Comparative Analysis of New Drugs and Clinical Trial Rules 2019 and its impact on Approval process of Oncology Drugs
Abstract
With the aim to make India as the hub for Clinical Trials and promote a transparent and faster drug approvals process for the early availability and accessibility of drugs in the country the New Drugs and Clinical Trials Rules were published on March 19, 2019. The subsequent amendments were also proposed from time to time from March 2019 till June 2022 to make the regulations and the processes more robust.
The ‘New CT Rules’ replaced the Part XA and Schedule Y of the Drugs and Cosmetics Rules 1945. The NDCT rules will be applicable to all Investigational New Drugs, Biologicals, New Drugs, and Subsequent New Drugs. These rules also laid down the procedures for the effective working of Ethics Committees. The ‘New Rules’ comes up with many desirable changes that will bring transparency, predictability and well defined requirements to speed up the drug approval process in India. The New CT Rules provides a defined protocol so that decision making becomes uniform and that mainly focuses on the Quality & Safety of Clinical Trials. With these rules in place the regulatory system aims to make India a global clinical hub, approvals for the drugs with predictable, transparent and effective regulations and to make faster availability of new drugs to Indian population. In this article, we have highlighted the key developments/changes in the revised regulatory pathway for clinical trials in India and brought the comparative analysis of what has changed from the previous rules till date as subsequent amendments were also notified from time to time. Also, the present work aims at providing the impact of NDCT rules 2019 and subsequent amendments on approval process of drugs for life threatening diseases, unmet medical need and rare Diseases like Cancer.
By these rules in place Indian pharmaceutical industry would be able to bring a number of medicines which could be promising and effective in treating this pandemic for which no country in the world has been able to find any cure so far. The clause for local CT waiver, accelerated approval, reduced times for CT application is like a boon for developing new drugs in India. This will ensure faster availability of drugs in the country for life threatening diseases, unmet medical needs and rare disease like Cancer. Thus, proving it right that NDCT rules and subsequent amendments brought to the rules will be developing the country’s reputation across the globe and will harmonize the regulations in line with the International standards.
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