US FDA has launched a voluntary program to promote safety of drugs manufactured outside the US.

Last year’s heparin contamination scandal might have led the FDA to initiate the program. The incident resulted in many deaths. It was discovered that the cause of deaths were specific vials of heparin that were adulterated with oversulfated chondroitin sulfate, that had deliberately added to crude heparin in China. The motive behind the act was increased profits.

Even in 2008, FDA had to ban several drugs made by Indian Pharmaceutical major Ranbaxy as they were manufactured in un-approved labs.

The FDA had been severely criticized for its inability to inspect the China made medicine.

According to the new regulations foreign manufacturers will be expected to meet certain criteria. The program would last for two years and would also make it mandatory for the company to maintain control over drug products from the time of manufacture through to entry into the US. It would also ensure that the products from those participating in the program will get an expedited entry into the US. The FDA is collaborating with the US Customs and Border Protection and other stakeholders on this issue.

According to the FDA it plans to select 100 applicants to participate in the Secure Supply Chain pilot program. The FDA targets to develop a secure supply chain program. It would be help to the agency to prevent the import of those drugs that don't comply with applicable FDA requirements.