THE REGULATIONS FOR DRUG CLINICAL TRIALS IN GOVERNMENT OF INDIAN LAW

AUTHOR – MR. YADAIAH J, LL.M,(PH.D) FACULTY OF LAW, BHASKAR LAW COLLEGE OSMANIA UNIVERSITY

BEST CITATION – MR. YADAIAH J, THE REGULATIONS FOR DRUG CLINICAL TRIALS IN GOVERNMENT OF INDIAN LAW, INDIAN JOURNAL OF LEGAL REVIEW (IJLR), 5 (14) OF 2025, PG. 32-38, APIS – 3920 – 0001 & ISSN – 2583-2344. DOI – https://doi.org/10.65393/YPFL3741  

YADAIAH.J   COMMENTS ON THE REGULATIONS FOR DRUG CLINICAL TRIALS IN GOVERNMENT OF INDIA LAW  MAKES AN ATTEMPT TO BALANCE OF PHARMACY INDUSTRY DEVELOPMENT AND WITH PUBLIC HEALTH, IN THIS REGARDS

ABSTRACT

The development of a new drug is a long process. Once the promising compound is identified, it has to be investigated in laboratory studies and be tested on laboratory animals. After years of work the newly developed drug is ready for clinical trials, or the testing on human volunteer.
Clinical trials with safeguards are necessary for the introduction of new drugs for a country like India considering its disease burden and emergence of new variants of diseases. It is the only way of establishing the safety and efficacy of any new drug before its introduction into the market for human use.

The major ethical risks detected in clinical research were related to errors in the methodology of obtaining informed consent, monitoring the participant’s safety during the clinical trial, and falsifying collected data.

A few famous cases of ethical misconduct were found and analyzed, and methods to decrease the risk of the re-appearance of such problems have been listed. Finally, this review is an invitation to explore the complexity of the methodology of clinical research and its ethical and legal risks, and to find new ways to mitigate the possibility of such risks related to the research process.

The Drugs and Cosmetics Act, 1940, and the Rules made thereunder-as also the New Drugs & Clinical Trials Rules, 2019-form the legal basis for these regulations.

MATERIALS AND METHODS A search of two electronic databases was performed using the terms malpractice OR ethical issues OR methodological errors OR legal issues AND clinical trials OR pharmacological research OR drug research OR psychopharmacology.

Keywords: clinical trial, volunteers, informed consent, vulnerable population, pharmacological agents, psychopharmacology, and ethical misconduct.