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.
|Published (Last):||12 November 2011|
|PDF File Size:||4.91 Mb|
|ePub File Size:||6.82 Mb|
|Price:||Free* [*Free Regsitration Required]|
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.
Schedule Y: Clinical Trial Regulation in India
Its headquarter is located at FDA Bhawan, Kotla Road, New Delhi and also has six zonal offices,four sub zonal offices,thirteen Port offices and seven laboratories spread across the country. CDSCO is constantly thriving upon to bring out transparency, accountability and uniformity in its services in order to ensure safety, efficacy and quality of the medical product manufactured, imported and distributed in the country. Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of New 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 about the uniformity in the enforcement of the Drugs and Cosmetics Act. Further CDSCO along with state regulators, is jointly responsible for grant of licenses of certain specialized categories of critical Drugs such as blood and blood products, I.
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.