Dr Maharaj K Bhan, former secretary, Department of Biotechnology
Q: Congrats to you as the rotavirus vaccine development has finally reached its culmination. Could you share some experiences that would benefit others?
Dr MK Bhan: There are two, three issues here. One is professional capabilities in academia and industry comes by from experience. You collaborate globally and slowly build the capacity. Suppose there was no Gates Foundation, who would have done these trials? Nobody I guess. Would they have given the money? Not in case of absence of a smart team. Capabilities and trust building issues therefore too play a role here.
Now people are saying give us data on rare side effects and it costs another Rs 40 crores to give that. The doctors on committees don't have expertise on clinical trials. There are money issues. In a country like India, when the system is not ready, we can't expect a cakewalk. What is called hurdles in a general way is to work hard and build capabilities. Nothing is easy as it takes hard work and you have to work well. But let us see and not ignore the overwhelming positive side of picture too.
Q: Critics from the industry feel that the regulatory regime is a big dampener. Do you see any change in the scenario over time?
Many people are hiding behind incompetency and to blame DCGI for our innovation problem is not really realistic. There were issues at DCGI at some point but to say that things haven't improved, would be to turn a blind eye. They deserve credit for that and people should appreciate the change.