I need your guidance in relation with phase IV studies that are designed to evaluate marketed drug in specifically designed studies, which have inclusion/exclusion criteria, objectives and end points. Is sponsor required to provide marketed product for study? Does the study need insurance? Is sponsor required to support costs of investigations and travel expenditure? Does the sponsor bear costs of treatment of study related SAE and provide compensation? Is audio-visual (AV) recording of consent necessary?

One important consideration is: What is the purpose of this study? Is the indication approved by DCGI office or is it a new indication? If the indication is new, it is a study for a new drug. Hence, it has to be considered like a phase III study, where all regulatory requirements for a clinical trial must be complied with.

The sponsor is required to provide marketed product and support the cost of investigations and travel expenditure.

If this is regulatory clinical trial, insurance would be essential. If not, it would depend on what ethics committee/institution expects. If this is regulatory clinical trial, compensation is mandatory. If not, it would depend on what ethics committee/institution expects.

If this is regulatory clinical trial, AV recording is essential. If not, AV recording is not required.

I have a few queries and need some clarity for conducting of epidemiology studies which are observational. The studies which may involve only collection of data or collection of data with some study procedures (e.g. blood draw) but no administration of drug. Are these studies governed under the law (e.g. Sch Y)? If not, then which regulation is followed for studies to be conducted in India? Do these studies need only EC approvals or do these studies need DCGI approval in addition to EC approval? What about safety reporting? Can EC ask sponsor to compensate subjects in similar lines to Sch Y requirements in case of CT related injury/death?

There is no regulation in India for non-intervention observational epidemiology study. ICMR ethical guidelines for biomedical research on human participants provide overall guidance for such studies. These studies need only EC approval. For such studies, EC submission requirements need to be followed as per ICMR guidance. The issue of safety reporting is not relevant as there is no drug/device being tried. If these are observational studies, and no drug/device is used, then there is no CT related injury. Hence, Rule 122 DAB for compensation of CT related injury/death is not applicable. However, EC can formulate its own guidance on compensation, if it feels that the observational study can pose risks to the patients.

Herbal drugs, for example, a dry fruit powder in the form of capsules, are any clinical trials necessary to use as food supplement? If a sponsor has already conducted a clinical trial in UK or USA, can he claim that food supplement is beneficial in the treatment of cardio vascular disease based on published study internationally or does he need to test it on Indian population?

At present, there is no requirement for conducting clinical trial of a food supplement if you do not make claim that the supplement can cure/mitigate a medical condition. The regulatory requirements depend on what claim is made. If the claim is about curing/mitigating a disease, it would be considered a drug and the company has to conduct clinical trials for a new drug as per CDSCO requirements.

What is the regulatory status of phase I trial in India?

Phase I is allowed in Indian for drugs discovered in India. Some of Indian R&D based companies conduct phase I in India. However, phase I is not allowed for new drug substances discovered outside India. See Schedule Y excerpt below:
(a) for new drug substances discovered in India, clinical trials are required to be carried out in India right from phase I and data should be submitted as required under items 1, 2, 3, 4, 5 (data, if any, from other countries), and 9 of Appendix I;

(b) for new drug substances discovered in countries other than India, phase I data as required under items 1, 2, 3, 4, 5 (data from other countries) and 9 of Appendix I should be submitted along with the application. After submission of phase I data generated outside India to the Licensing Authority, permission may be granted to repeat phase I trials and/or to conduct phase II trials and subsequently phase III trials concurrently with other global trials for that drug.  Phase III trials are required to be conducted in India before permission to market the drug in India is granted.