Bioequivalence and Bioavailability Forum

Dear all,

DCGI checklist for BE NOC contain "Pre-clinical single dose data and repeated dose toxicity data."

in the below example what should we submit DCGI for the above requirement?

Drug is approved in india, 5 years back at 1 mg dose and at 2 mg dose in combination product (according to DCGI approval list), however strength of 2 mg & 4 mg are also available in the market & also in the drug indices.

Study is planned with 2 mg, 3 mg & 4 mg drug alone.
So should we approach DCGI for NOC? if yes, for which doses?

If to apply do we need to do preclinical toxicity studies & submit (or) to find the suppoting literature and submit (or) can say that the section is not applicable as the drug is already available in the market & there are human studies already done at these doses.

Also are there any other clauses in regards to the API, where preclinical toxicity studies are mandatory.


Thanks in advance,

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Edit: Document linked. [Helmut]