What are the regulatory requirements re: clinical trial of FDC?
Divya Sekar
The regulatory submission requirements for FDC depend on the category.
Category I - Not marketed in India and one or more active pharmaceutical ingredient(s) is a new drug not approved in India.
Category II - Not marketed in India but the APIs are approved/marketed individually
- Category II A - Marketed abroad
- Category II B - Not marketed anywhere but individual APIs used concomitantly
- Category II C - Not marketed and individual APIs are not used concomitantly
Category III - Marketed in India but some changes are sought
A: Change the ratio of active pharmaceutical ingredients (provided single entity doses are approved) and the doses of the individual components are within the approved dose range for the individual drugs
B: Make a new dosage form and/or a new route of administration for the same indication (provided the new dosage form and/or route of administration are approved for the single entity)
Category IV - Subsequent approvals after the approval of primary applicant’s FDC
The following guidelines could be consulted for more details.
- System of preliminary scrutiny by CDSCO for approval of FDC
- CDSCO guidance for industry on FDC Aug 2010
- Policy guidelines for approval of FDCs in India 2013
Do we need EC approval to conduct a study of a home blood pressure monitoring device in patients?
Praveen Gajjela
As per ICMR 2006 guidance:
It is mandatory that all proposals on biomedical research involving human participants should be cleared by an appropriately constituted Institutional Ethics Committee.
An investigator cannot decide that her/his protocol falls in the exempted category without approval from the IEC.
Collection of data through non-invasive procedures routinely employed in clinical practice is listed under IEC full review category.
Hence, even if the device is marketed, the EC review is essential to protect rights, safety and well being of the subjects.
Can an independent EC review and approve an investigator initiated study?
Dr Abbas
The conditions listed in independent EC registration letter is:
The EC shall review and approve only the study protocols and related documents for bioequivalence studies of the approved drug molecules.
Hence, independent EC cannot review and approve any clinical trial sponsored or investigator initiated.
Can members of the Institutional EC insist on inspecting/checking the quality or working conditions of equipments/instruments used in research or clinical trial?
Dr Sreevatsa
As per GCP, the EC has to consider the qualifications of the investigator. Sch Y Appendix VIII documents for submission to EC include the investigator CV. None of the guidelines/regulations requires EC to check the equipments.
EC's main responsibility is to safeguard the rights, safety, and well-being of all trial subjects. If the EC is uncertain about the capability of the investigator/ institute to conduct the trial, it should refuse approval. However, checking the equipment is going beyond their regulatory responsibilities.
Can a study site team member perform the role of a sub-investigator at two different sites with two different principal investigator?
Dr Mina Yadav
Yes, so long as he/she can fulfill obligations/responsibilities listed in the delegation log at both sites.