Need create atmosphere innovation

Need to create an atmosphere for innovation

10:27 AM, 6th July 2016
Need to create an atmosphere for innovation
Sujay Shetty, partner, pharma and leader, life sciences, India, PricewaterhouseCoopers Pvt Ltd (PWC).

In an interview Sujay Shetty, partner, pharma and leader, life sciences, India, PricewaterhouseCoopers Pvt Ltd (PWC), with Shivani Mody, Editor, Chemical Today magazine, talks extensively about the growth in the Indian pharma industry, their loop holes and shares some mantras which will make the country a world leader in the pharma sector.

India is a significant producer of APIs and formulations. What factors have helped India achieve this growth in the industry?

We developed a great generic industry in the country long back and later started exporting to the US markets in the 80s. Since then we started meeting the US regulatory compliances. India started growing in the formulations industry because of process patents. We were able to produce and also had the foresight to enter the US market early. And that’s how we created a great formulations industry unlike anywhere else in the world. Ranbaxy, Dr Reddy’s were among the first few companies to start exploring the market potential.

In the API industry, we already had good chemistry skills along with processing and manufacturing technology. Thus we were able to make some very complex intermediates, and this has actually given a lot of fillip to the formulation industry. But over the last two to three decades, China has become a dominant player.

It has a huge chemical industry and has rapidly moved up the value chain in APIs and formulation. Currently India is importing heavily from China. But India still makes high level intermediates and APIs and there are many companies who have been making these APIs and moving up the value chain. But we cannot be compared to our Chinese counterparts as we do not have the size and scale similar to China.

What are the challenges that the Indian API industry is facing which is hampering the growth?

The main challenge faced by the API industry today is in the manufacturing segment. Manufacturing requires all the basic inputs to be available at cheap rates such as electricity, power, packaging, land etc. Presently, various types of infrastructural issues are affecting the quality of manufacturing and causing the slowdown in this industry.

In the formulation industry, issues are mostly in the area of quality of manufacturing, failure of inspections, lapses in the good manufacturing practices (GMP) to name a few. Since US is a significant market for Indian companies, these factors are important and need to be addressed.

In the domestic market, the rising pressure from the government in terms of National List of Essential Medicines (NLEM) is adding stress to the manufacturers. The government has implemented a new selling code on the domestic formulation companies which has new guidelines on how companies will sell their products to doctors. This is another area which is hampering growth.

However, globally and in the domestic market, Indian companies are in the middle of some of the strongest mergers & acquisitions in the last one year and we are expecting the companies to continue expanding overseas via these M&As and fill up the gaps in the portfolio.

Recently the government announced that there will be many changes in the bulk drug industry in lieu of the recommendation from the Katoch committee report which will make India self-sufficient. What are your thoughts?

That’s a good thing because as I said, it is difficult to set up a bulk drug facility because of infrastructural, environmental and various other constrains. So the government’s initiative to set up bulk drugs zones, parks complete with water treatment facility, effluent treatment and other infrastructural facilities will assist the industry to grow and expand. It is absolutely necessary for the industry in this scenario.

Will India be able to compete with China with these initiatives?

That can definitely happen as India has the required background. To be self-dependent and move on from importing from China is an achievable goal. But how long will it take to have these bulk drug parks is something that the government can answer.

How is India fairing in the vaccines and generic industry?

In vaccines, India is the world leader. There has been a lot of development in vaccines and we are recognised worldwide. There is work going on continuously in this segment of the industry and we are constantly innovating in areas like malaria, dengue, oncology, etc. Indian companies will continue to be world leaders in this area. And the same kind of growth is being seen in biosimilars and Indian companies are trying to develop biosimilars and trying to get similar success in this area.

However, we are still at the very early stages and we do not have the skills in biotech. But there are few companies like Biocon who are working in that area extensively in product development.

Are we also growing in the painkillers category as well?

In the individual therapy category, all of them have Indian producers. Among all therapy categories, Indian companies are in the top 20 category. India is extensively working in those areas so rather than singling out pain killers, I think in the therapy basket as a whole, we have companies which have competencies in one thing or the other.

Drug discovery is an area where we are still struggling. What needs to be done to strengthen ourselves?

Yes, in drug discovery we are still weak, and we will continue to be weak although India is trying hard to go up the innovation chain and value curve. There are just a handful of companies working in that area for chemical entity research or normal therapeutic drug research. The reasons being: it is expensive, it should be created globally, we need the skill sets and this process need long patience. India will come up with new drugs but right now the atmosphere is not fully suited for that. At present we just have a handful of success stories in that area like Glenmark, Biocon. We need to wait and watch how it shapes in the future.

Indian needs to support more innovation and then probably we can move ahead. Certain things needs to be done like academic interventions, industry collaborations, tech talks, clinical research - which is a big bottleneck in drug discovery, clinical R&D- because clinical trials in India actually comes to a halt for one reason or the other. All this will create an atmosphere for innovation and drug discovery.

Nano medicine is a growing area globally. How is India responding to this new technology?

This is a relatively new segment in the country and it will still take time to grow and develop. It needs people to come up with solutions and ideas. Compared to the US, right now there are a limited number of companies working in this direction in India and there are many gaps to increase the knowledge base and expertise.

Tell us about some of the prominent trends that are catching up in the pharma industry.

Things like pricing pressure, FDA, M&As, the entire process of producing new biosimilars, US FDA to meet the quality standards, UCPMT – which is a selling code, are very significant in the domestic market in terms of bringing a change and is drastically forcing the industry to change. All these are making an impact in every company’s strategy in 2016.

What are new technologies which are entering the pharma industry and adding strategic value to the industry?

I think digital analytics is an area which is picking up as every company wants to come into the modern world with the digitization of various things like the supply chain, understanding patients’ behaviour, distribution etc. So a lot of work is beginning to happen in digital analytics which will in turn bring in innovation. Those are the kind of technology we are talking about these days.

People are also trying to use mobile technology in better tracking and better data mining of customer etc. We are starting to see these technologies coming in. Although, it is just the early phase, people are becoming more and more mature about the solutions they want.

Are wearable devices going to be the next big thing in the country?

Maybe in the US, but not here yet. Even in the US, it is in the early days with Apple watches for fitness tracking. In India they are watching the wearable device trend, but there doesn’t seem to be anything happening from a strategic point of view that is making an impact.

India is far behind in filing patents as compared to Japan, South Korea and many other countries. How can we change this scenario?

All companies are engaging in innovative ideas, working either in the digital or internet based platform. Indian companies also know that they have to go up the innovation curve. I believe, over the years you will see more and more of those ideas coming in.

You had mentioned in a report that the Indian pharma market will grow at 15 - 20 percent and to reach up to $50 or $74 billion by 2020. What are the main factors that will lead us to that growth?

Usually the industry growth is twice the growth of the GDP. At present, India’s GDP is around 7 percent, so industries will grow around 14 percent. According to the latest statistics, the overall domestic market is growing at about 12 percent per annum, which is a strong growth figure.

The bigger growth comes from the overseas markets particularly the US markets which depends on couple of factors like new product launches, repeat appreciation etc. So even if the entire industry may not see that growth but the best in class pharmaceutical companies will certainly be aiming for a 20-22 percent growth.

© Chemical Today Magazine

  • See the Interview Coverage in Chemical Today magazine (Pg 32)

  • View the interview on Mobile, download the Chemical Today magazine app



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