Anvisa Approves Track and Trace System

The board of Brazil’s National Health Surveillance Agency, Anvisa, has approved a system that will be used to track drugs from manufacture to the time of sale.

Within three years, drug packaging will have a two-dimensional code, and the industry will need to have in place an electronic system to monitor each step of the package, from the factory to the pharmacy. In the case of prescription drugs, the monitoring will go further, with the ability to know who purchased a particular drug, explains Anvisa Director Dirceu Barbano.

The agency established an intermediate period of two years from the time of approval of the system to allow every drug company to submit a comprehensive report of traceability of at least three product lots that they have manufactured.

“The report will serve to demonstrate that the company has the system in place, and that it’s working. And the company would have an additional year to buy more equipment," Barbano said.

Another rule, yet to be issued, will define the process for communicating tracking information to Anvisa. The tracking data, says Barbano, should be created by the industry, possibly in partnership with pharmacies and distributors.

Nelson Mussolini, chief executive of Sindusfarma (Association of the Pharmaceutical Industry in the State of São Paulo), says the move brings certainty to the industry and the consumer. Mussolini said he believes it is possible to meet the deadline established by Anvisa, although there is some concern amongst manufacturers about the cost of the change and the availability of equipment necessary to establish traceability. There is no mention of passing costs to consumers, he said, since drug prices are controlled by the government.

The call for traceability was established by law in Brazil in 2009. In 2011, the agency gave up a proposal for traceability which involved the use of a stamp of the Mint, as it would have made products more expensive.

Brazil's ANVISA issues water purification norms for pharmaceuticals

Brazil’s National Health Surveillance Agency (ANVISA) has now issued a guidance on Quality Water Purification Systems for Pharmaceutical Use.

While these guidelines are issued early this month are for the pharmaceutical manufacturers in Brazil, the same is also applicable for the ANVISA approved facilities in India, according to industry experts.

The Indian companies which have been cleared as ANVISA approved facilities include Aurobindo Pharma, Akums Drugs, Torrent, Strides Arcolab, Cadila Healthcare, IPCA, Micro Therapeutic Research Labs, Jubilant Lifesciences, Panacea Biotec, Opto Circuits India Limited, Ranbaxy, FDC, Indoco, Micro Labs to name a few.

The guidelines are seen to be in line with the World Health Organisation (WHO) issued in 2005 and ANVISA too has come out with its own norms.

ANVISA has now provided the minimum requirements for the materials, construction, maintenance, operation and control of the distribution of water for pharmaceutical use. “It represents the harmonization of regulatory requirements in health inspections conducted by the National Sanitary Surveillance (SNVS). Resolution RDC 17/2010 has been agreed to for the first time. There is a chapter exclusively for the generation and distribution systems for water for pharmaceutical use and the guidance furthers the purpose of the Resolution. The norms are based on international benchmarks and national know-how,” reports the regulatory authority.

The specifications for water for pharmaceutical use (WPU), is for specific applications, such as the manufacture of active pharmaceutical ingredients (APIs) and dosage forms, and to provide guidance on the good manufacturing practice (GMP) regarding the design, installation and operation of pharmaceutical water systems, according to the guidance.

Pharma companies including Micro Labs are now viewing the norms as a welcome step as it would further elevate the quality requirements. There is need to focus on water quality standards which is the base for all drug manufacture, stated an official.

According to the Karnataka Drugs & Pharmaceutical Manufacturers Association, so long the pharma industry in India has been adhering to the World Health Organisation (WHO) Good Manufacturing Practices: water for pharmaceutical use. The WHO mandates importance of water quality as it forms of the core of drug manufacture. Even in drug research and development water quality is of prime importance.

According to WHO manual on application of water to processes and dosage forms, “water has unique chemical properties due to its polarity and hydrogen bonds. This means it is able to dissolve, absorb, adsorb or suspend many different compounds. These include contaminants that may represent hazards in themselves or that may be able to react with intended product substances, resulting in hazards to health”.

“Water is the most widely used matter, which is indispensable right from the commencement of production, processing and formulation of pharmaceutical products. Therefore these guidelines from ANVISA are important as Brazil too comes under the umbrella of emerging countries and therefore the guidance is seen as an important step towards quality adherence,” said researchers from the Indian Institute of Science who have entered into academia-industry partnerships in the pharma space which have ANVISA approved production plants.