Is it necessary to train and certify the EC member for GCP once in a year after EC registration?

Rule 122 DD mandates as follows but does not specify any frequency.

(d) Members should be conversant with the provisions of clinical trials under this Schedule, Good Clinical Practice Guidelines for clinical trials in India and other regulatory requirements to safeguard the rights, safety and well-being of the trial subjects 16. Policy regarding training for new and existing committee members along with standard operating procedures. Many ECs require that each member should be trained once in a year. There should be a documentation of training in CV and a certificate of training. From Jan 15 onwards, government will begin the process of accreditation of EC. During this process, the regulators will check training records of EC members and even assess whether EC members are trained or not. In view of this it is advisable to conduct training of all EC members at least once in a year.

During a recent audit, I found that the PI was MD (Ayurvedic medicine) and all the clinical investigators/physicians were BAMS (Ayurvedic). When questioned, their justification is that in Maharashtra and Karnataka they are allowed to prescribe allopathic. Hence, they said that they are all recognized by MCI. Is this acceptable?

Indian GCP 3.3.1 mandates: 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).

If you apply this requirement to Ayurvedic doctors, they are not qualified by education to assume responsibility for a study on an allopathic drug.  The Maharashtra Govt notification is for the purpose of allowing Ayurvedic doctors to serve in rural areas, where they can prescribe allopathic medicines. This is not MCI registration.

MCI registration is for allopathic doctors. The Ayurvedic doctors get registration from Ayurvedic Council and not MCI. Hence, Ayurvedic doctors cannot have MCI registration and cannot become principal investigators for BA/BE or clinical trials.


Main ethical considerations in all research are: the possible risks to the participants with proper justification, the expected benefits and adequacy of documentation for ensuring privacy, confidentiality and the justice issues.

The EC needs to evaluate: How the screening would be carried out? Does it pose any risk to subjects? e. g. blood collection. How will the subject’s privacy/confidentiality be protected?

Minimal risk would be defined as one which may be anticipated as harm or discomfort not greater than that encountered in routine daily life activities of general population or during the performance of routine physical or psychological examinations or tests.

Proposals which present less than minimal risk fall under may be considered exempt from review or for expedited review by EC.

Under section responsibilities of investigator in 122 DAB, it is mentioned that investigator shall report due analysis to DCGI, chairperson of EC and head on institution. What does this mean?

Due analysis report means an analysis of the SAE case providing justification for causality assessment-relationship between SAE and clinical trial. This has to be done by both investigator and sponsor separately and submitted to CDSCO.