Single-window system suggested to speed up the new drug approvals

A high-level government committee has suggested a single-window approval system in order to speed up the availability of new drugs in India as there has been an increasing rush to find the treatment for COVID-19.

The committee that has been set up by the Cabinet Secretary, after PM Narendra Modi overhauled India’s drug regulatory system, has suggested restructuring the permission process for new drugs by allowing parallel submission of applications for new drug approval and for grant of manufacturing and import license.

The committee was formed after Prime Minister Narendra Modi had raised concerns over the ability of the regulatory framework to keep pace with the industries and scientists.

Significance of Single window system:

As per the suggestions made by the committee, the single window system will enable the companies to manufacture drugs for the treatment of COVID-19.

As the long processes and involvement of multi agencies have been slowing the approval procedures, the suggestions will enable the availability of new drugs in the market at a much faster pace bringing people much closer to the COVID-19 vaccine or drugs.

What does the present system of sequential processing entail?

Under the current system of sequential processing, getting an import license for a new drug can take about a year as it takes 90 days to get permission to import and market a new drug.

Once the permission is obtained, the company requires an import registration certificate and the duration specified for processing this application is 270 days. After obtaining the Registration Certificate (RC), it again takes 30 more days to get the import license.

Suggestions made by the committee:

• As per the interim report submitted by the committee to Prime Minister’s Office, the parallel application system for new drug approval and grant of manufacturing and import license will be able to reduce the processing duration by about 3 to 6 months.

• The committee has also recommended the market authorization to be submitted simultaneously which will reduce the time duration by 2-3 months.

• As per the submitted report, the panel has also suggested allowing companies to manufacture the unapproved new drugs that are still under clinical development in order to enable faster access.

• In its report, the committee has also suggested that in case the manufacturer already has a license to manufacture the same category of drugs, the regulator Central Drugs Standard Control Organisation (CDSCO) must process the application within seven days from the date of the application, failing which it will be deemed approved.

• If the manufacturer has not been holding a license to manufacture the same category of drugs, the NOC (No- Objection Certificate) must be issued by the government within 30 days.

• As the multiple agencies are involved in the drug discovery in the pre-clinical stage, the committee has recommended setting up a timeline for the disposal of application, failing which proposals will be deemed approved.

• The newly formed committee recommended that a subcommittee under RCGM (review committee on genetic manipulation) must be formed to carry out all the functions of RCGM in respect of r-DNA derived drugs and must be permanently housed in CDSCO.

• In the report, the committee has recommended bringing all vigilance programmes like biovigilance, pharmacovigilance, materiovigilance, and haemovigilance under the direct supervision of CDSCO.