Decisions taken in the 52nd
Meeting of the Genetic Engineering Approval Committee (GEAC) held on 4th
March 2005.
The 52nd
Meeting of the Genetic Engineering Approval Committee was held on 4th
March 2005 in the Ministry of Environment and Forests under the Chairmanship of
Shri Suresh Chandra, Special Secretary & Chairman GEAC.
DECISIONS
A. Transgenic crops (commercial release)
1.0
Renewal of GEAC
permission for commercialization of three Bt. Cotton hybrids namely MECH – 12
Bt, MECH – 162 Bt, and MECH – 184 Bt containing with Cry 1 Ac gene developed by
M/s Mahyco in Central and South zones.
1. The Committee
noted that GEAC in its 32nd meeting held on 26.3.2002 had approved
three Bt cotton varieties namely- MECH – 12 Bt, MECH – 162 Bt, and MECH - 184
Bt containing cry 1 A(c) gene MON 531 developed by Mahyco for commercial
cultivation for a period of three years subject to compliance of certain
conditions. Since the validity of the
clearance expires in April 2005, the company has approached the GEAC for
renewal of the GEAC clearance date 5th April 2002.
2. The Committee
gave an opportunity to M/s Mahyco for presenting their case. The
representatives of M/s Mahyco made a presentation on their experience with
respect to performance of Bt Cotton and action taken on the compliance. To a
query on whether the Bt variety is resistant to bollworm complex or only
effective against American Bollworm it was clarified that Bt cotton is tolerant to Bollworm and not resistant. Over the
period of approval good control of spotted bollworm as well as pink bollworm
has been observed. However, as Bt cotton
is not resistant there is a need to undertake sprays if the ETL level has been
reached.
3. On the issue
of higher yield obtained in Bt cotton, it was clarified that Bt cotton gives
higher yield due to savings in the yield loss occurring because of bollworm
damage. Though the higher yields are in a broad range, the average increase in
the range of 29-30% over the non-Bt cotton hybrids has been observed during the
period of approval.
4. Regarding the
failure of Bt cotton crop in Andhra Pradesh and Government’s directive to the
company to pay compensation, it was clarified that the performance of Bt cotton
has been satisfactory in the state of Andhra Pradesh. This is reflected in the
total area coverage over the last few years. The sale of Bt cottonseed over the
period of approval has increased from 2853 acres in the year 2000 to an area of
28070 acres in 2004 and is expected to further increase to 100000 acres in
Kharif 2005. Regarding the compensation
issue, the company would be responsible for factors, which can be attributed to
its product as per the MOU, and they cannot be held responsible for other
extraneous factors outside its control. The Company further informed that
appropriate steps have been taken by them to respond to the request for
compensation.
5. To a query as
to why the sale in Tamilnadu is lower in 2004 over the previous years, it was
stated that the sales are lower due to drought conditions prevailing during the
sowing period. The Company was also
requested to comment on the deleterious soil effect because of Bt cotton use.
It was stated that they have not seen the report and would not be able to
comment at this stage. However extensive
tests have been done by the Company to find out the effect on soil and in all
the studies no adverse effects have been reported. Studies have been conducted
by Mahyco for three years (2000-2002) in different districts of Andhra Pradesh
(Adilabad, Medak, Warangal and Nalgonda). Regarding the lower yield of MECH-162
during the trials in Karnataka state, it was clarified that the expression of
low /high yield is a function of many more factors beside the germplasm.
6. After
detailed deliberation, the Committee noted that, on the various issues raised
by NGOs, most of the issues were relating to Warangal District. The Committee
further noted that agriculture is a State subject and no adverse reports on the
performance of Bt cotton have been received from any of the State Governments
in the six states where Bt cotton is under cultivation. However, before taking a final view, the
Committee opined that views of the State Government of Andhra Pradesh need to
be obtained, especially on the allegation made by Greenpeace regarding the
doctoring of the yield data at
Narasampet mandal in Warangal district.
It was agreed that a time frame of three weeks may be given to AP
Government for clarifying the above issue and the proposal may be placed before
the GEAC in the next meeting for taking a final view.
2.0
Permission for
commercialization of A-651 Bt. and A-2534 Bt. with Cry 1 Ac gene in the North
Zone and bulk Seed production by M/s Ankur Seeds Ltd.
&
3.0
Permission for
commercialization of MRC –6301 Bt and MRC–6304 Bt with Cry 1 Ac gene in the
North Zone by M/s Mahyco.
