Drug regulator gives conditional nod for sale of 5 FDCs, seeks efficacy & safety data for 3 of them

New Delhi: Indiasapex drug regulator has given conditional approval to continue the manufacture and sale of five fixed-dose combination (FDC) medicines, asking drugmakers to produce post-marketing safety and efficacy data on three combinations, and to change the dosage and information label in the case of two others...

FDC drugs are those that contain a combination of two or more active pharmaceutical ingredients (APIs) in a single form, which is usually manufactured in a fixed proportion...

In an orderissuedThursday, the Central Drugs Standard Control Organisation (CDSCO) has asked drug manufacturers to produce safety and efficacy data within one year in case of paracetamol + phenylephrine hydrochloride + caffeine anhydrous, and caffeine anhydrous + paracetamol + phenylephrine hydrochloride + chlorpheniramine maleate the drugs sold for treating cold and allergy symptoms...

The five FDC drugs part of the new CDSCO circular, like the 14 FDCs banned last year, were among 344 drug combinations that the government had first banned in 2016 after an expert panel, constituted at the behest of the Supreme Court, had declared them as irrational and found that they were marketed to patients without scientific data proving their efficacy and safety.The panel was headed by Dr C.K. Kokate...

While most drugs out of the list of 344 originally banned for sale and marketing in India were forced out of the market following the committees recommendation, some pharma companies contested the governments ban order in the Delhi High Court for 19 drugs, saying that these were launched prior to 1988 when the rule mandating marketing approval by the CDSCO for every drug came into force...

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