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India Bans 35 Fixed-Dose Combination Drugs to Safeguard Public Health
In a significant move to protect public health, the Indian government has banned 35 fixed-dose combination (FDC) drugs. The Central Drugs Standard Control Organisation (CDSCO) issued a directive on April 11, 2025, instructing all states and Union Territories to halt the manufacture, sale, and distribution of these unapproved FDCs.​
Understanding Fixed-Dose Combination (FDC) Drugs
FDCs are medications that combine two or more active pharmaceutical ingredients in a fixed ratio into a single dosage form. They are designed to simplify treatment regimens and improve patient compliance. However, without proper evaluation, some combinations may pose health risks or lack therapeutic efficacy.​
Reasons Behind the Ban
The CDSCO found that these 35 FDCs were approved by state authorities without adequate evaluation of their safety and efficacy. This lack of central oversight raises concerns about potential adverse drug reactions and ineffective treatment outcomes.​
List of Banned Fixed-Dose Combination Drugs
The banned FDCs include a range of medications such as painkillers, anti-diabetic drugs, fertility treatments, and nutritional supplements. Some of the notable combinations are:​
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Aceclofenac 50mg + Paracetamol 125mg tablet
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Mefenamic Acid + Paracetamol Injection
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Cetirizine HCl + Paracetamol + Phenylephrine HCl
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Levocetirizine + Phenylephrine HCl + Paracetamol
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Paracetamol + Chlorpheniramine Maleate + Phenylpropanolamine
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Camylofin Dihydrochloride 25 mg + Paracetamol 300mg
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Paracetamol + Tramadol + Taurine + Caffeine
These combinations were found to lack therapeutic justification and were deemed potentially harmful to patients.​
Government's Directive and Recommendations
Dr. Rajeev Raghuvanshi, the Drugs Controller General of India, emphasized the need for uniform enforcement of drug regulations across the country. He urged state regulators to review their approval processes and ensure compliance with the Drugs and Cosmetics Act, 1940.​
What Should Patients Do?
Patients currently using any of the banned FDCs should consult healthcare professionals for alternative treatments. It's crucial not to discontinue any medication without professional guidance.
