Issues of Clinical Trials in India by Vallinadh Karamcheti

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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…show more content…
Pre-clinical trials includes • Pharmacological testing to check that the drug do not produce any hazardous effects such as cardiac arrest, cardiac dysrhythmias, acute bronchoconstriction etc. • Preliminary toxicological testing to eliminate genotoxicity and to determine the maximum non-toxic dose of the drug. As well as being checked regularly for weight loss and other gross changes, the animals so treated are at the end of the experiment to look for histological and biochemical evidence of tissue damage. • Pharmacokinetic testing, including studies on the absorption, metabolism, distribution and elimination (ADME studies) in laboratory animals. • Chemical and pharmaceutical development to assess the feasibility of large-scale synthesis and purification, to assess the stability of the compound under various conditions, and to develop a formulation suitable for clinical studies. Much of the work of preclinical development, especially that relating to safety issues, is done under a formal operating code, known as Good Laboratory Practice (GLP). The aim of GLP is to eliminate human error as far as possible, and to ensure the reliability of the data submitted to the regulatory authority, and laboratories are regularly monitored for compliance to GLP

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