- 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:
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- You’re not certain the product caused adverse reaction
- You don’t have all the details although point nos. 1, 5, 6, 7, 8, 11 and16 in the ADR form are essentially required.
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- Any health care professional (Doctors including Dentists, Nurses and Pharmacists).
Q. Where to report?
- Complete the specified form with the appropriate details in the specified link.
- A list of countrywide Pharmacovigilance Centres is available at: www.cdsco.nic.in
Q. What happens to the information submitted?
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Information provided in this form is handled in strict confidence. Regional Pharmacovigilance Centres will do the causality analysis and forward this form to the Zonal Pharmacovigilance Centre. The data is statistically analysed and forwarded to Central Drugs Standard Control Organisation (CDSCO), Ministry of Health & Family Welfare, Govt. of India, New Delhi. Finally the report will be deposited in the Global Pharmacovigilance Database managed by WHO Uppsala Monitoring Center, Sweden.
Data is periodically reviewed by the National Pharmacovigilance Advisory Committee constituted by the Ministry of Health and Family Welfare. The Committee is entrusted with responsibility to review the data and suggest any interventions that may be required.
Q. Confidentiality
The patient’s identity is held in strict confidence and protected to the fullest extent. Programme staff is not expected to and will not disclose the reporter’s 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.
