We have facing a situation where current investigator will not be able to attend hospital for few months. Study will probably be completed when he will resume the duties. Should we continue trial with co-investigator? Should we notify to DCGI?
Nisarg Patel

As per the check list for applications for grant of approval of various categories of new drug, global clinical trial and bioequivalence study for export purpose, you have to apply to DCGI office with the following documents:
•    Covering letter
•    Copy of clinical trial permission letter
•    Copy of previous protocol amendment approval letter, if any
•    Reason for change of investigator in same site
•    Undertaking from new investigators as per Appendix VII of Schedule Y
•    CV / Statement of qualification
•    Copy of Ethics Committee approval letter, if available
Only after DCGI office gives approval, the new PI can take charge of the clinical trial.

In the interim period, no new patients can be screened or enrolled. The medical care of ongoing patients have to be provided by co-investigator or the potential new investigator.

What are the procedures to start new independent ethics committee. Can an independent ethics committee approve a trial conducted in primary health centre with already approved drugs?
Dr. Bharath Kumar

Rule 122DD describes the requirements and process of registration on an ethics committee (EC). No EC can review any study protocol without prior registration with CDSCO. The EC has to submit the application along with the check list.

As per the registration letters issued to independent EC, such an EC can only approve Bioavailability/Bioequivalence studies of approved drugs. It does not permit the independent EC to approve any clinical trial.

Will the DCGI/Ayush give approval to carry out clinical trial of ayurvedic capsules prepared from herbs for eye condition? Is it sufficient if investigator follows ICMR/Ayush GCP guidelines?
Dr Sreevatsa

In India, Ayurveda, Yoga & Naturopathy, Siddha or Unani (ASU) drugs have been under purview of Department of Ayush.

Herbal extracts are covered under Ayurvedic formulations.
In Indian regulations, the major class of Ayurveda, Siddha or Unani (ASU) drugs included are:
a)  Classical ASU drugs as mentioned in the authoritative books of ASU system drugs, which are manufactured and named in accordance with the formulations described in the authoritative texts, For this category, issue of license to manufacture is based on citation in authoritative books and published literature, unless the drug is meant for a new indication, when proof of effectiveness is required.
b)  Patent or proprietary medicine makes use of ingredients referred in the formulations of authoritative texts but with intellectual intervention, innovation or invention to manufacture products different from the classical medicine. For this category issue of license to manufacture requires proof of effectiveness, based on pilot study as per relevant protocol for ASU drugs.

In 2010, Department of Ayurveda, Unani, Siddha and Homeopathy (Ayush). introduced Rule 158(B) which made requirement of proof of effectiveness for licensing of patent or proprietary ASU medicine. This was followed by release of GCP guidelines for voluntary use by the researchers interested in taking up clinical trials by using ASU medicine.
Herbal product which you have referred would be classified as Patent or Proprietary medicine. This does not come under purview of DCGI. Also, there is no formal process of clinical trial approval by Dept of Ayush. However, the herbal product should have received manufacturing license from State Ayurvedic FDA. The investigator should follow Ayush GCP whilst conducting the clinical trial.

Does Schedule Y have any specific requirements or they accept ICH E3 guidance Format CSRs?
Dr Munish Mehra
Schedule Y Appendix II gives format of the study report. The format prescribed covers All ICH E3 guidance points covered. But the Appendix to the report format has some items which are different/additional.


Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com
Readers can send their queries at: arun_dbhatt@hotmail.com