Schedule Y Guidelines amended version-cdcso Submitted By…. Why India…: Why India… Large patient population with diverse gene pool Potential for multi patient recruitment at major cities across the country Majority of investigators western educated Pool of Highly skilled and well trained doctors, investigators, and medical personnel Compliance with International regulatory and GCP standards. Information on active ingredients 2. Physicochemical Data 2. Analytical Data 2.
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Schedule Y Guidelines amended version-cdcso Submitted By…. Why India…: Why India… Large patient population with diverse gene pool Potential for multi patient recruitment at major cities across the country Majority of investigators western educated Pool of Highly skilled and well trained doctors, investigators, and medical personnel Compliance with International regulatory and GCP standards.
Information on active ingredients 2. Physicochemical Data 2. Analytical Data 2. Complete monograph specification 2. Validations for methodology 2. Stability Studies Appendix IX 2. IV This information gives Efficacy of New drug General Principles: Specific and general pharmacological studies should be conducted to support use of therapeutics in humans.
I : Therapeutic potential for humans described according to animal models used. If possible Dose-response relationships and ED 50s shall be submitted. I Essential Safety Pharmacology item 1.
IV Safety pharmacological studies need to be conducted to investigate the potential undesirable pharmaco dynamic effects of a substance on physiological functions in therapeutic range and above. Aim to study the effects of test drug on vital functions of vital organs and systems like Cardiovascular system, CNS and Respiratory system.
I - ADME studies of test substance This helps to relate the drug effect with plasma concentration and should be given to the extent available. III :.
Schedule Y: Clinical Trial Regulation in India
This will ensure that sponsors and investigators have clear and uniform understanding of regulatory expectations. Hence, there is a need that the Indian regulators should clearly mention safety reporting requirements in the event an SAE occurs in a generic drug trial. This seems lenient since EC, the immediate body overseeing patient safety of the site, will not be able to take a decision to suspend the trial for more than 7 days, meaning more patients will be exposed to the drug even in the event of a serious safety concern. Hence, it is recommended that India should follow global practice and make reporting timelines more stringent, for example, 7 calendar days instead of 7 working days, in order to avoid reporting delays owing to holidays or weekends. Unless reviewed and compared with their background incidence in control group, individual report of such events will not offer enough evidence of reasonable causal association, and thus are uninformative. The global norm of considering causality as a critical reporting criterion is aimed at reducing the number of uninformative reports that do not meaningfully contribute in developing safety profile of investigational products.
Pharmacovigilance for clinical trials in India: Current practice and areas for reform
The regulations to be followed when conducting clinical trials in India are clearly documented to a large extent in this document. Schedule Y for India is a law and not a mere guideline. The enforcement that came into existence in was an essential provision for providing support to the upscale of generic pharma scenic present in those days. With the entry of large pharmaceutical companies along with the multiple multinationals in field of clinical research the needs changed and a revised version of Schedule Y in line with ICH-GCP International Council of Harmonisation and Good Clinical Practice standard was put forth in Since then multiple revisions to schedule Y took place to provide a healthy environment for clinical research to be conducted in India. Implementation of these, raises the bar for the industry to function as per quality standards expected by the foreign regulators.