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Checkbiotech: Now, a regulator modelled on FDA
Posted by: DR. RAUPP & madora (IP Logged)
Date: August 30, 2004 07:13AM ;

NEW DELHI - Close on the heels of government giving a green signal to a
single-window regulatory body for the biotechnology sector, there is more on
this front. Now, the taskforce on recombinant pharma headed by Dr RA
Mashelkar is also in the process of proposing a statutory single-window
regulatory authority for transgenic products, August 2004 by Ashok B Sharma

The proposed body, Indian Biotechnology Regulatory Authority (IBRA) will
have four separate wings to deal with transgenic crops, recombinant drugs
and industrial products, genetically modified (GM) food and feed, transgenic
animals and acquaculture. Each of the four wings will be headed by a
vice-chairman of the proposed authority and will comprise ?professionals who
have been well trained in regulatory affairs.?

The apex regulatory body, headed by a chairman, will comprise
representatives from all stakeholders, ministries and departments of the
government. Recommendations of the four wings will be forwarded to the apex
committee for approval.

The draft report of the Mashelkar panel, circulated by member-secretary MK
Bhan, said the proposed single-window regulatory authority should be
modelled on the lines of the Food and Drug Administration (FDA) in the US.
In the US, however, there are multi-agencies engaged in clearance of
transgenic products like FDA, Animal and Plant Health Inspection Services
(APHIS), Environment Proctection Agency (EPA) and United States Department
of Agriculture (USDA).

The draft report is slated for discussion on September 5.

Earlier, the MS Swaminathan panel had proposed an autonomous regulatory
authority with only two wings?one for transgenics in agriculture, fisheries
and animal husbandry and the other for recombinant pharma and other
industrial products. In contrast, the draft report of the Mashelkar
committee is in favour of four separate wings.

The Mashelkar panel has taken the cue from a Planning Commission proposal
which suggested the creation of Indian Council of Veterinary Research (ICVR)
as a separate apex research body in the public sector for animal husbandry
and fisheries.

The draft report of the Mashelkar panel also suggested a separate wing under
the proposed regulatory authority to deal with genetically modified food and
feed. This is in response to the environment ministry?s recent decision to
set up a panel of experts to suggest use of genetically modified products in
food and processed foods and any possible changes in the existing

The MS Swaminathan panel has suggested that the regulatory authority should
consist of single part-time members from five different fields like crop
sciences, animal husbandry, fisheries and forestry, health and food safety,
environment, social impact, intellectual property rights, legal affairs and
national legislation. In contrast, the draft report of the Mashelkar
committee has suggested a group of experts as members of the four wings of
the regulatory authority.

For the wing dealing with transgenic crops, it has suggested that it should
consist of a molecular biologist, a plant biologist, a plant geneticist, a
plant breeder, an agronomist, a plant ecologist, an environment biologist,
an agriculture economist and an environment biologist. Similarly, the wings
dealing with recombinant pharma and GM food and feed should each consist of
a molecular biologist, a pharmacologist, a toxicologist, an epidemiologist,
a microbiologist, a biochemist, an analytical chemist, a physicist and an
environment biologist.


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