The Central Drugs Standard Control Organisation (CDSCO) has published a notice on inspections/ audits of pharmacovigilance (PV) of importers and manufacturers of human vaccine. The notice was published on 23rd of December, 2022.
The New Drugs and Clinical Trial Rules, 2019 state that the importer of manufacturer of any new drug for sale and distribution shall have a PV system. The system shall include a place for collecting, processing and forwarding the Adverse Drug Reaction (ADR) reports to the central licensing authority. This information will emerge from the use of the new imported/ manufactured/ marketed drug by the applicant in India.
Th PV system should be managed by managed by trained and qualified personelle. Moreover, the officer in charge of collection and processing of data should be a pharmacist or medical officer trained in collection and analysis of ADR Reports. The importters and manufacturers of new drugs shall also publish Period Safety Update Reports (PSUR). These requirements may be subject to inspection at any time for verification of compliance.
Hence the CDSCO requests the following documents:
- Summary of established PV systems
- Name, email ID of PV officer-in-charge
- Name, address, contavt and email ID od the premises where PV system is established
- Self inspection report (if any)