evaluate the generic medicines is used by Anvisa, as well as by the drug agencies of the United States, Canada and Japan and European countries, among others.

However, although Fantástico has exhibited results of tests performed without complying with the technical and regulatory requirements for an appropriate analysis, Anvisa analyzed the results sent by CEDAFAR and reports that:

1 - All batches of drugs with active principles sildenafil (two samples) and losartan potassium (eight samples) were in satisfactory sanitary conditions, ie within the expected standards. The reports themselves state that the batches of the tested medicinal products are equivalent to the reference medicinal products. These results coincide with the similar tests that producers are obliged to submit to apply for registration and which are carefully analyzed by the Agency before granting the registration;

2 - Four of the five samples of sodium dipyrone tested were in satisfactory sanitary conditions;

3 - Lot b16d1090 of dipyrone sodium 500 mg / ml oral solution from Brainfarma showed an apparently unsatisfactory result in relation to the content test. The mean concentration of dipyrone found was 92.87%, lower than the reference value, which is 95.00%. Although the examinations carried out by contracting the Fantástico program are not legally valid, Anvisa, fulfilling its mission to protect the health of the population and as it does with any complaint about irregularities in medicines, has already begun the procedures to determine if, in this specific batch, There is even less than what is required. The Agency notified Brainfarma to provide information on the lot analyzed. In addition, the tax analysis of the product is being collected. These procedures have well-defined rules so that the results leave no doubt about their interpretation. Three groups of samples will be collected (proof, control and testimony) and the tests will be carried out in an official laboratory. It is worth mentioning that, in 2014, Brainfarma, on the occasion of the renewal of registration of this drug, submitted to Anvisa a pharmaceutical equivalence study carried out by a laboratory accredited by the Agency, which concluded by the pharmaceutical equivalence of sodium dipyrone. The report submitted by the company, at the time, obtained a result of 104.19%. The tests that ANVISA is presently conducting will resolve any doubts and will allow clarification as to whether this lot of the drug is regularly within the required parameters;

4 - On a possible irregularity in a batch of the medicine losartan potassium, tablet 50 mg, from the company EMS S / A, it must be clarified that the methodology used by CEDAFAR was different from that which is authorized and considered by reference by Anvisa to test equivalence Product. The average content of losartan potassium 50mg, of the company in question, was 94.82%, higher than that established as a reference in its current registration, which is 90.00%. Using different methodology means that it is not possible to compare the results obtained with those that should be presented by the product, there being no technical and scientific basis for considering that there may be irregularities;

5 - On the results of the dissolution profile tests of the batches of losartan of the companies Medley, Geolab and Pratti, Anvisa clarifies that the comparability of the dissolution profile between the generic drug and the reference drug is not conclusive for the registration or commercialization of Generic drug in Brazil, as well as establishing the main regulatory agencies in the world;

5.1 In the matter of the Fantastic, the specialists who were heard did not differentiate "dissolution" and "dissolution profile", confusing the two concepts. We do not know whether it was due to a failure to edit or because they did not know exactly which test had been performed. Dissolution is an assay used for quality control, while the dissolution profile is suitable for the development of formulations. Dissolution profile with pharmacopoeial means is not intended to provide bioavailability. That is, there is no scientific relationship between the performance of a drug in the dissolution profile test and the behavior that the product will exhibit in the human body. The report thus made statements completely devoid of technical and scientific basis. All information regarding methodologies was previously provided by Anvisa to the report. However, for reasons we do not know, they were not used in the matter.

5.2 - Generic losartan medicines from Medley, Geolab and Pratti provided satisfactory bioequivalence tests to Anvisa at the time of its application. Therefore, they are considered equivalent to the reference product;

6 - Unlike the Fantástico report, Anvisa was not questioned about how many laboratories used their own methodologies in the registry of the drug losartan potassium. The report asked what were the specific methodologies used in the records of each of the potassic maps analyzed by CEDAFAR. The Agency reported that the non-famoepetic methodologies developed by the manufacturers - which were analyzed and approved during the registration process - are made available to the official laboratories when they carry out fiscal analysis.

7 - The technical standards established by Anvisa are always based on the best available technical and scientific evidence and international best practices. The technical committees and working groups that assist the Agency in the elaboration of these norms, participate the best Brazilian professionals of diverse areas, always ensuring the absence of any conflict of interest and pluridade. Thus, there is no basis for the Fantastic's claim that there are "disagreements" between the Agency and experts.

8 - Anvisa carries out the permanent monitoring of the quality of medicines marketed in Brazil. In 2016, the Agency suspended the marketing of 95 different batches of medicinal products suspected of misuse. This action stems both from routine inspections in drug factories and from complaints by patients or health professionals about suspected ineffectiveness of a particular drug or unintended adverse reactions;

9 - The Agency did not receive any complaints of quality deviations from the lots of drugs that were "tested" in the laboratory contracted by Fantástico and related to possible inefficiency;

10 - To ensure the quality of medicines in use in Brazil, whether generic or reference, the Agency develops a set of complementary actions that include: the certification of the quality of the producers; Analysis of post-registration records and modifications; Pharmacovigilance actions; Manufacturer inspections; And a quality monitoring program, called Proveme. In 2016, 70% of the samples analyzed under this Program were generic drugs. None of these samples were considered unsatisfactory; and

11 - The consumption of generic medicines is safe, as are those of reference medicines. It is absolutely wrong, and dangerous for the health of the population, the statement made by the matter that it would be up to the doctors to indicate to each patient which generic has quality. Doctors do not have the means to make such an assertion. In the developed world, it is the regulatory agencies that set standards to ensure the quality, safety, and efficacy of medicines. Individual opinions, without any scientific basis, can lead to misguided orientations, based on prejudices, misinformation or even shady business interests. In this sense, the substance serves to dissolve the population by providing incomplete and unofficial information on the quality of medicines.

12 - Anvisa continuously develops this set of actions to guarantee the quality, safety and efficacy of all medicines produced in our country, always in convergence with the best international practices.


Anvisa Communications Department

Source: Anvisa


 

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