Revised Technical & operational Guidelines for TB

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ADVICE ABOUT REPORTING
Report adverse experiences with medications
Report serious adverse reactions. A reaction is
serious when the patient outcome is:
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
Report even if:
reaction
1, 5,
7, 8, 11, 15, 16 & 18 (see reverse) are essentially
required.
Who can report:
Any health care professional (Doctors including
Dentists, Nurses and Pharmacists)
Where to report:
Please return the completed form to the nearest
Adverse drug reaction Monitoring Centre (AMC) or to
National Coordinating Centre
A list of nationwide AMCs is available at:
http
What happens to the submitted information:
Information provided in this form is handled in strict
confidence. The causality assessment is carried out at
Adverse Drug Reaction Monitoring Centres (AMCs) by
using WHO-UMC scale. The analyzed forms are
forwarded to the National Coordinating Centre through the
ADR database. Finally the data is analyzed and forwarded
to the Global Pharmacovigilance Database managed by
WHO Uppsala Monitoring Center in Sweden.
The reports are periodically reviewed by the National
Coordinating Centre (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
and Family Welfare. The Committee is entrusted with the
responsibility to review the data and suggest any
interventions that may be required.
Suspected Adverse Drug
Reaction
Reporting Form
For VOLUNTARY reporting
of suspected adverse drug reactions by
health care professionals
Central Drugs Standard Control Organization
Directorate General of Health Services,
Ministry of Health & Family Welfare, Government of India
FDA Bhawan, ITO Kotla Road, New Delhi 110002
Pharmacovigilance
Programme
of
India
for
Assuring Drug
Safety
Confidentiality:
protected to the fullest extent. Programme staff is not ex- pected to
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 .
Pharmacovigilance Programme of India
(PvPI)
National Coordinating Centre,
Indian Pharmacopoeia Commission
Ministry of Health & Family Welfare,
Govt. of India
Sector-23, Raj Nagar, Ghaziabad-201 002.Tel.:0120-
2783400, 2783401, 2783392, FAX: 0120-2783311
E.mail:
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