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.