Review Of Controversial Drug Combinations

The Central Drugs Standard Control Organization (CDSCO) has announced a meeting to evaluate the safety and efficacy of 16 Fixed Dose Combination (FDC) drugs. These drugs were previously flagged as “irrational” by a the expert committee. This notice was issued on March 22, 2024.

What are FDCs?

FDCs combine two or more medications into a single pill. While convenient for patients, concerns exist about their effectiveness and potential for over-medication.

Review Process

The Drugs Technical Advisory Board (DTAB) subcommittee will convene on April 5, 2024, at 11:00 AM via WebEx video conferencing. They will thereby assess the FDCs. The WebEx link for the meeting will be shared on meeting day. This meeting is a response to submissions by drug manufacturers seeking approval for these combinations.

Stakeholder Participation and Procedures

Applicants and stakeholders are encouraged to attend the virtual meeting and present their case to the committee. Failure to participate could result in decisions being made solely based on available information.

Participating applicants/ stakeholder shall submit the following details to CDSCO:

  • details of presenter,
  • email address,
  • contact number, and
  • presentation slides (PPT)

These details must be submitted to by April 2nd, 2024