Q. Is it necessary to register the IRBs / IECs with ICMR or any other government organization?
● Dr. Shivani Acharya
ICMR guidelines of 2006 suggest the following:
Once the legislation of ICMR guidelines occurs which is currently under active consideration by the Ministry of Health, a Biomedical Research Authority will be set up under the proposed Bill on Biomedical Research on Human Participants (Promotion and Regulation) which would require that all IECs register with this Authority. It will also evaluate and monitor functioning of the IECs, and develop mechanisms for enforcing accountability and transparency by the institutions. The above process is not yet completed. Hence, registration of IEC will happen after the ICMR guidelines become a law.
Q. If we are amending the protocol, which is approved by the DCGI, do we need to send the amended protocol to the DCGI for re-approval? The amendment does not increase the exposure to the study drug and does not have any safety implications.
● Dr. Shivani Acharya
Current guidelines of DCGI office (www.cdsco.nic.in) are as follows:
Protocol Amendments
a) Those amendments which do not require any information or permission
i) Administrative and logistic changes
ii) Minor protocol amendments and additional safety assessments in case the institutional ethical committee has already approved these changes
b) Those amendments which require to be informed but need not wait for permission
i) Additional investigator sites
ii) Amended investigators brochure, amended informed consent
c) Those amendments which require prior permission before implementation of the amendments.
i) Change of principal investigator
ii) Additional patients to be recruited
iii) Major changes in protocol with respect to study design, dose and treatment options
All amendments must be approved by the concerned Institutional Ethics Committee before their implementation
Please see under which category is your amendment and act accordingly.
Q. What is the purpose of a "Tentative Approval Letter" for a drug, when issued by US FDA?
● Garima Sharma
Approvable Original New Drug Applications
An approvable letter indicates that FDA is prepared to approve the application upon the satisfaction of conditions specified in the approvable letter. Drug products which are the subject of approvable letters may not be legally marketed until the firm has satisfied the identified deficiencies, as well as any other requirements that may be imposed by FDA, and has been notified in writing that the application has been approved.
Q. What are the minimum ICH GCP requirements for essential documents at site before investigational product (IP) can be sent to the site?
● Garima Sharma
You need Regulatory and Ethics Committee approval before sending IP to the site.
Q. What are the Indian Regulatory requirements for conducting trial of dermato/cosmetic products?
● Vijal Pandya
No so specific requirements are mentioned in regulations. However, the requirements depend upon the indication for product fits into definition of cosmetic or drug as per Drugs & Cosmetics Act. The definitions are as follows:
"Cosmetic" means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic.
"Drug" includes
(i) all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes
(ii)such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of [vermin] or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette
(iii) all substances intended for use as components of a drug including empty gelatin capsules; and
(iv) such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government
If a cosmetic product for a trial fits definition of drug, you have to follow all trial regulations as per Schedule Y.