Detection and reporting of adverse drug reactions
Criteria for ADR and its Reporting to Regulatory Authority
What to report?
Following events can be reported to the nearest reporting centre or authority
- Life-threatening event or death
- Hospitalization of the patient
- Congenital anomaly
- Medically significant event (If the event is considered serious by physician)
- Lack of efficacy is connected with using a medical device or drug product.
- All suspected drug interactions
- All known or unknown, serious, non-serious, frequent or rare reaction caused due to use of vaccine or drug must be reported.
When to report?
- All spontaneous case should be reported within 10 days.
- All suspected ADR should be reported as soon as possible because over reporting is always better than under reporting.
- Death event must be reported as soon as possible, while all other serious ADR/event needs to report within 7 days only.
- All non-serious cases must be reported within 30 days.
- Reporting delay may create serious problem.
Who can report?
- Professionals working in healthcare team are the preferred source of information in PV, for example
- Medical specialists
- Along with HCPs patient, patient’s relatives, witness or any common person after medical confirmation can report
How to report?
- Duly filled  ADR reporting form needs to send to the nearest AMC or directly to the NCC.
- Dial toll free helpline number-1800 180 3024 to report ADRs.
- Mailing the filled ADR reporting form directly to email@example.com or firstname.lastname@example.org.
- Logging on to the http://www.ipc.gov.in, http://www.ipc.gov.in/PvPI/pv_home.html for list of authorised AMCs of India.
Where to report
Various Peripheral, Regional and Zonal centres have been proposed and established in India.
Peripheral PV centre: It is a primary ADR information gathering centre. It includes small medical centres, private hospitals, dispensaries, nursing homes and pharmacies. ADRs are recognized and synchronized
by RPCs or ZPCs. Every state, Union territory and few leading medical colleges in India have this peripheral centre.
Regional PV centre: It’s regarded as a secondary PV Centre. It is located in a medical college having relatively larger facilities. They are identified and coordinated by zonal centres. There are five such regional centres in India.
Zonal PV centres: It’s regarded as Tertiary PV Centre. Generally located in metro city’s medical college having attachment of sufficient facility. It is identified by CDSCO and act as first ADR data collection
centre. Zonal centre for North and East zone is AIIMS.
List of Central Drug Standard Control Organisation (CDSCO) Zonal and Sub-Zonal Offices
- Zonal Centre-Ahmadabad
- Zonal Centre-Hyderabad
- North Zonal centre-Ghaziabad a) Sub-Zone Office-Ghaziabad b) Chandigarh, c) Sub-Zonal Office, Jammu
- East Zonal Centre-Kolkata-Air Port and Sea Office, Kolkata
- West Zonal Centre-Mumbai-Air Port and Sea Office, Mumbai, Jawaharlal Nehru Port Office, Navi Mumbai
- South Zonal Centre-Chennai a) Air Port and Sea Office, b) Sub-Zonal and Port Office, Chennai c) Port Office, Kochi, Bangalore
Processing of ADR
All the ADR reports from various sources are collected at the AMC’s. PV staff at AMC study, validate and prioritise the report and perform provisional causality assessment. The assessed ADR forms are then directed toward the authorised coordinating centre for further proceedings.
The AMC’s staff maintains a record of all the activities of the centres and carries out ADR monitoring of drugs as per the standard watch list. The coordinating centres then conduct a final causality evaluation and feed the reports into the PV database. These centres also prepare an aggregate report of ADRs collected at said time interval and send it to WHO-UMC. The finding of PV analysis is then implemented and integrated into the general population health program.
Finally, the integrated ADR data is transferred through the Vigi-Flow database to the UMC database. UMC team analyses the submitted data and detects the drug-ADR relationship called as a signal, which is a very important aspect and communicates with NCC-PvPI via CDSCO to stop the marketing or use of drug in India.
A separate quality review panel exists for the maintenance of the quality of ADR processing which inspects or analyses all the centres based on their quality and timely completion of work records, and regularity of training provided
Reference: Amale PN, Deshpande SA, Nakhate YD, Arsod NA (2018) Pharmacovigilance Process in India: An overview. J Pharmacovigil 6: 259. doi:10.4172/2329-6887.1000259