Pharmacovigilance Programme of India for Assuring Drug …The National Pharmacovigilance Program was...

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 – pvgmchaldwani@yahoo.co.in 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.