The US FDA is considering to enforce effective measures to check counterfeiting of drugs and to lower the regulatory hurdles following issues like the mounting inflow of counterfeit and spurious drugs through Internet pharmacies, bio-terrorism and re-imports from countries like Canada, according to a global regulatory affairs expert.

The US FDA is planning to publish draft guidance on notification procedures for making changes to products, packaging or labelling for the purpose of deterring and detecting counterfeit drugs. The FDA came out with a counterfeit task force report in February, last year, which recommended the use of multiple anti-counterfeit measures in the design of drugs or drug packaging. Subsequently, the agency introduced bar code regulation related to the use of unit dose packaging in hospitals with a view to reduce medical errors.

Recently FDA stated that a trace marker (taggant) can be added to the coating of an existing immediate-solid oral dosage form and a sponsor simply needs to notify FDA in their annual report. Similar measures, including specific guidance to manufacturers, are being considered by the regulator to check counterfeiting, David R Schonekar, director of Global Regulatory Affairs, Colorcon told Pharmabiz.

At present, the US FDA is worried about sales of spurious drugs through Internet pharmacies, as it is estimated that 40 to 70 per cent of drugs coming into the US from the internet are considered to be fake. The same is about 80 to 90 per cent in the case of internet drug sales in the African continent. Currently internet drug sales are believed to be between 5 to 20 per cent of the drugs traded in US. The Internet could be the biggest conduit for counterfeit drugs in the future, estimate regulators worldwide. At present, the US lacks mechanism to monitor and regulate the Internet pharmacies, most of them suspected to be operating out of Canada and third world countries.

Re-importation of drugs through the Canada border is also an issue in US. Since drugs are under price control in Canada and offered at subsidized prices, many pharmacies and selling points have mushroomed in the Canadian border, causing cross-border sales. Same is the case with another border country, Mexico. The FDA is worried about the fact that a good percentage of such re-imports are counterfeit drugs.

He said bio-terrorism is another area FDAs in various countries have to be alert about, as terrorists can also participate in conventional ways of counterfeiting to find funds for their activities. A few years ago, the US Army was reported to have seized a few documents from Afghanistan on a detailed plot by terrorists to poison the American citizens.

Counterfeit Lipitor was discovered two years ago in the US when two dozen US consumers complained that their pills had a bitter taste and dissolved differently in their mouths. The incident traced to a sophisticated international criminal enterprise that conspired to exploit the weaknesses in the US system. Sourcing and distribution involved 16 companies in nine countries. Products were suspected to be manufactured in Brazil or Argentina. The incident led to recall of millions of tablets of Lipitor. A few months ago, UK MHRA and Pfizer recalled batch 004405k1 of Lipitor 20 mg due to the discovery of counterfeit in the UK market, as 73 fake drug packets were discovered.