Copyright infringement not intended

Picture Courtesy: www.businesstoday.in

Context: The Union Health Ministry has announced an ambitious plan to boost research and innovation in the pharmaceutical and medtech sectors. To achieve this goal, they have introduced the Promotion of Research & Innovation in Pharma-MedTech sector (PRIP) scheme, which has been approved by the Union Cabinet.

Details

• The Union Health Ministry has announced a plan to invest ₹700 crore in creating seven Centres of Excellence at various National Institutes of Pharmaceutical, Education & Research (NIPER) to boost research and innovation in the pharma and medtech sector.
• The scheme, called Promotion of Research & Innovation in Pharma-MedTech sector (PRIP), will be launched in September and will have a duration of five years, from 2023-24 to 2027-28.
• The Centre will also provide ₹4,250 crore to support research in the private sector through milestone-based funding. The Centre may also acquire equity stakes of 5-10% in these private entities in exchange for the funding.
• The scheme aims to enhance the capacity of PSUs and encourage private sector participation in research.
• The scheme's two components, dedicated funding for the National Institutes of Pharmaceutical Education & Research (NIPERs) and support for the private sector aim to address critical challenges and promote growth in these sectors.

NIPER Centers of Excellence (CoEs)

• The allocation of ₹700 crore for the establishment of seven Centres of Excellence across various National Institutes of Pharmaceutical Education & Research (NIPERs) is a strategic move to enhance research capabilities and technological innovation in the pharmaceutical and medical technology sectors.
• Each CoE will specialize in different research areas to collectively address key challenges and advance healthcare solutions.

Anti-viral and Anti-bacterial Drug Discovery

• Focus on developing new antiviral and antibacterial drugs to combat infectious diseases caused by viruses and bacteria. Research might involve identifying novel drug targets, designing molecular structures, and conducting pre-clinical studies.

Medical Device Development

• Aims to drive innovation in medical device design and development. Research could range from creating advanced diagnostic tools to designing cutting-edge implantable devices and wearable technologies for monitoring patient health.

R&D in Bulk Drugs

• Research in this area will be centred on producing active pharmaceutical ingredients (APIs) and other essential components used in drug manufacturing. Developing efficient and cost-effective methods for producing bulk drugs is crucial for pharmaceutical manufacturing.

Novel Drug Delivery Systems

• Work on developing innovative methods of drug delivery to improve patient adherence and treatment outcomes. This could involve technologies like targeted drug delivery, nanoparticles, and controlled-release formulations.

Phytopharmaceuticals and Biological Therapeutics

• Explore the potential of plant-based medicines and biologically derived therapies. Research might involve identifying bioactive compounds from plants and developing biological therapeutics like monoclonal antibodies and recombinant proteins.

Private Sector Support

• The allocation of ₹4,250 crore to support research in the private sector focuses on several critical areas that have the potential to transform healthcare and pharmaceutical industries.

New Chemical Entities and Molecular Entities

• Funding in this category aims to discover and develop novel compounds that can lead to new drugs targeting diseases with unmet medical needs. This involves activities like target identification, compound synthesis, and pre-clinical testing.

Complex Generics and Biosimilars

• Developing complex generic drugs and biosimilars helps increase accessibility to high-cost medications. Research in this area includes demonstrating equivalence to reference products and ensuring quality and safety.

Precision Medicines

• Research in precision medicine involves leveraging advancements in stem cell technology and gene therapy to create personalized treatment approaches. Tailoring treatments to an individual's genetic makeup can enhance efficacy and reduce side effects.

Medical Devices with AI and ML

• Integrating Artificial Intelligence (AI) and Machine Learning (ML) into medical devices can revolutionize diagnostics, treatment planning, and patient monitoring. These technologies can provide real-time insights and improve patient outcomes.

Orphan Drugs and Rare Diseases

• Focusing on orphan drugs for rare diseases addresses the needs of underserved patient populations. Research in this area can lead to therapies that might not be financially viable for large pharmaceutical companies.

Anti-Microbial Resistance (AMR)

• Tackling AMR is crucial to preserving the effectiveness of antibiotics and combating drug-resistant infections. Research efforts here might involve discovering new antimicrobial agents or alternative treatment approaches.

