Indian IP and liabilities law barrier to pharma RnD investment

BOSTON: India's intellectual property regulations and liabilities laws pose a major barrier to foreign companies, especially from the US, that prevents them from increasing their footprint in the country's huge market, pharma sector leaders have said.

Andrew Plump, chief medical and scientific officer of Takeda Pharmaceuticals, a major Japanese drugmaker, said his company has a very limited presence in India.

"But it is open to increase its footprint in India, with the improvement in IP protection laws and those related to liabilities," Plump said.

"I think more and more there's an intent in India to try to open up its doors. I think if that happens, and if it facilitates entry of innovative patent-protected pharmaceuticals you will see value-driven companies coming into India," Plump told PTI on the sidelines of the 12th annual biopharma and healthcare summit here.

"Historically it (IP sector regulations and liabilities law) has been not just a hindrance but a barrier and impediment (for the US pharma companies to invest in India)," Plump said.

On Tuesday, Takeda announced plans to acquire London-listed Shire Plc for USD 62 billion, which is being described as the biggest ever overseas acquisition by a Japanese company.

"Our geographical spread hasn't taken us to India, which is quite unusual for us because we're a company that thinks about patients and access and there's such a huge unmet medical need in India. So, I'm hopeful that as we move forward we'll find ways to bring medicines to patients in India," he said.

Observing that India has outstanding data scientists, strong capabilities that it has in the pharma sector, Plump said relative to the academic excellence in India, relative to the population size and, a concentration in healthcare, "it's underrepresented in R&D" in healthcare.

According to the India Brand Equity Foundation, India's pharmaceutical industry is expected to grow to USD 100 billion by 2025.

William W Chin, professor of Medicine, Emeritus, Harvard Medical School acknowledged that it is important that the ecosystem that helps one discover and develop medicines focus on meeting great unmet medical needs.

"You heard today all the complexity of the disease, ..how long it takes to develop a medicine. And as a business model, it needs to have a certain incentive for people to invest, and also for companies to continue to take risk in these areas. Because for every medicine that works, there are probably nine that fail," he said.

Chin argued that there are many diseases that could benefit from what he called as disruptive innovation.

Noting that the Indian government has made good progress recently, Chin said changes in science and regulatory policy which allows for more rapid development of medicines. "An example would be improving how clinical trials are done with safeguards to participants, privacy and the like," he said.

"But I think that the government will need to continue to invest in those academic groups and even companies want to innovate. They have to provide additional incentives for companies to solve the problems, but also create medicines that could be used for the global market as well, in which case it becomes very important to help the economy of India also," Chin said.

Karun Rishi, head of the US India Chambers of Commerce, which organizes the annual US-India Biopharma and Healthcare Summit, said that India can be a significant player in artificial intelligence, machine learning and blockchain technologies.

"The use of Blockchain can add muscle to the digital economy especially in the Biopharma and healthcare sector. This is one area, we see India playing a significant role globally," Rishi said.

The 12th edition of the annual biopharma and healthcare summit attracted top corporate leaders from the American pharma sector with a collective research and development budget of more than USD 50 billion.

During the day-long session, scientists, academicians and experts from the sector brain stormed on various aspect of India's biopharma and healthcare sector.