New Delhi: In an effort to reduce the backlog and clear the long-pending applications with lack of response from the applicants, the Central Drugs Standard Control Organisation (CDSCO) has introduced a structured reminder mechanism to dispose of such applications filed through the Sugam portal, after issuing three reminders and a final communication.
In line with the decision, the drug regulator has said that it will be rejecting all applications which are pending with the applicants for more than two years, in a period of 30 days from January 16. These applicants have already been notified through the three-reminder process.
According to the timeline, thirty days will be given between the first, second, and third reminder and another 30 days for the disposal notice, following which the application will be rejected, said the Drugs Controller General (India), Dr Rajeev Singh Raghuvanshi.
“In order to reduce the backlog of long-pending applications awaiting query responses across various divisions, namely Subsequent New Drugs, Investigational New Drugs, New Drugs, Fixed Dose Combinations, Import, Cosmetics, Biologics (applications pending since 2016) and Medical Devices and In Vitro Diagnostics (applications pending since 2018), the Central Drugs Standard Control Organisation (CDSCO) has initiated a structured reminder mechanism for applicants who have submitted applications through the Sugam portal,” said the drug regulator.
“As part of this mechanism, CDSCO issues reminders at fixed intervals to inform applicants to respond to the pending queries raised during the evaluation of their applications. A series of three reminders is sent to the applicants, requesting them to submit responses to the pending queries within the prescribed timelines….,” said the public notice to the stakeholders, issued by the drug regulator.
“In this regard, all stakeholders are hereby informed that applications pending with applicants for more than two years have already been notified through the three-reminder process, shall now be rejected after a period of 30 days from the date of issue of this public notice,” said CDSCO.
“A final rejection communication shall be issued according to the concerned applicants,” it added.
The drug regulator also advised all stakeholders to ensure that all pending queries are addressed within the stipulated time period to avoid rejection of their applications.
The drug regulator has been shifting its routine approval processes to online mode in various divisions, in order to streamline the regulatory and approval processes and aim at timely disposal of applications.
Submission of various applications has been completely moved to the online process, through the Sugam portal. The drug regulator can also raise queries, analyse the responses and issue final decisions on the applications through the online portal itself.
