New Delhi: The centre’s ambitious National Health Protection Scheme needs to be integrated with primary healthcare to make it viable and sustainable, Kiran Mazumdar-Shaw, chairperson and managing director, Biocon Ltd said in an interview.

Regulatory compliance is a big challenge for everyone across the world and firms in India need to adapt to changing regulatory environment at a rapid pace, she said, adding that India’s drug price regulator does not differentiate between large firms with high-quality standards and smaller ones lacking them while fixing prices, which is a problem. At Biocon, she wants to focus on insulin therapy and wants the company to provide a Biocon product to one in five people across the world. Edited excerpts:

What do you think about the health care sector in India? Do you think we invest enough? An ambitious National Health Protection Scheme (NHPS) was announced in this budget. What do you think about the scheme and the sector overall?

The NHPS announced in this budget is welcome and long overdue because it shows that there is a thinking and a focus on some form of Universal Health Care (UHC) for at least the poor strata of our population.

Because, without positive health indicators, India’s inclusive growth potential is stifled and it is already estimated that you can increase the GDP growth by 1.5% with better health indicators, while India has very poor health indicators when it comes to child and maternal mortality, nutrition and underweight, etc.

So, there is a huge problem and NHPS is extremely important that it has got the deserved focus. Now, coming to whether we are investing enough...there has been lot of discussion and debate about what is the model that we are going to follow...is it going to be an insurance model, a trust fund model that means reimbursement—what is it?

Insurance or a reimbursement model—that itself has to be figured out. Then the bigger question we need to ask is it is just a cash-less hospitalization scheme or is this is an end-to-end healthcare scheme.

That’s a fundamental question we have to ask...I personally believe that it has to be an end-to-end UHC scheme, which means we must actually integrate primary healthcare into this scheme. If you want to make it into a sustainable, viable model, then you will have to down-stage the disease to primary healthcare, which means preventive healthcare becomes a very important part of delivering on this particular goal.

Do you mean to say that we need to integrate primary and tertiary care to make it implementable?

Correct; if you don’t combine it and integrate it with primary care, it won’t work because you will only find people going to the hospitals. Now, we need to make sure that you down-stage the disease so that the people actually going to the hospitals, either secondary or tertiary, will really be the ones that need to go.

Are you concerned about implementation of the scheme?

I am saying if you want to implement the scheme and are looking at secondary and tertiary care hospitalization, it’s never going to be viable. It’s not going to sustain because of the amount you need.

Today, numbers from Rs10,000-20,000 crore are being talked about. What is the right number, you will never be able to address unless you understand what you are trying to do. I personally believe that healthcare has to be thought through in that way...

My view is, before you roll out a whole plan, you should do it on about a million families, like a pilot. Then, the Rs2,000 crore will be well spent because you need to map it out and see how it works... but somebody needs to run this pilot very holistically and if you get companies doing things under CSR, and give them some kind of partnering models to come together and roll this plan out, then you can do it fast.

But if the government wants to start from scratch and build it up ground up, it’s going to take a lot of time because I feel that it’s not been thought through fully.

You termed 2017 as a landmark year for Indian science in one of your blogs, given the fact that there are regulatory issues with severe criticism coming from US regulators. What is your take now?

Regulatory compliance is a big challenge for everyone, not just in India but across the world, because US and European regulators are becoming far more stringent than they ever were. In the past, compliance norms were not so stringent as they are now so as they become more stringent, we have to catch up and make sure we are as compliant today as before.

Now, we are trying to play in bio-similars. From that point of view, compliance has become so important for every large Indian pharma firm that we are actually investing a lot in beefing up our compliance systems making sure everyone has appointed a set of consultants to help us improve.

A few years back, due to some regulatory issues pertaining to clinical trials, you had to go to the US for your oral insulin. Is it still the same in India?

It has improved to a certain extent. The Indian regulator has improved its standards of inspection, and is accompanying the US FDA and European inspectors to learn how to inspect better; all that has improved I must say, but when it comes to regulating the smaller guy, it’s not yet done.

On one hand, NPPA doesn’t differentiate between large and small firms and they fix up prices based on the lowest common denominator—which is the small unregulated guy. Is it fair that as a patient, if I am taking a medicine, I don’t get to know the quality? Won’t I be willing to spend a little more if I know it comes from a larger reliable firm than just from some unknown small firm just because its cheap?

And the larger firm says I can’t make it at those prices because that person doesn’t have those standards and systems we have. Where is this discussion and disparity that has to be sorted out? And the government is not sorting it out equitably.

Coming to NPPA, what do you think about price control in India?

There has to be a price regulation, I agree. I don’t think we should just allow hospitals to charge whatever they want but I think every drug can be priced and there has to be ceiling price. But how to arrive at the ceiling price is the question. The logic that they are using is flawed. They are looking at a whole bunch of prices irrespective of quality, who is making it, what is the infrastructure, investment, R&D investment—they are looking at like-for-like comparison.

If I were to compare Cipla, Lupin, Sun and Biocon, I would say it’s a fair comparison but if I start comparing with some small company in the back of beyond which is a Rs50 crore or a Rs10 crore company—they are making medicines with no R&D, have no quality systems, QAQC (quality assurance, quality control) and are not inspected by any regulator. Today, we are all inspected by US and European regulators. So, how do you differentiate between the firms that have got EU kind of standards with firms that have very poor standards, and then say this firm is making it at 10 paisa, why are you charging Re 1? And then, you say everybody should charge 10 paise. That’s not acceptable... I feel that people who are taking these calls are not even scientific. It is becoming a commercial financial decision, which is absolutely wrong when it comes to drugs and science.

At Biocon, you have an exclusive league of biosimilars. What next?

Biocon is on a journey of making impact on global healthcare. I have to make sure that I have one in five persons who needs insulin therapy to use a Biocon product—that is my dream... in the next ten years, I want that to happen...whoever needs insulin and insulin analogs.

Let’s hope that one in five of those people around the world will use a Biocon product. That is a big dream…I want to make sure that our bio-similars capture a huge market share and help cancer patients around the world, which we are already doing in the developing world because we didn’t have access to these drugs.

Biocon enjoys a large reputation of giving them high-quality cancer drug...my biggest dream is I want Biocon to be a company of which at least one drug makes it big, whether oral insulin or fusion mAbs (monoclonal antibodies)...I want it to be a big drug and Biocon should be known for that—this is my ‘what next’!

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