Overall, the PRIP scheme aims to create a comprehensive ecosystem for research and innovation in the pharmaceutical and medical technology sectors in India. By focusing on these critical areas and promoting collaboration between public and private entities, the scheme aims to drive advancements that can contribute to improved healthcare outcomes, job creation, and economic growth.

Significant for India's pharmaceutical and medtech sectors

• The PRIP scheme's focus on research and innovation has the potential to transform India's pharmaceutical and medical technology sectors. By addressing healthcare challenges, promoting accessibility, generating employment, and enhancing global competitiveness, the scheme aligns with India's vision for a healthier and more innovative futu

Research and Innovation Boost

• The substantial funding allocated through the PRIP scheme will provide a significant boost to research and innovation in the pharmaceutical and medtech sectors. This funding can support groundbreaking research projects, foster collaboration between academia and industry, and drive the development of cutting-edge technologies and therapies.
• Discoveries and advancements resulting from this increased research focus can contribute to addressing healthcare challenges, improving patient outcomes, and driving the growth of the sectors.

Affordable and Accessible Healthcare

• The scheme's emphasis on critical areas, including the development of affordable treatments and medical technologies, aligns with India's healthcare goals. By supporting research in areas such as generic medicines, biosimilars, and precision medicine, the scheme can lead to the creation of cost-effective solutions that are accessible to a larger portion of the Indian population.
• This can have a direct positive impact on public health and the affordability of healthcare services.

Job Creation and Economic Growth

• The growth of the pharmaceutical and medtech sectors through research and innovation has the potential to create a significant number of new jobs. These jobs will span various fields, from research scientists and engineers to clinical trial specialists and manufacturing professionals.
• As these sectors expand, they contribute to economic growth by attracting investments, generating revenue, and contributing to the overall development of related industries and services.

Global Competitiveness

• Fostering innovation and development through the PRIP scheme can position India as a global player in the pharmaceutical and medical technology industries.
• As the sectors develop breakthrough therapies, technologies, and solutions, India can gain international recognition for its contributions to healthcare advancements. This can lead to increased collaboration with international partners, attract foreign investments, and enhance India's standing on the global stage.

Challenges and Way Forward

Funding

• The pharmaceutical and medtech sectors require substantial financial investment for research, development, and infrastructure.
• The government should not only allocate initial funding but also consider periodic increases to stay aligned with the evolving needs of the sectors. This could involve collaboration with private investors, venture capital, and international funding agencies.

Skill Development

• A shortage of skilled manpower can hinder research and innovation progress.
• Establishing collaboration between academia, industry, and research institutions can create training programs, internships, and workshops to enhance the skills of scientists, researchers, and engineers. This collaboration can also help universities tailor their curriculum to industry requirements.

Infrastructure

• Insufficient research infrastructure can impede the progress of projects.
• Continued investment in research facilities, laboratories, and clinical trial sites is essential. Public-private partnerships can also contribute to the development and maintenance of state-of-the-art infrastructure.

Intellectual Property Protection

• Inadequate IP protection may discourage companies from investing in research and development.
• Strengthening IP laws and regulations will provide companies with confidence that their innovations are adequately protected. This can lead to increased investment in R&D and foster a culture of innovation.

Regulatory Framework

• Complex and cumbersome regulatory processes can slow down research progress and hinder commercialization.
• Streamlining and simplifying the regulatory framework for drug development, medical devices, and other innovations can accelerate the journey from research to market. Close collaboration between regulatory bodies, industry experts, and researchers can lead to efficient processes.

Conclusion

• The PRIP scheme aims to bridge the gap in research spending between India and countries like the United States, where a higher percentage of pharmaceutical company profits are allocated to research and development. By doing so, the Indian government intends to promote innovation, attract investments, and foster the development of new medicines and technologies in the country's healthcare sector.

PRACTICE QUESTION Q. What is the significance of public-private partnerships in the medical sector, and how do they contribute to the advancement of healthcare? What are the challenges associated with implementing such partnerships, and what strategies can be employed to overcome these challenges and ensure a successful collaboration for the betterment of healthcare services?

https://www.thehindubusinessline.com/companies/health-min-allocates-4250-cr-rd-push-in-pharma-and-medtech-for-private-sector-700-cr-for-nipers/article67248743.ece