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Proposal for RLI scheme will soon be submitted to Union Cabinet for approval: Union health minister
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Shardul Nautiyal, Mumbai
June 27 , 2023
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Union health minister Dr Mansukh Mandaviya has said that work is in progress for the research linked incentive (RLI) scheme to boost research and development (R&D), and the proposal will be soon submitted to the Union Cabinet for further deliberations and approval.
Talking to Pharmabiz on the sidelines of the recently concluded Indian Pharmaceutical Alliance (IP Alliance) 8th Global Pharmaceutical Quality Summit held in Mumbai recently, Dr Mandaviya further added that in order to achieve both quantity and quality, R&D and innovation policy will soon be out for the pharma sector and the broader contours of RLI scheme is currently being contemplated by the government to create an enabling R&D environment. This will include initiatives like creating centres of excellence and industry academia linkages for growth of all stakeholders.
Pharma innovation is the focus area as per Para 30 in the Union Budget which provisions for a new programme to promote research and innovation in pharma. This will be taken through centres of excellence.
Government of India’s flagship production linked incentive (PLI) scheme today offers 5% incentive based on the production. The Department of Scientific and Industrial Research (DSIR) certification used to offer benefits in terms of GST which was one of the ways to promote research. The second incentive was a 150% weighted tax deduction on R&D which no longer exists post GST regime.
Dr Mandaviya further added, “India has proved its credibility as a resilient value chain and the Pharmacy of the World by showing a matured behavior in the time of Covid crisis. Such responsible behavior asks for accepting the challenges around good manufacturing practices (GMP), self-regulation, developing a quality culture, developing synergies and leveraging the potential of stakeholders towards moving up the value chain.”
The Union health minister further explained that a new programme for research in pharmaceuticals will be formulated. Besides this, facilities in select Indian Council of Medical Research (ICMR) labs will also be made available for research by public and private medical faculties as announced in Union Budget 2023-2024, which are a part of my recommendation.
The two-day Summit also deliberated on continuous manufacturing, regulatory expectations and digital technologies in pharmaceutical manufacturing. The highlight of the Summit was the panel discussion comprising leading CEOs of the pharma industry from Cipla, Dr Reddy’s, Lupin, Sun Pharma and Zydus on the future of the Indian pharmaceutical industry.
While talking on the sidelines of the Summit, Sudarshan Jain, secretary general, IP Alliance said, “Quality is the fundamental tenet of the pharmaceutical sector. Therefore, continuous investments in the quality systems, R&D, technology and talent are fundamental with the evolving regulatory and healthcare landscape.”
With the Indian pharma industry set to grow from a US$ 50 billion industry to a US$ 500 billion industry by 2047, there is an immense challenge to address in terms of introducing full automation in the analytical instruments industry for data integrity and quality assurance, according to industry experts.
Industry has also voiced the concern that there is an urgent need for government’s intervention to promote analysts community in pharma through a RLI scheme as analysts play a pivotal in assuring medicine quality for patient safety.
The Industry Associations had also made a representation to the Department of Pharmaceuticals (DoP) on proposed RLI scheme a few months back. The DoP also shared a concept note on the proposed RLI scheme in moon-shot areas of the pharmaceutical sector.
It was also suggested that the Committee set up for the RLI scheme need to be expanded with diverse field experts from formulations and manufacturing.
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