SUSPECTED ADVERSE DRUG REACTION REPORTING FORM

For VOLUNTARY reporting of Adverse Drug Reactions by healthcare professionals

(AMC/ NCC Use only

CDSCO
AMC Report no.
Central Drugs Standard Control Organization
Directorate General of Health Services,
Ministry of Health & Family Welfare, Government of India, Worldwide Unique no.
FDA Bhavan, ITO, Kotla Road, New Delhi -110002
www.cdsco.nic.in

A. Patient information 12. Relevant tests/ laboratory data with dates

1. Patient initials 2. Age at time of 3. Sex:  M F
Event or date of birth

4.Weight: Kgs

B. Suspected Adverse Reaction

5. Date of reaction started (dd/mm/yy): 13. Other relevant history, including pre-existing medical conditions
(e.g., allergies, race, pregnancy, smoking, alcohol use, hepatic/
6. Date of recovery (dd/mm/yy):
renal dysfunction, etc.)
7. Describe reaction or problem

14. Seriousness of the reaction

 Death (dd/mm/yy)  Congenital anomaly
 Life threatening  Required intervention
 Hospitalization-initial to prevent permanent
or prolonged impairment/ damage
 Disability  Other (specify)

15. Outcomes
 Fatal  Recovering  Unknown
 Continuing  Recovered  Other (specify)

C. Suspected medication(s)
Therapy dates (if unknown, Reason for Use
8. Name (brand Manufac- Batch No. Exp. Date
Sl. Dose Route give duration)
and / or generic turer (If / Lot No. Frequency or
No. (If known) used used
name) known) (If known) prescribed for
Date started Date stopped

ii

iii

iv

Sl. No. 9. Reaction abated after drug stopped or dose reduced 10. Reaction reappeared after reintroduction
As per C Yes No Unknown NA Reduced dose Yes No Unknown NA If reintroduced, dose
i
ii
iii
iv
11. Concomitant medical products including self medication and D. Reporter (see confidentiality section in first page)
herbal remedies with therapy dates (exclude those used to
treat reaction) 16. Name and Professional Address:

Pin code: E-mail:

Tel. No. (with STD Code):
Occupation: Signature:

17. Causality Assessment: 18. Date of this report (dd/mm/yy)

ADVICE ABOUT REPORTING Suspected Adverse Drug Reaction

 Report adverse experiences with medications
Reporting Form
 Report serious adverse reactions. A reaction is For VOLUNTARY reporting
serious when the patient outcome is: of suspected adverse drug reactions by
health care professionals
 death
 life-threatening (real risk of dying)
 hospitalization (initial or prolonged)
 disability (significant, persistent or permanent
 congenital anomaly
 required intervention to prevent permanent
impairment or damage Central Drugs Standard Control Organization
Directorate General of Health Services,
 Report even if: Ministry of Health & Family Welfare, Government of India.
FDA Bhavan, ITO, Kotla Road, New Delhi -110002

 You’re not certain the product caused www.cdsco.nic.in

adverse reaction
 you don’t have all the details, however, point nos. 1,
5, 7, 8, 11, 15, 16 & 18 (see reverse) are
essentially required.
Pharmacovigilance
 Who can report:
Programme
 Any health care professional (Doctors including of
Dentists, Nurses and Pharmacists)

 Where to report:
India
 Please return the completed form to the nearest
for
Adverse drug reaction Monitoring Centre (AMC)
or to National Coordinating Centre Assuring Drug
 A list of nationwide AMCs is available at:
http://cdsco.nic.in/pharmacovigilance.htm Safety
 What happens to the submitted information:

 Information provided in this form is handled in strict
confidence. The causality assessment is carried out Pharmacovigilance Programme of India (PvPI)
at Adverse Drug Reaction Monitoring Centres
(AMCs) by using WHO-UMC scale. The analyzed National Coordinating Centre,
forms are forwarded to the National Coordinating Department of Pharmacology,
Centre through the ADR database. Finally the data is All India Institute of Medical Sciences
analyzed and forwarded to the Global
Ansari Nagar, New Delhi – 110029
Pharmacovigilance Database managed by WHO
Uppsala Monitoring Center in Sweden. Phone no: 011-26593282, 26588422
 The reports are periodically reviewed by the National Fax no: 011- 11-26588663, 26588641
Coordinating Centre (PvPI). The information Email: pvpi.ncc@gmail.com
generated on the basis of these reports helps in
continuous assessment of the benefit-risk ratio of
medicines. Confidentiality: The patient’s identity is held in strict confidence
The information is submitted to the Steering and protected to the fullest extent. Programme staff is not ex-
Committee of PvPI constituted by the Ministry of pected to and will not disclose the reporter’s identity in response
Health and Family Welfare. The Committee is
to a request from the public. Submission of a report does not
entrusted with the responsibility to review the data
and suggest any interventions that may be required. constitute an admission that medical personnel or manufacturer
or the product caused or contributed to the reaction.