Updated on 17 October 2013
Indian drug makers command 10 percent share in the $30 billion US generic drug market.
India has in the past few years, emerged as the world's second largest drug exporter to the US. This surge in exports is expected to further increase under the US President Barack Obama's healthcare program. This scenario has put immense pressure on the US drug regulator (Food and Drug Administration - FDA) to ensure that the products that are imported in the country are of the highest level of quality.
In March this year, India approved FDA's addition of seven drug investigators to its team of 12. With the US FDA increasing work force in India, the country's top generic drug makers will now undergo frequent enforcement measures and inquiries. India, which has over 150 US FDA approved plants including manufacturing units of global pharmaceutical giants, has witnessed 19 US FDA imports alerts being issued to its companies since 2009.
Indian drug makers command 10 percent share in the $30 billion US generic drug market. About 40 percent of the over-the-counter (OTC) prescription drugs sold in the US market also comes from India. Furthermore, pharmaceutical exports from India to the US increased nearly 32 percent last year to $4.23 billion.
FDA widens its circle in India
Following the addition of seven new investigators to its team, a total of 19 American staff (including 10 specializing in medical products) will now handle regulatory issues associated with Indian generic drug firms, on behalf of the US FDA. Apart from this, other FDA staff would also include food and device inspectors and policy analysts.