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  • CDSCO orders...

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

Farhat NasimWritten by Farhat Nasim Published On 2023-01-05T18:00:54+05:30  |  Updated On 5 Jan 2023 6:00 PM IST
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New Delhi: The Central Drugs Standard Control Organization (CDSCO) has recently ordered inspections/audits of pharmacovigilance system of importers and 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).”

Also Read:CDSCO, State Drugs Control Administration begin joint inspection of drug manufacturing units

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).

Also Read:COVID intranasal vaccine: Bharat Biotech iNCOVACC priced at Rs 800 for private hospitals, Rs 325 for Govt
cdscodcgipharmacovigilancehuman vaccinencdt rulesDrug Controller General of Indiavg somaniauditadr reportpharma importersAdverse Drug Reaction
Farhat Nasim
Farhat Nasim

    Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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