New Fixed-Dose Combinations Approved by CDSCO: January 2024 - March 2025

The Drugs Controller General of India (DCGI) approved 43 new fixed-dose combinations (FDCs) between January 2024 and March 2025, spanning therapeutic areas from diabetes and cardiovascular disease to antibiotics, respiratory disease, and pain. The approvals are listed on the official CDSCO website and sourced directly from two DCGI approval PDFs.

This article lists every approved FDC from those two official documents, with therapeutic category and approval date. It does not include any information beyond what is in those documents.

What Is an FDC and How Does CDSCO Approve One?

A fixed-dose combination is a single dosage form containing two or more active pharmaceutical ingredients (APIs) in a fixed ratio. In India, a new FDC must be approved by DCGI under Rule 122E of the Drugs and Cosmetics Rules, 1945 before any manufacturer can produce or sell it.

The Rule 122E approval process requires:

• Clinical and pharmacological rationale for the combination - evidence that combining the APIs produces a better outcome than either alone
• Safety and efficacy data: either new clinical trials in Indian patients, a bridging study, or a literature-based justification for well-established combinations
• Review by CDSCO's Subject Expert Committee (SEC) for the relevant therapeutic area
• DCGI sign-off after SEC recommendation

Once approved, each manufacturer still needs a separate manufacturing licence from their State Licensing Authority (SLA) for that specific FDC. The DCGI approval is an approval of the combination, not a product-specific market authorisation.

New FDC approvals are distinct from the rationality review process for existing FDCs marketed without proper approval - that process resulted in bans of hundreds of irrational FDCs under Section 26A between 2016 and 2023 and is a separate regulatory track.

January 2024 - October 2024: Notable Approvals

Antidiabetic Combinations

The SGLT2 inhibitor combinations (Dapagliflozin, Empagliflozin) reflect the growing clinical evidence that SGLT2 inhibitors have cardiovascular and renal benefits beyond glycaemic control. The Dapagliflozin + Bisoprolol and Metoprolol + Dapagliflozin combinations are positioned for heart failure patients with T2DM - a population where both drug classes have demonstrated mortality benefit in large RCTs (DAPA-HF, EMPEROR-Reduced).

Cardiovascular / Lipid-Lowering Combinations

The Bempedoic acid + Rosuvastatin approval is particularly significant. Bempedoic acid (an ATP citrate lyase inhibitor) was developed for patients who are statin-intolerant or who need additional LDL-C reduction beyond statin monotherapy. Its approval as an FDC with Rosuvastatin reflects India's growing attention to patients with familial hypercholesterolaemia and high-risk atherosclerotic cardiovascular disease (ASCVD).

Respiratory Combinations

Antiallergic Combinations

Antidepressant Combinations

The Bupropion + Dextromethorphan combination (marketed as Auvelity in the US, FDA-approved 2022 for major depressive disorder) brings a novel mechanism - NMDA receptor antagonism combined with dopamine-norepinephrine reuptake inhibition - to Indian patients with MDD, particularly those with inadequate response to SSRIs.

Analgesic Combinations

The complete list of all 33 approvals (January-October 2024) is published in the official CDSCO PDF linked in the Sources section below.

November 2024 - March 2025: Notable Approvals

Spotlight: Aztreonam-Avibactam - A Critical Approval for Drug-Resistant Infections

Aztreonam is a monobactam antibiotic - uniquely active against gram-negative bacteria and stable against metallo-beta-lactamases (MBLs, including NDM-1) - the enzymes produced by the most dangerous drug-resistant organisms. However, Aztreonam alone is inactivated by serine beta-lactamases (ESBL, KPC). Avibactam is a novel beta-lactamase inhibitor that blocks serine beta-lactamases.

The combination covers organisms that produce both MBLs and serine beta-lactamases - the "pan-resistant" gram-negatives that are untreatable with any single existing antibiotic. The EMA approved Aztreonam-Avibactam (Emblaveo) in 2023 specifically for MDR gram-negative infections when other options are not appropriate. India's CDSCO approval in March 2025 brings this combination to Indian patients for whom it may be the only remaining treatment option.

Spotlight: Triple Inhaler for COPD and Asthma

The Vilanterol + Glycopyrronium + Fluticasone furoate triple inhaler (approved 5 March 2025) combines a LABA (Vilanterol) + LAMA (Glycopyrronium) + ICS (Fluticasone furoate) in a single device. Triple ICS/LABA/LAMA therapy is recommended in GOLD guidelines for symptomatic COPD patients uncontrolled on dual bronchodilator therapy. A single inhaler triple combination reduces device burden and potentially improves adherence.

Why FDC Approvals Matter for Healthcare in India

India's pharmaceutical market has one of the highest proportions of FDC prescribing in the world. The CDSCO approval process under Rule 122E is intended to ensure only evidence-backed FDCs reach the market. The 2024-25 approvals reflect several trends in Indian disease burden:

• Diabetes management: Multiple SGLT2 inhibitor-based combinations reflect established evidence and the growing use of SGLT2 inhibitors in India's large T2DM population
• Cardiovascular risk: Lipid-lowering combinations (Bempedoic acid) and heart failure combinations (SGLT2 + beta-blocker) address increasing cardiovascular disease burden
• Drug-resistant infections: The Aztreonam-Avibactam approval directly addresses the AMR crisis in Indian hospitals
• Respiratory disease: Multiple inhaler combinations address COPD and asthma, both high-burden conditions in India

Verifying FDC Approval Status

Manufacturers, doctors, and pharmacists can verify whether a specific FDC has DCGI approval:

1. Visit the CDSCO website → Drugs → New Drug Approvals → FDC Approvals
2. Check the approval PDFs linked in the Sources section below
3. For older approvals (pre-2024), use the CDSCO search portal or file an RTI

An FDC being available in the market does not guarantee DCGI approval. Always verify before stocking or prescribing a new combination product.

This article lists FDC approvals as published on the CDSCO website. It does not constitute a marketing authorisation for any specific brand. Manufacturers require a separate manufacturing licence from the State Licensing Authority for each approved FDC. Verify current approval status directly with CDSCO before manufacturing or marketing any FDC.