New Delhi: New drugs approved for use in select developed markets will be automatically allowed in India if the global trials included Indian patients.
The new Drugs and Clinical Trials Rules, 2019, has done away with the formality of conducting local trials so that the drugs can be introduced in Indian markets sooner.
“The move is expected to reduce the time taken by the company to introduce the drug in India and prevent duplication of studies. For example, if a US-based company conducted clinical trials that also included Indian patients and the drug is marketed in the US, there will be no need for conducting local clinical trials to prove its efficacy in India,” a senior government official said, requesting anonymity.
Requirement of local clinical trials has also been waived off for the drugs approved and marketed in the European Union, the UK, Australia, Canada, Japan and the US. “Data generated outside the country will be acceptable,” the official added.
As reported by Mint on 11 January, the government removed a clause in the clinical trials rules that mandated the sponsor (the entity initiating the trial) to pay 60% of compensation upfront in case of death or permanent disability of a patient. In case of application to conduct clinical trial of a new drug as part of discovery, research and manufacture in India, the application is to be disposed off within a period of 30 days.
In case of no communication from the Drug Controller General of India (DCGI) the application will be deemed approved.
The government also made it mandatory for firms to provide medical management as long as required, or till such time it is established that the injury is not related to the clinical trial. As reported by Mint on 11 January, the government removed a clause in the clinical trials rules that mandated the sponsor (the entity initiating the trial) to pay 60% of compensation upfront in case of death or permanent disability of a patient.
An amendment in the new rules said that companies will pay the total amount once it is proven that the injury occurred because of the trial. The earlier proposal said the interim compensation will not be recoverable even if investigations prove that the death or disability did not occur because of the trial.
The Union health ministry’s proposal drafted in February 2018 included a mandate for the company to pay 60% of the compensation within 15 days, if a person dies or suffers a permanent disability during the course of a trial.