India has the world’s third-largest number of custom DNA synthesis providers, but lacks a national framework to screen them. Suryesh Kumar Namdeo said, "Yet, we do not have any regulation or policy for biosecurity or DNA synthesis screening." Experts worry that AI tools could help misuse these biological services.
Is India's rapid growth in DNA synthesis and biomanufacturing outpacing its biosecurity preparedness?
What if a lab in India received an order to produce a DNA sequence that is designed with a malicious intent by a stranger using AI? That possibility may not be far-fetched, given that India, according to research published in Frontiers in Bioengineering and Biotechnology, has the world's third-largest number of custom DNA synthesis providers after the US and China, but no national framework governing it nor a mandate to screen customers and the DNA sequences ordered by them.
According to the India Bioeconomy Report 2026, the country's bioeconomy reached $195.3 billion in 2025, up 18 per cent from the previous year. Its AI market, worth $7.63 billion in 2024, is expected to record 42.2 per cent compound annual growth rate to $131.31 billion by 2032, according to a Competition Commission of India market study.
AI-powered biological tools, which have significantly accelerated the search for drugs and vaccines, can be misused to create new microorganisms with selected traits that combine high lethality and contagiousness, rarely found together in a natural pathogen.
The missing code
An analysis by the International Biosecurity and Biosafety Initiative for Science (IBBIS) has found that India is home to 31 companies offering custom DNA synthesis, and 21 third-party vendors in the broader nucleic-acid services sector. "Yet, we do not have any regulation or policy for biosecurity or DNA synthesis screening," says Suryesh Kumar Namdeo, who is leading the Bio-Responsibility Initiative at the Indian Institute of Science, aimed at strengthening safe and responsible life-sciences research.
DNA synthesis screening provides a crucial digital-to-physical barrier to help detect dangerous sequences. Most countries lack such screening requirements.
In the US, however, the 2024 federal framework, now awaiting revision following a 2025 executive order, mandated procuring synthetic nucleic acids through compliant screening providers to receive federal funding for life-sciences research. With countries such as the UK and China also moving in that direction, Dr Namdeo says screening DNA could become a competitive advantage for Indian companies.
Based on their needs, Indian companies can choose free, open-source platforms such as IBBIS's Common Mechanism (Commec) and SecureDNA Foundation's SecureDNA to screen synthetic DNA and RNA sequences, or join the International Gene Synthesis Consortium (IGSC), an industry-led group of gene synthesis companies that uses a common protocol and public databases to screen both DNA sequences and customers.
However, the use of AI to circumvent current screening methods -- which match sequences against those of potentially dangerous or pathogenic organisms, known as 'sequences of concern' -- poses a challenge. "AI has made it easy to find sequences that won't be caught by the current lists but will have a similar function, effectively yielding a similar protein structure from a very different DNA sequence," says Namdeo. Research is on to devise improved safeguards.
The missing mile
India does not have a sequence-of-concern list. The Special Chemicals, Organisms, Materials, Equipment and Technologies (SCOMET) list, used to control the export of dual-use technologies, covers genetic elements but not synthetic DNA.
"Institutional biosafety committees could offer a way to maintain oversight as the system is vertically connected all the way from labs to a central repository managed by the Department of Biotechnology," says Namdeo.
In a recent report, the Lancet Commission on 21st Century Global Threats to Health has identified "the malicious use of AI", including biological weapons development, alongside nuclear conflict as "major catastrophic threats" with "extinction potential".
It urged governments to regulate high-risk "frontier" AI technologies and tools that could turn laboratory-created pathogens into serious threats. India's AI governance guidelines explicitly prioritise "innovation over restraint", but have yet to establish a specific high-risk category for AI systems that could be used in biological design, protein engineering or DNA sequence generation.
The US AI Action Plan has an entire chapter on biological threats. The UK is investing up to £300 million to set up a dedicated AI Biosecurity Lab. While India is building bio-AI hubs, biofoundries and biomanufacturing facilities under its BioE3 (biotechnology for economy, environment and employment) policy to push for AI-enabled biological innovation, it has yet to detail how these facilities will screen biological designs, verify users, control access to sensitive models or datasets, or respond to dual-use incidents. There is clearly a lot of catching up to do.