The Ministry of Health and Family welfare amended the New Drugs and Clinical Trials Rules, 2019 in consultation with the Drugs Technical Advisory Board, DTAB, and specified non-clinical testing methods to assess the safety and efficacy of a new drug or investigational new drug.
The general requirements of non-clinical studies have been specified in the Second Schedule. The Non-Clinical testing methods to assess the safety and efficacy of a new drug or investigational new drug may include the Cell-based assay; Organ chips and micro physiological systems; Sophisticated computer modeling; Other human biology-based test methods; and Animal studies.
The non-clinical (or pre-clinical) development phase primarily aims to identify which candidate therapy has the greatest probability of success, assess its safety, and build solid scientific foundations before transition to the clinical development phase. Also, during the non-clinical development phase, the candidate compound should meet non-medical objectives, including defining the intellectual property rights and making enough medicinal product available for clinical trials.
The Central Government will consider objections and suggestions which may be received from any person within the period specified.
