Govt unveils new guidelines for safer drug prescriptions

New Delhi: In a fresh bid to curb overprescribing and irrational use of medicines, which typically drive up patients’ medical bills and fuel drug resistance, the health ministry’s Indian Pharmacopoeia Commission (IPC) has laid out clearer criteria for selecting medicines included in the National Formulary of India (NFI) 2026, according to two officials and an IPC document reviewed by Mint. The move aims to encourage safer, more appropriate treatments without restricting doctors’ clinical judgement.

The updated guidelines cover a wide range of essential treatments, such as everyday priority medicines: antibiotics, pain relievers, government-cleared drugs, low-cost generic substitutes sold at Jan Aushadhi outlets, and vital medicines stockpiled for public health emergencies.

Earlier, these guidelines mainly focused as an academic handbook for listed with basic medicine dosages and safety details drawn primarily from national drug approvals.

Reference for doctors

The guidelines serve as a reference for doctors and pharmacists on the appropriate prescribing, dispensing and administration of medicines across healthcare settings. While intended to promote rational drug use, they remain advisory and do not override professional clinical judgment or existing regulations.

The guidelines include monographs drawn from five broad categories: the National List of Essential Medicines (NLEM); treatments under National Health Programmes (NHPs); drugs cleared by the Central Drugs Standard Control Organisation (CDSCO); formulations meeting Indian Pharmacopoeia (IP) standards; and drugs recommended by an expert panel. The panel selects therapies based on clinical urgency during emergencies, approvals by state licensing authorities, and formulations under the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) to boost affordable generic access.

The IPC document noted that medicine monographs and usual formulation strengths are based on medical literature, regulatory approvals, national programmes, and expert inputs, adding that the inclusion of specific strengths does not preclude doctors from prescribing other strengths when required.

“These guidelines are intended to guide physicians and pharmacists on safe dosages, standard formulations, and appropriate therapies, while curbing irrational use of medicines that can cause antimicrobial resistance, adverse drug reactions,” said one of the officials.

Curbing misuse

In an attempt to control misuse of drugs, India earlier banned several irrational fixed-dose combinations (FDCs) under the Drugs and Cosmetics Act, created the Schedule H1 prescription-audit register for critical antibiotics, launched public awareness campaigns against over-the-counter (OTC) antibiotic misuse, and mandated generic prescribing across public health facilities.

This assumes significance for the over 1.3 million registered modern medicine doctors in India, where the domestic pharmaceutical market size is valued at around $50-60 billion.

“Healthcare professionals are expected to exercise their professional judgement and clinical expertise when prescribing medicines to their patients. Applicable statutory provisions and regulatory requirements shall prevail in the event of any inconsistency with the contents of the Formulary,” the IPC document said, adding that it is periodically reviewed and updated, factoring in clinical inputs, new evidence and relevant recommendations to ensure its “continued clinical relevance”.

“These guidelines promote rational prescribing. It provides healthcare professionals with updated information on medicines, their appropriate uses, precautions and adverse effects,” said Dr Rajeev Jayadevan, public health expert and former president of Indian Medical Association, (Cochin). “While existing drug regulations continue to apply, rational prescribing requires doctors to choose appropriate treatments and doses based on individual patient’s needs.”

Queries emailed to the health ministry spokesperson on Wednesday remained unanswered until press time.