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Pharmacovigilance Programme
of India for
Assuring Drug Safety
The National Pharmacovigilance Program was officially inaugurated by the Dr. Anbumani Ramadoss on 23 November, 2004 at New Delhi.
Aims :
• Contribute to the regulatory assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective(including cost effective) use.
• Improve patient care and safety.
• Improve public health and safety.
• Promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public.
• Pharmacovigilance is defined as the detection, assessment and prevention of ADRs in humans.
It is the process of:
• Monitoring medicines as used in everyday practice to identify previously unrecognized adverse effects or changes in the patterns of their adverse effects.
• Assessing the risks and benefits of medicines in order to determine what action, if any, is necessary to improve their safe use.
• Providing information to users to optimize safe and effective use of medicines.
• Monitoring the impact of any action taken.
The AMC of this region is .. Department Of Pharmacology, GMC Haldwani Reports can also be emailed – [email protected] On line ADR Forms will shortly be available at GMC Haldwani website.
ADR MONITORING CELL
GOVT. MEDICAL COLLEGE, HALDWANI DEPARTMENT OF PHARMACOLOGY
Phone: 05946-255255, 255926 Ext. : 4370, 4378, 4373
DESIGNATION NAME CONTACT NO.
Coordinator Dr. Bhavana Srivastava 9412017320
Secretary Dr. Reena Bhardwaj 997006882
Co-coordinator Dr. Sanjay Gaur 9897152423
Member Dr. Hemant K. Dutt 9412783203
What happens to the submitted information:
• Information provided in this form is handled in strict confidence.
• The causality assessment is carried out at 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.