&
4.0
Permission for
commercialization of RCH – 134 Bt and RCH - 317 Bt in the North Zone by M/s
Rasi Seeds.
1. The
Committee noted that these companies have transferred their proprietary Bt.
Cotton hybrids (Ankur 651 Bt, Ankur 2534Bt. MRC 6301 Bt , MRC 6304 Bt ,
RCH 134 Bt and RCH 317 Bt ) with cry 1 Ac gene (Mon 531 event ) along with
gene cassette through traditional back crossing method. Of the six hybrids
under consideration, the Department of Agriculture and Co-operation of Ministry
of Agriculture have notified Ankur –651 on 1.1.1996.
2. The Member Secretary informed that the
GEAC in its 41st meeting held on 15.4.2004 had accorded approval for
conduct of large Scale trials of the six hybrids in the North Zone at 80
representative locations per genotype per zone based on the findings of the
contained field trials and recommendations made by MEC and RCGM. As requested
by GEAC the large-scale field has been evaluated by the MEC. The MEC in its
meeting held on 18.1.2005 has recommended that the above hybrids be considered
for commercial cultivation in the North Zone.
The MEC has also stated that these hybrids are resistance to CLCV and
very much fit in the desired cotton cultivation practiced in the North
Zone.
3. The Committee also took into consideration the results of the
two year ICAR trials and recommendations by ICAR. The Committee noted that the
incidence of the CLCV disease being higher at Sriganganagar as compared to
other locations, the data for this region may be taken into consideration as a
worst case scenario. The Committee
deliberated at length the issue of CLCV in North region and concluded that both
in terms of yield and resistance to CLCV, the six hybrids under consideration
were superior to the local check and its respective non-Bt counterpart.
4. While discussing the proposals, the Committee deliberated on the need or
otherwise for two years of large-scale trials under GEAC for
notified/un-notified varieties. The Member Secretary clarified that this issue
was discussed while according approvals for large scale trials in Kharif 2004
wherein the view taken was that one year of large scale trials was adequate for
notified varieties, however for un notified varieties, the need for second year
trials would be based on the results of the first year trials. Further to
ensure that various agro-climatic zones are represented adequately, the number
of large-scale trials was increased to 80 locations/genotype per zone. No
specific stipulations for 2 years of trials was stipulated by GEAC. In view of the above and taking into
consideration the results of large scale trials, recommendation of MEC and
results of 2 year ICAR trials, the Committee concluded that one year of large
scale trials under GEAC is adequate in the case.
5. After detailed deliberations and taking into consideration the
recommendation of MEC and results of ICAR trials the GEAC accorded approval for
commercial cultivation of Ankur 651 Bt, Ankur 2534Bt. MRC 6301 Bt, MRC 6304 Bt,
RCH 134 Bt and RCH 317 Bt for the North zone (Punjab, Haryana and Rajasthan)
for a period of 2 years subject to the following conditions:-
a. The applicant should look for the incidence of
sucking pests on these hybrids and carry out artificial screening for CLCV
resistance.
b. The post
release monitoring with specific reference to CLCV should be carried out by the
State Department of Agriculture through the State Agriculture Universities and
results of Kharif 2005 should be placed before the GEAC for further evaluation
before the hybrids are taken up for commercial cultivation for the second year
(Kharif 2006).
B. Transgenic crops (Large scale trials subsequent to RCGM trials
and MEC Evaluation)
5.0
Permission for large
scale field trial of MRC 6025 BG- 1 and
MRC-6029 BG I with Cry 1 Ac gene and seed production in the North Zone by
M/s Mahyco.
&
6.0
Request for large-scale
trials of RCH 314 Bt and RCH 308 Bt with Cry 1 Ac gene in the North Zone and
seed production by M/s Rasi Seeds Pvt. Limited .
&
7.0
Permission for
large-scale trials of NCS –138, NCS-570 and NCS –913 with Cry 1 Ac gene and
seed production in North Zone by M/s. Nuziveedu seeds Ltd.
1. These companies have transferred their proprietary Bt. Cotton
hybrids with cry 1 Ac gene (Mon 531 event ) along with gene cassette through
traditional back crossing method.
2. The
Companies have conducted multi-locational trials under RCGM during Kharif 2004.
Out of the seven hybrids under consideration, the MEC in its meeting held on 18.1.2005 has
recommended only six hybrids namely MRC 6025 BG-I , MRC 6029 BG-I ,
RCH 314 Bt, RCH 308 Bt , NCS 138, and
NCS 913 for large-scale trials in the North Zone.
