India: CDSCO's Safety Guidelines For Acne Drug ‘Isotretinoin'

Last Updated: 11 February 2019
Article by Singh & Associates

On December 19, 2018, the Central Drugs Standard Control Organization (CDSCO) re-issued safety guidelines15 for 'Isotretinoin' following public grievances related to drug's Adverse Drugs Reaction received at Centralized Public Grievance Redress and Monitoring System (CPGRAMS). Isotretinoin, is an oral drug used for the treatment and prevention of severe acne. The safety guidelines are published after consultation with Subject Expert Committee16 (SEC), CDSCO, where the committee examined the risk/benefit profile of drug for the approved indications in the country, and recommended that the drug may cause severe birth defects during the course of treatment. Therefore, the CDSCO directed all the State and Union Territories' drugs controllers to inform manufacturer/distributer/retail chemists under their jurisdiction to comply with the following safety guidelines:

  • The drug should be sold only on the prescription of a dermatologist.
  • The patients should sign a consent form before undertaking the treatment.
  • The Pack of the drug should carry box warning saying "the drug may cause severe birth defect; you must not take this medicine if you are pregnant or may likely to become pregnant during treatment". It also mentions that "You should also avoid pregnancy for 6 months after stopping the treatment".
  • The manufacturers should provide a package insert along with their product in major local languages.
  • The retail chemists should maintain the details of retail sale of the drug.

About Isotretinoin

Isotretinoin is a Retinoid, a naturally-occurring retinoic acid act and binds to the nuclear retinoic acid receptors (RARs), activated RARs serve as transcription factors that promote cell differentiation and apoptosis. This agent also exhibits immunomodulatory and anti-inflammatory responses and inhibits ornithine decarboxylase, thereby decreasing polyamine synthesis and keratinization. It is used as a topical dermatologic agent that is used in the treatment of ACNE VULGARIS and several other skin diseases17.

Note - Isotretinoin capsules 10mg and 20 mg were approved by the CDSCO in June 2002 for cystic and conglobate acne, severe nodular acne unresponsive to antibiotic therapy with various conditions. The said approval also comprised with boxed warning for female patients that 'the drug may cause severe birth defect and patient should sign a consent form before undertaking treatment'. At present the drug is available in Indian market with various brand names like Acneone, Acnex-20, Across, Aktret, Ratino and Isopad.

Footnotes

15. https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MjQxOQ==

16. https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/common_download.jsp?num_id_pk=MzQ=

17. https://pubchem.ncbi.nlm.nih.gov/compound/Isotretinoin#section=Top

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