India Plans New Drug Safety System to Track Medication Errors Before They Harm Patients

India is planning a new approach to drug safety that could help identify medication errors before they reach patients.

Under a proposed national framework, healthcare professionals will record “near-miss” cases, where a potentially harmful medication error is identified and stopped before the medicine is given to a patient. The initiative is being taken up by the Indian Pharmacopoeia Commission (IPC), which works under the Ministry of Health and Family Welfare.

A near miss could include an incorrect dose, a potentially dangerous combination of medicines or a medicine being prescribed to someone with a known allergy. In these cases, doctors, nurses or clinical pharmacists may identify the problem before it reaches the patient.

The proposed system aims to make these incidents easier to record and study. At present, India’s pharmacovigilance system mainly focuses on adverse drug reactions after a patient has experienced a side effect or other harm. The new approach would also look at mistakes that were caught in time.

Why recording near misses matters

A medication error that is stopped before reaching a patient may not result in any harm, but it can still reveal a weakness in the healthcare process.

For example, repeated near misses involving the same drug combination could show that doctors need clearer guidance. Similar errors could also point to problems with prescribing systems, medicine packaging, dosage instructions or allergy checks.

By collecting this information, regulators could identify patterns rather than waiting for patients to experience adverse reactions.

The proposed framework could therefore help shift India’s drug-safety system from mainly reacting to harm towards preventing avoidable harm.

New reporting form planned

The IPC is preparing a Monthly Prevented Adverse Drug Reactions Reporting form under the Pharmacovigilance Programme of India (PvPI).

The proposed form would allow hospitals to record medication risks that were identified and prevented during routine care. Hospitals and medical colleges within the PvPI network are expected to receive training on the standardised reporting process.

The proposed system may also be connected with national digital platforms, including the Central Drugs Standard Control Organisation’s SUGAM portal.

The IPC’s scientific body has recommended that the new reporting mechanism should first be evaluated in detail before it is implemented nationwide.

What it could mean for patients

For patients, the biggest potential benefit is safer medication use.

People often receive several medicines during hospital treatment, particularly when they have more than one health condition. Checking for drug interactions, allergies and correct dosages is therefore an important part of safe care.

A system that records errors caught before they cause harm could help hospitals learn from these incidents and improve their procedures.

The IPC already operates the Pharmacovigilance Programme of India, through which healthcare professionals and patients can report suspected adverse drug reactions. The commission also publishes drug safety alerts and recommendations for regulators.

The initiative also comes at a time when India’s pharmacovigilance system is receiving greater international recognition. In August 2026, the IPC was recognised by the WHO South-East Asia Regulatory Network as a Regional Centre of Excellence in Pharmacovigilance and a Technical Centre in Quality of Medicines.

The proposed near-miss system could add another layer to this work. Instead of learning only from medicines that caused problems, the healthcare system could also learn from mistakes that were caught before they reached patients.

That change may sound small, but it could make patient safety more proactive. The goal is not simply to understand what went wrong after an incident, but to identify the warning signs before a patient is harmed.