India To Mandate Drug Reaction Forms At Hospitals For Patient Safety

(MENAFN- Live Mint) New Delhi: The Union government is set to make a critical change to healthcare policy by mandating that all hospitals include an Adverse Drug Reaction (ADR) reporting form as a compulsory part of the patient admission process, officials familiar with the matter said, and documents reviewed by Mint showed.

This move is designed to create a more robust and consistent system for gathering data on drug side effects, which is crucial for the early detection of any new or serious risks associated with medications. The ultimate goal is to enhance public health by ensuring the safety of medicines in the market.

This new mandate is a key initiative of the Pharmacovigilance Programme of India (PvPI), overseen by the Indian Pharmacopoeia Commission (IPC).

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Pharmacovigilance is the science of monitoring drug safety and detecting, assessing, and preventing adverse reactions. Currently, some hospitals voluntarily include the PvPI's toll-free number on their outpatient cards.

This new plan, however, will make the ADR reporting form a mandatory component of a patient's admission file. This will ensure that doctors and nurses systematically document any potential drug-related side effects.

The IPC's scientific body discussed this important progress, highlighting the expansion of ADR Monitoring Centres and the issuance of drug safety alerts.

“The plan is that hospitals will now adopt this practice of reporting adverse drug reactions in patients and become more vigilant about patient health,” the official said.

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“Previously, reporting was inconsistent, but now, every hospital, whether private or government-run, must adopt this practice. This structured approach, inspired by successful models like the one at PGI, Chandigarh, makes reporting a routine part of clinical care, allowing us to be more vigilant about patient health, and PvPI should make efforts to promote adoption of this practice in other hospitals also,” the second official added.

Queries sent to the health ministry spokesperson remained unanswered.

Improved monitoring

A Fortis Healthcare spokesperson welcomed the government's decision to mandate Adverse Drug Reaction (ADR) reporting, stating that it will significantly strengthen India's pharmacovigilance framework and patient safety standards.“For hospitals, this creates a structured system to monitor and document drug-related risks, enabling data-driven decisions and policy modifications. For doctors and nurses, it is an integral part of their clinical responsibility, allowing them to recognize and systematically document potential side effects, which ensures transparency and continuous learning,” he said.

The spokesperson explained that identifying an ADR involves a clinical process including close observation, reviewing patient history, and using standardized tools like the WHO-UMC Causality Assessment Scale to verify suspected reactions.

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The Fortis spokesperson said mandatory reporting has both immediate and long-term benefits for patients. It allows clinicians to promptly modify or discontinue treatments, preventing complications. The data also helps regulators identify unknown risks and update drug safety guidelines, which protects future patients.“We view ADR reporting not merely as a compliance requirement but as a cornerstone of safe, evidence-based, and patient-centric care,” he said.

The pharmaceutical industry also viewed the mandate as a positive development. Arushi Jain, director of Akums Drugs and Pharmaceuticals, said that this is a welcome move that shows the government's commitment to patient safety and pharmaceutical vigilance.“By making ADR reporting mandatory, hospitals will be more diligent in tracking reactions, fostering a culture of transparency and accountability. This is crucial for pharmaceutical companies like ours, as it provides invaluable data that helps us continuously improve our products and services for a safer healthcare environment,” Jain said.

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