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.

Isotretinoin is an oral drug, which is used in the treatment of severe acne. 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.

It was later found that Isotretinoin can cause birth defects in progeny if not taken without proper guidance.

About CDSCO:

The Central Drugs Standard Control Organisation (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India.

Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of New Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice with a view to bringing about the uniformity in the enforcement of the Drugs and Cosmetics Act.

CDSCO along with state regulators is jointly responsible for grant of licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.

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