Plant genetic engineering, molecular farming and biosafety regulations in India

Molecular farming is a biotechnological approach that modifies plants or other organisms to produce desired and valuable products such as proteins, chemicals, or pharmaceuticals. These products are challenging to get or expensive to manufacture using classical biotechnological methods. The molecular production system primarily involves plants, animals and microorganisms such as algae, yeast and bacteria. The plants are often referred to as "bioreactors". Several biotechnological methods are applied, such as modifying plant-based expression systems involving nuclear or chloroplast genomes or enhancing plants' Heterologous Protein (HP) accumulation. The advantages of molecular farming are seen in their cost-effectiveness, scalability, faster production and safety. These bioreactors are known to produce antigen proteins used in vaccine development and nutraceuticals like omega-3 fatty acids, vitamins and nutritional benefits. The generated vaccines have become popular as edible vaccines. However, challenges and concerns associated with such products and methods as Genetically Modified Organisms (GMOs) having such potential are controversial, with concerns about environmental impact, safety and ethical issues. Also, molecular farming products are questioned for their yield, efficiency, purity and stability. This has led to the approval of only one non-food GM crop for cultivation in India despite several crops being ready to be launched. On the other hand, in terms of regulatory setup, India has a robust system and strict regulatory frameworks to ensure the safety of GMOs and the products they produce. India possesses adequate provisions under legal regimes, i.e., the constitution and various statutes that incorporate desired provisions as per national needs or international agreements on biosafety, the security of the environment, or public health. Despite issues, molecular farming holds great promise, especially in providing more affordable and scalable alternatives to traditional pharmaceutical manufacturing methods. As technology improves and regulatory hurdles are addressed, molecular farming could become an even more important tool in medicine, agriculture and environmental sustainability. The intended review aims to compile and analyze the available, relevant, legal-scientific and policy information about genetic engineering and products derived from such technologies, with special reference to products derived from molecular farming. The review includes two parts: the first covers molecular farming and genetic engineering-derived products and the second covers legal aspects related to their ethical consequences.