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accutest ☆ India, 2015-06-06 14:55 (3580 d 02:59 ago) Posting: # 14922 Views: 6,028 |
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Dear All Can anyone suggest that for all the anti cancer drug BENOC is required or BENOC is not required if the drug is old (More than four years). Is DCGI give us the permission to conduct the BE Study on healthy volunteers or we need to conduct the study on patients only? Your response will be highly appreciable. Regards Bharat N. |
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krish85 ☆ India, 2015-06-08 10:47 (3578 d 07:07 ago) @ accutest Posting: # 14924 Views: 5,163 |
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Dear Bharat, Considering your application for export puropose, you have to follow the checklist BE NOC for export purpose. Except for old drug DCGI will ask for data mentioned in checklist: For Cytotoxic drugs, Hormonal preparations, Narcotic and Psychotropic substances etc. in Healthy Human or subjects or Patients a Scientific justification with special emphasis on Safety of subjects with a proper Risk Mitigation Strategy shall be submitted. If Regulatory Guidance is available, enclose a copy of the same. You can perform study in healthy subject with justification otherwise it is advisable to perform patient base PK study. (e.g no saftey concern, single dose is well tolerated in healthy etc) And if the drug is old, already available/marketed in India then you can apply for test licence and DCGI will issue the same whether it is in healthy or patients |
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accutest ☆ India, 2015-06-09 15:23 (3577 d 02:32 ago) @ krish85 Posting: # 14931 Views: 5,029 |
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Dear krish, Many Thanks for reply, I will like to get one more clarification, My previous experience with DCGI for anticancer drug is that even drug is available in INDIA more than four years and if OGD is on healthy subjects, DCGI ask to do the study on patients and BENOC is also required for same. Awaiting for your response Regards Bharat N. Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut] |
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krish85 ☆ India, 2015-06-10 08:36 (3576 d 09:19 ago) @ accutest Posting: # 14938 Views: 4,949 |
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❝ even drug is available in INDIA more than four years.... Available means in IDR available or is it mentioned in the DCGI list of approved drugs? And can you mention the name of drug? DCGI might having different opionions which always depend on the reviewer also. It happens sometimes..... Try to respond the query with justification..( it might take more time for approval.....  )Still it does not convience, go for BE NOC as suggested. !!!!!  |
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accutest ☆ India, 2015-06-15 13:36 (3571 d 04:19 ago) @ krish85 Posting: # 14956 Views: 4,786 |
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Dear Krish Thanks I am talking about DCGI list approved drug only. We cant use other source like IDR, CIMS, NFI etc. as these books are not authorised by DCGI.  Regarding Anticancer drug i can give example of Imatinib 100 mg tablets though this drug is available in INDIA DCGI suggested to do study on patients and need to take BENOC also. And you are right that its depends on reviewer Sometime we are getting query (Published BA/BE) even drug is available more than four years. Regards Bharat N. Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut] |
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drgunasakaran1 ★★  2015-07-01 19:31 (3554 d 22:23 ago) @ accutest Posting: # 15007 Views: 4,454 |
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Dear Mr Acccutest, ❝ Can anyone suggest that for all the anti cancer drug BENOC is required or BENOC is not required if the drug is old (More than four years). We need to get BENOC from DCGI for all bioequivalence studies with anti cancer drugs irrespective of the approval status. ❝ Is DCGI give us the permission to conduct the BE Study on healthy volunteers or we need to conduct the study on patients only? It depends on the molecule. If the anti cancer drug does not have any cytotoxic potential, DCGI will permit to conduct study in healthy subjects. — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
Ing. Helmut Schütz