Guidelines and Handbook for IBSCs - Department of Biotechnology

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Kindly acknowledge the receipt of the same(Member Secretary, RCGM)Copy for information to:i. The Chairman, GEAC, Ministry of Environment and Forests, ParyavaranBhawan, CGO Complex, Lodi Road, New Delhi - 110 003ii.iii.iv.The Director, NBPGR (in case of import of any planting material)M/s_________ (applicant)Office copy for filev. Guard file69
FORM B3APPLICATION TO RCGM FOR EXPORT OF GENETICALLY MODIFIEDORGANISMS (GMOs)/LIVING MODIFIED ORGANISMS (LMOs) AND PRODUCT(S)THEREOF FOR RESEARCH AND DEVELOPMENT PURPOSE1. Name of the Applicant: ___________________________________________________70Designation: _____________________________________________________________Contact Address: _________________________________________________________Telephone No.: ___________________________________________________________Fax No.: _________________________________________________________________e-mail: __________________________________________________________________2. DBT Office Memorandum No.: ____________________________________________3. Objectives of the proposal: _______________________________________________4. Description of the GMOs/LMOs and product thereof (in scientific terms):(a) Morphology________________________________________________________________________(b) Physiology________________________________________________________________________(c) Pathogenicity, if any________________________________________________________________________(d) Number of copies of the genes incorporated________________________________________________________________________5. Details on:(a) Source of nucleic acid(s):________________________________________________________________________(b) Nucleic acid sequence (Please enclose the nucleic acid sequence map of thetarget gene):________________________________________________________________________
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Guidelines and Handbookfor Institut
Page 5 and 6:
8. Role of IBSC in approval .......
Page 7 and 8:
3.3 Source of funding .............
Page 12 and 13:
IntroductionIntroductionIn India, G
Page 14 and 15:
Introductionand responsibilities of
Page 16 and 17:
GUIDELINES FOR IBSCS
Page 18 and 19:
Guidelines for IBSCs3. Terminology
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Guidelines for IBSCs6. Composition6
Page 22 and 23:
Guidelines for IBSCsrenewal of IBSC
Page 24 and 25:
Guidelines for IBSCs• In case of
Page 26 and 27:
Guidelines for IBSCs• Ensure that
Page 28 and 29: Guidelines for IBSCs• Inspection
Page 30 and 31: Guidelines for IBSCs13. Reporting r
Page 32 and 33: Guidelines for IBSCsiv. Application
Page 34 and 35: Guidelines for IBSCsand guidance fr
Page 36 and 37: CHECK LIST FOR IBSCSGuidelines and
Page 38 and 39: Check List for IBSCsParticularsTabl
Page 40 and 41: Check List for IBSCs1.1 Molecular b
Page 42 and 43: Check List for IBSCsantigen, part o
Page 44 and 45: Check List for IBSCsv. Characterist
Page 46 and 47: Check List for IBSCsi. Toxicity stu
Page 48 and 49: Check List for IBSCs2. Containment
Page 50 and 51: Check List for IBSCsantivirus scree
Page 52 and 53: Check List for IBSCs3.2 Organisatio
Page 54 and 55: SUBMISSION OFAPPLICATIONS TO REVIEW
Page 56 and 57: Submission of Applications to RCGMb
Page 58 and 59: Submission of Applications to RCGMC
Page 60 and 61: FORM A1APPLICATION FOR REGISTRATION
Page 62 and 63: FORM A2APPLICATION FOR FOR RENEWAL
Page 64 and 65: 12. Suggestion for three suitable e
Page 66 and 67: 7. Examination & Clearance of the p
Page 68 and 69: FORM A4MEDICAL SURVEILLANCE REPORT1
Page 70 and 71: CONFIDENTIALITY AGREEMENT WITHIBSC
Page 72 and 73: FORM B1APPLICATION TO RCGM FOR IMPO
Page 74 and 75: 9. Source and transport details:9.1
Page 76 and 77: FORM B2PERMIT LETTER FOR AUTHORIZAT
Page 80 and 81: (c) Vector(s) (Please enclose the m
Page 84 and 85: FORM B5APPLICATION TO RCGM FOR RECE
Page 86 and 87: 9. Source & transport details9.1 So
Page 90 and 91: 9. Handling and packing instruction
Page 92 and 93: (b) Nucleic acid sequence (Please e
Page 94 and 95: Note:1. Please submit 23 copies of
Page 96 and 97: Name: _____________________________
Page 98 and 99: FORM C1INFORMATION TO RCGM TO CARRY
Page 100 and 101: 10. Risk management (Emergency plan
Page 102 and 103: FORM C3APPLICATION TO RCGM TO CONDU
Page 104 and 105: 8.5 Overall recovery of the product
Page 106 and 107: 19. Declaration :I declare that the
Page 108 and 109: ) The route of administration of th
Page 110 and 111: FORM C5FORMAT FOR SUBMISSION OF PRE
Page 112 and 113: Note:1. Please submit 23 copies of
Page 114 and 115: D. ACTIVITIES INVOLVINGRESEARCH AND
Page 116 and 117: 5.3 Description of the target gene
Page 118 and 119: FORM D2INFORMATION ON RECORD TAKEN
Page 120 and 121: 5.5 Copy number of gene(s):5.6 Nucl
Page 122 and 123: FORM D4PERMIT FOR CONDUCT OF SAFETY
Page 124 and 125: FORM D5FORMAT FOR SUBMISSION OF SAF
Page 126: 120NOTES
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