USFDA to closely watch imported drugs

In a move that expands its authority, the US Food and Drug Administration (FDA) signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA) in July last year. Under this, importers must submit information demonstrating that their drug complies with Federal Food, Drug and Cosmetic Act requirements before their products can enter the United States.

In addition, commercial importers must register with the FDA and meet good importer practices. These rules apply to both human and animal drugs. Now, with an aim to seek views from the public on this new Act, the USFDA is organising a day-long public meeting at its White Oak Campus in Maryland on July 12.

In a statement, it says, "The purpose of the July 12th meeting is to provide an overview of Title VII, discuss how FDA plans to implement it and hear public comment about those provisions that specifically address imported drugs and importers."

FDA Commissioner Margaret A. Hamburg, M.D. and other senior agency staff will be speaking at the meeting. It adds: "At the meeting, the public will have an opportunity to provide information and share views that will assist FDA in drafting regulations under these provisions."

Today, according to the FDA estimate, nearly 40 per cent of the finished drugs are imported from other countries. Also, almost 80 per cent of active ingredients come from overseas sources into the US.

India, incidentally, is its second largest provider of finished dose products constituting nearly 10 per cent of that market.

These developments are likely to be watched closely by many Indian pharma companies specially in the light of the May 13 settlement by Ranbaxy in the US where the company pleaded guilty and agreed to pay $ 500 million to resolve false claims allegations, CGMP violations and false statements to the FDA.

Those in the industry see a key message for Indian industry: it should expect to see the same level of rigour on foreign inspections by FDA as with the domestic US industry.

Recently, in response to questions from Business Today, an FDA spokesperson said the regulator planned to increase its activity in India. In March this year, it received an approval from the Indian government to add seven additional drugs investigators in India.