Bioequivalence and Bioavailability Forum

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