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Pharmacovigilance in India / National Pharmacovigilance Program

Clinical ResearchClinical Research & PharmacovigilancePharmacovigilance

Pharmacovigilance in India / National Pharmacovigilance Program

Pharmacovigilance is defined as “science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems”. While considering the incidence of Adverse Drug Reactions (ADR) in India, the general range was anywhere between 10-20% and in fewer cases even it has moved to 70% and above. Also when considered, in the current scenic, clinical trials are conducted in stringent environment with fixed criteria and thorough monitoring. With such a mind wobbling numbers and discreteness in data the need for an effective vigilance program was aroused.

Why Pharmacovigilance? Because Pharmacovigilance benefits ALL:
The issue of patient safety is addressed. Physicians are happy to prescribe and promote safer medicines. Pharmaceutical industry gets to keep its reputations intact, while regulatory authorities receive pertinent data that helps them to take essential decisions…

National Pharmacovigilance Program (NPP):

The National Pharmacovigilance Program was officially inaugurated by the honorable Health Minister Dr. Anbumani Ramadoss on 23 November, 2004 at New Delhi. Central Drugs Standard Control Organization (CDSCO) initiated a well structured and highly participative National Pharmacovigilance Program which is build on the structure recommended by WHO in a document titled as “Safety Monitoring of Medicinal Products – Guidelines for Setting up and Running a Pharmacovigilance Centre”. The Main focus of National Pharmacovigilance Program was to collate, analyze and archive adverse drug reaction data for creating healthy environment for the Regulatory Authorities to analyse the drugs to be marketed in India.

National Pharmacovigilance Program is a three layered structure consisting of peripheral, regional and zonal centres. These are monitored by an apex body i.e. National Pharmacovigilance Advisory Committee and the National Pharmacovigilance Centre which are based at the Central Drugs Standard Control Organization, New Delhi. The 3 tier structure report the serious, unexpected Adverse Drug Reactions to the National Pharmacovigilance Centre directly so as the regulators to act on it promptly.

Pros and Cons:

The basic advantage of National Pharmacovigilance Program is unrecognized, unidentified adverse drug reactions can be directly reported to regulators wherein the actions concerned with can be immediately implemented. However, the under reporting scenario needs to be improvised by creating the awareness for spontaneous reporting.

The key message given by Dr. Sandeep Bavdekar in his article in on National Pharmacovigilance Programme is…. Not only doctors but other healthcare providers, viz., pharmacists and nurses should actively participate in the program. They should start reporting adverse events to help ensure that our country receive safe drugs.

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