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Dear all,
Do we require BE No Objection Certificate from DCGI for conducting
bioequivalence study with FDC of Phenylbutazone and Paracetamol in
Indian volunteers?
Narasimha Reddy
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Dear Mr Narasimha Reddy,
As per CDSCO GSR NO. 633(E) Dated 13.09.1995, Fixed dose combination of
Phenylbutazone with any other drug is banned in India. Hence, you cannot
conduct
BE study of Phenylbutazone+Paracetomol in Indian volunteers.
Reference: http://www.cdsco.nic.in/drugs%20banned%20in%20thed%20country.pdf
Regards,
Dr.S.Gunasakaran, MD
Head - Clinical Research & Medical Affairs,
Azidus Clinical Research Organization, India
Global Moderator - ClinicalResearchForum
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I think Phenylbutazone is banned almost everywhere for human use, is
that not
correct?
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The following message was posted to: PharmPK
Dear Mr Paul Smrtc,
I think it is still marketed in countries like Philippines, Hong Kong,
Thailand, Singapore, Malaysia, Vietnam etc.,
References:
http://www.mims.com/Hongkong/drug/info/phenylbutazone/?q3Dphenylbutazone&type=brief&mtype=generic
http://www.mims.com/Philippines/drug/info/phenylbutazone/?q3Dphenylbutazone&type=brief&mtype=generic
http://www.mims.com/Singapore/drug/info/phenylbutazone/?q3Dphenylbutazone&type=brief&mtype=generic
http://www.mims.com/Thailand/drug/info/Pantazone/?q=phenylbutazone
http://www.mims.com/Vietnam/drug/info/Apo-Phenylbutazone/Apo-
Phenylbutazone%20Vie%C3%A2n%20ne%C3%B9n?q=phenylbutazone&type=brief
Regards,
Dr.S.Gunasakaran, MD
Head - Clinical Research & Medical Affairs,
Azidus Clinical Research Organization, India
Global Moderator - ClinicalResearchForum
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