All medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes.
Results in persistent or significant disability, incapacity
Results in or prolongs hospitalisation
Congenital anomalies/birth defects
Other: Medical judgment should be exercised in deciding whether a reaction is serious in other situations. Important adverse reactions that are not immediately life-threatening or do not result in death or hospitalisation but may jeopardise the patient should be considered as serious.
COORDINATION ACTIVITIEWS AT THE LEVEL OF DCGI DURING REPORTING OF ADVERSE EVENTS DCGI Reporting of Adverse Events State Licensing Authority Zonal Office of CDSCO STATE EPI CDL Statutory Action Manufacturer
Death reported following immunization with DPT Vaccine , Batch No. 364 of Biological. E. Ltd., Hyderabad at Pimpri , Chinkwada Distt. Regulatory investigation was performed by Sub-Zonal office , Hyderabad. Death was not due to the faulty practice by the manufacturer.
- Death reported following immunization with DPT Vaccine of Serum Institute of India Ltd., Pune . Regulatory investigation was performed . Death was not due to the faulty practice by the manufacturer.
- Death reported following immunization with Measles Vaccine of Serum Institute of India Ltd. , Pune . Regulatory investigation was performed . Death was not due to the faulty practice by the manufacturer.
In all the cases , no causality analysis was reported to DCGI.
- Death reported following immunization with imported Oral Polio Vaccine of GSK, Belgium. The matter was referred back to Deptt. of Family Welfare for causality report .
Time Frame for reporting different episodes of adverse events (Reference: National Child Vaccine Injury Act) e.g. In case of TT containing vaccine, anaphylaxis should be reported within 0-7 days and brachial neuritis within 0-28 days.
Causality analysis be performed before statutory action is warranted