Bioequivalence and Bioavailability Forum

Dear Dr. Pravin!

❝ give me detail idea about the Responsibility for PI in India. like conduct of BA/Be trials,

Indian GCP Regulations:

3.3. Investigator
3.3.1. Qualifications

The investigator should be qualified by education, training and experience to assume responsibility for the proper conduct of the study and should have qualifications prescribed by the Medical Council of India (MCI). The investigator should provide a copy of the curriculum vitae and / or other relevant documents requested by the sponsor, the ethics committee, the CRO or the regulatory authorities. He / she should clearly understand the time and other resource demands the study is likely to make and ensure they can be made available throughout the duration of the study. The investigator should also ensure that other studies do not divert essential subjects or facilities away from the study at hand.

The investigator should be thoroughly familiar with the safety, efficacy and appropriate use of the investigational product as described in the protocol, investigator's brochure and other information sources provided by the sponsor from time to time.

The investigator should be aware of and comply with GCPs, SOPs and the applicable regulatory requirements.

Thanks Kshitij for bringing this regulation to my attention!