Policy Updates
Bhavana Girase
Background
India is emerging as a global leader in biotechnology, with its biotech sector valued at USD 165.7 billion in 2024 and projected to reach USD 300 billion by 2030. Recognising the sector’s vast potential to address global challenges, the Government of India launched BioRRAP (Biological Research Regulatory Approval Portal) in 2022, an online platform developed and maintained by the Department of Biotechnology (DBT) under the Ministry of Science & Technology.
BioRRAP provides single window access for biotechnology-related approvals and information, significantly enhancing the ease of doing research and business in biotechnology, bringing multiple regulatory processes under one seamless platform.
It plays a pivotal role in supporting the sector’s rapid growth by streamlining approvals and fostering innovation.
Functioning
Biological research activities involve handling and exchange of materials that include microorganisms, plants, animals, human samples, and also biodiversity resources. To handle the regulatory oversight of such activities, BioRRAP provides a single route to direct the applicant to regulatory agencies providing the requisite approval relevant to the biological research. The system determines which regulatory agencies approvals may be necessary based on the applicant’s responses to a brief set of questions. These approvals are subsequently linked to the unique BioRRAP ID generated during submission.
Registration Process Overview:
Source: Department of Biotechnology, Ministry of Science & Technology, Government of India. BioRRAP (Biological Research Regulatory Approval Portal).
Source: Department of Biotechnology, Ministry of Science & Technology, Government of India. BioRRAP (Biological Research Regulatory Approval Portal).
Regulatory Approval Workflow via BioRRAP:
Source: Department of Biotechnology, Ministry of Science & Technology, Government of India. BioRRAP (Biological Research Regulatory Approval Portal).
Regulatory Approvals Required for Research & Development Using Biological Material.
Source: Created using Canva
Performance
The BioRRAP portal is intended to improve the efficiency of regulatory bodies that monitor different facets of biological research. The portal contributes to the larger objective of making biological science research in India easier by expediting the regulatory process.
BioRRAP is introduced with the vision of One Nation, One Portal. This single digital gateway will help track and initiate applicants to various regulatory agencies. The following are the effects that this portal brings.
- Credibility-Each research project receives a unique ID from BioRRAP. This allows for consistent tracking and verification throughout the project.
- Transparency and Governance-Digital tracking allows researchers to clearly see the status of their submissions through the portal platform, ensuring regulatory compliance, which eliminates uncertainty.
- Ease of Doing Research-Making the application process more transparent, centralised, and user-friendly aligns with the objective of Ease of Doing Research objectives.
- Improved Coordination-BioRRAP enhances interdepartmental coordination among regulatory agencies, which improves efficiency and accountability.
India’s Achievement in Biotechnology:
Source: Biotechnology Industry Research Assistance Council (BIRAC): Global Bio‑India 2024 Brochure
Impact
- Digital submission and tracking ensure approvals move faster compared to manual processes.
- One portal manages everything and tracks progress in real time, which lessens delay and removes barriers.
- Encouraged investment in the biotech and life science sectors.
- Created a strong foundation for digital governance in research approvals.
- BioRRAP supports India’s goal of becoming a key player in the global bio-manufacturing hub.
- India ranks among the top 12 destinations for biotechnology globally and the 3rd largest in the Asia Pacific region.
- By 2025, the contribution of the Indian biotechnology industry to the global biotechnology market is expected to grow to 19% from a mere 3% in 2017.
- BioRRAP will help in the ease of doing research and ease of business.
India’s Global Biotech Rankings & Growth:
Source: Biotechnology Industry Research Assistance Council (BIRAC): Global Bio‑India 2024 Brochure
Emerging Issues
Data Privacy- Strong security protocol for managing confidential research data.
System Stability- To handle increasing user traffic and sensitive data, the portal must have a strong, responsive, and secure system.
Limited Research- BioRRAP is specifically for research-related approvals, not for product development.
Awareness and Training- Successful adoption depends on awareness campaigns and user support.
Data Protection- Research data should have a backup plan to ensure it isn’t lost due to system errors.
Cybersecurity Enhancement-India is advancing data protection through initiatives like Digital Personal Data Protection Act,2023, Telecommunications Rules,2024, CERT-In and other measures, yet continuous upgrades are needed to safeguard sensitive biotechnology research data.
Way Forward
With the goal of One Nation, One Portal, BioRRAP has made biological research approvals easier by reducing time and removing barriers through a single-window framework. For smoother and more reliable operations, the focus should be on improving data security, ensuring consistent backups and updating policies in line with the latest biotech advancements.
BioRRAP can drive the growth of India’s bioeconomy and help research outcomes reach the market. With smart tracking tools and skill-building initiatives, it can build a strong base for sustainable progress in biological sciences.
References
Department of Biotechnology, Ministry of Science and Technology, Government of India. BioRRAP (Biological Research Regulatory Approval Portal). https://biorrap.gov.in/
Press Information Bureau, Government of India. Union Minister Dr. Jitendra Singh launches Single National Portal for Biotech researchers and Start‑Ups. https://www.pib.gov.in/PressReleaseIframePage.aspx?PRID=1827195
Department of Biotechnology, Ministry of Science & Technology, Government of India. Annual Report 2024–25. https://dbtindia.gov.in/sites/default/files/DBT%20Annual%20Report%202024-25.pdf
Open Government Data Platform
Biotechnology Industry Research Assistance Council (BIRAC). Global Bio‑India 2024 Brochure. https://globalbioindia.org/pdf/GBI_Brochure%202024%20_F.pdf
Biotechnology Industry Research Assistance Council (BIRAC). BIRAC Annual Report 2024. https://birac.nic.in/webcontent/birac_annual_report_2024_e.pdf
About The Contributor
Bhavana Girase is a Research Intern at Impact and Policy Research Institute (IMPRI). A data and policy research enthusiast, with a background in UPSC preparation and focusing on turning complex data into interpretative insights for a better understanding of policies.
Acknowledgement
The author sincerely thanks Ms.Aasthaba Jadeja and the IMPRI team for their valuable support and guidance.
Disclaimer
All views expressed in the article belong solely to the author and not necessarily to the organisation.
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