Abstract

A BRIEF REVIEW OF AMENDMENTS SCHEDULE Y (2005-2018) AND NDCT RULES 2019

Rajeev Sahai* and Ayasha Parveen

Abstract

India considered as a hub for conducting clinical trials, the Central Drugs Standard Control Organization (CDSCO), headed by Drug Controller General of India (DCGI), lays down the regulations for the conduct of clinical trial in India. The importance of clinical trials in promoting health services cannot be overemphasized. Because of conducting clinical trial on a new molecule/entity improve the quality and lifespan of patients in compliance with safety. While it is important that the number of clinical trials increases, the Government is also trying to ensure the right, safety and well-being of participants in clinical trial, and also ensure the quality of trial performed in India improve their standard in compliance with regulations, thus for further review on the changes in regulatory aspects introduced subsequently and their impact on clinical trial. Some proposals of amendment in D&G rules have been approved by Drug Technical Advisory Board (DTAB). The Government introduced the New Drugs and Clinical Trial Rules on 19th Mar 2019, to replace Part XA and Schedule Y of the Drugs and Cosmetics Rules 1945, and it applied on 25th Mar 2019. Many changes have been made in the NDCT rules to help Clinical research, clinical trial and BA/BE study in India like timelines for many regulatory functions, duplication of rule numbers is likely to complicate the regulatory procedures, Classification of Ethics committee, compensation and remove some discrepancies. The Government would do well to consider the suggestions made herein and amend the New Drugs and Clinical Trial Rules 2019. This article summarizes the essential changes information, impact, and brief description of NDCT rules 2019.

Keywords: Drug and Cosmetics act, New Drugs and Clinical Trial rules 2019, Schedule Y, Ethics Committee, Central Drugs Standard Control Organization (CDSCO), Drug Controller General of India (DCGI), Ministry of Health and Family Welfare (MoHFW).