This is the year that the Food and Drug Administration will be taking a long hard look at generic drugs; both domestic and imported. The agency has targeted over $20 million dollars to focus on the growing market. The testing of drugs and especially the quality practices of overseas manufacturers are all a result of increasing focus on imported generics. This past February the agency put India on alert and what they should expect as the program gears up.
FDA commissioner, Margaret Hamburg, during an eight day visit to India, that included meetings with Indian pharmaceutical companies and regulators, warned the manufacturers that they must know and follow the U.S. quality control standards and practices. She informed them that there will be an expansion of facility inspections and an increase of FDA presence in the country.
The commissioner did stress that the agency wants to continue to work closely with the companies but she did point out that any manufacturer wanting to continue doing business in the U.S. must be ready to accept responsibility for the quality of their product and ensure that it meets the expectations of the American public.
Pointing out the fact that there has been little to no participation by India at international meetings of drug safety and manufacturing standards, Dr. Hamburg urged Indian government officials to attend these meetings. Both parties also agreed to a strategy whereas Indian regulators will accompany and observe FDA inspectors in order to be better informed of the agency’s procedures.
So, what it comes down to is that overseas manufacturers, and especially India, who have a focus on the United States, must be prepared to step up their operations and incorporate higher standards of quality through quality by design projects. It is clear that closer generic drug monitoring will be a growing interest for the FDA.
If the Indian pharmaceutical industry adapts the agencies expectations then it can only be beneficial to their growth and expansion of markets.