What is Schedule Y in clinical trials?
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.
Is Schedule Y removed?
The earlier restrictions on number patients and centers in early phases stipulated in Schedule Y 1988 were removed allowing the sponsor company freedom to decide these in relation to protocol requirements. The phase lag requirements gave way to acceptance of concurrent Phase II-III as part of global clinical trials.
Which section of the Schedule Y deals with the requirements of an informed consent form?
(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 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.
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 is Schedule Y When did it come into existence and how many amendments have been made to it until now what are the different appendices of schedule Y?
During the revision of Drugs and Cosmetics Rules, 2005, the Schedule Y was comprehensively amended to take the Indian regulations on par with globally acknowledged definitions and measures. Freshly there have been three amendments in Schedule Y of the Drugs and Cosmetics Act.
Who is responsible for new drug approval in India?
Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice with a view of bring …
What is CPP in pharma?
A Critical Process Parameter (CPP) is a term used in pharmaceutical production for process variables which have an impact on a critical quality attribute (CQA) and, therefore, should be monitored or controlled to ensure the drug product obtains the desired quality.
What is schedule y in clinical trial regulation in India?
Schedule Y: Clinical Trial Regulation in India Posted April 26, 2011January 10, 2017admin DOWNLOAD Schedule Y HERE Schedule Y, the current regulator (CDSCO – Central Drugs Standard Control Organization) enforced law in India has been established under Drugs and Cosmetic Act 1945.
What are the regulations for clinical trials in India?
Schedule Y, the current regulator (CDSCO – Central Drugs Standard Control Organization) enforced law in India has been established under Drugs and Cosmetic Act 1945. The regulations to be followed when conducting clinical trials in India are clearly documented to a large extent in this document.
What are the appendices of schedule y of SAE?
Some highlights of Schedule Y in terms of its appendices; which provide the guidelines to conduct clinical trials are: Appendix V – Informed consent Appendix VII – Undertaking by the Investigator Appendix VIII – Ethics Committee Appendix X – Contents of Protocol Appendix XI – Data elements for reporting SAE
Which appendices provide guidelines to conduct clinical trials?
Some highlights of Schedule Y in terms of its appendices; which provide the guidelines to conduct clinical trials are: Appendix V – Informed consent Appendix VII – Undertaking by the Investigator Appendix VIII – Ethics Committee Appendix X – Contents of Protocol