India Lacks National Framework for DNA Synthesis Screening Amid Growing Bioeconomy

India holds the position of the world’s third-largest custom DNA synthesis provider market, trailing only the US and China. However, the country currently operates without a national framework governing DNA synthesis or a mandate requiring providers to screen customers and ordered sequences.

According to research published in Frontiers in Bioengineering and Biotechnology, an analysis by the International Biosecurity and Biosafety Initiative for Science (IBBIS) identifies 31 companies in India offering custom DNA synthesis, alongside 21 third-party vendors in the broader nucleic-acid services sector.

The absence of regulation comes as India's broader bioeconomy scales. Data from the India Bioeconomy Report 2026 indicates the country's bioeconomy reached $195.3 billion in 2025, marking an 18 per cent increase from the previous year. Meanwhile, a Competition Commission of India market study projects the domestic AI market—valued at $7.63 billion in 2024—to grow at a compound annual growth rate of 42.2 per cent to reach $131.31 billion by 2032.

While AI-powered biological tools have significantly accelerated drug and vaccine discovery, researchers note they can potentially be misused to design new microorganisms combining high lethality and contagiousness. Rapid growth in automated procedures, on-demand services, and doorstep delivery of genetic material further complicates the detection and prevention of misuse.

Suryesh Kumar Namdeo, who leads the Bio-Responsibility Initiative at the Indian Institute of Science, points out that India currently lacks policies for biosecurity or DNA synthesis screening. While countries like the US have introduced federal frameworks requiring screening for federally funded research—with the UK and China also moving similarly—Namdeo suggests that voluntary DNA screening could serve as a competitive advantage for Indian companies.

Providers can utilize free open-source platforms such as IBBIS’s Common Mechanism (Commec) and the SecureDNA Foundation’s SecureDNA, or join the International Gene Synthesis Consortium (IGSC) to screen sequences and customers. However, the use of AI to bypass traditional screening methods—which match sequences against known pathogens or 'sequences of concern'—presents an ongoing challenge.

India currently does not maintain a sequence-of-concern list. The Special Chemicals, Organisms, Materials, Equipment and Technologies (SCOMET) list covers certain export-controlled genetic elements, but does not include synthetic DNA.

Experts suggest institutional biosafety committees could help maintain oversight by connecting labs to a central repository managed by the Department of Biotechnology. Additionally, stakeholders emphasize the need for a comprehensive biosafety and biosecurity policy framework linking medical research, biotechnology, security, disaster management, and public health bodies, alongside a standing expert advisory body.

While India continues to develop bio-AI hubs, biofoundries, and biomanufacturing facilities under its BioE3 policy to encourage AI-enabled biological innovation, regulatory guidelines have yet to establish a specific high-risk category for AI systems utilized in biological design, protein engineering, or DNA sequence generation, or detail how facilities will verify users and screen biological designs.

"The rapid growth of India's bioeconomy and AI sector presents immense economic potential, but it also introduces critical responsibilities regarding biosecurity. As the data shows, India is a major hub for custom DNA synthesis without a formal national screening framework. For startups and enterprises operating in the life-sciences and bio-AI space, adopting voluntary screening mechanisms and proactive compliance will not only mitigate risks but also build global trust and competitive advantage as international standards tighten." — Dr. Shishir Gupta, Founder & CEO, StartupLanes