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Does NDCTR 2019 cover Suspected Unexpected Serious Adverse Reaction (SUSAR) and Development Safety Update Report (DSUR) submission requirements?
Dr Uma Sahay
NDCTR 2019 does cover suspected unexpected ADRs. See below:
• 82. Condition of permission for manufacture of new drugs for sale or distribution includes
(v) all reported serious unexpected adverse reactions related to the drug shall be intimated to the Central Licencing Authority and regulatory action resulting from their review shall be complied with;
• Table 6
Structure, Content and Format for Clinical Trial Report
13. Safety Evaluation: This section should include the complete list
13.1 all serious adverse events, whether expected or unexpected and unexpected adverse events whether serious or not (compiled from data received as per Table 5 of this Schedule).
• (C) Post marketing surveillance through periodic safety update reports
However, all cases involving serious unexpected adverse reactions must be reported to the licencing authority within fifteen days of initial receipt of the information by the applicant.
DSUR is not mentioned. However, if a company is developing a new drug in India, it would be required to submit DSUR to CDSCO.
Since indemnity form is signed sponsor, who does not have company representative in India is of the view that insurance policy is not required. Is it not the violation of NDCT Rules 2019?
Dr Sreevatsa
As per NDCTR 2019, Table 1 Format for approval to clinical trial protocol by the ethics committee, the ethics should review (e) Insurance policy or compensation for participation and for serious adverse events occurring during the study participation.
Medical Devices Rule 2017 Table 5 Clinical Investigation Plan 1.12 Statements of compliance includes (d) Statement specifying the type of insurance that shall be provided for subjects, if appropriate. So, insurance policy is a must as per regulatory requirement.
The sponsor can include Indian clinical trial in international insurance policy. The company which has obtained permission to conduct the clinical trial on behalf of the sponsor e.g. a Contract Research Organization is responsible for organizing insurance for the clinical trial.
Can an IEC member, who has been involved in the review and approval of an ongoing clinical trial, enrol in the study as a participant?
Hansa Joglekar
If an Ethics Committee member becomes a trial subject on a trial that he/she was involved in approving then there has been a major conflict of interest.
As per NDCTR 2019, Chapter III Ethics Committee for Clinical Trial, Bioavailability and Bioequivalence Study (10) no member of an Ethics Committee, having a conflict of interest, shall be involved in the oversight of the clinical trial or bioavailability or bioequivalence study protocol being reviewed by it and all members shall sign a declaration to the effect that there is no conflict of interest.
The following situations need to be considered:
IEC member reviews study without any prior knowledge of the study, votes, and then afterwards is approached by clinical research team to participate. Possibly this is acceptable. However, thereafter the member should no longer be part of the IEC that reviews that study. This could be difficult in practice, so therefore not advisable.
IEC member already knows about the study and is voting in order to be able to participate. This is clearly not acceptable and made worse if there is additional financial incentive for the study (e.g. volunteer study).
Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com
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