How to maintain trial master file at sponsor level - hard copy or electronic copy? What documents are filed? Is there any country specific regulation?

The sponsor/CRO keeps hard copy as the audit/inspections are on paper copy. In addition, an electronic copy is also kept. The list is as per essential document list. There is no country specific guideline. Yes, the regulatory inspectors review the files/paper copies of all essential documents.

Are API and NCE same? Do we need to perform clinical trials for both API, NCE?
API is active pharmaceutical ingredient (API), any substance used in a finished pharmaceutical product (FPP), intended to furnish pharmacological activity or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to have direct effect in restoring, correcting or modifying physiological functions in human beings.

A new chemical entity (NCE) is a drug that has not been approved by the regulatory agency. However, NCE is usually finished pharma product - a tablet, capsule, injection, cream etc. Hence, the trials are conducted with NCEs which include API + excipients.

If the company needs marketing approval, it would require clinical trials before the regulatory authorities approve the NCE/API.

If the trial is for a new formulation of marketed drug or a new indication, clinical trials are required. For formulations where BE cannot be conducted as it would be difficult to measure blood levels e.g. inhalers, topical creams, clinical trials are required.

Do the market research studies conducted using product available on  pharmacy shelf fall into purview of clinical trials?
If this is a trial of a marketed product, for a new indication/dosage form/dose etc, it would be considered a trial of new product (as per definition 122 E of D&C Act). For such studies, regulatory and EC approval are required. If the product is marketed and if the trial is for approved indications/approved dose/approved formulation, you need EC approval but regulatory approval is not required. If the study is part of post marketing surveillance as required by the regulatory authorities, you need regulatory and EC approval.

If it’s a consumer survey, you need in which risk category it falls (ICMR 2006 criteria) and then decide re: ethics approval.

We want to conduct a PMS study on our product (coronary stent), but the hospital do not have an EC and due to new regulation independent EC cannot give the approval, in such situation how do we go ahead with our study?
For phase IV study of device, you will require DCGI and EC approvals. You could conduct phase IV - PMS in hospitals which have EC. It would not be ethical to conduct study with EC approval.

Members whose training, background, and occupation would incline them to view scientific activities from the standpoint of someone within a behavioural or biomedical research discipline should be considered a scientist e.g., physicians, Ph. D. level physical or biological scientists.

Members whose training, background, and occupation would incline them to view research activities from a standpoint outside of any biomedical or behavioural scientific discipline should be considered a non-scientist. The intent of the requirement for diversity of disciplines was to include members who had little or no scientific or medical training or experience. Therefore, nurses, pharmacists and other biomedical health professionals should not be regarded to have "primary concerns in the non-scientific area.