CDSCO issues safety norms for acne drug

The Central Drugs Standard Control Organisation (CDSCO) has issued safety guidelines for Isotretinoin, an oral drug, which is used in the treatment of severe acne. Drug Controller General Dr. S. Eswara Reddy has directed Drug Controllers of all the States and the Union Territories to monitor the sale, manufacture and distribution of Isotretinoin, which can cause birth defects in progeny if taken without proper guidance. The directions have been given after taking recommendations from the Subject Experts Committee with CDSCO. The public notice states: “Pack of drug should carry box warnings including, ‘The medicine may cause severe birth defects; You must not take this medicine if you are pregnant or may likely become during treatment. You should also avoid pregnancy for six months after stopping the treatment.’”

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