The head of the US Food and Drug Administration (FDA) says the crackdown on substandard pharmaceuticals coming into the US is not unduly aimed at Indian companies.
As Reuters reports, the FDA recently banned medications from two Indian pharmaceutical companies, Wockhardt Ltd and Ranbaxy Laboratories Ltd from being imported to the United States because of quality concerns.
AFP reports that, in response to claims by some Indian officials that her organisation is concentrating unduly on Indian drugs, FDA Commissioner Margaret Hamburg told reporters that the FDA is “undertaking our required regulatory activities” and not targeting India.
“When products are sold in the United States for use by American citizens, then those products have to meet our standards,” she said.
After Canada, India is the second biggest importer of pharmaceuticals to the US. Indian companies currently supply about 40 per cent of the generic and over-the-counter drugs consumed in the country.
However, because of regulatory problems in India, quality has been a problem for India’s drug industry.
Hamburg met Indian health ministry officials in New Delhi and both parties signed their first statement of intent to cooperate in the field of medical products.
The FDA currently has 12 staff members in India, but there are plans to increase that number to 19.
“The fact that we have increased our presence in India is true but it reflects that fact that India is a very significant and growing player in the US marketplace with respect to both pharmaceutical products and food,” Hamburg said.