GENET archive


6-Regulation: Indian recombinant pharma sector should be regulatedby a 4-wing body

                                  PART I
-------------------------------- GENET-news -------------------------------

TITLE:  Now, A Regulator Modelled On FDA
        Mashelkar panel calls for 4 separate wings in regulatory body
SOURCE: The Financial Express, India, by Ashok B. Sharma
DATE:   27 Aug 2004 

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Now, A Regulator Modelled On FDA
Mashelkar panel calls for 4 separate wings in regulatory body

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.

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 regulations.

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.

                                  PART II
-------------------------------- GENET-news -------------------------------

TITLE:  Environment Policy Seeks Changes In Norms
SOURCE: The Financial Express, India, by Ashok B. Sharma
DATE:   29 Aug 2004 

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Environment Policy Seeks Changes In Norms

NEW DELHI, AUG 28: The draft new environment policy (NEP), 2004 has come
as a shot in the arm for the industry. It has advocated the need for
changes in different regulations for enabling speedy environmental clearance.

The new draft policy also called for enhancing and conserving
environmental resources, setting up of environmental standards, adopting
standardised management systems, and promoting environmental
certification and indicators.

At a time when the industry engaged in developing transgenic products are
demanding suitable changes in the government's regulation and formulation
of a national biotechnology policy, the NEP 2004 in the same tune has
called for reviewing the regulatory processes for living modified
organisms (LMOs) otherwise called genetically modified organisms (GMOs)
so that "all relevant scientific knowledge is taken into account and
ecological health and economic concerns are adequately addressed".
National biosafety guidelines and biosafety operation manuals should be
reviewed periodically to ensure that these are based on current
scientific knowledge. The transboundary movement of LMOs should be in
consistent with the multilateral biosafety protocol (Cartagena Protocol)
for ensuring conservation of biodiversity and human health.

On the issue of industry's demand for access to country's community-owned
bio-resources and traditional knowledge, the new draft policy advocated
formulation and adoption of an internationally recognised sui-generis
intellectual property rights legislation to enable the local communities
to derive economic benefits from grant of access to these resources. It
also suggested similar legislation for benefit sharing of entho-biology

On the issue of environment and forest clearances for setting up of
projects, the draft policy called for encouraging regulatory authorities,
central and state governments to institutionalise regional and cumulative
environmental impact assessments for ensuring that the concerns are
identified and addressed at the planning stage itself. Projects involving
largescale diversion of prime agricultural land would require
environmental clearance and the quality and productivity of land to be
converted for development activities should be considered. Diversion of
dense natural forests to non-forest use should be prohibited, except for
site-specific cases of vital national interest. 


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