A dose of innovation

Pharma sector needs a supportive environment

A top executive of Swiss pharmaceutical major Novartis, Judith Love, has underscored the importance of an ecosystem that’s conducive to innovation in India. In an interview to this newspaper this week, Ms Love cited regulatory data protection (RDP) and strong intellectual property (IP) rules as the pathway for India to establish itself as a cutting-edge research destination while attracting global investment in the pharma space. For investment to scale up, speedy reforms have to be brought in, she pointed out. Recently, Kiran Mazumdar-Shaw, founder and chairperson of Biocon, too, highlighted the need for reforms that allow early-stage biotech companies to access public markets. 

Focusing on related issues, Union Commerce and Industry Minister Piyush Goyal, in an address on Sunday, reiterated the importance of resilience so that India could draw higher investment for research & development (R&D) as well as clinical trials. Mr Goyal said that India’s drug industry could not just rest its case with generics and that it must focus on more R&D and patent its own products. Such a message cannot be ignored as India has largely remained a country of generic medicines, rather than harnessing its research potential in the pharma sector. The narrative of innovation-led original drugs versus generics is not new, but it’s a timely reminder for the industry as well as policymakers to thrash out issues to push India up in the global pecking order. At the centre of it all is the way forward on introducing RDP, a mechanism that would prevent generic drugmakers from relying on data on clinical trials and safety submitted by innovators for a fixed period after a medicine is approved in India. While research-based multinational companies are batting for a 10-year protection period starting from the date a drug receives marketing approval in India, domestic generic drugmakers are pushing back, saying that an RDP regime could delay the entry of low-cost medicines while raising prices overall. 

Even as the government is engaged in talks with the industry to find a balance between the two sides and break the deadlock over RDP, there are other issues at play as well — for instance, the lack of a level playing field. This is because the first company to seek approval for a new drug has to spend on local clinical trials and the late entrants can secure the regulatory nod for the same drug at a much lower cost by skipping clinical trials and submitting basic chemical and bioequivalence data. Besides stakeholders’ views on complex RDP and patent rules, India is also guided by international trade agreements. In a recent explainer on the India-European Union deal, the government said that the IP chapter did not restrict India’s right to grant compulsory licensing for public health. According to the World Intellectual Property Organization’s Global Innovation Index, India ranked 34th in the latest edition, while being called a leading “generics pharmacy to the world’’. For India to go up the innovation ladder, the Centre, the states and industry stakeholders have to work together for a future that’s grounded on research and innovation. There have been demands for research-development funds as well as R&D-linked waivers and tax benefits.  It’s time to look at all the options comprehensively.  And, it’s critical for the country to maintain focus on medicine affordability and their reach to the masses.