Despite increasing reports of drug counterfeiting, track and trace programs designed to help attack the problem continue to have problems getting off the ground in the face of industry opposition.
India has again delayed implementation of its barcoding program, pushing it back until next year. Indian drugmakers were supposed to have unique identifying numbers on their packaging this year but now have been given until January to convert secondary packaging and until July 1 for primary packaging, reports Securing Pharma. The plan originally was proposed to begin last year but industry groups said regulators' schedule was too aggressive.
That battle is not unlike what has happened elsewhere, including in the U.S. The FDA pushed hard to get a national track and trace provision into the user fee reauthorization bill just signed by President Obama. The pharma industry has been very resistant, seeking a long phase-in. It contends that the U.S. supply chain was not ready to be able to track individual units all along their paths. The plan was cut out of the bill in the final hours of political negotiations. The FDA did get provisions for a similar program for medical devices.
The European Union is slated to have a program begin in 2014. That measure is pitting generic drugmakers, which believe it will cost too much, against branded drugmakers, which want to stop their products from being illegally copied. With implementation still two years out, there is time for it to be killed or kicked further down the road.
India, where the government reports more than 5% of drugs are fakes or substandard, the system would have allowed consumers to text the unique number and receive a free return text saying whether the medication was certified or not.
- here's the Securing Pharma story