In a structured Post-Marketing Surveillance study is it necessary to provide free drug with insurance coverage and to meet other expenses of the patient? Since it is PMS sponsor does not want to provide any thing.
Dr. Sreevatsa
Post-Marketing Surveillance study differ in design depending on the objective. If the objective is monitoring of post-marketing safety, the studies are non-intervention in nature.
The description of the study is as follows:
A study where the medicinal product(s) is (are) prescribed in the usual manner in accordance with the terms of the marketing authorization. The assignment of the patient to a therapeutic strategy is not decided in advance by a trial protocol but falls within the current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures shall be applied to the patients and epidemiological methods shall be used for the analysis of the collected data”.

In such a case, the sponsor does not provide drug. But the patient buys a prescribed drug. Since this is not a regulatory approved trial, insurance does not apply.

However, if the design/objectives are not as per above non-intervention study, but like a Phase III trial, insurance/free drug/compensation for participation/other expenses must be borne by the sponsor.

Is it common and/or okay for an institutional Ethics Committee to demand for indemnity for themselves from the sponsors for a multi-centric global clinical trial?
Shalini Dayananda
Request for indemnification for EC poses several questions.
•    None of the regulations – Schedule y / 122 DD – require sponsor to indemnify the EC.
•    Relationship between the sponsor and EC. As the investigator applies for EC approval, there is no direct relationship between sponsor and investigator.
•    Legally, indemnity is given when a party is working on behalf of another party. The EC does not work on behalf of the sponsor.
•    The sponsors indemnity covers the institution and the investigator. As EC is a part of institution, it is covered indirectly this indemnity.
•    As EC works in an institution, the legal support of its decisions/actions should be provided by the institution.
•    If an EC insists on indemnification by the sponsor, it would be considered conflict of interest as ECs would only approve protocols of sponsors who provide indemnity. The EC will not be able to register or obtain accreditation, if such conflict of interest is observed.

Is it necessary to obtain CDSCO approval for post marketing observational/ non-interventional study?
Amit Kumar
In the Gazette Notification of 30 Oct 15, CDSCO has given some definitions which would be useful in deciding this issue.
In the Drugs and Cosmetics Rules, 1945 (hereinafter referred to as the principal rules), in rule 122 DA, in sub-rule (3), for the explanation, the following explanation shall be substituted, namely: ‘Explanation - For the purposes of these rules, -  (a) “Clinical Trial” means a systematic study of any new drug(s) in human subject(s) to generate data for discovering and/or verifying the clinical, pharmacological (including pharmacodynamic and pharmacokinetic), and/or adverse effects with the objective of determining safety and/or efficacy of the new drug; (b) “Global Clinical Trial” means any clinical trial which is conducted as part of multi-national clinical development of a drug; (c) “Investigational New Drug” means a new chemical entity or a product having therapeutic indication but which has never been tested earlier on human being;  (d) “New Chemical Entity” means an active substance in developmental stage which may be specified as a drug under the Act, after undergoing any clinical trial’.

If the study is an observational/non-interventional study, it will not fall into definition of clinical trial 1) as the study is not on a new drug (New Chemical Entity/new formation/new indication 2) as the drug is already marketed and 3) no drug is given.

Such a study is outside the purview of current CDSCO regulations.


Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com