Flawed moves for a National Biotechnology Regulatory Authority

| July 26, 2015 | 0 Comments

The proposed bill to create such an authority is entirely industry-centric.

The proposal to create a National Biotechnology Regulatory Authority (NBRA), for which a draft bill is now in circulation, is being moved in an unprofessional manner by the Government of India.

The bill is driven by the Department of Biotechnology. The DBT ought to know that biotechnology covers some 30 areas, of which many need to be regulated. These areas include stem cells, nanobiotechnology, biological warfare, vaccines, bioinformatics, organ transplantation, new drug delivery systems, new materials such as spider silk and bacterial ropes, plant-based traditional drug formulations, and assisted reproductive technologies. But the proposed bill is confined to Genetically Manipulated Organisms (GMOs) and their products. Should it not, therefore, have been called a National GMO Regulatory Authority instead of an NBRA? Biotechnology cannot be equated with genetic engineering. If the DBT really thinks so, it ought to change its own name to “Department of Genetic Engineering.”

The bill has a range of other problems as well.

The objective of any proposed bill should be to fill a defined void. There is already a regulatory procedure in place for GMOs and their products, involving the Review Committee on Genetic Manipulation (RCGM) of the DBT and the Genetic Engineering Approval Committee (GEAC) of the Ministry of Environment and Forests. Therefore, it should first be determined if anything is wrong with the present system. Then an attempt should be made to correct the existing system. Only if this is not possible should a new bill be considered. The authorities concerned should state what part of the existing procedures is undesirable and how the proposed bill will correct it. For example, the present system does not prescribe any penalty for contamination of a non-GMO farm by GMOs in an adjoining farm. The proposed bill is silent on such problems.

The bill is supposedly up for public debate. While the DBT organised meetings at several places to discuss the bill, participation was by invitation, and the invitees were selected “carefully.” At one of the meetings held in Hyderabad, this writer, who had a role in the setting up the DBT, as also the Centre for Cellular and Molecular Biology in Hyderabad, which was the first laboratory in the country to do any serious work in genetic engineering, was not invited. I had to invite myself to the meeting on learning about it. (I was the first chairman of the National Committee on Genetic Engineering and Molecular Biology set up by the Science and Engineering Research Council of the Department of Science and Technology, and had the privilege of coining the term “genetic engineering” and using it in a syndicated article in 1973.)

At a meeting in Bangalore held a day earlier, on June 11, 2008, no State government official was present. Farmers are the largest stakeholders in the business of GMOs, yet their representation at the meetings appeared to be minimal and unrepresentative.

The meeting was organised by the Biotechnology Consortium of India that is committed to the maximum possible deregulation of GMOs. As someone suggested, the name of the authority that the bill proposes to set up should have been “National Biotechnology Deregulatory Authority.”

The proposed bill has little substantive content, and no rules and regulations have been circulated or debated. Whatever little substance it has, is entirely industry-centric and not people or farmer-centric.

 Top-heavy authority

The proposed authority is top-heavy. It would make the processing of an application far more cumbersome than it is today. It has been said that the proposed authority will be autonomous but the bill does not say how that autonomy would be exercised. If it is going to be similar to the Atomic Energy Regulatory Board which operates under the Department of Atomic Energy, we can forget any autonomy.

It says “international standards” would be observed in regard to GMOs. The question is: are there any international standards? Will they follow Switzerland which has put a moratorium on GMOs till 2012, or the European Union, which requires labelling of GM food, or the U.S. which, for all practical purposes, has no regulation of GMOs?

There are many organisational flaws in the bill. For example, the laboratory that is to carry out appropriate tests such as for toxicity and allergenicity will be a part of the proposed authority, whereas it should be independent of it to be able to function objectively. There is hardly any attention paid to detail. For example, in Section 2 K, the term ‘modern biotechnology’ excludes in vitro fertilization but not intracytoplasmic sperm injection.

The bill proposes to dispense with existing laws relating to environmental safety, including the Food Safety Act, but without defining how it will take over their functions and discharge them in a better way. Also, it does not provide for any interface with the public.

Reference: Flawed moves for a National Biotechnology Regulatory Authority. P.M. Bhargava. The Hindu, 27th August 2008, Op. Ed. page.

Leave a Reply

Your email address will not be published. Required fields are marked *