Review Committee on Genetic Manipulation (RCGM)

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Main functions

 

To bring out manuals of guidelines specifying producers for regulatory process on GMOs in research, use and applications including in industry with a view to ensure environmental safety.

 

To review all on going r-DNA projects involving high risk category and controlled field experiments

 

To lay down producers for restriction or prohibition, production, sale, import & use of GMOs both for research and applications.

 

To permit experiments with category III risks and above with appropriate containment.

 

To authorize imports of GMOs/ transgenes/ transgenic seeds for research purposes.

 

 

To guide the applicant to generate relevant biosafety data on transgenic materials in appropriate test systems.

 

To examine information on preparation of MCB and WCB; QC tests conducted on the cell line; approaches adopted for expression of target gene in the host cell line; genetic analysis including copy number of inserts, stability;  level of expression of target gene; description of production process;  growth kinetics; fermentation parameters; in-process control measures; quality control & quality assurance data;  approaches adopted for extraction and purification of the target gene product; examine data on physico-chemical, biochemical, immunological and pharmacological  characterization of the bulk; characterization of the finished formulation; acceptability criteria for bulk and formulation as per IP, USP, BP or other national/international specifications etc; efficacy tests on the target product; trial batch fermentation data on the product; estimation of contaminants like DNA, RNA, lipids, carbohydrates, proteins etc, derived from the host organism and any toxic processing materials in the product;

 

To approve the protocols for conducting animal toxicity and allergenicity studies and examination of in-process and final QC data on the product etc; to submit its recommendation on the preclinical studies/data directly to the DCGI; for the products from Risk group III & above organisms, to examine the information on containment facilities at the R&D and production sites as well as the results of the pre-clinical studies and submit their recommendations both to the GEAC and DCGI.

 

 

To authorize field experiments in 20 acres in multi-locations in one crop season with up to one acre at one site.

 

 To examine the data generated in the Lab & Green house on the points like: source and sequence of trans-gene; cloning strategy; characteristics of expression vector(s); characteristics of inserted genes with detailed sequences; characteristics of promoters; transformation/cloning methods of target gene; genetic analysis including copy number of inserts, stability, level of expression of trans-gene, characterization of expressed gene product; mode of action of gene product; compositional analysis; description of the host plant; rationale for the development of transgenic plants in terms of agronomic, nutritional and other benefits; centers of origin of the host plant; geographical distribution of the host plant in the country of development;

 

To evaluate the data on back crossing duration; seed setting characteristics; germination rates; phenotypic characteristics; target gene efficacy tests; observations on the implications of toxicity and allergenicity, if any during handling, etc. (These points are indicative only. Depending up on the nature and characteristics of the target gene & the transgenic crop additional information may require to be generated). 

 

Also to evaluate information generated during the contained open field trials on the transgenic crops on the points like: comparison of germination rates and phenotypic characteristics; study of gene flow; possibility of transfer of gene to near relatives through out crossing; implications of out crossing; invasiveness; possibility of weed formation; susceptibility to diseases and pests; toxicity and allergenicity implications of plants/fruits/seeds and any other plant parts; food/feed  safety evaluation in animals; handling procedures for allergenic substances; agronomic advantages etc.

 

To inform and recommend to the GEAC about the containment facilities at R&D and production sites.

 

 

 

 

 

 

REVIEW COMMITTEE ON GENETIC MANIPULATION

COMPOSITION

 

S. No.

Name, Designation and Address

Position

1.

Dr. V.P. Kamboj, Ex-Director, CDRI and

CSIR Emeritus Scientist,

Central Drug Research Institute,

Chattar Manzil, Post Box. No. 173,

Lucknow - 226 001.

e-mail: kambojvp@yahoo.com

Chairman

2.

Prof. M. Udaya Kumar, Professor,                      

Department of Crop Physiology,

University of Agricultural Sciences, Hebbal,

GKVK, Bangalore -  560 065.

Phone: 080-2363 6713

e-mail: udayakumar_m@yahoo.com

Co-Chairman

3.

Dr. N.T. Yaduraju, Principal Scientist

Division of Agronomy,

Indian Agricultural Research Institute (IARI),    Pusa Campus, New Delhi ‑ 110 012.

Phone: 011-2584 1488; 

Fax :    011-2584 6420

e-mail: yaduraju@yahoo.co.uk

Member

4.

Dr. Rakesh Tuli (CSIR Nominee)

National Botanical Research Institute,

Rana Pratap Marg, P.B. No. 436,

Lucknow - 226 001.

Phone: 0522-220 5849# 324:

Fax:      0522-220 5836

e-mail: rakeshtuli@hotmail.com; rakeshtuli23@rediffmail.com

Member

5.

Dr. J. Nagaraju, Staff Scientist& Chief,

Laboratory of Molecular genetics,

Centre for DNA Fingerprinting and Diagnostics,

4-87/1, ECIL Road, Nacharam,

Hyderabad - 500 076.

