CDSCO tightens safety and labelling rules for ISOTRETINOIN,prescription of dermatologist mandatory

New Delhi: The Drug Controller General of India (DCGI) has asked drugs controllers in all states and Union Territories to ensure that Isotretinoin, used to treat severe cystic acne, is sold by retailers on prescription of dermatologists only. The Central Drugs Standard Control Organization (CDSCO), in a communique, said the packets containing the drug should carry a box warning stating 'this medicine may cause severe birth defects; you must not take this medicine if you are pregnant or may likely become pregnant during treatment' and 'you should also avoid pregnancy for six months after stopping the treatment'.

The communique stated the conditions should be followed during manufacture, sale and distribution of the drug as already stipulated by the CDSCO at the time of approval of the oral drug.

Isotretinoin capsule 10mg/ 20mg was approved by CDSCO on June 21, 2002, for treatment of cystic and conglobate acne, severe nodular acne unresponsive to antibiotic therapy, with various conditions.

In light of concerns raised regarding Isotretinoin, the matter has been examined by CDSCO in consultation with the Subject Expert Committee (Dermatology and Allergy) in its meeting held on July 26, the communique stated.

The Subject Expert Committee deliberated the matter in detail and opined that the drug has a favourable risk-benefit profile for the indications approved in the country. However, some conditions should be followed during manufacture, sale and distribution of the drug as already stipulated by CDSCO at the time of its approval, according to the communique.

"The committee also recommended that the manufacturers should provide package insert along with their product which should be in major vernacular languages. Retail chemists should maintain the details of the retail sale of the drug which should be strictly on the prescription of Dermatologist only," it stated.