Can a professor in community medicine act as a basic scientist in an EC?
Vinay Urs
The medical dictionary includes anatomy, physiology, biochemistry, molecular biology, pharmacology, microbiology, pathology as basic sciences. In the list of ICMR research projects in basic sciences, community medicine does not feature. Fields covered are biochemistry, pharmacology, physiology, toxicology. A professor of community medicine cannot serve as basic scientist.

The sponsor of a clinical trial wants to extend the shelf life of the study drug that is being currently used in a clinical trial based on the ongoing stability studies. Does this require approval from DCGI?
Vasumathi Prakash
In clinical trial setting, relabeling is done usually to change the expiry date of the trial sample batch, when new stability data are available. You need to inform both DCGI and Ethics Committee of the relabeling. Please see the relevant sections from Indian regulations Drugs & Cosmetics Act p 261. Any change in the process of manufacture, method of testing, labelling, packaging, designing of the sale pack, medical literature and documentation is to be intimated to the licensing authority forthwith and permission to be obtained from him within 30 days time period.

Can EC chairperson, member secretary or any other EC member of one ethical committee share same or different responsibility with other EC?
Chetan Somaiya
There are no regulations/ guidelines preventing a person from serving on 2 ethics committees. However, they need to be clear about 1) conflict of interest 2) if they want to hold a position on both committees e.g. chairperson/ secretary, how they will handle this responsibility from an ethical view point.

Can a person who is not medically qualified become a sub-investigator?
Shoeb Wagle
No. See the definition below. It appears from the definition that a person who is not medically qualified will not be able perform critical trial-related procedures and/or to make important trial-related decisions.

ICH GCP 1.56 Sub-investigator
Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows).

What are the requirements for conducting clinical trial with medical devices that are not to be registered in India?
Vasumathi Prakash
The requirements are similar to clinical trial of drugs. Please see CDFSCO website

Additional clarification to guidelines for import registration and manufacture of medical devices (5/9/2007).

A discussion was also carried out on global clinical trials. Whenever a firm applies only for Global Clinical Trial to be carried out in the country, this can be permitted as per the present norms been followed in case of drugs. However, if the same company wishes to also market the product in India, it has to comply with the norms mentioned above.

Dr Arun Bhatt is currently,
president, ClinInvent,
Research Pvt Ltd, Mumbai.
Readers can send their queries
at: arunbhatt@clininvent.com