pravin17
★    

India,
2010-09-29 12:48
(5751 d 13:54 ago)

Posting: # 5955
Views: 3,334
 

 DCGI NOC [Regulatives / Guidelines]

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Dear Sir,

Sir i want to know about criteria for taking DCGI NOC? Whether it is Drug specific or for every protocol we should take DCGI NOC?

Pravin
 
raghu
★    

India,
2010-09-30 21:37
(5750 d 05:05 ago)

@ pravin17
Posting: # 5967
Views: 2,813
 

 DCGI NOC

Post reply
Dear Pravin,

❝ 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
 
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