Establishment of Pharmacovigilance System

Office of Drugs Controller General, India issued a notification on 23 December 2022 regarding establishing the pharmacovigilance system for reporting the new drug's adverse drug reaction reports (ADR).

The notifications state the following:

1. According to the 5th schedule of NDCT rules, 2019, all manufacturers and importers of new drugs must have a pharmacovigilance system to collect adverse drug reaction reports (ADR).
2. The system must have trained and qualified personnel
3. The officer-in-charge must be a trained pharmacist or medical officer for collecting, processing data, and furnishing PSUR
4. It is subject to inspection at any time for verification of compliance.
5. Submit the following documents to Directorate:

• Summary of pharmacovigilance system
• Name, e-mail ID of officer-in-charge
• Name, e-mail ID, address, and contact of the premise of the pharmacovigilance system
• Self-inspection reports, if any