Reporting of adverse events for marketed drugs: Need for strengthening safety database

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Author: Aditi Apte
Date: July-September 2016
From: Perspectives in Clinical Research(Vol. 7, Issue 3)
Publisher: Medknow Publications and Media Pvt. Ltd.
Document Type: Report
Length: 2,146 words
Lexile Measure: 1840L

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Byline: Aditi. Apte

Pharmacovigilance is an evolving discipline in the Indian context. However, there is limited regulatory guidance for adverse event reporting outside the purview of clinical trials. There are number of deficiencies in the framework for adverse event reporting from the perspective of pharma industry, health-care professional and general public due to which adverse events for marketed drugs are highly underreported. This article discusses the need to strengthen national safety database by promoting and mandating reporting of adverse events by all the stakeholders.


Adverse drug events are important causes of mortality and hospitalization worldwide. [sup][1] Adverse drug events decrease patients' quality of life [sup][2] and may reduce their confidence in the whole healthcare system. They also add to the total cost of health care and increase the number of undue investigations as they mimic a disease process. [sup][3] Collection of adverse events helps to generate a signal regarding any new adverse event associated with a drug and also judge the health risk associated with it depending on the severity and commonness of the adverse event. [sup][4] This may further lead to change in the reference safety information (contraindications, warnings, and precautions, use in special population) and depending upon its risk-benefit analysis, may also be responsible for withdrawal of a drug from the market. For example, withdrawal of rosiglitazone due to associated risk of hepatotoxicity. [sup][5] Thus, it is extremely important to increase awareness among health-care professionals regarding diagnosis, prevention, and reporting of adverse drug events.


Indian pharmaceutical industry is estimated to be worth $4.5 billion and is growing at a rate of 8-9% annually. [sup][6] This includes the introduction of new chemical entities, biological products, vaccines, new dosage formulations, new routes of administration, and new uses of existing drugs. A drug during its evaluation in clinical trials is only exposed to few thousands of population excluding pregnant, lactating women, patients with hepatorenal dysfunction, patients with concomitant illnesses and medications. But once in the market, the drug is exposed to a large patient population with varied characteristics. [sup][7] Here, it becomes necessary to monitor the behavior of a new drug, as many uncommon and rare adverse drug events may come up in the postmarketing period.


Although a formal adverse event monitoring system for reporting of adverse events was suggested for India in 1986, nothing much happened till 1997 when India joined World Health Organization adverse event monitoring program based in Uppsala, Sweden. A formal national pharmacovigilance program only started in India since January 2005 and was based on the hierarchy of peripheral, regional, and zonal centers for collection of adverse events that reported to Central Drug Standard Control Organization (CDSCO) and Uppsala Monitoring Centre. It was aimed to order to collect and analyze safety data regarding a drug, communicate associated risk to the practicing physicians and general public and arrive at regulatory intervention if necessary. Since 2010, the program has been reorganized as Pharmacovigilance Programme of...

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Gale Document Number: GALE|A457067885