With US Food and Drug Administration (FDA) planning to work towards reducing the backlog of generic drug applications under the Generic Drug User Fee Act (GDUFA), Indian pharmaceutical companies have however cited challenges like approval time for abbreviated new drug applications (ANDAs)– the applications filed for generic drugs and heightened inspection activities, as GDUFA requires stepping up number of foreign inspections.
As of the end of January 2014, US FDA's Centre for Drug Evaluation and Research had taken a formal action on 45 per cent of backlogged generic drug applications. In December 2013 alone, the centre completed 174 actions, including 30 full approvals for generic drugs.
Says Dr Margaret Hamburg, Commissioner, US FDA, "I am happy to report that the FDA is working to reduce the backlog of generic drug applications that were pending when the new user fee program went into effect on Oct. 2, 2012. GDUFA also requires that we step up our number of foreign inspections."
Dr Hamburg has also reiterated the fact that every company supplying the US market need to ensure that their products are safe, effective and of high quality. In recent years the FDA has identified significant lapses in quality by some companies operating in the US and around the world. As a result, American consumers have had to endure greater risk of illnesses, recalls, and warnings about the products many of them rely on each day. This is unacceptable. Consumers should be confident that the products they are using are safe and high quality and when companies sacrifice quality, putting consumers at risk, they must be held accountable.
"Regulatory agencies around the world share my vision for ensuring that consumers, patients and healthcare providers in all of our nations have access to high quality products. I am pleased that, as a global leader in the pharmaceutical sector, India will continue partnering with us to ensure that the companies exporting products to the US are adhering to established quality standards. In order to focus on quality, the creation of a new Office of Pharmaceutical Quality is underway that will create one voice for drug quality at the FDA and improve our oversight of quality throughout the lifecycle of a pharmaceutical product," she explains.
Dr Hamburg concludes that all companies must understand that quality is the basis for the public’s trust and confidence in their products and maintaining high quality standards is part of the cost of doing business.