Bioequivalence and Bioavailability Forum

Dear Venkat,

1. The facility must be inspected and approved by DCGI
2. GCP and DCGI recommendations must be followed during a trial.
3. In case points 1 & 2 are clear and a drug is being tested, which has not been approved for use in Indian market yet, then a special permission has to be sought for running the trial.

Regards,

Dr. Gagandeep Singh
Senior Consultant
Domain Consulting Team - Lifesciences
Cognizant Technology Solutions

Dear Venkat

❝ Would you please let me know, what are all the approvals that are

❝ recquired from the Indian regulatory bodies for a sponsor(In India) who

❝ wants to conduct BABE studies by outsourcing work to the CRO's (in

❝ india).

It is required to obtain following approvals from DCGI (regulatory authority in India) before conducting a BA/BE study in India

1. Test-license
2. DCGI approval for protocol (required only if the drug has not been approved for marketing in India by DCGI before 4 years of date of application. If it has been approved, then it is not required)
3. Additionally, if the plasma samples or other matrices for analysis are going to be sent out of India for analysis, then DGFT approval is required (it is not required if analysis is being done in India)

However, in practice, sponsors, as such, need not bear this responsibility, they can pass on this (responsibility) to the CRO concerned .

best regards
Kshitij Soni
Lambda therapeutics research, India