The new drug approval process in India is expected to get simpler and faster, with the government initiating discussions on reforming the regulatory system. The Ministry of Health and Family Welfare has called a meeting of the committee constituted for this purpose on Friday, sources familiar with the developments said. This will be the second meeting of the committee.
The industry, which has been lobbying for faster approvals for quite some time now, says the Covid-19 pandemic should help expedite the reforms process. India now needs new drugs like Favipiravir (used for influenza in Japan) and Gilead Sciences’ repurposed Ebola drug Remdesivir in the market soon to treat a growing number of Covid-19 cases. There is a need for faster approvals for clinical trials, and quicker marketing approvals.
Currently, the approval timeline for a new drug application is around six to nine months, even for drugs that have been approved in other regulated countries.
The proposal from the drugmaker undergoes review of a subject expert committee (SEC). “At present, there is no prioritisation given to orphan drugs, which, according to the New Drugs and Clinical Trial Rules, 2019, can be reviewed fast,” said an industry source.
In a recent recommendation, the Federation of Indian Chambers of Commerce & Industry had proposed that for drugs already approved by one of the key countries like the US or the European countries, Canada, Japan, etc, the new drug approval should be granted by the Central Drugs Standard Control Organisation without going to the SEC.
The industry also felt any queries related to the local data about the drug should be issued within a time-bound manner and the process of approval itself be expedited.
This can reduce the approval time for new drug application to three months through a single window system. “There is a need to launch innovative products in India soon after they are available globally. The Covid-19 crisis has only pronounced that need. The reforms in the drug regulatory system are being considered,” said a government official.
At present, Glenmark is conducting clinical trials for Favipiravir. For Remdesivir, the Indian drug regulator has not asked for separate trials in India as the US drug regulator has given emergency approval for the drug. There is already a trend to fast-track approvals in the system; the idea is to extend it other drugs as well.