Updated on 17 April 2013
There have been reports in the past about the complaints against the state level drug controllers. What is your take on that?
A lot of issues are still to be addressed. Because as you know that earlier DCGI office was not there to address specific issues that have popped-up recently in clinical trials, medical devices, and new drug discovery approvals. It requires proper system procedure to be built up for that. In that direction, we are in constant touch with the state regulators. The drug regulatory act, one of the important component of DCGI will be helpful in the proper implementation of drug and cosmetic act. Recently I was in Maharashtra to meet the state level officers and it is good to know that despite less manpower they are doing great. In that state we will recruit a total 100 new officers at the different positions. Again 100 each in Karnataka and Gujarat and 40 in Uttar Pradesh by the end of the year.
Are we still lagging behind when compared to the international regulatory agencies?
I think the comparison with the US FDA is unfair. There are 14,000 people working there as compared to what would be the miniscule 327 people here by the end of the year 2013. However, we are building capacity and trying to ensure the quality of available manpower. From 18 people in 2008 to 90 people in early 2013, we are surely catching up. We are recruiting close to 90 assistant drug controllers and 90 joint drug controllers, 200 people in central drug controller in next 3-5 years. With time, we are moving forward and improving our performance constantly.
How do you look at the future scope of drug regulatory affairs?
At present close to 218 countries are importing medicines from India. We cannot say that we don't have any regulation at all. But, there is a gap that requires to be bridged and the onus is on us to keep our house in order. When we are working on the ground level, for generic drugs, we had a meeting with state drug regulators to keep a tab on the unwanted approvals. For oral capsules/tablets, we are making the science-based methods mandatory for any new license by state controllers. In 2014, we will make it mandatory for dissolution of tablets before they are taken. There is an increased level of awareness among general public on various issues including clinical research. Let us stay positive for future as we are improving our standards on a consistent basis.