CDSCO orders inspection of pharmacovigilance system of importers, manufacturers of human vaccines

The apex drug regulator also asked the importers and manufacturers to also furnish some of their documents to the directorate at the earliest

In an order recently, CDSCO said, “As per the fifth schedule of 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 or 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 collection and analysis of Adverse Drug Reaction Reports (ADR).”

It further said, “Accordingly, you are required to maintain qualified trained personnel and Officer-In-Charge of collection, processing of data and furnishing of PSUR as per fifth schedule of NDCT Rules, 2019, as the same may be subject to inspection at any time for verification of compliance.”

In this regard, CDSCO sought all the importers and manufacturers of human vaccines to furnish summary of established pharmacovigilance system; Name, email ID of Pharmacovigilance officer in-charge (PvOl), Name address, contact, Email ID of the premises where PV system is established; Self- Inspection report (if any).