**Executive Summary**
This document summarizes the ongoing research and regulation of synthetic biology in India, as presented in a Parliament Question. It highlights the government's support through the BioE3 Policy and the involvement of various research institutions and industries. Biosafety is governed by the Rules, 1989 of the Environment (Protection) Act, 1986.
**Key Points / Main Content**
* **Government Support and Initiatives:**
* The BioE3 Policy supports the development of a synthetic biology program for biomanufacturing of bio-based products.
* The DBT's BIRAC supports research and industrial applications in synthetic biology through a dedicated "Program on Synthetic Biology".
* Biofoundries are being set up at iBRIC+ institutes, NCCS, Pune and ICGEB, New Delhi under the BioE3 Policy.
* **Research Activities:**
* CSIR laboratories are actively involved in synthetic biology research, focusing on areas such as strain design, scale-up of production processes, and the development of pilot plant facilities.
* Institutions and industries are supported through BIRAC, working on areas like hyaluronic acid, delta-decanolactone, nicin, alpha-farnesene, steroid drug intermediates, homobutanol, sandalwood sesquiterpenes, and rose oxide.
* **Biosafety and Regulation:**
* Biosafety-related safeguards are governed by the Rules, 1989 of the Environment (Protection) Act, 1986.
* The Review Committee on Genetic Manipulation (RCGM) oversees safety aspects of research and development.
* Institutional Biosafety Committees (IBSCs) are crucial for handling GMOs and ensuring compliance with national guidelines.
* **Policy Alignment:**
* The research aligns with India's vision of Green Growth and the 'Lifestyle for Environment (LiFE)' initiative.
* Initiatives align with the vision of ‘Net-Zero' carbon economy and “Viksit Bharat 2047” goals.
**Impact Analysis**
**Research Institutions (CSIR, DBT, Universities, etc.)**
*Impact:*
* These institutions are impacted by the funding and support provided for research in synthetic biology.
* Must adhere to biosafety regulations.
*Action Required:*
* Continue conducting research in compliance with biosafety guidelines.
* Implement biosafety protocols and ensure compliance with national guidelines.
**Industries and Startups**
*Impact:*
* These are impacted by the funding and support provided for industrial applications in synthetic biology.
* Must adhere to biosafety regulations.
*Action Required:*
* Continue developing and scaling up biomanufacturing processes in compliance with biosafety regulations.
* Implement biosafety protocols and ensure compliance with national guidelines.
**Government (Ministry of Science & Technology, Ministry of Environment, Forests and Climate Change)**
*Impact:*
* Responsible for formulating and implementing policies and regulations related to synthetic biology research and development.
*Action Required:*
* Ensure the ongoing development and enforcement of biosafety regulations.
* Continue supporting research and development in synthetic biology.
Key Entities Referenced
BioE3 Policy: A Biotechnology policy for Economy, Environment, and Employment focused on fostering high-performance biomanufacturing.
The Environment (Protection) Act, 1986: An act that provides the framework for regulating environmental protection in India, including aspects related to Genetic Engineering.
Rules, 1989 (Manufacture, Use/Import/Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells): Rules under the Environment (Protection) Act, 1986, that govern biosafety related safeguards, specifically the manufacture, use, import, export and storage of hazardous microorganisms and genetically engineered organisms.
Council of Scientific and Industrial Research (CSIR): An Indian autonomous body whose constituent laboratories support research, industrial applications, and indigenous innovation in synthetic biology.
Biotechnology Industry Research Assistance Council (BIRAC): A DBT's Public Sector Unit supporting research, industrial applications, and indigenous innovation in synthetic biology through a dedicated program.
Ministry of Science & Technology
PARLIAMENT QUESTION: Research and
regulation in synthetic biology
Posted On: 05 FEB 2026 3:56PM by PIB Delhi
As part of the BioE3 Policy (Biotechnology for Economy, Environment and Employment) for ‘Fostering
High-performance Biomanufacturing’, synthetic biology programme is being developed for
biomanufacturing of bio-based products.
