Question : SETTING UP OF BRAI



(a) whether the Government has set up Biotechnology Regulatory Authority of India (BRAI);

(b) if so, the details alongwith the proposed functions thereof; and

(c) the time by which the said Authority is likely to be set up by the Government?

Answer given by the minister



MINISTER OF STATE FOR MINISTRY OF PLANNING MINISTER OF STATE FOR THE MINISTRY OF SCIENCE & TECHNOLOGY AND MINISTER OF STATE FOR THE MINISTRY OF EARTH SCIENCES (ASHWANI KUMAR)

(a) No, Madam.

(b) However, the Government of India has prepared a draft Bill to establish Biotechnology Regulatory Authority of India. According to the Biotechnology Regulatory Authority of India (BRAI) Bill, 2011, the Authority will be an autonomous and statutory agency to regulate the research, transport,import, manufacture and use of organisms and products of modern bio-technology. The Authority shall consist of a Chairperson, two whole-time Members and two part-time members, each with expertisein life sciences and biotechnology applications in agriculture, health care, environment and generalbiology. The Bill provides for setting up of Inter-ministerial Governing Board to oversee theperformance of the Authority and a National Biotechnology Advisory Council of stakeholders to provide feedback on use of organisms and products of biotechnology in society. The Bill also provides for an elaborate risk assessment process involving scientific panels of experts andrepresentatives of concerned ministries including a special public review system for evaluation of applications before final approvals.

(c) No time frame can be given for the establishment of Biotech Regulatory Authority of India at this stage.