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kishor ☆ 2010-08-17 15:17 (5793 d 16:18 ago) Posting: # 5796 Views: 5,895 |
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Dear all, can any body tell me what is the T-license in BA/BE and what is the process for obtaining T-license. Regards kishor Edit: Category changed. [Helmut] |
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Helmut ★★★   Vienna, Austria, 2010-08-17 16:12 (5793 d 15:22 ago) @ kishor Posting: # 5798 Views: 5,360 |
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Dear Kishor! ❝ […] what is the T-license in BA/BE The T(rade) license is the study specific import license for foreign drugs issued by the DCGI. You have to apply by means of Form-11 (download Word-doc from clinicalresearchforum.com). See also this guideline. The Indian members of the forum (74%!) surely will be happy to give you the details.  — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Helmut ★★★ Vienna, Austria, 2010-08-26 14:52 (5784 d 16:43 ago) @ Helmut Posting: # 5839 Views: 5,099 |
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Dear members from India! ❝ The Indian members of the forum (74%!) surely will be happy to give you the details. Obviously I was overly optimistic in my statement above.  It’s a pity that not a single one of our current 808 (!!) Indian members attached importance answering Kishor’s question (which was viewed 200+ as of today). I’m getting the impression that Indian members are eagerly “sucking in” information, but are reluctant in sharing knowledge themselves, even if they would be best qualified in doing so. If this poor attitude persists, I will reconsider my personal engagement — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Cmax ☆ India, 2010-08-27 21:46 (5783 d 09:49 ago) @ Helmut Posting: # 5859 Views: 5,014 |
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Dear Kishore, T license is an application you have to file to DCGI to import any new drug to india for analytical or testing purpose, there is a prescribed fee for that after obtaining this you can import from desired country and if it is a narcotic drug then you have to obtain a clearence from the narcotic cell, this will be intimated by DCGI in the NOC.For any new drug for clinical study you have to apply seperatly in form 44. you will get all information if you check with Drugs and cosmetic act... fee is little more with this application... All regulatory agencies seeking this NOC in their Audit... Additionally for BE studies of new drug (see schedule Y definition) you have to obtain BE NOC separatly (check in CDSCO SITE)... Hope it may help you... dear helmut, hope you also happy...  |
Ing. Helmut Schütz