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drshayana ☆ 2007-03-02 09:13 (7061 d 00:19 ago) (edited on 2007-03-02 11:54) Posting: # 553 Views: 6,174 |
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Sir, is it necessary to take approval from DCGI for conducting each and every BA/BE study in a CRO on generic drugs. If it is required only once and not every time please mail me the name of regulatory guidelines which we have to go through to get this point {i.e DCGI approval is not required to conduct ba/be study on generic drugs} Edit: Entire message in capitals reformated. [HS] |
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drshiv ★ India, 2007-03-04 19:56 (7058 d 13:37 ago) (edited on 2007-03-06 11:25) @ drshayana Posting: # 557 Views: 5,052 |
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Hi, It is necessary to take DCGI (Drugs Controller General [India]) permission to conduct all BA/BE studies in India. Also it is a requirement to get the permisssion from DCGI to import study drugs (reference drugs) and in case you need to export plasma samples for analysis out side the country, you will not get DGFT (Directro General of Foreign Trade) clearance (which is a must) without DCGI permission letter. Dr. Shiv Edit: Full quote removed. [HS] |
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drshayana ☆ 2007-03-06 08:16 (7057 d 01:17 ago) @ drshiv Posting: # 558 Views: 4,930 |
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Dear Dr Shiv Thanks for the information Regards Dr. shayana |
Ing. Helmut Schütz