Securing Synthetic DNA in India

Syllabus: GS3/Science and Technology 

In News

  • Synthetic DNA has become central to advances in health, food security, climate and biotechnology, but its growing accessibility has created significant dual-use and biosecurity risks.

Synthetic DNA 

  • It is defined as artificially created genetic material that can be synthesized from digitized genome sequences and used to construct synthetic genomes.
  • It expands the possibilities for the development of improved or entirely new biomolecular therapies, including enzymes, peptides, RNA catalysts, and DNA and RNA aptamers.

Applications of Synthetic DNA

  • Medicine and Therapeutics: It promotes expeditious development of mRNA vaccines, tailored targeted gene treatments, CRISPR-based diagnostics, and synthetic monoclonal antibodies.
  • Agriculture & Food Systems: It engineers climate-resilient crops, nitrogen-fixing non-legume plants to reduce fertiliser consumption, and lab-grown alternative proteins.
  • Industrial Biotechnology: It aids in the bio-manufacturing of bioplastics, bio-fuels, specialised enzymes and high-value fine chemicals employing synthetic microbial factories.
  • Data Storage: It assists in using high-density DNA molecules as long-term, ultra-compact digital data storage media that can survive for millennia.

Global Control of Synthetic DNA

  • Global control of synthetic DNA has advanced from informal monitoring to more robust biosecurity mechanisms. 
  • The 2010 guidance from the US Department of Health and Human Services (HHS) emphasised customer and sequence screening as important protections, which led to the establishment of the IGSC and its voluntary harmonised methodology.
  • European countries are slowly adding DNA screening to their national biosecurity programs and countries such as Nigeria, South Korea and China are also taking initiatives. 
  • IBBIS Common Mechanism (2024) will standardise worldwide screening and data sharing procedures, with support from programs at EBRC and RAND.
    • Today governance is frequently three fold: mandatory screening at the provider level; self-regulation within the sector; and safeguards at the device level (e.g. user authentication, local sequence screening, recording and alarms).

Importance for India 

  • BioE3 Policy Alignment:  India’s BioE3 (Economy, Environment and Employment) Policy is a transition to a high-performing bio-economy driven by synthetic biology.
    • BioE3 Policy is helping to strengthen India’s position as a global powerhouse for biotechnology, supporting its rapidly growing bioeconomy. India’s bioeconomy is estimated at US$ 165.7 billion in 2024, projected to touch US$ 300 billion by 2030.
  • Healthcare Self-Reliance: Enabling local creation of affordable medications, APIs and rapid diagnostics for the Indian population.
  • Agri-Resilience: Supports India’s agrarian economy to withstand climate extremes (droughts, high salinity) and worsening soil fertility.
  • Decarbonisation: Replace petrochemical processes with sustainable bio-based alternatives to assist India in reaching its Net-Zero emission targets.

Challenges and Concerns 

  • Cyber-biosecurity threats:  The use of international providers for DNA screening may generate issues of control and access to sensitive biological data.
    • Technologies enabling vaccinations and medical achievements could also be leveraged to replicate lethal viruses or enhance destructive biological agents.
    • Hacking into DNA design software, synthesis-device firmware and cloud repositories might lead to data theft, manipulation, or malicious modification.
    • Cyberattacks could modify the DNA design files during synthesis, introducing malicious genetic material and avoiding typical screening processes.
  • Import dependence: India’s synthetic DNA requirements are largely met through imports, mainly from suppliers and distributors in the US and China, which could make it vulnerable to geoeconomic and supply chain risks.
  • Limited Screening: It is reported that most of the DNA providers in India have very little rigorous sequence and client screening, hence creating biosecurity gaps.
  • Weak regulatory framework; no national standard for checking DNA orders from commercial suppliers & importers.
    • India lacks a comprehensive database of Sequences of Concern (SOC) and robust AI-enabled solutions to detect potentially harmful or modified sequences.
    • Indian biosecurity certification and enforcement processes do not specifically include imported benchtop DNA synthesisers.
  • Limited training and skills: Biosecurity is not taught well in university curricula, and many researchers and safety experts lack specific skills in screening.

Suggestions 

  • India has to shift from a fragmentary knowledge base to a coordinated synthetic-DNA biosecurity strategy, linking its domestic systems with global norms and the One Health idea. 
  • It should build a comprehensive database on human-animal-plant pathogens, set up a National DNA Synthesis Screening Cell and provide a two-step verification procedure for imported benchtop synthesisers. 
  • It should support industrial self-regulation through biosecurity certification and enhanced institutional oversight by integrating biosafety, biosecurity and dual-use ethics in education and by strengthening Institutional Biosafety Committees. 
  • India should engage in biosecurity diplomacy with allies like the US, EU and ASEAN to harmonise screening standards and develop secure DNA supply chains, while leading a regional network for early warning, information sharing and standardised screening. 
  • India needs a risk-based, technology-enabled and internationally coordinated biosecurity policy to deal with growing synthetic biology and dual-use dangers.

Source :ORF

 

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