The Centre has alerted the Indian drug exporters who export their products to the United States about a new bill 'Food and Drug Administration (FDA) Globalization Act 2009' which has been recently introduced in the US. The bill is designed to impose strict monitoring, manufacturing and reporting requirements on all products overseen by the US FDA. The bill also creates a dedicated foreign inspectorate to increase the US FDA's ability to monitor foreign facilities producing food, drugs, devices and cosmetics.

Alerting the Indian drug exporters to the US about the consequences of the new Bill and asking them to take caution, the Union commerce ministry has offered all kinds of assistance from the government for meeting issues arising out of the new bill introduced in the US. Senior ministry officials said that the government will soon conduct awareness programmes in this regard to educate the Indian exporters about the new bill. Besides, the government will introduce one subject on US FDA in the Export Management Course at NIPER, Hyderabad.

The new law in the US is seen by many as yet another step by the US administration to improve the quality of generic drugs being sold in the US. Indian pharma companies have a large presence in the US generic drug market.

The new US law requires all food, drug medical device and cosmetics facilities operating within the US or exporting such goods to the US to register with the US FDA and pay a registration fee every year. It requires the US FDA to establish a risk-based schedule for inspecting foreign and domestic food facilities, with a minimum inspection frequency of once every four years, and provides that refusing, impeding or delaying an inspection would be cause for suspension of registration and for barring entry into the US.

As per the new law, the US FDA requires to inspect foreign and domestic drug facilities every two years (with some exceptions allowed) and denies entry to drugs coming from facilities that limit, delay or deny US FDA inspections. It requires foreign food manufacturers to be certified by US FDA accredited third parties as meeting all US food safety requirements and prohibits uncertified facilities from exporting to the US.

The new law creates a fast-track import process for food meeting security standards. It provides the US FDA with new authority to issue mandatory recalls of foods and drugs and strengthens fines for failure to comply with safety requirements. It requires drug importers to affirmatively demonstrate that their products come from registered facilities and meet all requirements related to safety and quality.

The new law requires drug manufacturers, when requested by the US FDA, to provide documentation of their complete supply chain and to document measures taken to secure their supply chain. It has created a dedicated foreign inspectorate to increase US FDA's ability to monitor foreign facilities producing food, drugs, devices, and cosmetics.