Pharmacovigilance shield protecting India

Decoding Drug Safety: What You Need to Know About Pharmacovigilance

Soraya Malik in Health & Wellness December 2025 • 4 min read.

"A look at how India is strengthening its drug monitoring systems to protect public health."

In today's world, ensuring the safety of medications is a top priority. The concept of pharmacovigilance, which involves monitoring and preventing adverse effects of drugs, has become increasingly important. This article will explore the current state of pharmacovigilance, particularly in the context of India's healthcare system.

Pharmacovigilance, as defined by the World Health Organization (WHO), encompasses the science and activities related to detecting, assessing, understanding, and preventing adverse effects of drugs or any other drug-related problems. It begins during clinical trials and continues throughout a drug's lifecycle. A key focus is on adverse drug reactions (ADRs), which are unintended and harmful responses to a drug at normal doses.

India's Ministry of Health and Family Welfare established the National Pharmacovigilance Programme (NPP) in 2004 to ensure that the benefits of medicine use outweigh the risks, thereby safeguarding the health of the Indian population. As India emerges as a global hub for generic drugs and clinical trials, monitoring ADRs across a large and diverse population poses significant challenges. A robust pharmacovigilance system is essential to identify and address potential drug-related issues.

Why is Pharmacovigilance Important?

Pharmacovigilance shield protecting India

In a country as vast and diverse as India, with its unique genetic variations, disease patterns, and healthcare practices, a standardized pharmacovigilance program is crucial. Collecting and analyzing data on drug safety allows for informed decisions about medication use. This information can lead to changes in drug labeling, warnings, precautions, or even the withdrawal of a drug from the market. It also helps educate healthcare providers about ADRs and informs official drug regulations.

The national coordinating center for the Pharmacovigilance Programme in India is located at AIIMS (All India Institute of Medical Sciences), supported by zonal, regional, and ADR monitoring centers (AMCs). The program operates under the Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare, with the following objectives:

To monitor Adverse Drug Reactions (ADRs).
To raise awareness among healthcare professionals about the importance of ADR reporting in India.
To monitor the benefit-risk profile of medicines.
To generate independent, evidence-based recommendations on the safety of medicines.
To support the CDSCO in formulating safety-related regulatory decisions for medicines.

Spontaneous reporting, where healthcare professionals voluntarily report suspected ADRs, is a core component of pharmacovigilance. However, underreporting remains a significant challenge. Overworked medical staff may not prioritize reporting, especially if symptoms are not severe or are not recognized as drug-related. This highlights the need for increased awareness and training among healthcare professionals.

Moving Forward: Strengthening Pharmacovigilance

The study underscores the need to enhance pharmacovigilance awareness and practices among healthcare professionals in India. Improving ADR reporting through education, training, and simplified reporting processes is essential. By addressing these challenges, India can strengthen its drug safety monitoring systems and protect the health of its population.

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Everything You Need To Know

What exactly is Pharmacovigilance and why should I care?

Pharmacovigilance is the science and activities related to detecting, assessing, understanding, and preventing adverse effects of drugs or any other drug-related problems. It's important because it helps to identify potential drug-related issues and make informed decisions about medication use. The implications of not having effective Pharmacovigilance include potential harm to patients, lack of awareness and underreporting of ADRs, and an inability to respond to official drug regulations effectively.

What is the National Pharmacovigilance Programme and why was it established?

The National Pharmacovigilance Programme (NPP) was established by India's Ministry of Health and Family Welfare in 2004. Its purpose is to ensure that the benefits of medicine use outweigh the risks, thereby safeguarding the health of the Indian population. The NPP is significant because it provides a framework for monitoring ADRs and making evidence-based recommendations on the safety of medicines. Without the NPP, India would be vulnerable to unregulated drug use and a lack of coordinated efforts to monitor and respond to ADRs.

What are Adverse Drug Reactions and why is it important to monitor them?

Adverse Drug Reactions (ADRs) are unintended and harmful responses to a drug at normal doses. Monitoring ADRs is critical in pharmacovigilance to ensure patient safety and improve drug regulations. The failure to monitor ADRs can lead to a lack of awareness about the potential harms of medications, resulting in continued use of unsafe drugs and increased health risks for the population.

What is 'spontaneous reporting' in the context of drug safety?

Spontaneous reporting refers to the voluntary reporting of suspected ADRs by healthcare professionals. It is a core component of pharmacovigilance because it allows for the early detection of potential drug-related problems. However, underreporting remains a significant challenge due to factors like overworked medical staff and a lack of awareness. Enhancing spontaneous reporting is crucial for strengthening drug safety monitoring systems.

How does the Central Drugs Standard Control Organization support drug safety?

The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, is crucial in supporting pharmacovigilance efforts. It plays a pivotal role in formulating safety-related regulatory decisions for medicines based on recommendations generated through the Pharmacovigilance Programme. The CDSCO's involvement ensures that regulatory actions are informed by evidence-based assessments of drug safety, safeguarding public health by preventing the distribution and use of unsafe medications.