Key Points
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 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..
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 purposesand new drugs having significant therapeutic advances over the current standard care...
Launches of several drugs like Zolgensma a blockbuster gene therapy used to treat spinal muscular atrophy, a disease that causes muscle-function loss in children, and considered one of the costliest drugs globally by Swiss pharma giant Novartis, and dengue vaccine QDenga by Japanese firm Takeda, have been delayed in India due to insistence on local bridging studies...
In response to a query by ThePrint, the Organisation of Pharmaceutical Producers in India (OPPI), a network of global pharma companies, said that it welcomes the decision to grant waiver of requirement of local clinical trials for drugs, subject to conditions...
