Table of Contents
What is Schedule Y and Z?
Schedule X drugs include hallucinogens like psilocybin (mushrooms) and hashish. Schedule Y drugs include certain prescription drugs like codeine, diazepam, and phenobarbitals. Schedule Z drugs include all other drugs that are not categorized above.
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.
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 Schedule N drug?
Schedule N: Contains various regulations and requirements for a pharmacy. Schedule O: Contains various regulations and requirements for disinfectant fluids. Schedule P: Contains regulations regarding life period and storage of various drugs.
What is scheduled P?
Schedule P describes the life period of drugs in months (unless otherwise specified) between date of manufacture and date of expiry which the labelled potency period of the drug shall not exceed under the conditions of storage specified in column no. 1 defines the serial number of drug listed.
What does Schedule Y stands for?
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 is darf in clinical trials?
A common tool used to fulfill these requirements is a DARF (Drug/Agent Accountability Record Form). Investigational product can be used only by official study patients and must be used in accordance with the approved protocol.
What are Schedule H drugs?
Schedule H is a class of prescription drugs in India appearing as an appendix to the Drugs and Cosmetics Rules, 1945 introduced in 1945. These are drugs which cannot be purchased over the counter without the prescription of a qualified doctor.
What is Schedule H warning?
“SCHEDULE H1 DRUG – WARNING: It is dangerous to take the preparation except in accordance with the. medical advice. – Not to be sold by retail without the prescription of a Registered. Medical Practitioner.”