Author: Alana Rizzo and Maria Clara Prates

Source: Jornal do Commercio Brasil - RJ - 26/11/2009

On the same day that the Federal Police seized more than two tons of counterfeit drugs in Pará, the National Health Surveillance Agency (Anvisa) took the first step to combat the practice in the country, implementing yesterday the National Control System (SNC) that creates the Unique Drug Identifier (IUM). Each box or package in circulation in Brazil will have a two-dimensional bar code (datamatrix) with information on who manufactured it, when, when the factory was shipped, who are the distributors and the final destination. It took almost four years of discussion before the model was defined. Entrepreneurs in the technology sector disputed the lode, which obliges all laboratories to adapt, and should cost approximately R $ 150 million.

Anvisa will be responsible for organizing the database and guarantees that there will be no increase for the consumer and no cost from the government. “With the new model, bar codes and scratch cards will no longer need to be included in the packaging, reducing costs,” says Anvisa's deputy director, Rafael Aguiar Barbosa, arguing that the system will also avoid tax evasion and cargo theft.

Law 10.903 / 2009 establishes a maximum period of three years for the operation of the traceability system. Yesterday, a cooperation agreement was signed with the Mint. “It is a pilot project to test the technology,” explains Barbosa, suggesting that the federal authority may be responsible for the label: “As has been done with cigarettes and cold drinks”. The result of this test should be ready in 30 days.

The project establishes that the model adopted must have a low implementation cost; equipment replacement capacity; national and international supply of equipment and software; quick visual identification of the authenticity of the product 24 hours a day and seven days a week with an unavailability index below 0,1%; low possibility of fraud.

SEIZURE. About two tons of fake drugs, smuggled and unregistered, were seized in Redenção, in the south of Pará, in a major operation by Anvisa and the Federal Police, which increased to more than 300 tons seized, this year alone. According to the PF delegate, Adilson Bezerra, coordinator of the action, part of the drugs arrived in the state by the most traditional route, Paraguay.

Most of the contraband drugs were Pramil, a drug for erectile dysfunction without registration in the country, and Rheumazin, for rheumatism, which was denied registration by the Brazilian authorities. According to Bezerra, part of the seized drugs were in a truck and about 500 kilos were seized in pharmacies in the city. The action of Anvisa and PF resulted in the closure of 15 pharmacies and also in the arrest of 10 people suspected of involvement in illegal trade.

How is it

In the next three years, all medicines in circulation in Brazil will have to contain the following information electronically:

Manufacturer (operating authorization, state license and municipal sanitary license of the manufacturing establishments)

Buyer

Supplier (wholesalers, retailers, exporters and importers of medicines)

Product

Transport / logistics units

Consumer / patient

Prescription