Exclusive | Pharma manufacturing needs a robust regulatory system: Kiran Mazumdar-Shaw

Kiran Mazumdar-Shaw, the founder of Biocon, said country needs a regulatory governance model to ensure non-complying firms do not get away with unethical practices.

Amidst several reports of adulteration in drugs manufactured by some Indian pharmaceutical companies, Biocon Founder Kiran Mazumdar on February 15 said that the country needs a regulatory governance model to ensure non-complying firms do not get away with unethical practices.

“I think it is for us to build a very robust regulatory system. We need to have a regulatory governance model that allows all companies to be under the watch of regulatory inspections … which makes sure that companies that are not compliant cannot get away,” Shaw told Moneycontrol in an exclusive interaction.

On the issue of drug adulteration, the Biocon founder said it is a criminal activity and needs to be dealt with differently.

“I think when you look at adulteration and spurious drugs that’s a very different matter. I’m not even looking at that, because that is a criminal activity,” she added.

Also read: Is uniform implementation of drug approval system a possibility in India?

Shaw appreciated the Indian pharma sector’s commitment to ethical manufacturing practices but highlighted the need for credibility and quality control. “The normal pharmaceutical manufacturing activity, I think, is very robust. But I think our regulators also need to be able to build that credibility for Indian industry, through their own approaches to regulatory control,” she added.

The Biocon chief believes that maintaining quality standards in manufacturing products makes companies stand out and that should be the way forward.

Robust third-quarter growth

During the conversation, Shaw also highlighted Biocon’s stellar quarterly results. “I’d like to say that we’ve had a stellar quarter from my point of view. This is the first time we have crossed Rs 3,000 crore at a consolidated level and Rs 1,500 crore at the biologics business level,” she noted.

Also read: USFDA issues CRL for Bevacizumab license application moved by Viatris

Biocon’s third-quarter results were announced on February 14. The company posted a 25 percent year-on-year dip in net profit before exceptional items to Rs 140 crore.

Shaw said core EBITDA (Earnings Before Interest, Taxes, Depreciation and Amortisation) margins have improved, and widened from 33 percent to 36 percent.

“We have seen EBITDA grow substantially to Rs 723 crore, which is 35 percent year on year growth. This is also the first time we have crossed a core EBITDA of Rs 1,000 crore, so, overall I think the business is very robust, very healthy, very strong,” she added.

The Biocon founder said the company is anticipating approvals for its Aspart injection and Bevacizumab in this calendar year and was buoyant on US and Europe market sales, which will add to the business.

"We see a good trajectory when it comes to improving the market share of our existing business in the US. Europe actually is a market where all seven of our products are approved, and many of them will be launched this calendar year. So, we expect a lot of contributions from those products, even in the US and Europe,” she added.