CDSCO Cracks Down on 35 Unapproved FDCs including Antibiotics, Analgesics and Cough Syrups, Warns Strict Action
Moneylife Digital Team 25 April 2025
The central drugs standard control organisation (CDSCO) has directed all drug manufacturers across India to immediately cease the production and sale of 35 fixed-dose combinations (FDCs) that have not received regulatory approval. This crackdown comes amid ongoing concerns about the public health risks posed by the indiscriminate use of certain drug combinations, particularly in antibiotics, analgesics and cough syrups, which have been linked to antibiotic resistance and adverse drug reactions.
 
For coughs and colds, patients often buy some common FDC medications over the counter. It includes dextromethorphan hydrobromide 10mg + phenylephrine hydrochloride 5mg per 5ml (sold under different brand names like Deletus D, Ascoril D and Tousq DX). The FDC of chlorpheniramine maleate 4mg, codeine phosphate 10mg and sodium citrate 75mg is a cough syrup that is sold in the market under some popular names like Corex, Tossex and Planokuf. The combination of ambroxol hydrochloride 20mg, dextromethorphan hydrobromide 10mg and chlorpheniramine maleate 2mg per 5ml is used for the treatment of dry cough. One example of this FDC is Soventus D syrup, which thins mucus in the nose, windpipe and lungs, making it easier to cough out. 
 
CDSCO clarified that despite earlier notices and communications, certain manufacturers continue to produce or market unapproved FDCs, either directly or under the guise of deemed approvals. The notice unequivocally states that no FDC can be manufactured or marketed unless it has received prior approval from the central licensing authority (CLA) as required under rule 81 of the New Drugs and Clinical Trials Rules, 2019.
 
As per the order, state and Union Territory (UT) drug controllers have been instructed to take stringent action against companies violating these norms. This may include suspension or cancellation of manufacturing licences for products found to be in breach of the law.
 
CDSCO also reminded manufacturers that FDCs not found in the lists cleared by the drugs technical advisory board (DTAB) or those still under review by the subject expert committees (SECs) should not be treated as approved. Companies are further instructed to withdraw such products from the market with immediate effect.
 
The regulator has urged all manufacturers to submit proof of approval for the FDCs they are producing or marketing, failing which enforcement action may follow. The measure is expected to curb the proliferation of irrational drug combinations and ensure only safe, effective formulations reach Indian consumers.
 
The public notice, issued by the drugs controller general of India (DCGI), aims to reinforce compliance with national drug safety standards and prevent the marketing of potentially unsafe or irrational drug combinations, CDSCO says.
Comments
iaminprabhu
1 month ago
Why nit ARREST & PROSECUTE the Owners & Directors of such companies found violating laws & playing with life of Patients and Common Citizens!
Meenal Mamdani
1 month ago
When we were studying medicine, our Pharmacology professors explained how fixed dose combinations in drugs were detrimental and should always be avoided.

A person may need the same dose of one of the combination drug while the second drug in the combination needs to be increased. One cannot increase one component and keep the other component the same.

This elementary principle of pharmacology seems to be missing in India's Drug Control authority.
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