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Indian GCP mandates sponsor should perform audit
Dr Arun Bhatt | Wednesday, May 2, 2018, 08:00 Hrs  [IST]

I am planning to conduct a study using herbal products as intra canal medicament for root canal treatment in dental patients. Do I need to take DCGI approval for my study?
Dr Kishan K V

Intra canal medicament would be covered by new Indian rules for medical device 2017. The rules cover use of device with a drug, which would be applicable to your study.  

You should consider device data to be generated as clinical evidence and whether the herbal products you plan to use are indicated for dental treatment in the way you wish to use and objective of the academic research or to support commercialization/marketing of these procedure and herbs.

If the objective is commercialization, you would require DCGI approval. If the objective is academic, you would need ethics committee approval as per G.S.R. 313(E) of 16 Mar 16: No permission for conducting clinical trial intended for academic purposes in respect of approved drug formulation shall be required for any new indication or new route of administration or new dose or new dosage form where, - (a) the trial is approved by the Ethics Committee; and (b) subject to the provisions of sub-rule 5, the data generated is not intended for submission to licensing authority. The Ethics Committee shall however inform the licensing authority about the cases approved by it and about cases where there could be an overlap between the clinical trial for academic and regulatory purposes and where the said authority does not convey its comments to the Ethics Committee within a period of thirty days from the date of receipt of communication from the Ethics Committee, it shall be presumed that no permission from the licensing authority is required.

If sponsor has outsourced clinical trial activity to CRO, sponsor’s project manager is responsible for the oversight, is project specific audit is required?
Vishal Nakrani

Indian GCP mandates that the sponsor should perform an audit.  See GCP 3.1.14. Audit: Sponsor should perform an audit as a part of QA system. This audit should be conducted with the purpose of being independent and separate from routine monitoring or quality control functions. Audit should evaluate the study conduct and compliance with the protocol, SOPs, GCPs and applicable regulatory requirements. For the purpose of carrying out the audit – the sponsor may appoint individuals qualified by training and experience to conduct audits. The auditors should be independent of the parties involved in the study and their qualifications should be documented.

The sponsor should ensure that the auditing is conducted in accordance with the sponsor’s SOPs on what to audit, how to audit, the frequency of audit and the form and content of audit reports. Auditors should document their observations which should be archived by the sponsors and made available to the regulatory authorities when called for.

Sponsor should initiate prompt action in case it is discovered that any party involved has not entirely complied with the GCP, SOPs, protocol, and/or any applicable regulatory requirements. If monitoring/auditing identifies serious and/ or persistent non-compliance - the sponsor should terminate the defaulting party’s participation in the study and promptly notify to the regulatory authority.

Can sponsor’s monitor/auditor view audio video recording of informed consent as part of monitoring or audit?
Vishal Nakrani

This is not desirable as there ethical and practical issues. Ethically the investigator is supposed to guard the privacy and confidentiality of the subject. As per CDSCO guidance 2014, the investigator must safeguard the confidentiality of trial data, which might lead to the identification of the individual subjects. Also, if there is a practical issue, what would auditor/monitor observe in a consent, which could be in local language not understood by the auditor/monitor. They can just comment on the quality of recording, but not of the consent.

Could you tell me what regulations exist now for clinical trials of food supplements?
Sooraj Rajasekharan Kartha

If a food supplements make a claim like a drug/new drug, as defined by Indian regulations/Schedule Y, you would require DCGI approval.
As per regulations definition of drug includes all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings.

New drug definition as per Rule 122 E includes: New Chemical Entity (NCE);  A drug already approved being evaluated for - new claims, new indication, new dosage form/new route of administration, modified release dosage form; and Fixed Dose Combination.

There are separate regulatory guidelines for food products. Please check food safety and standards authority of India. Check the link

Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries

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