The Department of Biotechnology, Ministry of Science & Technology recently unveiled a draft foresight paper on synthetic biology. This report emphasizes the necessity for a national policy to manage India’s position on this evolving scientific domain. Synthetic biology offers a wide range of applications in sectors such as energy, agriculture, and biofuels. However, its use also poses potential risks, especially if components are released into the environment.
Understanding Synthetic Biology
Synthetic biology was first defined by Barbara Hobom in 1980 as an aspect of science related to genetically engineered bacteria using recombinant DNA technology. The field has since expanded to include creation of unnatural organisms or organic molecules that can function within living systems. Scientists accomplish this by designing and synthesising new DNA sequences from scratch. In broader terms, synthetic biology refers to the efforts made to ‘redesign life’.
The Applications of Synthetic Biology
A broad spectrum of applications exist within the realm of synthetic biology. These include:
1. Standardised Biological Parts: Scientists identify and classify standardised genomic elements that can be used (and synthesized quickly) to construct new biological structures.
2. Applied Protein Design: This involves modifying existing biological parts to enhance natural protein functions. For instance, rice can be altered to produce beta-carotene (a nutrient typically found in carrots), helping prevent Vitamin A deficiency.
3. Natural Product Synthesis: Microorganisms can be engineered to produce all necessary enzymes and biological functions for complex multistep natural product synthesis. For example, microbes can be utilized for bioremediation (degrading environmental contaminants into less toxic forms) to purify water, soil and air.
4. Synthetic Genomics: Scientists design and construct a simplified genome for a natural bacterium. One example is yeast that has been engineered to produce rose oil as an eco-friendly alternative for luxury scents.
Potential Negative Impacts of Synthetic Biology
While synthetic biology holds promise, it can also be associated with potential risks and ethical concerns. For example, the release of genetically engineered organisms into the environment could lead to significant damage to human health and the environment. In addition, the growing trend of “Do-It-Yourself Biology” sees enthusiasts conducting experiments in makeshift labs. Unintended consequences could result in irreversible environmental harm.
Ethical questions also arise. Are humans overstepping moral boundaries by redesigning organisms using synthetic biology techniques? If synthetic biology produces new treatments for diseases, who will have access to them?
Policy and Regulatory Aspects Relevant To Synthetic Biology
Regulatory aspects at both national and international levels are crucial for the sustainable practice of synthetic biology. Internationally, India is a signatory to numerous agreements and conventions related to this field, including Convention on Biological Diversity (CBD), Nagoya Protocol on Access and Benefit Sharing, Food and Agricultural Organisation (FAO) Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES), and more.
Domestically, India regulates synthetic biology under laws such as the Drugs and Cosmetics Rules – 1988, Protection of Plant Varieties and Farmers’ Rights Act, 2001, Biological Diversity Act, 2002, and the Food Safety and Standards Act 2006.
Way Forward
India’s policy and regulatory framework needs to align with international standards while establishing guidelines for the private sector. Future considerations should also include intellectual property rights. The development and use of this technology should be regulated, keeping in mind environmental and socio-economic concerns. As India develops its national strategy, principles of international law, such as the precautionary principle, prevention of transboundary harm, and sustainable development, should be at the forefront.