Issues of Clinical Trials in India by Vallinadh Karamcheti
Clinical trials in INDIA- Legal issues
By: Vallinadh Karamcheti
Abstract: Clinical trials are conducted to ensure the safety and efficacy of the drug. They are conducted on the human subjects. Hence the clinical trials are liable to many legal aspects. Clinical trials are conducted in four phases. (Phase I, Phase II, Phase III, & Phase IV). All the phases of the clinical trials should comply with several legal aspects, as life of a person may be at risk if anything goes wrong with the clinical trials. They should comply with the Schedule Y of Drugs and Cosmetics Act, 1940, Drugs and Cosmetics (II Amendment Rules) Rules 2005, Good Clinical Practices guidelines, 2001 etc.
What are clinical trials?
Clinical trials are the tests conducted on human subjects to test the safety, efficacy, tolerability, and phamaco-kinetic properties of the drug.
Why and how are they conducted?
Clinical trials are conducted in four phases
• Phase I trials are performed on a small group (normally 20-80) of normal healthy volunteers, and their aim is to check for safety (does the drug produce any potentially dangerous effects, for example on cardiovascular, respiratory, hepatic or renal function?), tolerability (does the drug produce any unpleasant symptoms, for example headache, nausea, drowsiness?) and pharmacokinetic properties (is the drug well absorbed? What is the time course of the plasma concentration? Is there evidence of cumulation or non-linear kinetics?). Phase I studies may also test for pharmacodynamic effects in volunteers (e.g. does a novel analgesic compound block experimentally induced pain in humans? How does the effect vary with dose?).
• Phase II studies are performed on groups of patients (normally 100-300) and are designed to test for efficacy in the clinical situation, and if this is confirmed, to establish the dose to be used in the definitive phase III study. Often, such studies will cover several distinct clinical disorders (e.g. depression, anxiety
By: Vallinadh Karamcheti
Abstract: Clinical trials are conducted to ensure the safety and efficacy of the drug. They are conducted on the human subjects. Hence the clinical trials are liable to many legal aspects. Clinical trials are conducted in four phases. (Phase I, Phase II, Phase III, & Phase IV). All the phases of the clinical trials should comply with several legal aspects, as life of a person may be at risk if anything goes wrong with the clinical trials. They should comply with the Schedule Y of Drugs and Cosmetics Act, 1940, Drugs and Cosmetics (II Amendment Rules) Rules 2005, Good Clinical Practices guidelines, 2001 etc.
What are clinical trials?
Clinical trials are the tests conducted on human subjects to test the safety, efficacy, tolerability, and phamaco-kinetic properties of the drug.
Why and how are they conducted?
Clinical trials are conducted in four phases
• Phase I trials are performed on a small group (normally 20-80) of normal healthy volunteers, and their aim is to check for safety (does the drug produce any potentially dangerous effects, for example on cardiovascular, respiratory, hepatic or renal function?), tolerability (does the drug produce any unpleasant symptoms, for example headache, nausea, drowsiness?) and pharmacokinetic properties (is the drug well absorbed? What is the time course of the plasma concentration? Is there evidence of cumulation or non-linear kinetics?). Phase I studies may also test for pharmacodynamic effects in volunteers (e.g. does a novel analgesic compound block experimentally induced pain in humans? How does the effect vary with dose?).
• Phase II studies are performed on groups of patients (normally 100-300) and are designed to test for efficacy in the clinical situation, and if this is confirmed, to establish the dose to be used in the definitive phase III study. Often, such studies will cover several distinct clinical disorders (e.g. depression, anxiety
References: http://cdsco.nic.in/html/copy%20of%201.%20d&cact121.pdf http://cdsco.nic.in/html/GCP.htm http://dbtbiosafety.nic.in/act/Schedule_Y.pdf http://www.thehindu.com/todays-paper/tp-national/tp-andhrapradesh/article2133307.ece?css=print http://www.halsburys.in/regulation-of-clinical-trials.html http://clinicaltrials.gov/ct2/info/understand Text book: RANG and DALE’S Pharmacology referred for Drug discovery and development