PF seizes 15 bags of fake drugs

By ETCO

Author: Fernando Pires

Source: Jornal da Cidade - Sergipe - Aracaju / SE - 25/09/2010

Two people were arrested and three pharmacies were closed in the interior of Sergipe for the irregular sale of medicines. The seizures were made during a joint operation between the State Health Surveillance Coordination, the National Health Surveillance Agency (Anvisa) and the Federal Police, which ended last Thursday. In a press conference held yesterday morning, fake and out-of-date medications were displayed, which were sold in establishments in the cities of Cristinápolis, Carira and Lagarto. There is a suspicion of the participation of other states in the criminal scheme.

Since last Tuesday, more than 20 pharmaceutical establishments have been inspected in seven municipalities in the interior of Sergipe: Ribeirópolis, Carira, Pinhão, Estância, Umbaúba, Cristinápolis and Lagarto. In Cristinápolis, about 80% of a pharmacy stock was made up of expired products. Because of this, the establishment was banned and, in all, 15 bags with medicines out of date were collected.

In Carira, an establishment sold medicines without registration with Anvisa, including natural products and pregnancy tests. Its owner was arrested in flagrante delicto, sent to the municipal police station and then released. However, he will be indicted and will be responsible for the crime of falsification and adulteration of medicinal products, provided for in Article 273 of the Penal Code.

Finally, in Lagarto, an establishment was caught selling, in addition to counterfeit drugs, psychotropic drugs (also called “black stripe”) without authorization. In these cases, the pharmacy needs to obtain, in addition to the health license for its normal operation, a special authorization granted by Anvisa for the marketing of these drugs, a document that was not in the possession of the pharmacy owner.

PF delegate Walter Portugal said that the owner RASJ, 43, detained in Lagarto, is under arrest at the disposal of the courts and will be charged with the crime of drug trafficking. “He was caught in the act selling black label drugs without the necessary special authorization from the health surveillance agencies. In this case, the legislation is rigid and his sentence can reach 30 years of imprisonment, provided for by the Drug Law ”, said the delegate.

The coordinator of the state Sanitary Surveillance, Antônio Pádua Pombo, stated that the production of these fake drugs is being carried out outside the State of Sergipe. “We have strong indications that they were produced in the interior of Bahia, both by information on the labels of adulterated products, as well as by information from sellers here in the state. In addition, fake medicines are also labeled in the states of Minas Gerais, Espírito Santo and São Paulo. But there is still nothing proven in relation to the participation of these States ”, he declared. Padua said it will notify health surveillance in those states.

The investigation was initiated after the Phos Kola Laboratory denounced the illegal sale of one of its products, which had its production interrupted in 2008. The complainant had information that the product was being produced illegally and sold in pharmacies within the country. Sergipe and Bahia States. According to Antônio Pombo Pádua, the investigations will continue, including investigations carried out with establishments in Aracaju. Leandro Viana, herbal medicine coordinator at Anvisa, declared that this type of crime must be combated with rigidity. "We are making several partnerships with health surveillance in the State, with the Federal Police and the Public Ministry to combat this crime, which constitutes a threat to public health," said Leandro Viana. “The population also needs to report the sale of illegal or unregistered drugs. For this we have our communication channels ”, he added. The state coordinator of the Sanitary Vigilance stated that the criminal practice does not represent the pharmaceutical sector of the State in general. “I can say with peace of mind and confidence that businessmen in the sector do not act in this way. We have partnerships with industry unions and we know that this criminal scheme cannot be used to represent the entire segment, ”he said.

Prohibited drugs are still sold


Even though they are banned by the National Health Surveillance Agency (Anvisa), drugs like Varicell and Atroveran Plus are still found in pharmacies in Aracaju. This week, the JORNAL DA CIDADE report called five stores at major drugstore chains in the city and they all said they had Varicell. Atroveran Plus already had it only in a pharmacy. In the others, the information was that the medicine was missing and that they were waiting to arrive. When asked about the form of inspection of drugs banned in pharmacies, the manager of medicines of the Municipal Sanitary Surveillance, Renata Cláudio de Souza, said that she was not aware of this and that the JORNAL DA CIDADE initiative will motivate an inspection in that sense. . “When there is a ban, Anvisa notifies and guides everyone: the Health Surveillance coordinators, pharmacies, drugstores and the population. But the manufacturers are responsible for the collection of prohibited or irregular products ”, explained Renata Cláudio, emphasizing that the Municipal Health Surveillance Coordination only apprehends irregular products when manufacturers do not collect them. “This work by the press is of great value to us. Since we have now been informed of the sale of Varicell in pharmacies in the capital, we will inspect it accordingly. Let’s know what happened, why they didn’t take the medication off the shelves? ”. The medication manager also explained that the Health Surveillance inspects pharmacies daily for the renewal of operating permits. And, in this process, the inspectors check the products by also doing a health inspection. However, no pharmacy in Aracaju has been notified of the marketing of Varicell or other prohibited products. Surveillance did not even apprehend any medication whose name appears on the list of banned by Anvisa. According to Renata Cláudio, there are about 200 pharmacies in the capital of Sergipe alone. “The consumer also has a responsibility to cooperate with our work. When you go to a pharmacy and see that they are selling products that are prohibited, report it ”he requested, adding that the complaint must be made by calling 2106-9762 or 156 (Ombudsman).

Safety


Varicell has been banned from manufacturing by Anvisa since 2007. Anvisa's measure, which has already been published in the Federal Official Gazette, also determines that advertising for Varicell capsules, produced by Eversil Produtos Farmacêuticos should be suspended throughout the country . According to Anvisa, Eversil registered the drug in dragee and Varicell in capsules has no record in the organ. The drug is used to prevent and treat varicose veins and hemorrhoids. Atroveran Plus had its registration canceled by Anvisa because the base formula is different from that of Atroveran Compound. Plus has paracetamol (analgesic) as a base, and the compound, dipyrone (anti-inflammatory). According to Anvisa, the term "Plus" could lead the consumer to misinterpret the function of the product, believing that the formula would enhance the active ingredient of the compound medicine. According to data from Anvisa, more than 130 pharmaceutical products have been withdrawn from the world market in the last 40 years for safety reasons. 1/3 in the first years and 50% up to five years. The main reasons for the withdrawal of these products from the trade were adverse reactions to drugs, liver, hematological and cardiovascular. Anvisa also explains that no matter how much previous clinical research exists, which identifies a minimum standard of safety and efficacy for a drug to enter the market, only after thousands of people are exposed to this product is it possible to draw a safety profile of it, a fact that only occurs after registration. In Brazil, since February this year, companies are obliged to monitor the medicines they place on the national market. At the same time, Anvisa also carries out this pharmacovigilance work with health professionals, pharmacies, hospitals and international organizations. Some drugs that have been withdrawn from the market for safety reasons are: Vioxx (2004): cardiovascular risk; Lipobay (2001): problems of muscle degeneration; Rapitiva (2009): brain infection; Anti-inflammatory selective COX 2 inhibitors (2008) with withdrawal of Prexige from the market and one of Arcoxia's presentations: liver problems; Tacrolimos (200): lack of effectiveness; Closapina (2009): deregistration due to lack of effectiveness; Emagrill (200): withdrawal from the market due to lack of registration.