PharmPK Discussion - DCGI permission for the BE study on patients

• On 24 Jan 2014 at 11:36:46, narayanakumar.r.aaa.ethicsbiolab.com sent the message
  

  
  Dear Friends
  
  Is it required to have BENOC from DCGI for conducting the BE study on patients for the drug (which
  is NOT a New Drug as per DCGI).
  
  Regards
  Narayana Kumar
  Ethics Bio Lab
  
  

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• On 24 Jan 2014 at 22:45:13, Abirami (abirami.-a-.microtheraps.com) sent the message
  

  
  I think we only have to register in CTRI.
  
  Thanks & Regards
  R.Abiraamasundari
  Manager Project Management
  Micro Therapeutic Research Labs Pvt. Ltd.
  Door No.29 A, Krishna Madura Vanam,Vellakinar Pirivu,
  Thudiyalur, Coimbatore ­ 29, TN, India.
  
  

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• On 24 Jan 2014 at 22:58:20, Manisha (manishab.-at-.anazeal.com) sent the message
  

  
  Hi,
  
  I think in the present scenario it is safer to take permission from DCGI &
  IEC.
  
  Regard
  Manisha Banavalikar
  GM (CLinical Research)
  Anazeal Analyticals & Research Pvt.Ltd.
  
  

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• On 25 Jan 2014 at 00:06:53, Bapi Gorain (bapi.gn.-at-.gmail.com) sent the message
  

  
  Friends,
  
  It is mandatory to get NOC from DCGI before conducting a BE study in India whether in patients or in
  healthy subjects.
  
  Bapi Gorain
  Bioequivalence Study Centre
  Jadavpur University
  Kolkata
  
  

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• On 25 Jan 2014 at 08:43:32, DRGUNA SAKARAN (drgunasakaran.-a-.gmail.com) sent the message
  

  
  Dear Mr Narayanakumar,
  
  As per the Revised Pre-Screening Checklist issued by CDSCO few days back for submission of BENOC for
  Export purposes, we need to get BENOC for drug molecules which are approved by DCGI for more than 04
  years also.
  
  Dr S Gunasakaran MD
  Head - Clinical Research & Medical Affairs,
  Azidus Laboratories Ltd,
  Chennai.
  Global Moderator - ClinicalResearchForum
  www.clinicalresearchsociety.org
  
  

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• On 28 Jan 2014 at 08:43:53, Ajit Gadekar (gadekar.pharma.-at-.gmail.com) sent the message
  

  
  Dear Mr Narayanakumar,
  
  Since DCGI is drug control authority in India, it is mandatory to take BENOC to conduct of BE
  studies for new formulation of existing marketed drugs to market it in India.
  
  Regards,
  Ajit Gadekar
  Senior Research Scientist,
  Advinus Therapeutics Limited,
  Bangalore
  
  

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