Confident that clinical trials climate will improve in next six months: Kiran Mazumdar-Shaw, Biocon

Updated: Oct 23 2014, 07:23am hrs
With its biopharma business impacted by multiple factors, Biocon is now stepping up focus on key markets like Latin America and Southeast Asia to offset the challenges it is facing elsewhere. Besides, the company is also hoping to address its capacity constraints over the next two years through expansions. At a post-results media conference call on Wednesday, Kiran Mazumdar-Shaw, Biocons chairman and managing director outlines the companys efforts on these fronts and also says that she is confident that the climate for clinical trials in India will improve in the next six months.

Is the challenging business situation in the MENA (Middle-East North Africa) region, likely to prolong

It is very difficult to predict what is going to happen in that region. What we are concerned with really is the credit risk pertaining to the region. There is no lack of demand. Therefore, we are watching it very carefully. When things improve, obviously we will get back into that market.

Which are the new markets you are looking at

Most of these markets are in Latin America, South East Asia and Eastern Europe. We have been addressing these markets even in the past. There is a regulatory gestation period and therefore as we get more and more approvals in these markets, we will focus more aggressively on these kinds of opportunities. Im pleased to say that many more new regulatory approvals are being received in some of these important emerging markets.

By when will the capacity constraints ease

There are many types of constraints. The insulin capacity, of course, we are addressing through our Malaysian facility. While the facility will be operationalised by this fiscal, it will all depend on how quickly we will get regulatory approval for this facility which could be anywhere between 12-18 months. And, for some of the markets it could even be as long as 24 months. But at least for the EMs we hope that it will be sooner than later. When it comes to Syngene expansion for the contract manufacturing business, it will take at least a year or two before they can really ramp it up. In terms of our other incremental brownfield expansion of many of the requirements for our current needs, that can be within the next fiscal.

Have you decided any timeline for listing Syngene

We will be starting the process very soon so I cannot really give you a very accurate picture of when the actual listing will happen. But at least it will give you some idea when we say we are in the process of appointing bankers.

Given that the government has been looking at streamlining the process for trial approvals and compensation, do you believe the ground situation has improved

I would say that the clinical trial climate is certainly improving. I think the Ranjit Roy Chaudhury committee is coming out with norms that will be clear and transparent and would set at rest a lot of the concerns. So Im very confident that in the next six months, you will see a very clear path ahead for clinical trials.