Phone: 040-2717 1427(D); 040-2715 1344# 1100(O), 1120(L)

Fax: 040-2715 5610/2715 5479

e-mail: jnagaraju@mailcity.com

Member

6.

Dr. T.P. Rajendran, ADG (Plant Protection)

Indian Council of Agricultural Research (ICAR),

Krishi Bhawan,

New Delhi - 110 001.

e-mail: tprajendran@yahoo.com

Member

7.

Dr. V.V.S. Suryanarayana, Principal Scientist,

Indian Veterinary Research Institute,

Hebbal, Bangalore - 560 024.

Phone: 080-2341 8078

e-mail: veluvarthy@yahoo.com

 Member

8.

Dr. B.M. Khadi, Director,

Central Institute for Cotton Research (CICR),

(Indian Council of Agricultural Research)

Post Bag No. 2, Shankar Nagar P.O.,

Nagpur - 440 010.

Phone: 07103-275 536

Fax :     07103-275 529

e-mail: cicrngp@rediffmail.com

Member

9.

Dr. A.R. Reddy, Professor,   

Department of Plant Sciences,

School of Life Sciences,

University of Hyderabad,

Hyderabad - 500 046.

Phone: 040-2301 0265;

Fax:     040 2301 0145

e-mail: arjulsl@uohyd.ernet.in

Member

10.

Dr. V. Siva Reddy, Group Leader,   

Plant Biology: Plant transformation,

International Centre for Genetic Engineering and Biotechnology,

P.O. Box No. 10504,

Aruna Asaf Ali Marg,  New Delhi - 110 067. 

Phone: 011-2618 1212(L); 2618 9358/9360/ 94361/2619 5007 # 351

Fax :    011-2616 2316

e-mail: vsreddy@icgeb.res.in

Member

 11.

Prof. Har Narayan Gour,

Professor and Head,

Department of Plant Pathology,

Rajasthan College of Agriculture,

Maharana Pratap University of Agriculture and technology

Udaipur - 313 001, Rajasthan.

Phone: 0294-241 3612;

Fax:     0294-242 0447

e-mail: gour_hn@sancharnet.in

Member

12.

Dr. Rakesh K. Jain, Scientist-F,      

Institute of Microbial Technology,

Sector 39A, Chandigarh - 160 036

Phone: 0172-269 0908/5215/5225

Fax:    0172-269 0585/0632

E-mail:rkj@imtech.res.in; rakesh110@yahoo.com

Member

13.

Dr. Hemant J. Purohit, Head,

Environmental Genomics Unit,

National Environmental Engineering Research Institute (NEERI),

Nehru Marg, Nagpur - 440 020.

Phone: 0712-2241 974;

Telfax: 0712-2249 883

e-mail: hemanthdrd@hotmail.com

Member

14.

Dr. A.K. Panda, Staff Scientist,

National Institute of Immunology,

Aruna Asaf Ali Marg,

New Delhi - 110 067

Member

15.

Dr. P. Kondaiah, Professor,  

Department of Molecular Reproduction, Development & Genetics,

Indian Institute of Science, Maleswaram,

Bangalore - 560 012.

Phone: 080-2293 2688

Fax :    080-23360 0999

e-mail: paturu@mrdg.iisc.ernet.in

Member

16.

Dr. Debi P. Sarkar,   

Professor & Head,

Department of Biochemistry,

University of Delhi South Campus,

Benito Juarez Road, New Delhi - 110 021.

Phone: 011-2411 1967/2411 6178 (L)

Fax:     011-2411 0283/ 2411 5270

e-mail: dpsarkar59@rediffmail.com

Member

17.

Dr. B. Sesikeran, Dy. Director,

Head Pathology Division,               

National Institute of Nutrition (NIN),

Jamai-Osmania PO.

Hyderabad - 500 007.

Phome: 040-2700 8921# 309

Fax:      040-2701 9074

e-mail: sesikeran@gmail.com

Member

18.

Dr. N.B. Singh,

Assistant Director General (Seeds)

Indian Council of Agricultural Research (ICAR),

Room No. 214, Krishi Bhawan,

New Delhi - 110 001 

Member

19.

Dr. Balram Ghosh, Scientist-F, (CSIR Nominee)

Institute of Genomics and Integrative Biology, University Campus, Mall Road,

Delhi - 110 007

Member

20.

Dr. O.P. Agarwal, EMS, (Nominee, ICMR)

Indian Council of Medical Research (ICMR),

Prof. V. Ramalingaswamy Bhawan,

Ansari Nagar, Post Box No.4911,

New Delhi - 110 029.

e-mail: op_agarwal@yahoo.com

Member

21.

Director

National Bureau of Plant Genetic Resources (NBPGR)

Pusa Campus,         

New Delhi - 110 012 

Member

22.

Sh. Satyapal Shani

Technical Officer (Drug),

Room No. 547, Drug Section,

Directorate General of Health Services,

Nirman Bhawan, 

New Delhi 110 011. 

e-mail: satyapalshani@msn.com 

Member

23.

Dr. K.S. Charak,  

Scientist-F,

Department of Biotechnology

Ministry of Science & Technology, Govt. of India

New Delhi - 110 003

Official Member

24.

