Regulations in Biotechnology

Regulations in Biotechnology

Regulations apply to the production, sale and use of biotech products and genetically modified organisms. GMOs are carefully tested and documented before the products are available. GMOs should be labelled and used according to instructions. These regulations are designed to protect the people, living organisms and the environment. The Biotechnology Regulatory Authority of India (BRAI) is a proposed regulatory body in India for uses of biotechnology products including GMOs. The Genetic Engineering Approval Committee (GEAC), a body under the Ministry of Environment, forests and climate change (India) is responsible for approval of genetically engineered products in India. If the bill is passed the responsibility will be taken over by the Environmental Appraisal Panel, a subdivision of the BRAI. The bill also proposes setting up an inter ministerial governing body to oversee the performance of BRAI and a National Biotechnology Advisory Council of stakeholders to provide feedback on the use of, import and manufacture of biotechnology products and organisms in the society. The regulatory body is an autonomous and statutory agency to regulate the research, transport, import and manufacture of biotechnology products and organisms.

GEAC is assisted by the State Biotechnology Co- ordination Committee (SBCC) and District Level committee (DLC). The most important committees are The Institutional Biosafety Committee (IBSC), responsible for the local implementation of guidelines; Review Committee on Genetic Manipulation (RCGM) is responsible for issuing permits and the GEAC is responsible for monitoring the large scale and commercial use of transgenic materials.

Biopiracy can be defined as “the use of bioresources by multinational companies and other organisations without proper authorization from the countries and the people concerned without compensatory payment”.

Bioethics is the study of the ethical issues emerging from the advances in Biology and medicine. It is also a moral discernment as it relates to the medical policy and practice.

The biotechnology industry is governed by different enactments depending on their relevance / applicability on a case to case basis. “Recombinant DNA safety guidelines, 1990” were released by the Department of Biotechnology (DBT) which cover areas of research involving genetically engineered organisms and these guidelines were further revised in 1994.

RCGM under the DBT comprises representatives of DBT, Indian Council for Medical Research, Indian Council for Agricultural research and Council for Scientific and Industrial Research.

Industrial licensing under the Industrial (Development and Regulation) Act,1951 is compulsory for bulk drugs produced by the use of recombinant DNA technology.

Being a signatory to the Trade Related Intellectual Property Rights (TRIPS) Agreement of WTO, India has amended its legislations pertaining to intellectual property through various legislations including Patents (Amendment) Act, 1999.