INTRODUCTION

 

Home

 

 

Modern Biotechnology (recombinant DNA technology) is recognized as having great potential for the promotion of human well being, particularly in meeting critical needs for food, agriculture and healthcare. Biosafety refers to the need to protect the environment including human and animal health from the possible adverse effects of the Genetically Modified Organisms (GMOs) and products thereof derived from the use of modern biotechnology. Biosafety also refers to promoting safe laboratory practices, procedures, proper use of containment equipment and facilities, risk assessment and risk management, evaluation of GMOs etc. Biosafety regulations are to facilitate and regulate use of modern biotechnology work at different stages to achieve the objectives of biosafety.

For facilitating and regulating the research work on GMOs & products thereof at laboratory scale and also in commercial applications, the Government of India has notified “Rules for the Manufacture/Use/Import/Export and Storage of Hazardous Microorganisms, Genetically Engineered Organisms or Cells” through the Notification No. G.S.R.1037(E), dated 5th December, 1989 under the provisions of Environment (Protection) Act, 1986 through the Ministry of Environment & Forests (MoEF).  These rules are commonly referred as ‘Rules 1989’.   The two main agencies identified for implementation of the Rules 1989 are the Ministry of Environment & Forests and the Department of Biotechnology (DBT), Ministry of Science and Technology, Government of India.  The Rules 1989 have also defined Competent Authorities and the composition of such Authorities for handling of various biosafety aspects.

For implementation of the Rules 1989, DBT has brought out Guidelines from time to time. In 1990, the Guidelines under the title “Recombinant DNA Safety Guidelines” were published. These Guidelines provide information to the researchers on the Rules, implementation of the provisions of the Rules, approval mechanisms, risk groups, handling of GMOs, import of GMOs, etc. In 1998, DBT has published guidelines under the title “Revised Guidelines for Research in Transgenic Plants and Guidelines for Toxicity and Allergenicity Evaluation of Transgenic Seeds, Plants and Plant Parts”. These Guidelines provide the information on level of approvals for conducting research in transgenic plants, category of experiments and testing procedures for toxicity and allergenicity etc. DBT in 1999, also brought out guidelines for “Generating pre-clinical and clinical data for r-DNA based Vaccines, Diagnostics and other biologicals”. From time to time, DBT is devising proformas for submission of applications to various Competent Authorities for specific approvals.

Several countries have also formulated biosafety regulations and guidelines on modern biotechnology for research, production processes, large-scale use of GMOs & products thereof and their release into the environment.

The website on Indian biosafety rules and regulations is to advice, facilitate and regulate modern biotechnology work at different stages to achieve the objectives of protecting environment including human and animal health from the unintended adverse effects of GMOs and products thereof. This website is developed with the objective to facilitate and disseminate the statutory requirements to be adhered by the researchers who are undertaking research work using modern biotechnology tools. As the knowledge in the modern biotechnology area is ever expanding, the biosafety guidelines could never be one time exercise. DBT shall continue to bring out the latest information and also modifications, amendments in the guidelines etc. from time to time to the stakeholders through the website. All the relevant Acts, Rules, guidelines, proformas, stepwise procedures to be adopted for development of transgenic crops, r-DNA therapeutics etc. as on date can be viewed or downloaded from the website for compliance by the users of rDNA technoloy.

In addition to information exchange, the website would provide tracking of regulatory clearance applications to RCGM and e-monitoring of IBSCs on personalized web features.