India and China have become major suppliers of low-cost drugs and drug ingredients to America. Even with this explosion of manufacturing overseas, the FDA does not conduct enough quality-assurance inspections. Over the past seven years the FDA has conducted only 200 or so inspections on plants in these countries, but in the United States, the agency made 1,222 of these quality-assurance inspections just last year.
Since there have been recalls on many products such as toothpaste, pet food, and children’s toys from China recently, experts think that drugs from China and India pose a similar risk of being contaminated, counterfeit, or ineffective. The poor quality of inspection, combined with greater amounts of imports from these countries increases consumers’ potential for buying and using problematic products.
The FDA says they are unaware of any health problems caused by drugs from these countries and that the American companies that import these products normally do their own safety inspections.
Dilip Shah, secretary general of the Indian Pharmaceutical Alliance, said he would like to see more FDA presence in India because it would help improve standards and have more companies follow FDA guidelines. But Shah and executives from other Indian and Chinese companies warn that when questions are raised about the quality of their products, it may be because some American companies are trying to protect their market shares.