Version-1.

SUSPECTED ADVERSE DRUG REACTION REPORTING FORM

For VOLUNTARY reporting of Adverse Drug Reactions by Healthcare Professionals

INDIAN PHARMACOPOEIA COMMISSION FOR AMC/NCC USE ONLY

(National Coordination Centre-Pharmacovigilance Programme of India)
Ministry of Health & Family Welfare, Government of India AMC Report No. :
Sector-23, Raj Nagar, Ghaziabad-201002
Report Type Initial Follow up Worldwide Unique No. :
A. PATIENT INFORMATION 12. Relevant tests/ laboratory data with dates
1. Patient Initials 2. Age at time of
3. M F Other
Event or Date of
_________ Birth _________
4. Weight________Kgs

B. SUSPECTED ADVERSE REACTION 13. Relevant medical/ medication history (e.g. allergies, race,
pregnancy, smoking, alcohol use, hepatic/renal dysfunction etc.)
5. Date of reaction started (dd/mm/yyyy)
6. Date of recovery (dd/mm/yyyy)
7. Describe reaction or problem

14. Seriousness of the reaction: No if Yes (please tick anyone)

Death (dd/mm/yyyy) Congenital-anomaly
Life threatening Required intervention to
Prevent permanent
Hospitalization/Prolonged impairment/damage
Disability Other (specify)
15. Outcomes
Recovered Recovering Not recovered
Fatal Recovered with sequelae Unknown
C. SUSPECTED MEDICATION(S)
Frequency Therapy dates
8. Name Manufacturer Batch No. Exp. Date Dose Route Causality
S.No (OD, BD Indication
(Brand/Generic) (if known) / Lot No. (if known) used used Date started Date stopped Assessment
etc.)
i
ii
iii
Iv
S.No 9. Action Taken (please tick) 10. Reaction reappeared after reintroduction (please tick)
as Drug Dose Dose not Not Unkn
per C withdrawn Dose increased reduced changed applicable own
Yes No Effect unknown Dose (if reintroduced)
i
ii
iii
iv
11. Concomitant medical product including self-medication and herbal remedies with therapy dates (Exclude those used to treat reaction)
S.No Name (Brand/Generic) Dose used Route used Frequency Therapy dates Indication
(OD, BD, etc.) Date started Date stopped
i
ii
iii
Additional Information: D. REPORTER DETAILS
16. Name and Professional Address:________________________
_____________________________________________________
Pin:____________E-mail_________________________________
Tel. No. (with STD code)__________________________________
Occupation:___________________ Signature:________________

17. Date of this report (dd/mm/yyyy):

Confidentiality: The patients identity is held in strict confidence and protected to the fullest extent. Programme staff is not
expected to and will not disclose the reporters identity in response to a request from the public. Submission of a report does not
constitute an admission that medical personnel or manufacturer or the product caused or contributed to the reaction.
 National Coordination Centre
Pharmacovigilance Programme of India Pharmacovigilance
Ministry of Health & Family Welfare,
Government of India Programme of India for
Sector-23, Raj Nagar, Ghaziabad-201002
Tel.: 0120-2783400, 2783401, 2783392
Assuring Drug Safety
Fax: 0120-2783311
www.ipc.nic.in

ADVICE ABOUT REPORTING

A. What to report
Report serious adverse drug reactions. A reaction is serious when the patient outcome is:
Death
Life-threatening
Hospitalization (initial or prolonged)
Disability (significant, persistent or permanent)
Congenital anomaly
Required intervention to prevent permanent impairment or damage
Report non-serious, known or unknown, frequent or rare adverse drug reactions due to Medicines,
Vaccines and Herbal products.
B. Who can report
All healthcare professionals (Clinicians, Dentists, Pharmacists and Nurses) can report adverse drug reactions
C. Where to report
Duly filled Suspected Adverse Drug Reaction Reporting Form can be send to the nearest Adverse Drug
Reaction Monitoring Centre (AMC) or directly to the National Coordination Centre (NCC).
Call on Helpline (Toll Free) 1800 180 3024 to report ADRs.
Or can directly mail this filled form to [email protected] or [email protected]
A list of nationwide AMCs is available at:
http://www.ipc.gov.in, http://www.ipc.gov.in/PvPI/pv_home.html
D. What happens to the submitted information
Information provided in this form is handled in strict confidence. The causality assessment is carried out at
AMCs by using WHO-UMC scale. The analyzed forms are forwarded to the NCC through ADR database.
Finally the data is analyzed and forwarded to the Global Pharmacovigilance Database managed by WHO
Uppsala Monitoring Centre in Sweden.
The reports are periodically reviewed by the NCC-PvPI. The information generated on the basis of these
reports helps in continuous assessment of the benefit-risk ratio of medicines.
The information is submitted to the Steering committee of PvPI constituted by the Ministry of Health &
Family Welfare. The Committee is entrusted with the responsibility to review the data and suggest any
interventions that may be required.
E. Mandatory field for suspected ADR reporting form
Patient initials, age at onset of reaction, reaction term(s), date of onset of reaction, suspected
medication(s) and reporter information.

For ADRs Reporting Call on PvPI Helpline (Toll Free)

1800 180 3024
(9:00 AM to 5:30 PM, Working Days)