YOU what can help consolidate the advantages of the Indian pharmaceutical industry and help it grow to $130 billion by 2030 from $42 billion in 2020, and address unmet medical needs:
It has been over a year since the production-related incentives for major raw materials, intermediates and APIs were notified. How should the diet be improved?
Now is the time to consider a research-related incentive program and also consider offering grants for accessing and implementing new technologies in projects under the existing PLI program, to to allow better performance. In addition, the 41 products identified along with any future inclusion of KSM, DI and API are expected to be exempt from any price controls under the Medicines (Price Controls) Order 2013 for a period of 10 years or so. ‘at the end of the scheme’s mandate. The scheme should allow for backward integration of identified products, which would contribute to its broad base. Such programs, coupled with a well-defined policy that includes intellectual property protection as well as innovation-driven private enterprises, will go a long way in making India a center of excellence.
The growth of India’s pharmaceutical industry has slowed down over the past five years. Is there a structural problem?
India is the world’s third largest drug manufacturer by volume and ranks 14th by value. However, according to the Global Innovation Index 2021, India is the 46th most innovative country in the world. Stimulating research and innovation will be relevant to inaugurate the next stage of growth. For India to evolve as an epicenter of biopharmaceutical research, sustained policy interventions and strategic partnerships are imperative to focus on high-risk innovation and strengthening government-industry-academia partnerships. Being ready for the future is about advancing the development of new treatments and cures to address unmet medical needs.
How to streamline India’s drug regulatory system?
We foresee a more complex therapeutic landscape that will shift from the old model of one-size-fits-all pharmaceuticals to more complex and targeted solutions that involve, for example, companion diagnostics, biomarkers and/or combinations of medical technology and products pharmaceuticals. With this rapid evolution, the need for harmonized guidelines and systems aligned across processes, therapeutic areas and product categories, as well as close dialogue with regulators, is imperative. There is a need to establish transparency through the creation of a single end-to-end digital portal that will act as an interface between the innovator and the regulator.
During the pandemic, the government introduced regulatory policies to expedite the introduction of Covid vaccines, treatments and diagnostics. Such strategic policy interventions, through sustained push, can not only increase the ease of doing business or increase the sector’s export footprint in under-penetrated markets, but also accelerate access to affordable solutions, innovative and lifesaving.
Interestingly, the New Drugs and Clinical Trials Rules 2019 contain specific provisions for the rapid approval of drugs for which there is an unmet need in India. Local Phase 3 clinical trial data may be deleted if a new drug is approved and marketed in countries specified by the Central Licensing Authority under Rule 101. However, this list of countries remains absent and the implementation of provisions above remains open to subjective interpretations and delays in the launch of innovative therapies.
What changes would you suggest in the operation of the intellectual property regime?
Dedicated specialist patent benches with the technical know-how required to adjudicate patent disputes are essential, particularly as patents granted under the Patents Act 1970 only enjoy protection for a limited period. On average, economies with stronger IP environments host 9-10 times more clinical trials than countries with weaker IP systems.
Indian law allows national drug regulatory authorities to grant marketing authorization for a generic version of a drug four years after the original product was first approved. During this time, state regulatory authorities are not required to verify the remaining term of patent protection on the original product. Therefore, an infringer can obtain marketing authorization for a generic version of a patented medicine, forcing the patent holder to seek redress through the Indian court system. OPPI called for the development of policies to resolve ambiguities between intellectual property laws and other laws or authorities whose jurisdictions impact patent enforcement.
Is pharmaceutical R&D hampered by inadequate contributions from academia?
Less than 0.5% of Indian students pursue a doctorate or its equivalent. India also lags behind other countries in the number of researchers: it has only 216 researchers per million inhabitants compared to 1,200 in China, 4,300 in the United States and 7,100 in South Korea. It is crucial that all innovation hubs have a solid academic base that propels research in collaboration with various actors. This requires identifying key academic institutions as centers of excellence, supporting them with adequate funding, focusing on therapeutic areas of national importance, and encouraging collaboration with industry. India should also incentivize foreign institutes to set up campuses through tax breaks, repatriation of profits, simplified visa standards, one-stop-shop permits, etc.