Guidelines and Handbook for IBSCs - Department of Biotechnology

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14. IBSC records ..................................................................................................... 1515. Persons responsible for compliance.............................................................. 1615.1 Head of the Organisation .................................................................... 1615.2 Principal Investigator (PI) ................................................................... 1616. Addressing noncompliance ........................................................................... 1716.1 Noncompliance by Principal Investigator ........................................ 17(PI)/ Organisation16.2 Noncompliance by IBSCs .................................................................... 1717. Training............................................................................................................. 1717.1 Training of IBSC Members .................................................................. 1717.2 Training of Laboratory Personnel ..................................................... 1818. Laboratory inspections................................................................................... 1819. Security of GMOs/LMOs/rDNA materials................................................... 1820. Disposal ............................................................................................................. 19II.Check List for IBSCs1. Scientific Considerations ................................................................................ 231.1 Molecular biology details ..................................................................... 261.2 Human health considerations ............................................................ 311.3 Environmental considerations............................................................ 332. Containment facilities ..................................................................................... 343. General considerations ................................................................................... 373.1 Status of the Organisation .................................................................. 373.2 Organisational structure...................................................................... 38
3.3 Source of funding .................................................................................. 383.4 Status of other approvals required..................................................... 383.5 Status of documentation ...................................................................... 393.6 Availability of trained/skilled personnel ............................................ 39III. Submission of Applications to Review Committeeon Genetic Manipulation (RCGM)1. General guidance for applicants.................................................................... 432. Application forms ............................................................................................ 45A. IBSC Registration and ReportingForm A1: Application for Registration of an Institutional .......................... 49Biosafety Committee (IBSC)Form A2: Application for Renewal of an Institutional ................................ 51Biosafety Committee (IBSC)Form A3: Annual Report of the Institutional ............................................... 54Biosafety Committee to RCGMForm A4: Medical Surveillance Report ............................................................. 57Form A5: Confidentiality Agreement with IBSC ........................................... 59members including DBT nomineeB. Import, Export, Transfer and ReceiveForm B1: Application to RCGM for Import of GMOs/ ................................. 63LMOs and product(s) thereof for researchand development purpose.Form B2: Permit letter for authorization to import of ................................ 67GMOs/ LMOs and products thereof for researchand development purposeForm B3: Application to RCGM for export of GMOs/ .................................. 70LMOs and product(s) thereof for researchand development purpose.
Page 3 and 4: Guidelines and Handbookfor Institut
Page 5: 8. Role of IBSC in approval .......
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
Page 20 and 21: 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
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Submission of Applications to RCGMC
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FORM A1APPLICATION FOR REGISTRATION
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FORM A2APPLICATION FOR FOR RENEWAL
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12. Suggestion for three suitable e
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7. Examination & Clearance of the p
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FORM A4MEDICAL SURVEILLANCE REPORT1
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CONFIDENTIALITY AGREEMENT WITHIBSC
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FORM B1APPLICATION TO RCGM FOR IMPO
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9. Source and transport details:9.1
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FORM B2PERMIT LETTER FOR AUTHORIZAT
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Kindly acknowledge the receipt of t
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(c) Vector(s) (Please enclose the m
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FORM B5APPLICATION TO RCGM FOR RECE
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9. Source & transport details9.1 So
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9. Handling and packing instruction
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(b) Nucleic acid sequence (Please e
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Note:1. Please submit 23 copies of
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Name: _____________________________
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FORM C1INFORMATION TO RCGM TO CARRY
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10. Risk management (Emergency plan
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FORM C3APPLICATION TO RCGM TO CONDU
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8.5 Overall recovery of the product
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19. Declaration :I declare that the
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) The route of administration of th
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FORM C5FORMAT FOR SUBMISSION OF PRE
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Note:1. Please submit 23 copies of
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D. ACTIVITIES INVOLVINGRESEARCH AND
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5.3 Description of the target gene
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FORM D2INFORMATION ON RECORD TAKEN
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5.5 Copy number of gene(s):5.6 Nucl
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FORM D4PERMIT FOR CONDUCT OF SAFETY
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FORM D5FORMAT FOR SUBMISSION OF SAF
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120NOTES
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