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News: In this article, S Sridhar, the President of the Organisation of Pharmaceutical Producers of India (OPPI) lists what can help consolidate India’s pharma industry’s advantages and help it touch $130 billion by 2030 from $42 billion in 2020.
|India is the world’s third-largest drug manufacturer in volumes and ranks 14th in value terms. However, as per the Global Innovation Index 2021, India is the 46th most innovative country in the world.|
How can the PLI scheme for key starting materials, intermediates and APIs be improved?
Such schemes, along with a well-defined policy including Intellectual Property (IP) protection as well as innovation-driven private enterprises, will go a long way in creating India as a centre of excellence.
Suggestions to improve the scheme:
– A research-Linked Incentive Scheme
– Offering subsidy for access to and the implementation of new technology in projects under the existing PLI Scheme, to enable better output.
– Already identified products as well as any future inclusions for KSMs, DIs and APIs should be exempted from any price controls under the Drugs (Prices Control) Order, 2013 for a period of 10 years, or till the end of the tenure of the scheme.
What are the issues that need to be sorted?
– The New Drugs and Clinical Trials Rules, 2019 have specific provisions for expeditious approval of drugs for which there is an unmet need in India. The local Phase 3 clinical trial data may be waived 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 implementation of the above provisions remains open to subjective interpretations and delays in launch of path-breaking therapies.
– Indian law permits state drug regulatory authorities to grant marketing approval for a generic version of a medicine four years after the original product was first approved. Meanwhile, state regulatory authorities are not required to verify
the remaining term of the patent protection on the original product. Such gaps need to be resolved.
– Inadequate inputs from academia: Less than 0.5% of Indian students pursue a PhD or its equivalent. India also trails other countries in the number of researchers: It has only 216 researchers per million population versus 1,200 in China, 4,300 in the US and 7,100 in South Korea.
How should India’s drug regulatory system be streamlined?
The ecosystem of therapeutics is evolving from the old model of one-size-fits-all pharmaceuticals to offering more complex and targeted solutions. For instance: companion diagnostics, biomarkers, and/or combinations of medical technology and pharma products.
Suggestions for streamlining regulatory set up in India:
With a fast-moving evolution, there is a need:
– for harmonised guidelines and aligned systems across processes, therapeutic areas and product categories
– for a close dialogue with regulators
– to establish transparency through the creation of a single end-to-end digital portal which will act as an interface between Innovator and Regulator.
– Strategic policy interventions, as done during the pandemic by the Govt. During the pandemic, the government introduced regulatory policies to fast-track introduction of Covid vaccines, therapeutics and diagnostics.
What is the way forward
Encouraging research and innovation will be important to usher the next era of growth.
For India to evolve as an epicentre of biopharma research, sustained policy interventions and strategic partnerships are necessary.
Dedicated specialised patent benches with the requisite technical know-how for adjudication of patent disputes are critical, especially as patents granted under the Patents Act, 1970 have protection only for a limited period of time.
A strong academic foundation is reqd that drives research in collaboration with various stakeholders. This means identifying key academic institutions as centres of excellence, supporting them with adequate funding, focussing on therapy areas of national importance, and encouraging collaboration with industry. India should also incentivise foreign institutes to set up campuses.
Source: This post is based on the article “India trails other countries in researchers” published in Times of India on 22nd Mar 22.