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?
A new Rule 122DAC has been inserted which states that clinical trial shall be conducted in compliance with the approved protocols, requirements of Schedule Y, GCP guidelines for conduct of clinical trials in India and other applicable regulations. No trial shall begin without the approval of the ethics committee.
What are the schedules under Drug and Cosmetic Act 1940?
Schedule M-II: Requirements of factory premises for manufacture of cosmetics. Schedule M-III: Requirements of factory premises for manufacture of medical devices. Schedule S: Standard for cosmetics. Schedule T: Good manufacturing practices for Ayurvedic, Siddha and all Unani medicines.
Which appendix in Schedule Y gives details of informed consent?
(iii) A checklist of essential elements to be included in the study subject’s informed consent document as well as a format for the Informed Consent Form for study Subjects is given in Appendix V. safeguard the rights, safety and well being of all trial subjects.
What is GCP ICH?
ICH-GCP. 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.
What is Schedule Z?
Schedule ‘Z’ The draft of Schedule Z as prepared by the sub-committee of Ayurveda, Siddha, Unani Drug Technical Advisory proposed to make clinical trials mandatory for all the patent or proprietary) medicines so as to examine the shelf life of ASU medicines.
What is ICH GCP?
What is Indian GCP?
INTRODUCTION Good clinical practice (GCP) is an international ethical & scientific quality standard for designing, conducting , recording & reporting trials that involve the participation of human subjects.
What is Schedule T?
Schedule T is defined as the schedule of drugs and cosmetic act & rules which represents the good manufacturing practice of asu (ayurvedic, siddha and unani) medicines along with area required for premises, specification required, qualification required, recommended machinery and equipment etc.
What is Schedule C and C1 drugs?
What is Schedule C and C1 Drugs? Schedule C and C1 drugs includes biological and special products. Schedule C and C1 under drug and cosmetic act & rules covers generally serum, hormones, vaccines, toxins, anti toxins and other biological and special products.
What is a schedule Y?
Schedule Y defines the clinical trials as the requirements and guidelines for import and manufacture of new drugs for sale or for clinical trials. It describes the details of application process for conducting clinical trials; responsibilities of the sponsor, investigators and the Independent Ethics Committee.
What are the 3 main GCP principles?
Three basic ethical principles of equal importance, namely respect for persons, beneficence, and justice, permeate all other GCP principles.
