Context: The Centre is engaged on a nationwide coverage on artificial biology, an rising science that offers with engineering life varieties for a variety of purposes from making designer medicines to meals. 
About Synthetic Biology

• The term ‘synthetic biology’ was first used by Barbara Hobomin in 1980, to describe bacteria that had been genetically engineered using recombinant DNA technology.
• Synthetic biology refers to the science of using genetic sequencing, editing, and modification to create unnatural organisms or organic molecules that can function in living systems.
• Synthetic biology enables scientists to design and synthesise new sequences of DNA from scratch.
• The term was used to describe the synthesis of unnatural organic molecules that function in living systems.
• More broadly in this sense, the term has been used with reference to efforts to ‘redesign life’.

Key applications of Synthetic Biology

• Standardised Biological Parts- identify and categorise standardised genomic parts that can be used (and synthesised quickly) to build new biological systems.

Applied Protein Design- redesign existing biological parts and expand the set of natural protein functions for new processes.

• For e.g, Modified rice to produce beta-carotene (a nutrient usually associated with carrots), that prevents Vitamin A deficiency.

Natural Product Synthesis- engineer microbes to produce all of the necessary enzymes and biological functions to perform complex multistep production of natural products.

• For e.g, Microorganisms harnessed for bioremediation (use of living microorganisms to degrade environmental contaminants into less toxic forms) to clean pollutants from water, soil and air.

Synthetic Genomics- design and construct a ‘simple’ genome for a natural bacterium.

• For e.g, Yeast engineered to produce rose oil as an eco-friendly and sustainable substitute for real roses that perfumers use to make luxury scents.

Negative Impacts of Synthetic Biology

Negative Environmental Health: The intentional or accidental release of genetically engineered organisms into the environment could have significant negative impacts on both human and environmental health.

• Misuse of these technologies and a failure to account for unintended consequences could cause irreversible environmental damage.

Do-It-Yourself Biology: It’s a movement of “citizen scientists” interested in synthetic biology experiments that has become an international phenomenon over the last decade.

• Often with little prior knowledge of the field, enthusiasts meet in makeshift labs to take crash courses in biotechnology and conduct hands-on experiments.

Ethical Concerns: Many of the ethical questions relevant to synthetic biology are similar to ethical discussions related to genome editing like:

• Are humans crossing moral boundaries by redesigning organisms with synthetic biology techniques?
• If synthetic biology yields new treatments and cures for diseases, who in our society will have access to them?
• What are Governance, Policy And Regulatory Aspects Relevant To Synthetic Biology?

International Bodies & Agreements

• Convention on Biological Diversity (CBD)
• Cartagena Protocol on Biosafety
• Nagoya Protocol on Access and Benefit Sharing
• Nagoya-Kuala Lumpur Supplementary Protocol
• Food and Agricultural Organisation (FAO)
• Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES)
• International Union for the Conservation of Nature (IUCN)
• Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS)
• UN Convention on the Law of the Sea (UNCLOS)
• Biological Weapons Convention.

Note: India is a party to all the International governance bodies discussed above.
Indian Regulatory System

• Drugs and Cosmetics Rules – 1988,
• Protection of Plant Varieties and Farmers’ Rights Act, 2001,
• Biological Diversity Act, 2002
• Food Safety and Standards Act 2006

Key Suggestion

• India is yet to formally come up with its national strategy on synthetic biology (both policy and regulatory).
• In this context, India’s policy and regulatory framework needs to focus on issues like,
• Defining what constitutes the science of synthetic biology.
• What kind of research and development priorities will be made for the public sector.
• Guidance for the private sector for future research and what all considerations will be undertaken related to relevant policy frameworks, including those in intellectual property rights.
• How India will regulate the development and use of this technology, considering issues related to environment and socio-economics.

While making a national strategy India should consider Principles of International Law which are:

• The precautionary principle
• State sovereignty and prevention of transboundary harm.
• State responsibility and Environment Impact Assessment
• Principles of access to information, public participation and access to justice
• People’s right to self-determination and free prior informed consent
• Sustainable development and inter-generational equity

Road Ahead

• Synthetic biology has multifarious applications of energy, agriculture and biofuels. Thus, there is always a perceived threat of components releasing into the open environment.
• Though it is not customary to elaborate the principles of international law and policies, as presented in this compilation, it is important to consider these elements while developing the national policy, especially since the science and regulatory framework related to use of the science is driven by global considerations and decision.