New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has mandated all companies to address queries on drug applications within a 30-day period, warning that non-compliance will lead to rejection.

Issuing a public notice, the agency said, “the applicants who fail to respond to these queries raised during the evaluation of their applications, even after issuance of the three reminders are subsequently issued a final communication, informing them that their application stands rejected, with the fee amount forfeited,”

“All stakeholders are advised to ensure that all pending queries are addressed within the stipulated time period to avoid rejection of their applications,” it added.

Through this directive, the central regulator seeks to address the backlog of applications pending since 2016, due to pending of responses across various divisions, including global clinical trials (GCT), bioavailability and bioequivalence (BA\BE), ethics committee and veterinary division.

It has initiated a structured reminder mechanism for applicants who submitted applications on the SUGAM portal and a series of three reminders are sent to the applicants, requesting them to submit responses to the pending queries within the prescribed timelines.

According to the latest notice, applications pending for more than two years, have already been notified through the three-reminder process, and will be rejected after 30 days.

Source: ET Pharma - May 06,2026