What is a Schedule Y drug?
Refers to requirements and guidelines to be followed in order to attain permission of: Importing and/or Manufacturing New Drugs to market or To undertake clinical trials in India.
How many appendices are in Schedule Y?
16. Appendices List of Appendices to the Clinical Trial Report a.
What are the ICH-GCP guidelines?
The ICH-GCP is a harmonised standard that protects the rights, safety and welfare of human subjects, minimises human exposure to investigational products, improves quality of data, speeds up marketing of new drugs and decreases the cost to sponsors and to the public.
How many people are selected for phase trials?
Explanation: Phase I trials are the first stage of testing in human subjects. Normally, a small group of 20-50 healthy volunteers will be selected. This phase includes trials designed to assess the safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a drug.
When was schedule Y introduced?
Schedule Y was introduced under the Drugs and Cosmetics Act (1940-1988 -> amended 2005) to introduce requirements for countries to get permission for 1) importing 2) making new drugs 3) conducting clinical trials. Primarily in India due to large patient pool and large biopharma marketshare.
What amendments are in Schedule Y?
The recent amendments in schedule Y are
- Introduction of Rule 122DAB – Specifying the procedures for payment of compensation to the subjects of the trial in cases of injury or death.
- Introduction of Rule 122DAC – Specifying various conditions for conduct and inspection of clinical trials.
What does the rule 122DAB of schedule Y specify?
As per Rule 122DD ethics committee should not review and accord its approval to a clinical trial protocol without prior registration with DCGI. An application for registration of Ethics Committee is required to be made to DCGI as per Appendix VIII of Schedule Y.
Why do most clinical trials never go to Stage 3?
Hwang et al.  noted that 22% of the failed phase 3 studies they examined failed due to lack of funding. The costs required to complete the entire development process from discovery to bringing a drug to market vary, and so do estimates of these costs; however, they have been reported in excess of $2.5 billion .