Within DSIR, the constituent laboratories of Council of Scientific and Industrial Research (CSIR) are
supporting research, industrial applications and indigenous innovation in synthetic biology. Research
works in synthetic biology being under taken in CSIR-NCL, Pune aims to design strains for multiple
chemical classes of compounds from Polyhydroxyalkanoates (PHA), and pigments like violacein and
vanillin. CSIR-CFTRI, Mysuru is carrying out the projects for scale-up of sustainable production of
squalene and linalool, using engineered Saccharomyces cerevisiae. CSIR-CIMAP, Lucknow is working on
a project for production of high-value terpenes through synthetic biology. A pilot plant facility for bio-
processing related to synthetic biology applications is being developed at CSIR-CIMAP, Lucknow.
Several extramural funded research projects are also being implemented in these laboratories.
The DBT’s Public Sector Unit, Biotechnology Industry Research Assistance Council (BIRAC) has been
supporting research, industrial applications and indigenous innovation in synthetic biology through a
dedicated “Program on Synthetic Biology”. Two calls for proposals were announced in this area by
BIRAC and several hands on trainings and webinars have been organized. Under this call the institutions,
startups and industries supported include: IIT, Madras for hyaluronic acid; iBRIC NII, New Delhi for
delta-decanolactone/ delta-dodecanolactone; Fermentech GSV Pvt Ltd for nicin; CIMAP and M/s.
Amnion Biosciences Pvt Ltd for alpha- farnesene; Hi Tech Biosciences India Ltd and IISc Bengaluru for
steroid drug intermediate; SRM Institute of Science and Technology for homobutanol; ICGEB, New Delhi
for high value metabolites; CSIR-CIMAP, Lucknow for sandalwood sesquiterpenes; Jananom Private
Limited and IBAB, Bengaluru for rose oxide; CSIR-CFTRI for anthocyanin and Saha Institute of Nuclear
Physics for an efficient CRISPY Brick for yeast synthetic metabolic engineering. Further, Biofoundries
setup at iBRIC+ institutes, NCCS, Pune and ICGEB, New Delhi under the BioE3 Policy, aim at rapid
strain engineering and development of microbial chassis for biomanufacturing of biobased products.
There are safeguards in place to address ethical, biosafety and biosecurity concerns related to research
work being carried out in national research institutions, startups and industries. In India, biosafety-related
safeguards are governed by the Rules, 1989 (The Rules for the Manufacture, Use/Import/Export and
Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells) of the Environment
(Protection) Act, 1986. These rules explicitly define 'Genetic Engineering' and encompass new gene
technologies like Synthetic Biology. The Environment (Protection) Act, 1986, is administered by theMinistry of Environment, Forests and Climate Change (MoEF&CC). The Review Committee on Genetic
Manipulation (RCGM) oversees safety aspects of research and development involving hazardous
microorganisms, Genetically Engineered (GE) organisms, cells, and products, evaluating projects for risks
to health and the environment, and issuing guidelines and SOPs for GE organism work. Institutional
Biosafety Committees (IBSCs) are crucial bodies within organizations handling Genetically Modified
Organisms (GMOs) or hazardous microbes, implementing biosafety protocols, facilitating safe research,
and ensuring compliance with national guidelines.
The research involving biomanufacturing of biobased products using emerging technologies such as
synthetic biology tools under BioE3 Policy aims to bridge the gap between research, industrial
application, and sustainable economic goals. The Policy is aligned with India’s vision of Green Growth
(announced in the Union Budget 2023-24) and also with the clarion call of the Hon’ble Prime Minister on
‘Lifestyle for Environment (LiFE)’ that envisions collective approach towards sustainability. The various
initiatives under the Policy also align with the Hon’ble Prime Minister’s vision of ‘Net-Zero’ carbon
economy of the country. Further, the setting up of Biomanufacturing Hubs, Biofoundries, Bio-AI Hubs
aims to strengthen Make-in-India and drive biotechnology sector’s contribution to GDP and export
potential, thus aligning with the “Viksit Bharat 2047” goals.
This information was given by Union Minister of State (Independent Charge) for Science & Technology
and Earth Sciences, and Minister of State in the Prime Minister’s Office, Personnel, Public Grievances and
Pensions, Atomic Energy and Space, Dr. Jitendra Singh in a written reply in Rajya Sabha today.
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