Bioconís oral insulin IN-105 programme is now looking at doing its clinical trials overseas, seeing the uncertainty around clinical development in India, and says it could have saved a few months if it had taken the decision earlier. Biocon chairman and managing director Kiran Mazumdar-Shaw tells Ajay Sukumaran that it would be difficult for companies doing drug innovation in India to take all the trials outside India. Edited excerpts:
You are looking at doing the clinical trials for the IN105 oral insulin drug overseas because of a delay in India. How big a concern is this?
It is a big concern because for all of us, who are trying to do drug innovation in India, it will be difficult to take everything outside India. You can see Quintiles has shut down its phase 1 unit in the country. All the big contract research organisations are folding up in India and MNCs are saying we donít want to do trials in India. It is not a good thing.
Apart from the IN105 trials, does this impact Clinigeneís clinical services business?
Clinigene has always been a small part of our research services business. Over time, it has differentiated its model. It is not focussing much on conducting big phase clinical trials, so because of that it is not affected. We are merging it with Syngene, so it is not really affecting us in that sense. But if you look at it from a longer term point of view, if clinical trials were a very big sector in India, then Clinigene could have benefitted from it.
What has been driving the growth in the research services arm?
Basically, Syngene is surging ahead if you compare it to any other research services company in India because we have high-end capability. We completely went away from the commoditised, fee-for-service model. I think we see ourselves being the market leader in Asia. Today we are No.2, WuXi (Chinaís WuXi AppTec) is still No.1. But in the near future, we expect to overtake WuXi once our CRAMS (contract research and manufacturing services) business becomes more mature. Today, we are just supplying clinical quantities of material but when we start supplying commercial quantities, then our business can be much larger. Thatís what separates us and them because they supply commercial-scale innovative products.
How will you step up capability?
We will be doing a lot of capacity expansion for Syngene. There are various aspects, I mean,