Minutes of 102nd RCGM meeting held on 28th June, 2011

MINUTES OF THE 102 nd MEETING OF THE
REVIEW COMMITTEE ON GENETIC MANIPULATION (<strong>RCGM</strong>)
HELD ON 28.06.2011 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 102 nd <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.
2. The Committee adopted the minutes and recommendations <strong>of</strong> the 101 st <strong>meeting</strong> <strong>of</strong> the
<strong>RCGM</strong> with certain modification on the application <strong>of</strong> one applicant to be communicated to
GEAC,
3. On action taken report, the Member Secretary informed that during the 101 st <strong>RCGM</strong>
<strong>meeting</strong> <strong>held</strong> on 15.05.2011, a total <strong>of</strong> 91 applications including information items were
considered and the Secretariat is in the process <strong>of</strong> issuing the requisite permit letters based on
the recommendations <strong>of</strong> the <strong>RCGM</strong> and GEAC.
4. Proposals considered:
4.1 Applications in the area <strong>of</strong> Pharmaceuticals
The committee considered applications in the area <strong>of</strong> pharmaceuticals to import
immortalized human PBMCs; MOP8 cells; CHO clones producing humanized monoclonal
antibody Bevacizumab; genetically modified CHO and Sp2/0 cells expressing Cetuximab
(Recombinant Chimeric Anti-EGFR Monoclonal Antibody); recombinant dengue viruses; E.
coli carrying recombinant genes and plasmid DNA expressing siRNA targeting uPAR, MMP-
9; to receive genetically modified Escherichia coli (DE3) pLysS strain expressing recombinant
Plasmodium vivax Duffy binding protein region II (PvDBPII); TNFR:Fc fusion protein
(Etanercept); to transfer recombinant E. coli strain BL21 DE3+ producing human PTH protein;
recombinant CHO cell lines transformed with coding sequences <strong>of</strong> monoclonal antibody
Rituximab and E. coli (Rosseta) strain producing Calreticulin protein were considered.
Applications for validity extension for conducting preclinical toxicity studies on recombinant
anti-staphylococcal protein P128; to conduct preclinical toxicity studies on recombinant
products viz. Insulin Lispro R, Insulin Lispro 25/75 & Insulin Lispro 50/50, Interferon beta-1b,
human Exendin-4, rhG-CSF and HPV vaccine; to carry out intravenous comparative safety
study on Streptokinase (SK) and Clot Specific Streptokinase (CSSK) were considered. Pre-
Clinical toxicity study reports <strong>of</strong> recombinant monoclonal antibodies viz. Trastuzumab and
Bevacizumab were also considered. After deliberation on each application, appropriate
decision was taken by the Committee. Information on R&D work was also noted by the
<strong>RCGM</strong>.
4.2 Applications in the area <strong>of</strong> Agriculture
The Committee considered applications in the area <strong>of</strong> agriculture to import insecticidal protein
Cry1Ac <strong>of</strong> Bacillus thuringiensis origin, transgenic rice events, devitalized plant material; to
transfer opened leaves each <strong>of</strong> three cotton transgenic events; to export <strong>of</strong> ground meal and
dried leaf tissues <strong>of</strong> transgenic rice lines, desiccated samples <strong>of</strong> leaves, flower, bolls, fibers,

oots etc. <strong>of</strong> transgenic cotton; to transfer seeds <strong>of</strong> transgenic Coker 310 and to receive
extracted oil and agro-infection kit.
Applications to conduct confined field trial for event selection on transgenic cotton
(Gossypium hirsutum); pigeon pea, red gram (Cajanus cajan (L.) Millsp), transgenic rice; to
conduct Biosafety Research Level-1 Trials (BRL-1) on cotton and rice (Oryza sativa); to
conduct F1 Hybrid seed production <strong>of</strong> transgenic rice events under confined open field
condition were also considered. After deliberation on each application, appropriate decision
was taken. Information on R&D work submitted by IBSCs was also noted by the <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 26.07.2011. 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: 18.07.2011
Sd/
(Dr.V.P.Kamboj)
Chairman, <strong>RCGM</strong> &
INSA Honorary Scientist

Annexure-1
List <strong>of</strong> participants
1. Dr. V.P. Kamboj, Honorary Scientist, INSA - Chairman
2. Dr. B. Sesikeran, NIN, Hyderabad - Member
3. Pr<strong>of</strong>. A.N. Radha, CCTR, Nagpur - Member
4. Dr. A.K. Kondapi, University <strong>of</strong> Hyderabad - Member
5. Dr. J. Nagaraju, CDFD, Hyderabad - Member
6. Dr. Anjali A. Karande, IISC, Bangalore - Member
7. Dr. D.P. Tiwari, GBPUA&T, Pant Nagar - Member
8. Dr. A.K. Panda, NII, New Delhi - Member
9. Dr. Dilip Kumar De, BCKV, West Bengal - Member
10. Dr. Raj K. Bhatnagar, ICGEB, New Delhi - Member
11. Dr. S.J. Rahman, ANGRAU, Hyderabad - Member
12. Dr. P.K. Gupta, CCSU, Meerut - Member
13. Dr. S.S. Gosal, PAU, Ludhiana - Member
14. Dr. Jay G. Varshney, DWSR, Jabalpur - Member
15. Dr. K.V. Prabhu, IARI, New Delhi - Member
16. Dr. S.R. Rao, Scientist-G, DBT - Member
17. Dr. K.K. Tripathi, Scientist-G, DBT - Member Secretary
18. Mrs. Rajalakshmi Muralidharan, Scientist-D, DBT - Co-Member Secretary
19. Dr. Nitin K. Jain, Scientist ‘D’, DBT - DBT <strong>of</strong>ficial
20. Dr. Amit P. Parikh, Scientist ‘C’, DBT - DBT <strong>of</strong>ficial
Other representatives:
21. Shri Vrancken Ermst, M/s. BASF India Ltd., New Delhi
22. Ms. Prateeksha Sharma, M/s. BASF India Ltd., New Delhi
23. Dr. S.M.H Qadri, Central Sericultural Research & Training Institute, Mysore
24. Dr. J. Nagaraju, Centre for DNA Fingerprinting and Diagnostics, Hyderabad
25. Dr. Harinarayana Rao, M/s. Reliance Life Sciences Pvt. Ltd., Navi Mumbai
26. Dr. Sachin R. Tendulkar, M/s. Reliance Life Sciences Pvt. Ltd., Navi Mumbai
27. Dr. K. S. Jaganathan, M/s. Shantha Biotechnics Ltd., Hyderabad
28. Shri B. Annamalai, M/s. Shantha Biotechnics Ltd., Hyderabad
29. Dr. Mandeep Singh Dhingra, M/s. Shantha Biotechnics Ltd., Hyderabad
30. Dr. Raman Rao, M/s. Shantha Biotechnics Ltd., Hyderabad
31. Shri D. Vijayarangan, M/s. Shantha Biotechnics Ltd., Hyderabad
32. Shri Tomal Dattaroy, M/s. Metahelix Life Sciences Pvt. Ltd., Bangalore
33. Shri S. Mukundan, M/s. Metahelix Life Sciences Pvt. Ltd., Bangalore