The stakes are considerable. Synthetic DNA is a foundational input for experiments ranging from basic molecular biology to the engineering of therapeutic proteins, and the barriers to producing it are falling steadily as costs decline and technology spreads. More than 700 companies worldwide now sell, resell, or distribute customized synthetic DNA. That decentralization carries an inherent biosecurity risk: the same technology that enables legitimate research could, in principle, be used to reconstruct or enhance harmful pathogens. The most direct safeguard against such misuse is consistent screening of both customers and requested sequences, ensuring that sensitive genetic material reaches only verified users with legitimate purposes. The authors argue that this safeguard is not consistently implemented worldwide, and India exemplifies the gap.

The scale of India’s bioeconomy amplifies the concern. The sector has expanded from roughly 10 billion US dollars in 2014 to more than 165 billion in 2024, with projections reaching 300 billion by 2030. Often described as the “pharmacy of the world,” India plays a major role in global vaccine and generic medicine production, and its life sciences ecosystem spans thousands of researchers across academic institutions, national laboratories, hospitals, and industry. Synthetic DNA is a critical input for much of this work, driving strong domestic demand. The industry clusters in established innovation hubs such as New Delhi, Bengaluru, and Hyderabad, mirroring the broader geography of Indian biotechnology.

On the regulatory side, the picture is fragmented. India’s oversight architecture rests on instruments that were never designed with synthetic DNA in mind. The Environment Protection Act of 1986 and the 1989 rules on hazardous microorganisms and genetically engineered organisms created an institutional structure that includes the Recombinant DNA Advisory Committee, the Review Committee on Genetic Manipulation (RCGM), Institutional Biosafety Committees (IBSCs), and the Genetic Engineering Approval Committee. Under these rules, producing genetically engineered products without approval is prohibited, and researchers must obtain IBSC clearance for genetic experiments, including those involving synthetic DNA. But the framework’s focus is biosafety, preventing accidental exposure, laboratory releases, and environmental contamination, rather than biosecurity, the deliberate misuse of biological tools.

Guidelines issued in 1990 and revised in 2017 govern the biosafety of recombinant DNA research and biocontainment, and they include an updated list of infectious organisms organized by risk group whose DNA could, in principle, be screened. None of these instruments, however, imposes any specific requirement for customer screening or sequence screening. Export controls offer the most concrete point of oversight: under India’s SCOMET list, genetic elements that could enhance the pathogenicity of listed microorganisms are implicitly regulated, and export licenses are issued by the Directorate General of Foreign Trade. But this mechanism applies only at the border. The domestic synthesis transaction itself, the moment when a customer orders a sequence from an Indian provider, remains entirely unregulated.

Two criminal statutes provide a backstop. The Weapons of Mass Destruction Act of 2005, amended in 2022, implements the Biological Weapons Convention in India and prohibits material support for biological weapons, though synthetic DNA is not explicitly referenced. The Unlawful Activities (Prevention) Act of 1967 could apply to terrorist use of biological agents. Both laws, the authors note, focus on deterrence rather than prevention, offering no specific measures to stop the development of bioweapons before it begins. National biotechnology strategies have largely ignored biosecurity, with rare exceptions such as the Karnataka State Biotechnology Policy 2024–2029, which mentions the risks at the state level.

The industry mapping reveals how these regulatory gaps translate into practice. Of 59 companies in India associated with nucleic acid services, 31 conduct custom in-country synthesis and 21 operate as third-party vendors, often reselling products sourced from large, predominantly US-based synthesis firms. Survey responses collected during the study indicate a general lack of sequence screening among Indian companies; typically, only the name of a gene is required to place an order. Few companies maintain oligo order forms on their websites that could even support customer verification. Notably, no Indian company is a member of the International Gene Synthesis Consortium (IGSC), the industry body whose harmonized protocol sets the global benchmark for screening. Several IGSC member companies do have Indian distributors and subsidiaries, but whether screening is applied to orders fulfilled within India could not be determined.

The authors propose a staged path forward that draws on existing institutions rather than demanding immediate legislative overhaul. The Department of Biotechnology (DBT) should take a central coordinating role, in consultation with the export-control and medical research agencies, to develop a national “sequences of concern” framework aligned with the IGSC Harmonized Screening Protocol, along with a mechanism for reporting flagged orders. IBSC members, who increasingly handle responsibilities extending into biosecurity, need dedicated training to distinguish deliberate misuse risks from conventional biosafety concerns. The Bureau of Indian Standards and DBT could establish a certification scheme for providers that adopt screening, initially incentive-based, with public research funding and government procurement progressively favoring compliant providers. Free tools such as IBBIS’s Common Mechanism, which performs automated sequence screening, could lower the cost of adoption.

The US experience offers both a model and a caution. The 2024 US Framework for Nucleic Acid Synthesis Screening leverages federal funding and procurement rather than universal mandates: researchers receiving federal money are expected to buy synthetic nucleic acids from providers that follow the screening framework, creating market pressure for compliance. But the US policy landscape is itself in flux; a May 2025 executive order directed the Office of Science and Technology Policy to revise the framework and to demand screening that is comprehensive, scalable, and verifiable. Rapid advances in AI-enabled protein design, which can generate substantially modified sequences that evade conventional similarity-based screening, mean that screening tools require continuous evaluation and updating. The authors frame India’s position not as an outlier but as part of a broader global implementation gap, arguing that countries can progress along a continuum from awareness raising and voluntary screening through certification and incentives to, if necessary, minimum mandatory requirements. Given India’s standing as the third-largest synthesis hub in the world, they conclude, closing that gap is among the most consequential biosecurity tasks of the coming decade.

Subject of Research: Biosecurity regulation of the synthetic DNA synthesis industry in India

Article Title: India’s DNA synthesis landscape: regulatory frameworks, industry structure, and biosecurity gaps

Article References: Namdeo, S. K., & Ameneiros, M. (2026). India’s DNA synthesis landscape: regulatory frameworks, industry structure, and biosecurity gaps. Frontiers in Bioengineering and Biotechnology, 14, Article 1879032. https://doi.org/10.3389/fbioe.2026.1879032

Image Credits: AI Generated

DOI: 10.3389/fbioe.2026.1879032

Keywords: biosecurity, DNA synthesis, India, sequence screening, customer screening, regulatory framework, synthetic biology, IGSC, biotechnology policy, export controls, biosafety committees, Global DNA Synthesis Map