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RegisterDCGI NOC [Regulatives / Guidelines]
Dear Pravin,
DCGI NOC is required to conduct clinical trial/BE study in INDIA for the new drugs(Def: Drug products approved by DCGI for marketing in INDIA less than 4 years) and drug products in modified release dosage form irrespective of their approval status for marketing in INDIA. Refer rule-122E as per D&C act Schedule-Y
You should take DCGI per clinical trial/protocol.
You may contact DCGI, if you need further information.
Regards
Raghavender
❝ Sir i want to know about criteria for taking DCGI NOC?
DCGI NOC is required to conduct clinical trial/BE study in INDIA for the new drugs(Def: Drug products approved by DCGI for marketing in INDIA less than 4 years) and drug products in modified release dosage form irrespective of their approval status for marketing in INDIA. Refer rule-122E as per D&C act Schedule-Y
❝ Whether it is Drug specific or for every protocol we should take DCGI NOC?
You should take DCGI per clinical trial/protocol.
You may contact DCGI, if you need further information.
Regards
Raghavender
Complete thread:
- DCGI NOC pravin17 2010-09-29 10:48 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- DCGI NOCraghu 2010-09-30 19:37
Ing. Helmut Schütz