Processes must be robust; merely being better no longer an option: Siddharth Mittal, Managing Director, Biocon

Drugmaker Biocon Ltd’s new managing director Siddharth Mittal said the company is embarking on a digital journey to strengthen its quality system. In an interview with Divya Rajagopal, he talks about prospects and plans for Biocon Biologics. Edited excerpts:
How do you look at challenges on the regulatory front?
The industry has seen an impact from regulatory action more on the good manufacturing practices (GMP) side, but not on drug approvals.

We have a very good track record on GMP compliance. We are taking a digital journey in strengthening our quality system, which will help us be dependent on systems and processes and less on people. We have to make our process robust. It is not an option to (merely) stay ahead of others. In this whole India issue, very credible companies have been impacted, so we have to continue to invest. We have created a dedicated team.

Do you see an increase in frequency of inspections?
We don’t see frequency in inspections. It is triggered after we file a product or as part of a regular audit. We are progressing well with our R&D pipelines and inspections are corresponding with that. Their approach has gotten stricter from what it was a few years ago. They would have looked at outstanding issues, where there were many repeats coming in areas such as data integrity, so that would have led them to increase inspections.

Will there be an increase in expenditure on research & development?
We have guided for 15% R&D in the coming years for topline. The digital investments would be more on the capex side.

What is the biosimilars landscape like?
The US is the biggest market for us for R&D.

We are focusing on large emerging markets — Malaysia and Brazil, where we have local partners — and direct presence in countries such as India. This gives us an opportunity to expand the market. Trastuzumab expanded access for the drug in India dramatically. The biologics are still unaffordable and this is why there is still an opportunity.

How far has the plan on spinning off Biocon biologics progressed?
We have indicated earlier that this is one of the options we are looking at. We are in discussions with various private equity funds to invest in our fund, as they see tremendous opportunity. Timing is difficult to say. However, we are in discussions. The number we are looking at is $200-300 million. And we don’t want to rush into an IPO too.