| Consider the following statements about the Biotechnology Regulatory Authority of India (BRAI) Bill, 2013 |
| 1. Field trials for certain organisms cannot be conducted unless BRAI recognizes them as aiding the development of modem biotechnology. |
| 2. The Bill will also apply to the clinical trials of drugs, food or food additives. Which of the statement given above is/are correct? |
A) 1 only
B) 2 only
C) Both 1 and 2
D) neither 1 nor 2
Correct Answer: A
Solution :
[a] highlights of the BRAI bill:| The Bill sets up an independent authority, the Biotechnology Regulatory Authority of India, to regulate organisms and products of modern biotechnology. |
| BRAI will regulate the research, transport, import, containment, environmental release, manufacture, and use of biotechnology products. |
| Regulatory approval by BRAI will be granted through a multi-level process of assessment undertaken by scientific experts. |
| BRAI will certify that the product developed is safe for its intended use. All other laws governing the product will continue to apply. |
| A Biotechnology Regulatory Appellate Tribunal will hear civil cases that involve a substantial question relating to modem biotechnology and hear appeals on the decisions and orders of BRAI. |
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