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For a new drug evaluation DCGI approval is required

Wednesday, September 30, 2015, 08:00 Hrs  [IST]

Can an EC chairperson act as chairperson for any other EC? Similarly can other EC members also act as members of other EC? Is this practice acceptable as ethics points of view?
Tarun Goswami

This practice would be considered unethical by an auditor or regulatory agency. The question would be (1) how do the chairperson/EC members ensure that there is no conflict of interest when they serve on 2 ECs? (2) How do they give enough time to 2 ECs to participate in the EC review, approval and post-approval oversight? When the EC applies for re-registration/accreditation, and regulatory agency notices such behaviors, they may disqualify both the ECs.

We are in the process of submitting an investigator driven academic clinical trial to CDSCO for clearance on already approved vaccines in infants with alternate dose schedule. Do we need to have an AV recording of consent process in this study?
Dr. Girish Dayma

The new GSR 611(E) requires that an audio-visual recording of the informed consent in case of vulnerable subjects in clinical trial of new chemical entity or new molecule entity shall be maintained by the investigator for record.

As per ICH GCP definition vulnerable subjects include:
Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.

Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, and patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.

As most chronic medical conditions are incurable, the definition would include most patients taking part in clinical trials. However, the terms new chemical entity or new molecule entity are not defined in Indian regulations. Hence, it would be advisable to go by the available definition of new drug and vulnerable population. Also, since you are in the process of submitting the application, it would be better to seek the clarification on AV recording for your trial from CDSCO.

Do we have to take re-approval of the investigational product label, if the local company address has changed?  
Sneha Gupta

Yes. As per Drugs & Cosmetics Act any change in the process of manufacture, method of testing, labelling, packaging, designing of the sale pack, medical literature and documentation is to be intimated to the licensing authority forthwith and permission to be obtained from him within 30 days time period.

My institutional EC has asked for DCGI approval before conducting my thesis study on use of ketamine via nebulisation route for prevention of sore throat. Does this study need DCGI approval?
Dr Swapnil Baraskar

As per DCGI office order of July 2014, if a new drug is being evaluated or a new use for an existing drug is being evaluated in academic clinical trial, DCGI approval is required. You need to consider whether use of ketamine for prevention of sore throat is a new use.

If a CRO is utilizing services from 4 to 5 different EC as backup, is it necessary to obtain generic screening ICF approval from all ECs?
Tarun Goswami

For the purpose pre-screening of volunteers to generate a pool, EC approval from one EC is adequate. The EC giving project approval should be aware of how the volunteer pool is generated as one of the requirements as Schedule Y Appendix VIII requires EC to review and approve Proposed methods for patient accrual including advertisement(s) etc proposed to be used for the purpose.

Dr Arun Bhatt is currently, president, ClinInvent, Research Pvt Ltd,
Mumbai. Readers can send their queries at: arun_dbhatt@hotmail.com


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