IGMPI India

US FDA took an initiative for reducing quality control issues at pharmaceutical manufacturing sites. At a news conference Dr. Janet Woodcock, head of the FDA's pharmaceuticals division, said that a project has been designed which may take 10 years to get complete in order to establish consistent quality standards for all drugs, whether brand name or generic.

A new division called Office of Pharmaceutical Quality has been established by FDA wherein new applications will be filed and they will also be responsible for taking 10000 decisions in a year and manage the process. This will enable more integrated review and greater communication with the agency. However drugs which are currently being evaluated for approval will remain with the existing review team at the FDA.A set of quality matrics will be proposed by FDA for the drug makers and final rule will be produced after a public comment period though exact time frame still has not been decided.

There was reduction in the number of recalls by 20 % between 2013 and 2014 amongst which class I recalls which are considered most dangerous for the public is reduced by 30 %.The average annual number of recalled units between 2010 and 2012 was 225 million whereas the number between 2013 and 2014 was roughly 70 million units. Although there has been a decreasing trend but there is increased regulatory scrutiny leading to more adherence to quality guidelines by the manufacturers. Numerous generic drugs from India which is the supplier of roughly 40 percent of generic and over-the-counter drugs used in the United States has been banned over the past few years by US FDA over quality control issues.