In the wrong ministry?

Biotech Regulatory Authority will have too much power, no checks
In the wrong ministry?

FEW laws have been embraced as wholeheartedly by industry as BRAI or the Biotech Regulatory Authority of India Bill, 2011. Yet to be introduced in Lok Sabha, following a last-minute hitch, the proposed law has received the full support of the Association of Biotech Led Enterprises (ABLE) and other leading organisations that campaign for the promotion of biotechnology primarily for one reason: a single-window mechanism that will streamline the regulatory processes.



“It is a visionary step forward,” finds V Ram Kaundinya, chairperson of ABLE-AG, the agriculture interests section of the lobby group. ”Once BRAI comes into place we are sure we will have a more science-based, predictable and consistent regulatory policy environment, so critical to take the agri-industry to the next level.” BRAI will replace the current regulator, the Genetic Engineering Appraisal Committee (GEAC), which operates under the Environment Protection Act’s rules of 1980.

Industry says it does not have any quibbles with the Bill because, as Kaundinya points out, it “takes good care to ensure the authority is filled with people of reputed scientific and academic calibre”. The Bill was to have been introduced in the monsoon session of Parliament by Science and Technology minister Vilasrao Deshmukh. But it was delayed apparently on the account of objections from some Congress MPs. It is learned that ruling party MPs had pointed out that the Bill was not “implementable” in its current form because of the inherent conflict between different regulators in the pharmaceuticals sector. But this apart, there has been widespread criticism of where the law is being housed—in the Science and Technology ministry.

Basic flaws
 
 
  • Wrong ministry overseeing the regulation
  • Centralised, narrow authority; no checks on its power
  • States have no say although agriculture is their domain
  • No interface with biodiversity and plant protection laws
  • Excessively secretive, negates people’s right to information
 
 
 
CANADA:
THE UK:
AUSTRALIA:

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