(a) whether clinical trial reports are prepared by medical advisers of drug
producers and the investigators put their signatures only;
(b) if so, the details thereof; and
(c) the details of the arrangements made by Drug Control Authority to
monitor such allegations?
THE MINISTER OF STATE IN THE MINISTRY OF HEALTH & FAMILY WELFARE (SMT. PANABAKA LAKSHMI)
(a)&(b) : Schedule Y of Drugs and Cosmetic Rule, prescribes the role of Sponsor
and Investigator as follows:
Responsibility of Sponsor –The clinical trial Sponsor is responsible for implementing
and maintaining quality assurance systems to ensure that the clinical trial is conducted
and data generated, documented and reported in compliance with the protocol and Good
Clinical Practice (GCP) Guidelines, as well as with all applicable statutory provisions.
Standard operating procedure should be documented to ensure compliance with GCP
and applicable regulations.
Sponsors are required to submit a status report on the clinical trial to the Licensing
Authority at the Prescribed periodicity.
Responsibilities of the Investigator (s) – The Investigator (s) shall be responsible
for the conduct of the trial according to the protocol and the GCP Guidelines and also
for compliance as per the undertaking given in Appendix VII of the Schedule Y.
(c)In case of any report of non-compliance of Schedule Y of D&C Rules, & GCP
Guidelines investigation by the competent authority is initiated. In case any
irregularity is confirmed marketing authorization for relevant drugs can be
withdrawn/ suspended.