ADVICE ON REPORTING
What is Adverse Drug Reaction?
A response to a drug which is noxious and unintended and which occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of disease or for the modification of physiological function (WHO, 1972).What to report?
1. 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
2. Report non-serious, known or unknown, frequent or rare adverse drug reactions due to Medicines, Vaccines and Herbal products.Who can report an ADR?
All healthcare professionals (Clinicians, Dentists, Pharmacists and Nurses) can report adverse drug reactions.How to report an ADR?
Duly filled Post Marketing Surveillance Form / Suspected Adverse Drug Reaction Reporting Form can be sent to,
Indoco Remedies Limited,
R&D Center, R-92/93, TTC MIDC Industrial Area,
Thane Belapur Road, Rabale, Navi Mumbai 400 701For ADRs Reporting Call on Helpline
Toll Free No.: 1800-313-3636 (India)
1-855-642-2594 (for USA)
Email
For India: safetyindia@indoco.com
For Other Countries: safety@indoco.com
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