Want regulatory reforms to expedite launch of new drugs in India: OPPI director general

KG Ananthkrishnan, director general, Organisation of Pharmaceutical Producers of India.

The coronavirus pandemic perhaps was the biggest challenge that the pharma sector faced in recent memory. From vaccines, drugs to diagnostics, the industry saw academia and industry work in tandem and cross-continent collaborations resulting in some excellent work.

The pandemic has changed the course of the industry but what lies ahead and what do multinational companies working in India want?

KG Ananthkrishnan, who is the director general of the MNC pharma body Organisation of Pharmaceutical Producers of India, has a few points to offer, some of which were also raised by OPPI members at its annual summit in Mumbai recently.

India needs to strengthen its R&D to sustain its leadership position in the pharma sector, Ananthkrishnan, who has in the past been with MSD India, Pfizer and Novartis India, told Moneycontrol in a video interview last week. He also sought the government’s support to protect intellectual property and simplify patent process. Edited excerpts:

MNC pharma companies in India seem to be restructuring their business models. Can you help us understand the reasons for it and what can we expect in the future?

Every organisation, irrespective of whether it is domestic or multinational, keeps looking at its structure to meet the needs of the market. This is a continuous exercise irrespective of the segment you are in and there are multiple factors why do we do this restructuring exercise—it is pan -industry stuff.

Number one is that the market dynamics can change, which will make an organisation relook at the current structure and see whether there is a need for certain modifications. That could be a function of the portfolio: I had an X portfolio, I am expanding that portfolio or I'm contracting that portfolio or I'm changing from that portfolio and that can have an impact on my organisational structure.

When I'm launching a new product within an existing market or entering a new market, I may need to review my organisational structure because if I’m entering a new segment, I may have to hone skills and have certain specific organisational requirements to drive that particular segment.

So, the organisation may strategically decide on how best to make use of this portfolio by extending it to deeper geographies, etc. Then organisations enter into strategic collaborations with others so that they're able to penetrate the market deeply.

At the end of the day, the idea is to be as patient-centric as possible and make products accessible to as wide a population as possible.

Are there new therapy areas that MNC pharma companies are looking at?

If you look at the new product portfolio that is coming in from many of my members, which are research-based pharmaceutical companies, they are highly focused in areas like oncology, in rare diseases, in neurological diseases, in cardiovascular diseases.

These are all areas where a lot of products are in the pipeline such as immuno-oncology.  Just a year back, when the COVID-19 pandemic was raging, our members were deeply involved in research related to COVID-19 vaccines and therapeutics.

Let's take antibody cocktails as an example. We were not talking about this much earlier but the demand of this pandemic has shifted the focus of many organisations to see how we can support and bring therapeutics against COVID-19, right? So, the antibody cocktails came. You also have products like antivirals Molnupiravir and Paxlovid.

Are there any changes or interventions that you want from the government in the regulatory framework to support companies?

At the outset, I must tell you that this government is making a lot of efforts to streamline the policy environment. If you look at the new drugs and cosmetics act, there is a whole mandate to revisit it.

Similarly, there is a committee looking at decriminalisation of certain regulatory stuff because the laws are archaic, and you're trying to make them a bit more modern. Also, for the first time ever, there is a draft policy aimed at catalysing R&D in the pharma, bio-medical technology and medical technology sectors.

Having said that, there are still some areas where we want improvement and one of the examples I'm taking is rule 101 of the New Drugs and Clinical Trials Rules, 2019.

The high-powered committees that framed the rules said that if a molecule is approved in other countries, particularly countries like the US, Europe or Japan, it can be fast-tracked in India without a phase-three study here.

The reason is that during the global studies, normally all population groups such as Caucasian, Mongoloid and Asiatic origin, among others, are covered. The committee felt that companies here should do Phase-4 post-marketing studies after the product launch and the big benefit would be that the lag between the launch of a product in the US or Europe and India will condense but unfortunately, until now, the list of countries that was to be prepared under rule 101 has not been finalised.

Another area is intellectual property and India has a patent law but despite that, there are issues of infringement. We are saying that if a product has been given a patent then we must not allow frivolous infringement of that patent in the country.

And, what we have been also requesting is that the process be very simple—that is, if anybody is applying for a manufacturing and marketing license for a patented product, that information should be available on a Sugam portal. Then a patent owner can alert the person who has made the application that if you launch this, it will be infringing on my patent. So, it will minimise patent infringements.

These are simple mechanisms that will also bring in a lot of transparency.  We are also saying let us streamline the pre-and post-grant opposition part.

And then finally, when any new research molecule comes, you invest a huge amount in creating clinical study data. Now, there is a provision called regulatory data protection—every country gives regulatory data protection, which means that a third party cannot use your proprietary data for their submissions and filings.

So, there is a minimum period—some countries give eight years, some give five years of data protection. What we are saying is that there must be some form of regulatory data protection because what is happening in most infringement cases is that the infringers are actually taking researchers’ data, submitting it to the regulator, and taking approval.

What do you have to say about the government’s drug price control policy? Do you have any suggestions? Are you happy with the way things are?

We are still awaiting the new National List of Essential Medicines because it has not been released and there is still work going on but fundamentally, what we have been saying is that the list should be created on the basis of essentiality.

Also, we are supportive of trade-margin rationalisation (TMR) but we are only a little bit disappointed with the further formula that has been applied. There are private market supplies and government supplies and within private market supplies most of my member companies are for these high-end products for rare diseases and oncology, among others.

Today, in the TMR calculation, we are also including free supplies that are going to patients directly. I must say that the government is engaging with us and we will be able to find a solution that is in the best interests of patients because, at the end of the day, the patient is at the centre of whatever we do.

What do you think about the R&D scenario in pharma companies in India?

India has over the three-four decades emerged as a powerhouse in manufacturing and pharmaceutical development but if you want to sustain the leadership position, what is going to help you remain the leader is R&D.

We have to shift gears from “Make in India” to “Discover in India”. There is a draft R&D policy and there is a suggestion that there must be a lot of collaboration between industry and academia.

Also, there has to be the development of innovation infrastructure. Take the example of Boston, which is a biopharmaceutical research hub. Today Biopolis in Singapore has also become a sort of hub for R&D in pharmaceuticals.

India must start establishing such infrastructure hubs that will attract people to start doing advanced research in the biopharmaceutical space.

Similarly, our academic curriculum has to be moved in a manner that really encourages R&D. In IITs, there are hubs and startups coming up. And finally, innovation must be incentivised, recognised and rewarded.

You've been talking a lot about academia-industry collaboration. Why isn’t that happening in a big way in India?

In the US, there is something called the Bayh-Dole law (legislation dealing with inventions arising from federal government-funded research), which allows academic institutions to collaborate with the private sector.

You can realise support, monetary support, and you can also get royalties on your inventions. In fact, if you look at the draft R&D policy, during discussions, we had suggested this and they (the government) have captured that a Bayh-Dole type of provision is needed in the Indian regulation so that it encourages academia to actively pursue collaborations with industry and take research to the next level. So, such refinements in the law are also required. Many of them are pretty well captured in the draft policy as well.