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taresh41 ☆ Mumbai, 2011-05-11 10:28 (5528 d 08:04 ago) Posting: # 7000 Views: 5,081 |
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Hello, I am intrested in knowing that till how much time DCGI BE NOC for a drug product is valid from the date of approval by DCGI, i.e in what time time period (within 1 or 2 or 3 years after getting the DCGI BE NOC) i will have to use the DCGI BE NOC for conduct of Bioequivalence study before it expires. Kindly also send me reference for the same if any. Thanks in advance. Regards, Taresh |
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swapnil.kuche ★ 2011-06-08 08:38 (5500 d 09:53 ago) @ taresh41 Posting: # 7096 Views: 4,160 |
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Dear Taresh, I had checked complete guidance as well as some BE NOC but nothing is mentioned about it's validity  . In my experiance there are some instances that BE studies were conducted after 2/3 years after getting approval from DCGI. I will request all BE regulatory experts to check the same from their end as well and reply to this post to avoid any such scenario in future. Best Regards, Swapnil D. Kuche |
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vishal ☆ 2011-08-29 17:12 (5418 d 01:19 ago) (edited on 2011-08-29 18:35) @ swapnil.kuche Posting: # 7310 Views: 3,731 |
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Hello, I had experience with using the 2 years old BE NOC. I have revised the existing protocols after 2 years of getting NOC due to some administrative changes and notified to DCGI and i have received querry from DCGI "reason for not conducting the study for the last after two and half years to this directorate". So better to conduct the study within one year. Thanks vishal Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe] |
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