gmo regulations in india - (CUSAT) â Plant Biotechnology laboratory

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Characteristics of the purifiedproducts from GMOs (e.g.:recombinant therapeutics)- Identity, strength, quality, purity-Evaluation of functional assaysincluding potency of active component,sensitivity, specificity, variability ofassays-Estimates of variability including upperand lower limits for each specificationfor final release of the product- If purified product is held prior tofurther processing, information ondescription of storage conditions andverification of stability
Categorization of microorganisms based on pathogenicityHazard Group 1Hazard Group 2Organisms that are most unlikely to cause human diseaseOrganisms capable of causing human disease and which may bea hazard to laboratory workers, but are unlikely to spread to thecommunity. Laboratory exposure rarely produces infection andeffective prophylaxis or effective treatment is usually availableHazard Group 3Hazard Group 4Organisms that may cause severe human disease and present aserious hazard to laboratory workers. They may present a risk ofspread to the community, but there is usually effective prophylaxisor treatment availableOrganisms that cause severe human disease and are a serioushazard to laboratory workers. They may present a high risk ofspread to the community, and there is usually no effectiveprophylaxis or treatment
Page 1: GMO REGULATIONS ININDIACikesh P.CMi
Page 4 and 5: Department of Biotechnology guideli
Page 6 and 7: • 1998 DBT guidelines cover areas
Page 8 and 9: • DBT provides the secretariat fo
Page 10 and 11: GEAC (Genetic Engineering ApprovalC
Page 12 and 13: IBSC constitution• (i) Head of th
Page 14 and 15: • If research is conducted on org
Page 16 and 17: ‣ Inspection of containment facil
Page 18 and 19: FUNCTIONS- IBSC• The role of IBSC
Page 20 and 21: • Based on the feedback received
Page 22 and 23: FUNCTIONS- IBSC• Head of the inst
Page 24 and 25: • DBT NomineeEach IBSC has a nomi
Page 26 and 27: • Based on the nature of the GMO,
Page 28 and 29: To make available the protocols tha
Page 30 and 31: Research• IBSC has to review all
Page 32 and 33: • The categories of genetic engin
Page 34 and 35: • Different levels of containment
Page 36 and 37: • The interstate shipment of indi
Page 38 and 39: Characteristics oftransformed/modif
Page 40 and 41: Environmental ConsiderationsApplica
Page 44: BiosafetyLevelPractice and Techniqu

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gmo regulations in india - (CUSAT) â Plant Biotechnology laboratory