More fixed-dose combo drugs are facing the axe in India
Even as the Health Ministry is slated to exempt a popular contraceptive fixed dose combination (FDC) of centchroman and ethinyloestradiol from the Schedule H category (which has drugs that cannot be purchased over the counter without a valid prescription), a Central Drugs Standard Control Organization (CDSCO) expert committee is looking to further ban another lot of 324 FDCs, reports The Pharma Letter’s India correspondent.
The committee has asked pharmaceutical companies to prove that the 324 FDCs, termed rational, are indeed safe and effective for patients, in a bid to decide whether these drugs should continue to be sold in India and/or whether they can be strictly regulated.
Sources said an apex advisory board on drugs has also approved a report backing the Health Ministry's decision to ban many more FDCs.
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