**Summary:**
The Drugs Controller General of India (DCGI), under the Central Drugs Standard Control Organization (CDSCO), has issued a notice regarding inspections and audits of the Pharmacovigilance (PV) systems of importers and manufacturers of human vaccines, as per the New Drugs and Clinical Trials (NDCT) Rules, 2019. The notice, dated October 12, 2020, File No. PSUR/WHO/GB/TV/IG/001/2022-8196358, addresses all manufacturers and importers of human vaccines.
The NDCT Rules, 2019, specifically the 5th Schedule, mandate that importers and manufacturers of new drugs for sale and distribution establish a Pharmacovigilance system to collect, process, and forward Adverse Drug Reaction (ADR) reports to the Central Licensing Authority. This system must be managed by qualified and trained personnel, with the Officer-In-Charge of data collection and processing being a trained Pharmacist or Medical Officer.
Therefore, all concerned manufacturers and importers are required to maintain qualified personnel and an Officer-In-Charge for data collection, processing, and Periodic Safety Update Report (PSUR) submission, as stipulated in the 5th Schedule of the NDCT Rules, 2019. Compliance may be subject to inspection at any time.
The notice requests the following documents be furnished to the Directorate at the earliest:
1. A summary of the established pharmacovigilance system.
2. Name and email ID of the Pharmacovigilance Officer in-charge (PVOIC), along with the name, address, contact details, and email ID of the premises where the PV system is established.
3. Self-inspection report (if any).
Dr. V. G. Somani, Drugs Controller General of India, issued the notice. Further inquiries can be directed to psur.drugs@cdsco.nic.in or dei.nic.in. A copy of the notice has been forwarded to the QMS division, CDSCO HQ.
Key Entities Referenced
Directorate General of Health Services: A government directorate under the Government of India.
Central Drugs Standard Control Organization: A national regulatory body for pharmaceuticals and medical devices in India.
Drugs Controller General India: The head of the Central Drugs Standard Control Organization (CDSCO) in India.
NDCT Rules, 2019: National Drugs and Cosmetics Trial Rules, 2019, a set of regulations in India.
Pharmacovigilance: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
PSUR: Periodic Safety Update Report, a document required by regulatory authorities.
Adverse Drug Reaction Reports ADR: Reports documenting adverse reactions to drugs.
Dr. V. G. Somani: The Drugs Controller General of India at the time of this notice.
Government of India
Directorate General of Health Services
Central Drugs Standard Control Organization
Office of Drugs Controller General (India)
(PSUR/PV Cell), FDA Bhawan,
Indrajeet Gupta Road, New Delhi-1 10002
E-mail: psur.drugs@cdsco.nic.in, dei@nic.in
File No. PSUR/WHO/GBT/VIG/001/2022/8196358 Dated:
OQ) 124202
NOTICE
Subject: Inspections/ Audits of Pharmacovigilance (PV) system of Importers
and manufacturers of human Vaccine; -reg.
As per the 5tt 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 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).
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 you are requested to furnish the following documents to this
directorate at the earliest.
1. Summary of established pharmacovigilance system.
2. Name, email ID of Pharmacovigilance officer -in-charge (PvOlI), Name address,
contact, Email ID of the premises where PV system is established.
3. Self- Inspection report (if any)
We
(Dr. V. G. Somani)
Drugs Controller General (India)
To;
1. All the Manufacturers and importers of Human vaccines
Copy to;
1. QMS division, CDSCO(HQ)
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