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India's BioE3 Policy Boosts Gene Therapy & CRISPR Self-Reliance

The Indian government has outlined its push for self-reliance in gene-editing and cell therapies through regulatory guidelines and the BioE3 policy. National guidelines issued by CDSCO, ICMR, and DBT provide a framework for the safe development of gene therapy products. A Phase-I clinical trial for Hemophilia A gene therapy has shown promising results, with stable production of Factor VIII. The BioE3 policy aims to transform India into a global biomanufacturing hub, fostering industry-academia collaboration for affordable, indigenous advanced therapies.

Key Points: India Advances Gene Therapy with BioE3 Policy & National Guidelines

  • National guidelines for safe gene therapy
  • BioE3 policy for biomanufacturing hub
  • Phase-I trial success for Hemophilia A
  • Focus on affordable indigenous therapies
2 min read

BioE3 advances India's gene‑editing and cell therapy drive: Minister

India issues national guidelines for gene therapy and launches BioE3 to boost indigenous CRISPR and cell therapy development, aiming for affordable treatments.

"National Guidelines for Gene Therapy Product Development and Clinical Trials, 2019, issued by CDSCO, ICMR and DBT, guide stakeholders to comprehend and comply with regulatory requirements - Dr. Jitendra Singh"

New Delhi, March 19

Regulatory bodies have issued national guidelines to ensure safe, ethical deployment of CRISPR-based therapies in India, while the BioE3 is accelerating indigenous capacity for cell and gene therapeutics, the government said on Thursday responding to a question on self-reliance in CRISPR and gene editing.

The government through various programs has been steadily advancing the precision medicine ecosystem with a strong emphasis on next-generation cell and gene therapies that includes approaches to modify cells or genetic material through gene augmentation, gene editing, gene silencing, and other cell-based approaches, MoS Ministry of Science and Technology & Earth Sciences Dr. Jitendra Singh said in a written reply in the Rajya Sabha.

"National Guidelines for Gene Therapy Product Development and Clinical Trials, 2019", issued by CDSCO, ICMR and DBT, guide stakeholders to comprehend and comply with regulatory requirements for research and development of gene therapeutic products (GTPs) in India.

The first-in-human Phase-I clinical trial for gene therapy of Hemophilia A has shown clinically significant outcomes, whereby stable production of Factor VIII has been observed, offering potential treatment for long-term reduction of bleeding episodes, the minister cited progress of government supported initiatives.

The BioE3 (Biotechnology for Economy, Environment, and Employment) Policy, approved by the Union Cabinet in August 2024, aims to transform India into a global biomanufacturing hub, promoting sustainable growth and reducing import reliance.

The program focuses on high-performance biomanufacturing for chemicals, enzymes, agriculture, and therapeutics, the statement said.

CSIR-Institute of Genomics and Integrative Biology (CSIR-IGIB) is working with Serum Institute, Pune, towards commercialisation of the gene therapy, having executed a technology transfer agreement for clinical translation and upscaling its novel gene therapy.

Several research projects supported by ICMR strengthen translational research, infrastructure development, and industry-academia collaboration to create a sustainable pipeline of indigenous CGTs and to ensure that advanced gene-editing therapies are affordable and have widespread access, the minister noted.

- IANS

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Reader Comments

P
Priya S
Great step forward, but the 2019 guidelines feel a bit dated for a field moving this fast. We need continuous updates to keep pace with global standards and ethical challenges. The focus on affordability is the most important part.
R
Rohit P
CSIR-IGIB and Serum Institute collaboration is a game-changer! When our top research bodies and industry giants work together, we can truly become a biomanufacturing hub. Reduce import reliance and create jobs. Win-win!
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Sarah B
As someone who follows global biotech, it's impressive to see India laying down a structured path. The emphasis on "safe, ethical deployment" alongside innovation is the right balance. Hope the guidelines are enforced strictly.
N
Nikhil C
Biotechnology for Economy, Environment, and Employment (BioE3) – the name itself says it all. If executed well, this can transform our agriculture and healthcare sectors simultaneously. Fingers crossed for proper implementation on the ground.
M
Meera T
This is the kind of news that makes me proud. We have the brainpower, now we are building the framework. Making advanced therapies affordable is the real challenge. Let's hope the industry-academia collaboration delivers on that promise.

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