Every month the FDA issues dozens of import alerts to flag imported products that are either unfit for the US domestic market or are illegal. The flow of unapproved drugs into the country is potentially a huge problem and, in order to ensure the integrity of the drug supply chain in America the FDA is planning to perform a major overhaul of the current import protocols.

Legislation passed in 2012 gave the FDA greater powers to collect and analyze data about drug imports in an effort to make risk evaluation-based decisions about the supply of drugs from foreign facilities. There are also resources allocated to allow closer partnership with foreign authorities in order to share information and to establish recognition of foreign inspection procedures. It is hoped that, in the rapidly changing global economic environment, these measures can keep up with the demands for continually updated regulations to manage the foreign supply of medicinal drugs and to set standards of safety and quality throughout the US drug supply chain.

The import alerts already routinely issued by the FDA have wide-ranging economic impacts in many countries. These places often have hundreds of millions of dollars in revenue tied up in drugs manufactured for export to the United States. In recent months several Indian companies have come under FDA scrutiny for not meeting US quality standards. Wockhardt Ltd., a huge multinational manufacturer of pharmaceuticals, including many generic brands, has had an import alert placed on one of its plants resulting in the loss of an estimated $100 million in revenue and causing a 20% decline in the share value of the company. Another Indian generic drug manufacturer, Ranbaxy, have recently come to a $500 million settlement with the US government, raising concerns in India about whether they should worry about the quality of the drugs in their domestic market.

The implementation of the new FDA regulations will be discussed at a meeting in mid-July to determine the most efficient ways to deal with the import of drugs into the US. This will cover even the most basic concepts such as the definition of an ‘importer’ compared to a ‘commercial importer’, the information importers will need to submit before their products will be allowed into the US, and whether importers should supply a certificate of analysis as one condition of admission. The meeting will also examine the economic and social impacts of issuing import alerts and establish what added burden compliance will impose on importers. With billions of dollars in revenue at stake, India will have to wait for the results of the FDA deliberations before they can decide on their next move.