Explained: India halts 35 drug combinations over health risks — here’s the full list and what it means for you

In a major crackdown on drug safety violations, India’s Central Drugs Standard Control Organisation (CDSCO) has banned 35 fixed-dose combination (FDC) drugs. These include popular formulations used to treat diabetes, hypertension, pain, infections, and more.

The April 11 order directs an immediate halt on manufacturing, sale, and distribution of these drugs, citing that they were approved without mandatory safety and efficacy evaluations under the New Drugs and Clinical Trials (NDCT) Rules, 2019.

Why were these drugs banned?

State drug regulators had approved them without following central oversight procedures. The Drugs Controller General of India (DCGI) called this a “serious risk to public health.” The CDSCO emphasized the importance of uniform enforcement of India’s drug safety rules across states.

What are FDC drugs?

Fixed-Dose Combinations (FDCs) contain two or more active ingredients in a single pill or dose. While they can improve convenience and adherence to treatment, they must undergo thorough safety checks — especially when combining powerful medications.

Here's the full list of the 35 banned FDCs:

Dapagliflozin + Glimepiride + Metformin

Cilnidipine + Metoprolol Succinate

Etodolac + Paracetamol + Chlorzoxazone

Trypsin-Chymotrypsin + Diclofenac + Paracetamol

Glucosamine + Diacerein + Methyl Sulfonyl Methane

Nimesulide + Serratiopeptidase + Paracetamol

Diacerein + Glucosamine + Methyl Sulfonyl Methane

Levocetirizine + Montelukast + Ambroxol

Nimesulide + Paracetamol + Serratiopeptidase

Paracetamol + Chlorzoxazone + Aceclofenac

Ofloxacin + Ornidazole + Racecadotril

Cefixime + Ofloxacin + Lactobacillus

Diacerein + Glucosamine + Boswellia Serrata

Etodolac + Paracetamol + Serratiopeptidase

Pantoprazole + Domperidone + Levosulpiride

Glucosamine + Methyl Sulfonyl Methane + Boswellia Serrata

Diacerein + Methyl Sulfonyl Methane + Boswellia Serrata

Trypsin-Chymotrypsin + Diclofenac + Serratiopeptidase

Glimepiride + Metformin + Voglibose

Trypsin-Chymotrypsin + Diclofenac + Methyl Sulfonyl Methane

Paracetamol + Aceclofenac + Chlorzoxazone

Paracetamol + Diclofenac + Chlorzoxazone

Etodolac + Paracetamol + Methyl Sulfonyl Methane

Cefixime + Lactobacillus + Ofloxacin

Paracetamol + Chlorzoxazone + Nimesulide

Drotaverine + Mefenamic Acid + Paracetamol

Glucosamine + Diacerein + Boswellia Serrata

Serratiopeptidase + Diclofenac + Paracetamol

Diclofenac + Methyl Sulfonyl Methane + Paracetamol

Glucosamine + Methyl Sulfonyl Methane + Diacerein

Paracetamol + Diclofenac + Serratiopeptidase

Pantoprazole + Domperidone + Simethicone

Trypsin-Chymotrypsin + Diclofenac + Boswellia Serrata

Nimesulide + Paracetamol + Methyl Sulfonyl Methane

Pantoprazole + Domperidone + Simethicone + Activated Dimethicone

What should you do if you're taking these?

Stop use immediately and consult your doctor for safe alternatives.

Pharmacies are instructed to remove stock of these drugs. Patients should report any adverse effects experienced from these combinations to their healthcare provider or through India’s pharmacovigilance program.

What happens next?

State regulators must cancel existing licenses for these drugs. Drug enforcement teams across ports and zones will monitor and enforce the ban. A wider review of drug approval processes is expected in the coming months.