The Union Health Ministry has decided to end the present regulatory procedure of requiring clinical trials for imported medications, provided the producers obtain permission for their new products in the United States, United Kingdom, Japan, Australia, Canada, and the European Union (EU).
As one of the exempt categories is "new drugs having significant therapeutic advance over the current standard care," the officials claim that this step will aid in the speedy launch of patented drugs into the Indian market.
The following categories are exempt: orphan medications for rare diseases; Gene and cell therapy products; novel medications utilized in pandemic conditions; and new medications for specific defense use.
The companies will not be required to complete the obligatory trials in any of the five categories, which usually take a few years.
Following the modification of Rule 101 of the New Drugs and Clinical Trial Rules, 2019, a policy change was implemented.
The policy adjustment, according to officials, will allow for the quicker introduction of some of the newest medications to treat autoimmune diseases, rare conditions including Duchenne Muscular Dystrophy (DMA) and Spinal Muscular Atrophy (SMA), and malignancies, as opposed to previous five- to 20-year delays.
“Removing the clinical trial requirement for entry can hasten the process of new drugs and vaccines reaching the Indian market. The liability of the company, however, remains. We are only doing away with bridge studies (needed for medicines approved by other regulatory agencies),” said an official.
When a company requests a waiver, the Drugs Controller General of India (DCGI) will either approve it or determine that the application has to be reviewed by a Subject Expert Committee (SEC). This decision will be made by the Central Drug Standards Control Organization (CDSCO).
SEC will mostly not ask for any local studies, but in rare cases, if the SEC feels the need for local data, it will have to give a justification on why a study is needed in India,” he said, pointing out that only medications produced and distributed in six countries with strict regulatory bodies were subject to the waiver standards.
(Input from various sources)
(Rehash/Priyanka Pandey)