• Bangalore
  • 23 October 2014
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  • By Aishwarya Venkatesh & Rahul Koul

Accepted or Rejected: BRAI bill needed?

The bill sought to create an independent regulator called Biotechnology Regulatory Authority of India (BRAI) besides a 17-member inter-ministerial governing board to oversee the authority’s performance


Since the BRAI bill was introduced in the 15th Lok Sabha and the 16th Lok Sabha was constituted on May 18, 2014, the BRAI bill in the previous avatar has lapsed

How important is BRAI bill for the biotech industry?
Ms Kiran Mazumdar Shaw: Biotechnology can be a powerful tool in addressing India's challenges of meeting the food, fuel and healthcare needs of millions. It can play a very positive role in enhancing the quality of life of the people. However, multiple and complex regulations have been holding back all progress in the biotechnology sector. The Biotechnology Regulatory Authority of India (BRAI)
was envisaged as the final authority on all issues related to the biotechnology industry in India. BRAI could have played a critical role in the country's progress in biotechnology by streamlining the regulatory structure. With the BRAI bill having lapsed, India has again lost an opportunity to unlock the immense potential of biotechnology.

ABLE: The preamble to the BRAI Bill acknowledges the potential of biotechnology for India, stating that "modern biotechnology offers opportunities to address important needs related to agriculture, health, food production and environment." A bill recognizing the potential of biotechnology to contribute to India's health as well as substantially increase agricultural production to meet India's food, feed, fiber, and energy demands in the face of population growth is undoubtedly very important to the industry. ABLE supports the BRAI bill because of its potential to:

  • Improve efficiencies in the regulatory process
  • Create greater certainty and predictability for researchers, technology developers and the processing industry
  • Encourage investment, research and development of products important for India
  • Improve public information and awareness concerning modern biotechnology

Dr BV Ravi Kumar: There is no government body with authority and domain knowledge. It is required if biotech sector has to grow. Biotech is equated with pharma and no special attention is paid. There are lot of apprehensions among people about biotech and government reacts to public protest with excessive regulation. We need a science-based regulation.

Dr Swapan Datta: BRAI bill is important for science-based perception of moving forward with the genetically improved crops and for other biological material. The
bill shows the clarity, time-bound track record and accountability which is appreciated by the responsible Industry.

How can the bill further foster the biotech sector?
ABLE: While we sincerely feel that India already has a strong and well-developed regulatory framework to deal with all matters related to regulation and safe deployment of biotechnology products, the need of our times is to strengthen a regulatory regime in India to further promote innovation and development that is critical for our growing nation. This will help in bringing certainty and stability to regulatory environment governing the biotechnology sector that allows them to deliver the technological breakthroughs necessary to further our national interests.

Dr Swapan Datta: Biotech sector usually works with responsibility and in a  time-bound manner. The bill certainly will foster the motivation of the Industrial
growth as a commitment with predictability.

Have you approached the government regarding the lapse?
ABLE: Yes, we have written to the Prime Minster and all the ministries concerned requesting to introduce and pass this bill after adequate discussion, and take steps to create and empower BRAI quickly to start its work.

How soon can we expect the bill to be introduced or passed in the parliament?

ABLE: This is very difficult to state; however, we wish this should happen as soon as possible, at least by the next budget session.
Dr Swapan Datta: We would like to see the bill placed in Parliament soonest possible.


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