Regulation of emerging gene technologies in India

Abstract

In India, genetically modified organisms (GMOs) and the products thereof are regulated under the "Rules for the manufacture, use, import, export & storage of hazardous microorganisms, genetically engineered organisms or cells, 1989" (referred to as Rules, 1989) notified under the Environment (Protection) Act, 1986. These Rules are implemented by the Ministry of Environment, Forest and Climate Change, Department of Biotechnology and State Governments though six competent authorities. The Rules, 1989 are supported by series of guidelines on contained research, biologics, confined field trials, food safety assessment, environmental risk assessment etc. The definition of genetic engineering in the Rules, 1989 implies that new genome engineering technologies including gene editing and gene drives. May be covered under the rules. India is a signatory to the Cartagena Protocol on Biosafety (CPB), however, the definition of modern biotechnology, as in CPB is yet to be adopted in the national regulations. The regulatory authorities review and take into account the experience by other countries in dealing with new technologies. However, there is yet no clarity on how the emerging technologies will be dealt with in India, though research has been initiated in several leading institutions.