The Drugs Controller General of India (DCGI) has directed manufacturers of Fluconazole formulations to include hyperpigmentation as an adverse drug reaction in the drug's label, package insert, and promotional literature. This action follows a recommendation from the Subject Expert Committee (SEC) and consideration by the DCGI's office, prompted by a suggestion from the Pharmacovigilance Programme of India (PvPI). Zonal and sub-zonal offices of the Central Drugs Standard Control Organisation (CDSCO) have been informed, and manufacturers are requested to report their compliance.
Key Entities Referenced
Fluconazole: An antifungal drug, the subject of the package insert modification.
PvPI: Likely refers to Pharmacovigilance Programme of India, which suggested the drug reaction update.
SEC: Refers to Subject Expert Committee, which made the recommendation considered by the office.
Hyperpigmentation: The adverse drug reaction to be mentioned in the drug's labeling.
Dr. S. Eswara Reddy: Drugs Controller General of India, the signatory of the notification.
Drugs Controller General India: The title of the signatory of the notification.
CDSCO: Central Drugs Standard Control Organisation, zonal and sub-zonal offices are mentioned in the copy.
Nirman Bhawan, New Delhi: Location of MoHFW (Ministry of Health and Family Welfare) mentioned in the copy.
MoHFW: Ministry of Health and Family Welfare, the parent ministry.
drug reaction in the package insert of the drug Fluconazole as suggested by
PvPI.
The recommendation of the SEC has been considered by this office.
Accordingly, you are requested to direct the manufacturers of Fluconazole
formulations under your jurisdiction to mention Hyperpigmentation as an
adverse drug reaction in the label/Package insert/Promotional Literature of the
drug.
Action taken in this regard may be intimated to this office.
Yours faithfully,
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Dr. S. Eswara Reddy
Drugs Controller General (India)
1. Copy for information & follow-up: -
All Zonal / Sub Zonal Offices of CDSCO.
2. Copy for information to: -
JS(R), Nirman Bhawan, MoHFW, New Delhi-110002.