ABSTRACT

Dear Reader,

It is indeed heartening to note that the Indian Government has notified Rules for fast-track launch of new, breakthrough drugs including block-buster molecules, waiving or bypassing clinical trials in India under Chapter V of the Rules, where the relevant drug has already been approved in specified countries, such as the European Union, US, UK, Japan, Australia and Canada. This decision was announced through an executive order specifying the list of developed countries under Rule 101 of the New Drugs and Clinical Trials Rules (NCDT) 2019, issued by the DCGI, Dr. Rajeev Singh Raghuvanshi. For the time being, the list of drugs covered under the order for approval of new drugs, under Chapter X are restricted to those for treatment of orphan drugs (rare diseases), new drugs for special defence purposes and those used in pandemic diseases, gene and cellular therapy products. It is further to be noted that drugs having significant therapeutic advances over the standard care, are also covered under this notification waiving domestic clinical trials. Indirectly, this waiver will not only help State Government and other public procurement agencies such as DGHS and Ayushman Bharat to reduce expenditure in their budgets, but also do away with animal trials in India in line with Indian and global initiatives. This initiative to selectively waive clinical trials will be a boon to research-based Indian Pharma companies too, for introducing generic equivalents of these drugs having significant therapeutic benefits to patients.