Government bans manufacture, sale of 35 unapproved fixed-dose combination drugs
Health Risk Medicine : Union Health Ministry Restrictions Imposed On 35 Fixed Dose Combination Medicines . 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
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.
Apex drugs regulatory body CDSCO has directed drug controllers of all states and Union territories to stop the manufacture, sale and distribution of 35 unapproved fixed-dose combination drugs that include painkillers, nutrition supplements and anti-diabetics.
They have also been asked to review their approval process for such fixed-dose combination drugs (FDC) and ensure strict compliance of the provisions of the Drugs and Cosmetics Act 1940 and rules.
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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.
Restrictions Imposed On 35 Fixed Dose Medicines ,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.
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