What is the status of data privacy/confidentiality in Indian setting?

The terms confidentiality and privacy appear at several places in Indian GCP and seem to be used synonymously. The principles of privacy and confidentiality mentions that no details about identity of said human subjects, which would result in the disclosure of their identity, are disclosed without valid scientific and legal reasons. It would important to consider (1) whether masking of name is adequate to conceal the identity of the subject and (2) are there valid scientific and legal reasons for asking lab data for the subjects?

Although India does not have dedicated privacy law, there are several provisions in Indian legal system, which are applicable to a person's privacy.
Confidentiality

Maintenance of privacy of study subjects including their personal identity and all medical information, from individuals other than those prescribed in the protocol.

Subject files/Patient files

A file containing demographic and medical information about a study subject. It includes hospital files, consultation records or special subject files allowing the authenticity of the information presented in CRF to be verified and where necessary allowing it to be completed or corrected. The conditions regulating the use and consultation of such documents must be honoured as prescribed under confidentiality

Principles of privacy and confidentiality whereby, the identity and records of the human subjects of the research or experiment are as far as possible kept confidential; and that no details about identity of said human subjects, which would result in the disclosure of their identity, are disclosed without valid scientific and legal reasons which may be essential for the purposes of therapeutics or other interventions, without the specific consent in writing of the human subject concerned, or someone authorised on their behalf; and after ensuring that the said human subject does not suffer from any form of hardship, discrimination or stigmatisation as a consequence of having participated in the research or experiment.

2.4.2.4 Review procedures
2.4.2.5 The Ethics Committee (EC) should review every research proposal on human subjects. It should ensure that a scientific evaluation has been completed before ethical review is taken up. The committee should evaluate the possible risks to the subjects with proper justification, the expected benefits and adequacy of documentation for ensuring privacy, confidentiality and justice issues

2.4.4.Essential Information on Confidentiality for Prospective Research Subjects

Safeguarding confidentiality - The investigator must safeguard the confidentiality of research data, which might lead to the identification of the individual subjects.

One of the institutional EC which functions under the auspices of a university, which has four health science colleges. Each college has a chairperson, who is a member of another college of the university. Does this comply with regulations?

Ethics Committee has to function as per spirit of ethics and not just the legal interpretation. The chairperson of the Committee should be from outside the Institution and to maintain the independence of the Committee. Hence, chairman cannot be from the college/university where the study will be conducted. As per ICH GCP EC should have at least one member who is independent of the institution/trial site.

What is adequate gender representation in EC?
Adequate would imply matching the expected ratio of 2 genders in the population. Hence, if there are 7 members, 4 could be women and 3 could be men, or vice versa.

Should the photocopy of the ICD be given to the subjects immediately (when ICDs are signed by subjects at check in of a study) after all the signatures are  complete or can these documents be handed over to the subjects at check out from the bioequivalence facility?
GCP recommends as follows:

ICH GCP 4.8.11   Prior to participation in the trial, the subject or the subject's legally acceptable representative should receive a copy of the signed and dated written informed consent form and any other written information provided to the subjects. During a subject’s participation in the trial, the subject or the subject’s legally acceptable representative should receive a copy of the signed and dated consent form updates and a copy of any amendments to the written information provided to subjects.

Hence, the copy should be given immediately (when ICDs are signed by subjects at check in of a study) after all the signatures are complete, before the study procedures begin.

Does sponsor require to maintain MSDS (Material Safety Data Sheet) for placebo used in clinical trial?
GCP considers placebo as an investigational product. Hence, the sponsor has to maintain the information for placebo as per requirements for an investigational product
ICH GCP
1.33 Investigational Product
A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial
5.13.1 The sponsor should ensure that the investigational product(s) (including active comparator(s) and placebo, if applicable) is characterized as appropriate to the stage of development of the product(s), is manufactured in accordance with any applicable GMP, and is coded and labelled in a manner that protects the blinding, if applicable. In addition, the labelling should comply with applicable regulatory requirements.