3. The Committee noted that above hybrids
have undergone one year of ICAR trials under AICCIP during kharif 2004. However results of two years of ICAR trials
is a requirement for commercials release.
4. The Committee
noted that the hybrids under consideration have fulfilled the following
requirements for its consideration for large scale field trials.
·
Completion of Multi-locational field trials under RCGM
·
Monitoring & Evaluation of the multi-locational trials
by MEC
·
Recommendation of MEC & RCGM on suitability of the hybrids
for the North zone.
5. In view of
the above stated facts and noting the findings of the contained field trials
the GEAC approved large scale trials of MRC 6025 BG-I , MRC 6029 BG-I , RCH 314 Bt,
RCH 308 Bt, NCS 138 and NCS 913 at 80 representative locations per genotype
per zone and seed production in an area of 100 ha for each variety with the
following conditions:
a) The applicant should look for the incidence of sucking pests on these
hybrids during large-scale trials and also artificial screening for CLCV
resistance.
b) The Agricultural Universities would be involved in the monitoring of
large scale trials with specific reference to incidence of CLCuV.
c) Until an alternate mechanism for monitoring of large scale trials is
established, these trials may be monitored by the MEC.
8.0
Permission for large
scale trials of MRC-7017 BG-II , BG -
7025 BG – II and MRC – 7031-BGII containing Cry X gene (s) (Cry 1 Ac & Cry
2 Ab) in the North Zone & seed production by M/s Mahyco.
1. The Company has conducted multi-locational
trials under RCGM during Kharif 2004. These trials have been evaluated by the
MEC. Out of the three hybrids under consideration, the MEC in its meeting held
on 18.1.2005 has recommended only
MRC-7017 BG-II and MRC –
7031-BGII for large-scale trials in the North Zone. The MEC has also desired that the applicant
should look for the incidence of sucking pests on these hybrids during
large-scale trials and also artificial screening for CLCV resistance. The Committee was of the view that the recommendation
of MEC should be applicable for all hybrids approved for the North zone.
2. The Committee noted that the hybrids under consideration have
fulfilled the following requirements for its consideration for large scale
field trials.
·
Completion of Multi-locational field trials under RCGM
·
Monitoring & Evaluation of the multi-locational trials
by MEC
·
Recommendation of MEC & RCGM on suitability of the
hybrids for the North zone
3. In view of
the above stated facts and noting the findings of the contained field trials
and recommendation of MEC, the GEAC approved large scale trials of MRC-7017
BG-II and MRC – 7031-BGII at 80
representative locations per genotype per zone, ICAR trials and seed production in an area of 50 ha for
each variety subject to the following conditions.
a) The applicant should look for the incidence of sucking pests on these
hybrids during large-scale trials and also artificial screening for CLCV
resistance.
b) The Agricultural Universities would be involved in the monitoring of large
scale trials with specific reference to incidence of CLCuV.
c) Until an alternate mechanism for monitoring of large scale trials is
established, these trials may be monitored by the MEC
C.
Transgenic crops (Direct GEAC Large scale trials)
9.0 Permission for large-scale
trials of ACH – 11 - 1 and ACH-155-1 with Cry 1 Ac gene in the North Zone by
M/s Ajeet Seeds.
&
10.0 Permission for large scale
trials of BCHH - 6317 – Bt and HE- 563 Bt with Cry 1 Ac gene in the
North Zone and seed production by Bioseed Research India Pvt. Ltd.
&
11.0 Permission for large scale
trials of Ankur-2226 BG, Sita BG, Ankur 1286 BG and Jassi BG with Cry 1 Ac gene
in the North Zone and seed production by M/s. Ankur Seeds.
&
12.0 Permission of large-scale trials GK 206 Bt, GK- 207 Bt, GK-210 Bt
with Cry 1Ac gene in the North Zone and seed production by M/s G.K. Seeds Pvt.
Ltd.
&
13.0 Permission for large-scale trials of BG I with Cry 1Ac gene in the
North Zone and seed production by Krishidhan Seeds Ltd.
1. The
Committee noted that these companies have transferred their proprietary Bt.
Cotton hybrids with cry 1 Ac gene (Mon 531 event) along with gene cassette
through traditional back crossing method. The present request is for direct
entry into the GEAC large-scale trials.
