Drug Regulation

SpicyIP Tidbit: The National Biotechnology Regulatory Authority Bill

The Department of Biotechnology, Ministry of Science & Technology, Government of India has finally announced a draft National Biotechnology Regulatory Authority Bill (NBRA). Unfortunately the link to the draft Bill on the website of the DBT is not working currently. The NBRA has been in offing for the last 5 years i.e. ever since the government had constituted the Taskforce on Application of Agricultural Biotechnology under the chairmanship of Dr. M.S.Swaminathan. The report had urged the government to setup an independent regulator in order to foster public confidence in genetically modified organisms. This assertion was backed up in 2005 by the report of the Task Force on Recombinant Pharma chaired by Dr R A Mashelkar.

The NBRA Bill confers upon the regulator the power to regulate research, manufacture, import and marketing of genetically modified organisms. As of now the entire process relating to the regulation of genetically modified organisms is quite ad-hoc and it is exactly this problem that the NBRA seeks to solve by providing a single window clearance mechanism. Currently there are more than a handful of regulators in the field – the first being the Genetic Engineering Approval Committee (GEAC) under the Ministry of Environment which was the main body regulating the genetically modified organisms. Until now the Drug Controller General of India (DCGI) was involved in the process when it came to the question of drugs and live vaccines. However as Jyoti Dutta reports, with the setting up of the NBRA, all approvals regarding recombinant biologics, DNA vaccines and other genetically modified drugs will be granted by the NBRA and not the DCGI.

Ms. Dutta also has an important word of caution on possible turf wars between different regulators and I quote from her report below:

To illustrate, in the proposed framework, GM wheat would be under the purview of the NBRA, but biscuits or flour made from GM wheat are to be regulated by the FSSA (Food Safety and Standards Authority). The underlying logic here is to treat products that expose humans and animals to ‘live’ genetic modifications on a different plane.

“If the proposal is to use the NBRA for GM crops, live vaccines, cell and gene therapies, while excluding recombinant protein therapeutics, that is fine. However, I have concerns if products have to straddle two regulatory agencies, viz, DCGI and NBRA. We need to have clarity in who regulates what and any blurred boundaries will introduce inefficiencies and inconsistencies,” according to Dr Kiran Mazumdar-Shaw, CMD, Biocon.

Ms. Dutta is very right in pointing out these possible turf wars, given the sour experiences that India has had in regards the turf wars between the various financial regulators such as SEBI, RBI, MCA etc. The focus should be on stressing on a spirit of co-operation rather than confrontation.

Prashant Reddy

Prashant Reddy

T. Prashant Reddy graduated from the National Law School of India University, Bangalore, with a B.A.LLB (Hons.) degree in 2008. He later graduated with a LLM degree (Law, Science & Technology) from the Stanford Law School in 2013. Prashant has worked with law firms in Delhi and in academia in India and Singapore. He is also co-author of the book Create, Copy, Disrupt: India's Intellectual Property Dilemmas (OUP).

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