Bill to set up biotech regulator introduced in LS
New Delhi: A bill to establish a statutory independent regulator for biotech sector covering research, transport, import, manufacture and use of organisms and products of modern biotechnology was introduced in the Lok Sabha on Monday.
The Bill, which has been on the drafting board for years and had run into stiff opposition from green activists, was introduced by Minister for Science and Technology S Jaipal Reddy, who rejected objections raised by CPI(M) member Basudeb Acharia.
As Reddy sought the leave of the Lok Sabha to introduce the Biotechnology Regulatory Authority of India Bill, Acharia objected to it contending that Department of Biotechnology, the promoter of the science, cannot be its regulator.
"Recently, the Standing Committee on Agriculture in its Report on Genetically Modified Foods and Crops, recommended that there should be a non-incumbency Regulatory Authority," said Acharia, who is the chairman of the Standing Committee.
Reddy termed Acharia`s objections as untenable and said that the Bill was being done within the legislative competence of Parliament.
The proposed regulator would be a nodal agency of the government to ensure comprehensive safety assessment of organisms and products of modern biotechnology.
The commercialisation of biotechnology products in agriculture and healthcare would be subject to all other laws for the time being in force, the Bill stated.
The biotech regulator would regulate trials preceding the clinical trials in the health sector and the present mechanism for regulating clinical trials would continue, it said.
The BRAI will be a five-member body which will have the final say in deciding the "safety and efficacy" issues of genetically-modified crops leaving no scope for political interference in this field.
An Inter-Ministerial Board of Governors, chaired by Secretary Department of Science and Technology and comprising officers not less than additional secretary rank, would oversee the performance of the Authority.
The Biotechnology Regulatory Advisory Council, with representatives from 17 government agencies involved in the regulation of biotech products, will render strategic advise to the Authority on matters relating to developments in modern biotechnology and their implications in the country.
The Council will have representatives of all stakeholders, including farmers associations, consumer organisations and NGOs.
The Bill also has provisions for setting up an appellate body, to be headed by a retired Supreme Court judge, for redressal of grievances of the applicant.
The Bill provides for setting up of regulatory divisions of the Authority dealing with agriculture, forest and fisheries, human health and veterinary products and industrial and environmental applications for implementation of safety assessment procedures and processes.
It also proposes constitution of Risk Assessment Unit for elaborate risk assessment process involving scientific experts and representatives of concerned ministries, including a special public review system for evaluation of applications before final approvals.
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