2. The
Member Secretary informed that the basis
for this request is linked to the decision taken in the
RCGM meeting held on 13th May 2004, wherein it was decided that Bt cotton hybrids containing
Cry 1 Ac gene MON 531 event need not go to the RCGM for clearance regarding
conduct of multi-locational field trials as the event has already been
evaluated for its biosafety with diverse
tests and the applicant should directly approach GEAC and ICAR for conduct of
large scale trials and ICAR trials. In view of the decision taken by RCGM, the
GEAC had taken a view that the hybrids may go for direct large-scale trials
subject to the following case verification:
·
Evidence that the same gene or its equivalent
has been used.
·
Measurement on the level of protein expression
to confirm that the protein expression level is the same as that in the
originally released variety.
·
Evidence that transgenic variety is equivalent to the
corresponding non-transgenic variety -Bt hybrids in the form of DNA
fingerprinting.
3. After detailed deliberation, the Committee was of the view
that none of the above companies have fulfilled the criteria of ‘case
verification’ as enumerated in para 3 above and therefore their request cannot
be considered. Further, no preliminary tests have been conducted to verify the
suitability of theses hybrids in terms of its early maturity and resistance to
CLCV for the northern region. The Committee, therefore, concluded that the
proposals are pre-mature for consideration for large scale trials.
14.0 Permission for large scale
trial of BCHH - 6317 - 2 BG II containing Cry X gene (s) (Cry 1 Ac & Cry 2
Ab) of Bt cotton hybrids for North Zone by Bioseed Research India Pvt. Ltd.
1. M/s. Bioseeds Research India Pvt. Ltd is a sub-licensee of
Mahyco and has transformed their propriety Bt cotton hybrid with Cry X (Cry 1 Ac and Cry I Ab) gene along with gene
cassette through traditional back crossing.
2. The Committee
noted that multi-locational trials under RCGM have not been conducted and the
present request is for direct entry into the large-scale trials under GEAC.
3. The Committee
noted that the RCGM decision dated 13.5.2005 is only for approved events and
therefore the criteria for direct entry into large-scale trials through ‘case
verification’ would not be applicable in this case. The Committee therefore directed the
applicant to approach RCGM for conduct of multi-locational trials. The
Committee concluded that after evaluation of the contained trials by the MEC
and RCGM the matter may be considered at the appropriate stage. Hence the GEAC
rejected the request of the company.
B-PHARMACEUTICALS
15.0 Permission to develop
formulation and marketing of r- Human Insulin from Biocon by M/s USV Ltd.
Mumbai.
1. The Committee noted that the present application dated
20.1.2005 is for preparation of formulation of r-insulin from the bulk procured
from M/s Biocon. The r-insulin developed
by M/s. Biocon India Ltd. has been approved for manufacture and marketing of
the product in India by the GEAC in its meeting held on 14.7.2004 after
evaluation of the phase III clinical trials data. The product has also been
approved by DCGI.
2. The GEAC approved the request of the company.
16.0 Revalidation of GEAC permission for Import and Marketing of
Recombinant Human Growth Hormone (SAIZEN)) by M/s Serum Institute of India Ltd.
1. The
Committee noted that the GEAC in its 15th meeting held on
4.11.1997 had approved the import and marketing of the drug SAIZEN (r-Human
Growth Hormone) from M/s Laboratories Serono, Switzerland. Subsequently permission for revalidation for
another two years was accorded by GEAC in its 35th Meeting held on
7.3.2003.
2. The Committee conveyed their ‘No
Objection’ for revalidation of the GEAC approval.
17.0 Revalidation of GEAC permission for Import and
Marketing of Recombinant Human Follicle Stimulating Hormone (follitropin aplha)
Gonal-F by Serum Institute of India Ltd.
1. The
Committee noted that the GEAC in
its 15th meeting held on 4th November 1997 had approved
the import and marketing of the drug Gonal –F (r-Human Follicle stimulating
Hormone) from M/s. Ares Serono, Switzerland.
Subsequently permission for revalidation for another two years was
accorded by GEAC in its 35th Meeting held 7.3.2003.
2. The Committee conveyed their ‘No
Objection’ for revalidation of the GEAC approval.
18.0 Permission for manufacture and marketing of
r-human Epidermal Growth factor by M/S Bharat Biotech International Ltd.
Hyderabad.
1. The Committee noted that the above proposal was considered by
the GEAC in its meeting 10.2.2005. The
Member Secretary informed that the revised clarification submitted by the
Company has been circulated to the Expert for the comments. The Committee was
of the view that the specific comments of the Expert may be obtained before the
next GEAC meeting for consideration of the proposal.
Date of the Next GEAC Meeting: The next GEAC meeting
would be held on 13th April 2005.
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