26 February, 2025

The Central Drugs Standard Control Organization (CDSCO) has issued a circular dated 24.02.2025 for all the manufacturers of Category D Fixed Dose Combinations (FDCs). CDSCO has previously provided two separate pathways for the approvals of Category D FDCs. There were different pathways for the Category D FDC manufacturers, manufacturing the subject FDC prior to 01.10.2012 and post 01.10.2012.

Background

As per the pathway for the manufacturers holding licenses from State Licensing Authorities (SLAs) before 01.10.12, they were required to submit their applications for Phase IV clinical trial protocol/ Active Post Marketing Surveillance to CDSCO. However, CDSCO noted that many of the manufacturers did not submit their applications till date.

CDSCO Directive

CDSCO has now directed all such manufacturers to submit their applications w.r.t. Category D FDCs within three months, i.e., by 24.05.2025.

The detailed order along with the list of Category ‘D FDCs is attached here.

How Vaayath Can Help?

Vaayath will support you in the following ways:

  1. Preparation of Phase IV clinical trial protocol/ Active Post Marketing Surveillance.
  2. Filing of the applications.
  3. Responses to the concerns raised by the Authority, if any.
  4. Follow-up for expedited approvals.

For further assistance, feel free to reach out to Vaayath at vaayath@gmail.com.