CDSCO issues safety guidelines for Isotretinoin

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 now directed Drug Controllers of all the States and Union Territories to monitor the sale, manufacture and distribution of Isotretinoin, which can cause birth defects in progeny if not taken without proper guidance. The directions have been given after taking recommendations from the Subject Experts Committee (SEC) 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.’”

Isotretinoin may sold by retailers only against a dermatologist’s prescription, and details of the sale have to be strictly maintained as required under the Drugs and Cosmetics Rules, 1945.

Isotretinoin capsules of 10 mg/20 mg were approved by CDSCO in 2002 for the treatment of cystic and conglobate acne, and severe nodular acne unresponsive to antibiotic therapy.

The directions are based on recommendations from CDSCO’s Subject Experts Committee (SEC).

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Printable version | Jan 19, 2022 3:16:36 AM |

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