New Delhi: The US Food and Drug Administration (FDA) opened an office in India in January—its second outside the US, after China. As part of its Beyond the Borders initiative, the office will serve as a regional centre for India’s drug and food companies. The agency’s Washington-based deputy commissioner for international and special programmes,Murray Lumpkin, spoke by phoneabout plans and expectations from the India office. Edited excerpts:
How is the FDA office in New Delhi doing?
At this point of time we have an acting director, Beverly Corey, who has been in Delhi for several months. We have also selected a director, Bruce Ross, and he will be in India towards the end of the summer. Our initial goal is to have nine people in India and another three later this year. The first nine (including Ross) have already been hired and will be coming across over the next several months. They include two senior technical experts in medicines, two senior technical experts in foods, one senior technical expert in medical devices and three inspectors.
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These are...senior people at FDA. We did not advertise outside the FDA for these positions. We wanted people who knew the agency, who had worked at the agency for a good deal of time, who understood the policies and procedures of our agency—people who we felt would be able to be a very effective face of the FDA in India when they get there.
Will FDA’s office in India have a working relationship with the Indian regulatory authority?
Absolutely. That’s one of our major goals. Clearly we are there to help assure that products from India coming to the US that are regulated by the FDA indeed meet our standards and expectations. ...one of the major ways is by interacting with our counterparts, regulatory agencies in India, to learn more about their capabilities, to learn how we can leverage better the information and resources they have regarding these products that will be coming to the US.
Do you have any collaboration?
We have a history of working with our counterparts even before we thought about setting up the FDA posts in India. Last year we had a very successful collaborative workshop on good clinical practices held there in India.
Since the office opened in India, there hasn’t been much interaction between the industry and FDA.
I think that’s probably a true assessment when it comes to the Indian piece and it is not for lack of wanting to, it is simply the fact that we have only one person there at this point of time and...once we get the full compliment of FDA staff actually at posts in India, the industry there will see more of the interactions that I think they expect and we expect.
Will the India office help in boosting application approvals for drugs meant for the US market?
I think it depends on how one looks at it. If one is talking about adding to or boosting the numbers that get approved, ...it depends on how many applications are submitted, which is not something that the FDA has control over. I would hope that the fact that we have people there (will mean) that there will be greater interaction and understanding by the industry there as to what our expectations are, that the applications they submit will be of a high quality and will have the data we need in order to make an approval decision. But the decision really doesn’t depend on whether we have people in India or not, it depends on quality and completeness of the data we receive.
There has been a lot of talk about FDA inspecting Indian manufacturing units. Is that something that is specific to India or is that a general stand that FDA has taken?
We inspect manufacturing units wherever in the world they may happen to be. We do not choose as an agency where manufacturers choose to manufacture their products. It doesn’t matter to us if they are manufactured in New Jersey or New Delhi. What matters to us is that they are manufactured in a quality manner and in accordance with good manufacturing practices.
Can we also expect more approvals to manufacturing units once FDA gets going in India?
I am not sure that there is a link between new approvals and the fact that we have an office there. I mean even before we had an office...we would send our inspectors to India and inspect those plants and we authorized many Indian manufacturing sites before we had an office there. I think the benefit of having the office is indeed we will have some inspectors there (who) can do some inspections, but we will still have to send inspectors from the US to also augment the individuals we have there. But I think what they will be able to do is on a much more consistent manner work with the industry, work with others in the community there in India who are responsible for those products.
Would the India office function much as the Chinese office?
They are organized in very much the same way.
What are the main focus issues for FDA in India?
I think clearly the main focus is to interact with various segments of the community there in India to help assure that products coming from India to the US are indeed safe and quality products... We will be engaging, when we are requested to do so by Indian officials, in any kind of joint capacity building that they would like to be involved in.
We will be looking and trying to gather information from...various sources that will help us make better decisions here in the US and at our borders. When Indian products show up at our borders, we will know already that these are quality products and we can expedite their entry into the US by knowing before hand that they have been manufactured or grown or produced in ways that meet our standards.
So, exporters should be happy.
I would hope so, and I would think that the real issue here is to make sure that they understand what our standards are and make sure that we have confidence in the way that the products have been produced.