Dr. S. R. Rao   

Adviser,

Department of Biotechnology

Ministry of Science & Technology, Govt. of India

New Delhi - 110 003

Official Member

25.

Dr. Rajesh Kapur  

Adviser,

Department of Biotechnology

Ministry of Science & Technology, Govt. of India

New Delhi - 110 003

Official Member

26.

Dr. Bindu Dey  

Scientist-F,

Department of Biotechnology

Ministry of Science & Technology, Govt. of India

New Delhi - 110 003

Official Member

27.

Dr. Suchita Ninawe, 

Scientist-E,

Department of Biotechnology

Ministry of Science & Technology, Govt. of India

New Delhi - 110 003

Official Member

28.

Dr. Ravi K. Khetrapal, Scientist

National Bureau of Plant Genetic Resources (NBPGR)

Pusa Campus,         

New Delhi - 110 012

Official Member
29.

Dr. Ranjini Warrier 

Additional Director & Member Secretary (GEAC),

Ministry of Environment & Forests, Govt. of India

Paryavarna Bhavan, CGO Complex,

New Delhi - 110 003

Member
30.

Dr. Rajalakshmi Muralidharan, 

Scientist-D,

Department of Biotechnology

Ministry of Science & Technology, Govt. of India

New Delhi - 110 003

Co-Member Secretary
31.

Dr. K. K. Tripathi

Adviser,

Department of Biotechnology

Ministry of Science & Technology, Govt. of India

New Delhi - 110 003

Tel: 011-24361559

Email: kkt@dbt.nic.in

Member Secretary

 

Terms of Reference of RCGM

 

1.) The RCGM shall function in the DBT to monitor the safety related aspects in respect of all ongoing r-DNA projects & activities involving Genetically Engineered Organisms/ Hazardous Micro-organisms and controlled field experiments as per the Rules-1989 of EPA-1986.

 

2.) The RCGM shall constitute Monitoring-cum-Evaluation Committee (MEC) through DBT as per the ‘Revised Guidelines for Research in Transgenic Plants and Guidelines for Toxicity and Allergenicity Evaluation of Transgenic Seeds, Plants & Plant Parts-1998’. RCGM may also appoint subgroups to undertake specific activities related Biosafety.

 

3.) The RCGM shall bring out manuals of guidelines specifying procedure for regulatory process with respect to activities involving genetically engineered organisms in research, use and application including industry with a view to ensure environmental safety.

 

4.) The RCGM shall lay down procedures restricting or prohibiting production, sale, importation and use of such genetically engineered organisms or products thereof for research and applications that may have biohazard potential.

 

5.) The RCGM shall review all on-going research projects involving high-risk category and controlled field experiments.

 

6.) The RCGM or its constituted subgroups shall visit periodically the experimental sites where projects with biohazard potential are being pursued to ensure that adequate safety measures have been taken as per the guidelines.

 

7.) The RCGM would issue the clearance for import of genes, DNA fragments, vectors, plasmids, etiologic agents & vectors, transgenic germplasm(s) including transformed calli, seeds, plants & plant parts for research use only.

 

8.) The RCGM can authorize applicants to conduct contained field trials limited to a total of 20 acres in multi-locations in one crop season in the country to seek answers to relevant and necessary questions on biosafety including risks related to environment, animal and human health. In one location, where the experiment is conducted with transgenic plants, the land used should not be more than one acre. The design of the trial experiments is either provided by the RCGM or it may approve the protocol designed by the Investigator.

 

9.) The RCGM, on case-by-case basis, can authorize applicants to use bioreactors beyond 20 ltrs capacities exclusively for research purposes only to produce sufficient material/ products of GMOs required for generating pre-clinical and other relevant data required to establish the product for commercial use.

 

10.) The RCGM, if required, can direct the applicants to generate toxicity, allergenicity and any other relevant data on transgenic materials/ GMOs in appropriate test systems. The RCGM may design or approve a protocol for conducting experiments to seek answers to the above.

 

11.) The RCGM, if required, can direct the applicants to generate long term environmental safety data, who are seeking release of transgenic plants into the open environment after completion of initial safety evaluation.

 

12.) The RCGM, if required, can generate or examine the research projects, proposals for conduct of workshops, seminars, symposia, training courses etc., creation of information systems/ data banks in electronic media, websites etc. and recommend to the DBT for funding of specific projects for furthering the cause of generating specific biosafety data related to use of GMOs in the environment and strengthening infrastructure facilities & dissemination of biosafety rules, regulations & guidelines in the country.

 

13.) The RCGM may also invite, induct or appoint experts in their individual capacities for furthering the cause of RCGM.

 

14.) The RCGM shall maintain the classified information provided by the applicants as confidential.

 

15.) The RCGM shall function for a period of three years from the date of notification.

 

16.) The RCGM shall meet at least twice in a year or as and when required

 

17.) The Members of RCGM shall be paid TA/DA and honorarium as per the Government rules & regulations.