New Delhi: Paving way for faster launch of breakthrough therapies for conditions like cancer and rare diseases, the Union government Wednesday ordered that certain categories of drugs which have already been approved in specified developed countries can be directly launched in India without local clinical trials. The countries included in the list are the US, UK, Japan, Canada, European Union and Australia. The decision came through an executive order specifying the names of the countries under rule 101 of the New Drugs and Clinical Trials Rules (NDCT), 2019.
Under this rule, the Drugs Controller General of India (DCGI) can specify certain countries for considering waiver of local clinical trials for approval of new drugs. However, over the past 5 years, since the NDCT’s implementation, the government had not listed the countries from where drugs could be considered for exemption from local clinical trials, despite a push from the foreign drugmakers. In the order issued Wednesday, DCGI Rajeev Singh Raghuvanshi said the names of the countries were now being specified in exercise of the powers conferred under rule 101.
However, the order, a copy of which is with ThePrint, restricts the categories of drugs that can be considered for the local clinical trial waiver. These include orphan drugs for rare disease, gene and cellular therapy products, new drugs used in pandemic situations, new drugs used for special defense purposes and new drugs having significant therapeutic advanc.