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6-Regulation: Indian panel suggests harmonisation of laws for biotech commission

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TITLE:  Move for draft of biotech policy draws flak
SOURCE: The Financial Times, India, by Ashok B. Sharma
DATE:   19 Sep 2005

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Move for draft of biotech policy draws flak

NEW DELHI, SEPT 18: The National Commission on Farmers has joined the
race for drafting national biotechnology policy for the country. The move
has invited flak from some leading farmers' organisations in the country
who said that such a move is "unwarranted and waste of public money."

They argued that the country's first transgenic crop, Bt cotton, failed
to benefit farmers and rather placed them in heavy losses. They demanded
that the Bt cotton growers should be compensated by the seed
multinational, Monsanto.

As a first step towards formulation of such a policy, the commission has
convened a one-day conference of farmer leaders on September 22. The
conference will be presided over by the panel chairman Dr MS Swaminathan.

This would be the fourth attempt to prepare a national policy on
biotechnology. In June 2004 the taskforce on agriculture biotechnology
had submitted its report to agriculture minister Sharad Pawar. The report
recommended formation of an autonomous national biotechnology regulatory
authority. The taskforce had also invited the public opinion on the draft
of national biotechnology development strategy and finalisation of the
draft is pending.

On September 13, the taskforce on recombinant pharma in its report
suggested a different model structure for a single-window regulator for
all transgenic products.

Speaking to FE, executive chairman of Bharat Krishak Samaj (BKS) Dr
Krishan Bir Choudhary said, "There are already three government's reports
on biotechnology but none of these stresses the need for compensations to
farmers for crop failure. The fourth report which is contemplated to be
prepared by NCF should adequately address this issue."

BKS president reiterated "the losses on account of crop failure should be
determined at the farm level with the participation of farmers and
panchayat leaders. The concerned seed company should be made to pay the
compensation directly to farmers to save them from harassment".

Kavitha Kuruganti of the Secunderabad-based Centre for Sustainable
Agriculture alleged that tobacco streak virus has affected Bt cotton
fields in Warrangal district in Andhra Pradesh this year. She said that
this virus is unusual on cotton crop and occurs generally groundnut and

A prominent farmer leader from Andhra Pradesh, Malla Reddy, also demanded
that affected farmers should be compensated in full.

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TITLE:  Panel suggests harmonisation of laws for biotech commission
SOURCE: The Financial Times, India, by K.G. Narendranath & Ashok B. Sharma
DATE:   16 Sep 2005

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Panel suggests harmonisation of laws for biotech commission

NEW DELHI, SEPT 15: The taskforce on recombinant pharma has called for
harmonisation of all relevant laws as a pre-requisite for setting up of a
single autonomous regulator for transgenic technology in the country.

The taskforce headed by noted scientist RA Mashelkar submitted its report
to the Union environment and forests ministry early this week. It has
also defined the roles of existing different regulating agencies for
transgenic technology.

While proposing an independent National Biotechnology Commission, the
panel cautioned unless the relevant statutory requirements under
Environment Protection Act, Seeds Act and Drugs Controller General of
India (DCGI) are harmonised, the proposed authority will become "one more
window clearance instead of a single window clearance".

The report said, "Creation of a professionally managed single authority
will send a strong signal to the international community and promote
trade and investment as well as ensure timely and effective regulation."

The taskforce proposed one model structure of the proposed autonomous
regulator. It also suggested setting up of an inter-ministerial group to
examine different model structures for the single-window regulator.

The panel suggested to consider the model structure proposed by the
secretary, department of biotechnology, MK Bhan. This proposed model is
similar to the Food and Drugs Administration (FDA) in the US.

The single window regulator will have four wings namely, agricultural
products and transgenic crops, pharmaceuticals drugs and industrial
products, transgenic food and feed and transgenic animals and
aquaculture. The four wings will have well-trained professionals. A vice-
chair of the regulatory authority will head the secretariat of all the
four wings.

The recommendations of the secretariat will be forwarded to the apex
committee with statutory powers. The members of the apex committee will
comprise of representatives from all stakeholders, ministries and
departments concerned. The apex committee will report to the chair.

The panel suggested that the the environment ministry redefine living
modified organism as organisms modified by r-DNA techniques through human
through human interventions. As presently the responsibility of according
market authorisation for recombinant drugs is with DGCI, there is need
for strengthening the committees under the Drugs & Cosmetic Act & Rules.


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