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ICMR guidelines are applicable for investigator initiated studies

Wednesday, December 2, 2020, 08:00 Hrs  [IST]

What guidelines or rules govern the grants provided by a pharma company for investigator initiated studies or trials in India? What extent companies can have visibility over grants provided, as in the usage of the same by the investigator and institution/sponsor? What extent companies can seek info from the grantee with respect to utilization of grant proceeds?

Harshal Joshi
Investigator initiated studies are not under purview of any regulation unless they are for a new drug as defined in New Drugs and Clinical Trials Rules 2019. For such investigator initiated studies, ICMR guidelines are applicable. ICMR guidelines recommend that financial arrangements must be made by the institution/investigator for the conduct of the study as well as to pay for free management of research-related injury and compensation, if applicable. However, there are no specific guidelines about grant for such studies sponsored by a pharma company.  

For sponsored investigator initiated studies, the sponsor makes a study agreement, which covers ethical/legal/financial conditions. The company can stipulate any conditions it wants to include in the agreement.  

MCI regulations/UCPMP guidelines will be relevant if the study is with a marketed drug. However, as per New Drugs Rules 2019, academic studies for a new indication or new route of administration or new dose or new dosage form of approved new drug cannot be used for regulatory submission or marketing or commercial or promotional purpose.

Can a CEO of company who is the manufacturer/supplier of a device become a co-investigator of an in-house study and collect the charges for the devices directly from the patient to his company account?
Dr Sreevatsa
As per Indian Medical Device Rules 2017 clinical performance evaluation shall be conducted in accordance with the approved clinical performance evaluation plan and good clinical practices guidelines.

Indian good clinical practices guidelines define co-investigator as a person legally qualified to be an investigator, to whom the investigator delegates a part of his responsibilities. The investigator should be qualified by education, training, and experience to assume responsibility for the proper conduct of the study and should have qualifications prescribed by the Medical Council of India (MCI). The guideline also mandates that subjects should be reimbursed for expenses incurred, in connection with their participation in research.

ICMR 2017 guidelines recommend that the researcher should guard against conflicts of commitment that may arise from situations that place competing demands on researchers’ time and loyalties. 

For payments, ICMR 2017 guidelines mandate as follows:

The participants should not be made to pay for any expenses incurred beyond routine clinical care and which are research related including investigations, patient work up, any interventions or associated treatment. This is applicable to all participants, including those in comparator/control groups.

Patients should not be charged for any intervention including standard of care in the control arm. In view of these requirements, the manufacturer can not become a co-investigator and cannot charge subject for the devices.

Are there any clear guidelines for conducting clinical studies for nutraceutical or health supplements in India?
Jestin Thomas 
Nutraceuticals are regulated by FSSAI. Nutraceuticals are meant for healthy individuals to obtain physiological benefits and maintain good health. Clinical trials for nutraceutical should be conducted as per accepted scientific and ethical standards for conduct of clinical trials.

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


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