Minutes of 78th RCGM meeting held on 23rd June, 2009

MINUTES OF THE 78 th MEETING OF THE
REVIEW COMMITTEE ON GENETIC MANIPULATION (<strong>RCGM</strong>)
HELD ON 23.06.2009 IN THE DEPARTMENT OF BIOTECHNIOLOGY
Dr. V.P. Kamboj, Chairman, <strong>RCGM</strong> extended a formal welcome to the members <strong>of</strong>
<strong>RCGM</strong> for the 78 th <strong>meeting</strong> and initiated the process <strong>of</strong> the <strong>meeting</strong>. The list <strong>of</strong> participants is
given at Annexure-I.
Dr. M.K. Bhan, Secretary, DBT addressed the members and appreciated the role <strong>of</strong> <strong>RCGM</strong> in
ensuring a smooth and fair process <strong>of</strong> regulatory approvals. He suggested a constant review <strong>of</strong>
the various steps <strong>of</strong> the regulatory process by <strong>RCGM</strong> and provided suggestions on expediting the
process <strong>of</strong> communication between the applicants and the regulators in view <strong>of</strong> the crucial role <strong>of</strong>
the regulatory system in biotechnology development.
2. As no comments were received from <strong>RCGM</strong> members on the minutes and
recommendations <strong>of</strong> 77 th <strong>meeting</strong> <strong>held</strong> on 25.05.2009, the committee adopted the minutes and
recommendations.
3. On action taken report, the Co-Member Secretary informed that during the 77 th <strong>RCGM</strong>
<strong>meeting</strong>, a total <strong>of</strong> 32 applications including information items were considered and the
Secretariat is in the process <strong>of</strong> issuing the requisite permit letters on the recommendations <strong>of</strong> the
<strong>RCGM</strong>.
4. Proposals considered:
4.1 Applications in the area <strong>of</strong> r-DNA Pharmaceuticals
The Committee considered applications in the area <strong>of</strong> r-DNA Pharmaceuticals to import
recombinant CHO cell lines producing antibody that putatively targeting CD6 antigen on the
surface <strong>of</strong> T cell (Bmab600); GMZ2 protein for formulation, filing and lyophilisation; SupT1
cell line, CEM SS cell line, Jurkat tat III cell line, PM-1 cell line, Molt-4 Clone 8, Huh-717D,
HEP G2, HUT -78, MT -4, CHO K1, HIV-1 931N101 virus, HIV-1 931N905 virus, HIV-1 strain
type, HIV-1 97USSN54, HIV-1 MN 570719, Anti-human CCR-5 Mab, CXCR-4 Monoclonal
Antibody (12G5), Monoclonal Antibodies to HIV-1 p24, HIV-1 gp41 Monoclonal Antibody,
HIV-1 RT Monoclonal Antibody, HIV-1 IN Monoclonal Antibody, RNA quantification
standards, HIV-1 resistance mutations kits for NRTI's, HIV-1 resistance mutations kits for
NNRTI's , HIV-1 resistance mutations kits for Protease inhibitors, HIV-1 gp120 CM envelope
protein, Recombinant Soluble Human CD4, HIV-1SF162 gp120, HIV-111IB p55 Gag, HIV-1
HXB2 Reverse Transciptase (P66E>Q/p5) and HIV-1NL4-3 Integrase Protein (F185H/C280S);
plasmid DNA; and recombinant Embryonic Kidney Cell line (HEK293). The committee also
considered the request for extension <strong>of</strong> validity <strong>of</strong> the permission granted to import 150 Ltr milk
<strong>of</strong> transgenic pig.
The Committee also considered applications to conduct pre clinical toxicity study on
Bmab 200 (Trastuzumab) Monoclonal antibody putatively targeting epidermal growth factor
receptor (EGFR); Bmab 100 Monoclonal antibody putatively targeting vascular endothelial
growth factor (VEGF), Filgrastim Injection, recombinant Human Insulin API and oil adjuvanted
recombinant tick vaccine antigen (Bm95); and Reports on pre clinical study on recombinant Anti
Rho (D) immunoglobulin and Teriparatide (rDNA origin) Injection. Applications to scale up the
production <strong>of</strong> batches <strong>of</strong> modified Streptokinase; and for extension on the validity <strong>of</strong> the
permission granted to conduct non-clinical safety toxicology studies on recombinant BVX20.
were also considered. After deliberation on each application, appropriate decision was taken.
