Building Bridges for Sustainable Growth through Strategic Alliances in Ethical Pharmaceuticals

In an interaction with India Pharma Outlook, Sudheendra Kulkarni, MD & CEO of Ferring Pharmaceuticals India shares insights about India's evolution from volume-based to value-based healthcare. He emphasizes the necessity of building biopharma manufacturing capabilities, adopting new technologies, and creating innovation-led ecosystems. Also, he emphasizes the cooperation between industry, academia, and the government in pushing sustainable growth and reforms in clinical research. As CEO of integrated Ferring Pharmaceuticals operations, Sudheendra leads commercial operations and guides R&D and manufacturing operations for India and South Asian countries. He is part of the APAC leadership team and actively contributes to collaboration across the AP region.

India's transition from a volume-based healthcare model to a value-driven one is gaining traction. How can businesses enhance high-value manufacturing capabilities in biopharma to lead this shift?

India has developed capabilities in reverse engineering for a long time. Reverse engineering is helping in building a strong capacity to manufacture and develop the molecules locally, which were off-patented. However, the difference is most of these were small molecules. It is small molecule chemistry-based reverse engineering, which is also a great capability to build on and India invested in that. Many companies have become big on that front, today, we have been able to cost-effectively manufacture and service most of the world. This is what gave the volume-based advantage.

Most of these small molecules are treated for general-purpose ailments or not very specialized disease treatments. So the need for biologics, biosimilars, or large molecules, which are like the latest class therapy that comes out. This is where India needs to transition now. Efforts are being made. However, they are still in the early phases. India is getting traction.

One of the key enablers is how to build technology platforms. Because manufacturing of large molecules, complex biologics requires a technological understanding that comes over some time. And it is far different from the chemistry-based competencies that we have developed. This is where working with multinational companies, educational technological institutions in India, and the companies or the R&D labs working together can make it move from not just the volume-based, but also value-based biopharma shift India can do.

Global capability centers, GCCs in India are evolving into innovation apps. How can India scale these GCCs to drive breakthroughs in digital health and medical R&D?

The global capability centers, India is catching up very fast. This is the next phase of innovation or outsourcing which is happening. This is mainly linked to using India's capabilities for very highly educated youth available as a workforce in India as compared to anywhere else in the world.

Most of the mandates with the global capability centers are currently delivering are based on their global mandates and global requirements. So we are still working as a back-end hub rather than a front-end hub. That is also important because the back-end hub will give you a lot of muscle strength to develop the capabilities, to develop the capacity building is what we call us. With that capacity building, global capability centers need to leverage, use, and start creating fresh innovation from India, which is still not happening. Because mainly all the GCCs are MNCs, back-end centers or MNCs, captive centers of knowledge.

India has taken the first advantage as compared to many other countries around the world. We need to work very closely in partnership with other enabling information providers like educational institutions, technological hubs. All of this can help in making GCCs also as an innovation hub.

How can clinical trial policy reforms attract investments?

India's clinical trial reform is underway. This is a work in progress. We can make it more streamlined. Clinical trials in India can be conducted at a very nominal cost as compared to what the global clinical trials will cost. But this is not being perceived very aggressively across all multinational companies. Multinational companies are doing trials in India. But these are mostly the registration trials or required for registration to enter the local market.

Not to solve the global clinical questions that they would have had when they did the initial phases of the trial. So, the government needs to work along with the industry and create a separate single window clearance type mechanism within the Department of Biotechnology and other places that look into these proposals. And also at the drug controllers and, at the CDSCO levels, which are our regulatory authorities, if they can further empower the companies to leverage the advantage that India offers. So that will be a great step forward in terms of bringing global clinical trials into India.

How can streamlining regulations improve local production efficiency?

The government has done a lot in a couple of decades, but still, we are not in the best place in terms of shifting manufacturing to India because there are bottlenecks. We still have central regulatory bodies, local regulatory bodies, state regulatory bodies, FDAs, and then other authorities. So there are several overlapping authorities taking care of several requirements. This makes life very complicated for the companies to come and invest.

It is not just about the production-linked incentives. A production-linked incentive is one way to attract capital also how to do the business easily and helping the businesses to come and invest without any worries. Even though the government intent is very good at the very senior and top level, but on ground at the bureaucratic level, at the local level or at the regional level or state level, it is still not very conducive for the companies to come and invest and start manufacturing in India.

The U.S. wants to manufacture in the U.S. So they are asking all the companies to come back and invest. So every country wants manufacturing to shift back because manufacturing means economic activity, job creation, so on and so forth. So we must look into this as a strong enabler. India has a clear advantage but the advantage is just not readily available on a free plate for us.

How can Indian companies build deeper, impactful collaborations to drive sustainable ethical medicine growth?

There are alliances within the Indian companies and local companies. But it is still at very industry association level, reacting to the government policy interventions or addressing the policy related issues, etc. But company to company, building collaboration, building a common knowledge, leveraging that common knowledge from one company to another company and to bring some innovation from India, we are still far away from that.

We don't have even a single new chemical entity hitting the global markets and creating waves. For example, in obesity, India has one of the largest diabetic populations, and obesity is going to be a big challenge for a country like India.

But today the most innovative new drugs approved for managing obesity are coming from elsewhere. This is not just private companies working together. In India, collaboration is required between educational institutions, universities, the Indian Institutes of Technology, other technology hubs, and government agencies that promote innovation in technology. It is a collaborative ecosystem that needs to be created.

How can India ensure it remains a global leader in healthcare innovation by 2030?

One of the biggest advantages for India is having a very strong technology bent in terms of technology talent, credibility, and credentials. Most of the AI and digital technology for global companies is driven by India or people of Indian origin. So we have a very strong bent of technological innovation across the country.

Private sector, public sector, the government and academia can come together to build a platform, an ecosystem which can really help in looking into how technology can deliver this. Now we are seeing that how India can participate in the new era of artificial intelligence, machine learning, and all these things. And we are working on how to build our own LLM, a large language model.

China has already got into something. It created waves around the tech world a month ago. We can create something that can be different from what is established or what already exists, and then this route will be open for us. Currently, we are working in the mindset of servicing the other's needs. The mandate comes, but the requirement is from elsewhere.

We are in the process of meeting existing needs right now. Actual progress is when we begin to create new needs and establish new benchmarks. That is when we start working on building our LLMs or even establishing brand-new models. The next ChatGPT or OpenAI game-changer can come out of India. If there is a proper ecosystem, genius brains, and government backing, much can be done. This will take a multifocal approach and lots of cooperation.