Last Updated on October 9, 2024 by The Health Master
The Central Drugs Standard Control Organization (CDSCO) has recently ordered inspections and audits of the pharmacovigilance systems of importers and manufacturers of human vaccines.
In an order recently, CDSCO said, “As per the fifth schedule of the NDCT Rules, 2019, the importer or manufacturer of any new drug for sale and distribution shall have a pharmacovigilance system in place for collecting, processing, and forwarding the adverse drug reaction (ADR) reports to the Central Licensing Authority emerging from the use of the new drug imported, manufactured, or marketed by the applicant in the country.”
“The pharmacovigilance system shall be managed by qualified and trained personnel, and the officer-in-charge of collection and processing of data shall be a trained pharmacist or medical officer in the collection and analysis of ADR reports.”
It further said, “Accordingly, you are required to maintain qualified trained personnel and an officer-in-Charge of collection, processing of data, and furnishing of PSUR as per the fifth schedule of the NDCT Rules, 2019, as the same may be subject to inspection at any time for verification of compliance.”
The order also asked the importers and manufacturers to also furnish some of their documents to the directorate at the earliest.
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