Information on R&D work was noted by <strong>RCGM</strong>.
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4.2 Applications in the area <strong>of</strong> Agriculture.
The Committee considered applications in the area <strong>of</strong> agriculture to receive
uncharacterized T1 generation cotton seeds; import <strong>of</strong> seeds <strong>of</strong> GAT (glyphosate acetyl
transferase) corn; transgenic rice lines; transgenic Arabidopsis seeds; lyophilized cotton leaf bits;
cry1Ac-F and cry1Fa1gene gene construct in binary vector as Agrobacterium
tumifacience/E.coli; transgenic lines <strong>of</strong> Arabidopsis transformed with plasmid vectors; Bacillus
thuringiensis proteins; Cry3bB and TIC1088 protein standards; and transgenic crop species
carrying the marker genes for development <strong>of</strong> protocols for detecting marker genes. The
committee also considered applications to conduct confined field trials on BG-II Roundup Ready
Flex cotton hybrids; to conduct net house trials on transgenic cotton and event selection trials in
net house under confined field conditions for evaluation <strong>of</strong> transgenic groundnut plants etc. R&D
proposal “Monitoring for changes in bollworm susceptibility to Bt toxins deployed in pest
resistant in transgenic cotton plants” for joint funding <strong>of</strong> the project by MoE&F & DBT was also
considered. After deliberation on each application, appropriate decision was taken. Information
on R&D works submitted by IBSCs was also noted by <strong>RCGM</strong>.
5. Any other point with the permission <strong>of</strong> the Chairman.
The next <strong>meeting</strong> <strong>of</strong> the <strong>RCGM</strong> was scheduled on 28.07.2009. No other transaction took
place and the <strong>meeting</strong> ended with vote <strong>of</strong> thanks to the Chair.
The minutes are approved.
Place: Lucknow
Date: 29.06.2009
Sd/
(Dr. V.P. Kamboj)
Chairman, <strong>RCGM</strong> and
INSA Honorary Scientist
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List <strong>of</strong> participants
Annexure-1
1. Dr. V.P. Kamboj, Honorary Scientist, INSA - Chairman
2. Dr. B. Sesikeran, NIN, Hyderabad - Member
3. Dr. Raj Bhatnagar, ICGEB, New Delhi - Member
4. Pr<strong>of</strong>. A.N. Radha, ITTR, Nagpur - Member
5. Dr. Anjali A. Karande - Member
6. Dr. D.P. Tiwari, GBPUA&T, Pant Nagar - Member
7. Dr. A.K. Panda, NII, New Delhi - Member
8. Dr. P.K. Gupta, CCSU, Meerut - Member
9. Dr. I.S. Katageri. ARS, Dharwad - Member
10. Dr. Jay. G. Varshney, DWSR, Jabalpur - Member
11. Dr. S.K. Majumdar, IISR, Lucknow - Member
12. Dr. Rakesh Tuli, NBRI, Lucknow - Member
13. Dr. P. Ananda Kumar, IARI, New Delhi - Representative <strong>of</strong>
Director, IARI, New Delhi
14. Dr. K. Satyanarayana, ICMR, New Delhi - Member
15. Dr.S.R.Rao, Adviser, DBT - Member
16 Sh. S.Sinha, Adviser, DBT - Member
17. Mrs. Rajalakshmi Muralidharan, Scientist-D, DBT - Co-Member Secretary
Other representatives:
18. Dr. Sriram Akundi, M/s. Biocon Ltd., Bangalore
19. Dr. Dev Chandran, M/s. Indian Immunologicals Ltd., Hyderabad
20. Mr. Mannan, M/s. Bharat Serum and Vaccines Ltd., Mumbai
21. Mr. Prakash, M/s. Bharat Serum and Vaccines Ltd., Mumbai
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