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:
- 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,
Dano Vaccines & Biologicals Private Limited,
Address: DANO Vaccines & Biologicals Pvt. Ltd.
575, Sivareddyguda, Ghatkesar,
Medchal district, Hyderabad-501301,
Telangana State, India
For ADRs Reporting Call on Helpline
Toll Free No.: 1800 309 6009 (Timings – Monday to Saturday 9:00 AM to 5:30 PM)
Email : [email protected]