If a trial is ongoing in India as well as in USA what is to be done in different scenarios: Do we have to report all SAEs which take place in India or only unexpected India events require reporting?
Dr Mohit Trivedi

Schedule Y refers to Indian SAEs. These are to be submitted within 14 calendar days to DCGI office. Any unexpected serious adverse event (SAE) (as defined in GCP guidelines) occurring during a clinical trial should be communicated promptly (within 14 calendar days) by the sponsor to the licensing authority and to the other investigator(s) participating in the study (see Appendix XI).

Indian GCP applies to all SAEs anywhere in the world.

3.1.11. Adverse Drug Reaction Reporting:

The sponsor should expedite the reporting to all concerned (including the Ethics Committee and the regulatory authorities) of all serious and/or unexpected adverse drug reactions

For international events (SUSAR), there is no specific timeline in Indian regulations. However, most sponsor/CROs follow the international norms of reporting.

Is DCGI the governing authority for the clinical trial application for nutraceutical products? Or any other parallel authorisation required for the study like in case of biotech products? Is there separate guideline available for these products in India and also for global clinical trial?
Namrata Nadkarni

Dr Mashelkar Committee report of the expert committee on a comprehensive examination of drug regulatory issues, November 2003 discusses the issues of nutraceuticals. You will find a copy on the internet search.

DCGI office does not regulate nutraceuticals. However, if you plan to conduct clinical trials, you should decide in which indications you wish to do this. If the indications are falling into the category of New Drug as per 122E of Drug Rules, you will need permission from DCGI office. There is no separate guideline available for nutraceuticals. If the origin of nutraceutical is herbal, Indian GCP covers this under herbal guidelines.

Appendix XI of revised Schedule Y describes the form meant for reporting clinical trial happening in India. But our trial is a global clinical trial and India is one of the countries participating in it. The SAEs are happening in India and could we submit the same form?
S. Lakshmanan

The Appendix XI form title is data elements for reporting an SAE. These are standard elements covered in global SAE forms. You can provide information in the international SAE form. If you are using CIOMS form in an Indian trial, you can submit the same. Otherwise, follow Schedule Y Appendix XI.

What is the difference between QA and QC in GCP?
Kavita A

Please see the definitions in ICH GCP

1.46 Quality Assurance (QA)

All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s).

1.47 Quality Control (QC)

The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.

QA is validated through in-process Quality Control and in and post-process auditing of clinical trial process as well as data. QC activities concern everybody involved with planning, conducting, monitoring, evaluating, data handling and reporting.

Do we have to get any regulatory permission if we have to send a blood sample of subjects outside India for genotype testing?
Hardik Parmar

You need to obtain permission from DCGI office and Directorate General of Foreign Trade (DGFT). You will need to submit the laboratory details - name(s), address(s) in the protocol to avail Licensing Authority's permission to send clinical trial related samples to such laboratory(ies). In addition, you will need an undertaking from the laboratory that the samples will be used for genotype testing as the protocol and will not be used for any commercial purpose.