The Government has introduced new guidelines for safer prescribing

New Delhi: In a fresh bid to curb over-prescribing and irrational use of drugs that usually increase patients’ medical bills and fuel drug resistance, the health ministry’s Indian Pharmacopoeia Commission (IPC) has set clearer criteria for selecting drugs to be included in the National Formulary of India (NFI) 2026, according to two officials and an IPC document reviewed by Mint. The move aims to promote safer and more appropriate treatment without limiting the clinical judgment of doctors.

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

Previously, these guidelines were mainly intended as an academic guide for listing basic drug dosages and safety details drawn primarily from national drug approvals.

Link for doctors

The guidelines serve doctors and pharmacists as a reference for the correct prescribing, dispensing and administration of medicines in all healthcare facilities. Although intended to promote rational drug use, they remain advisory and do not override professional clinical judgment or existing regulations.

The guidelines include monographs from five broad categories: National List of Essential Medicines (NLEM); treatments under national health programs (NHP); drugs approved by the Central Drug Standards Control Organization (CDSCO); formulation meeting Indian Pharmacopoeia (IP) standards; and drugs recommended by the expert committee. The panel selects therapies based on clinical urgency during emergencies, approval by state licensing authorities, and Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) formulation to support affordable generic access.

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The IPC document states that drug monographs and usual formulation strengths are based on medical literature, regulatory approvals, national programs and expert input, adding that the inclusion of specific strengths does not prevent doctors from prescribing other strengths if necessary.

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

Limiting Abuse

In an effort to control drug abuse, India has previously banned several irrational fixed-dose combinations (FDCs) under the Drugs and Cosmetics Act, created a Schedule H1 critical antibiotic prescription-audit registry, launched public awareness campaigns against the misuse of over-the-counter (OTC) antibiotics, and mandated the prescription of generic drugs in public health facilities.

This has implications for over 1.3 million registered practitioners of modern medicine in India, where the size of the domestic pharmaceutical market is estimated at US$ 50-60 billion.

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“Healthcare professionals are expected to exercise their professional judgment and clinical expertise when prescribing medicines for their patients. In the event of any inconsistency with the contents of the Formulary, applicable statutory provisions and regulatory requirements take precedence,” the IPC document said, adding that it is regularly reviewed and updated, taking into account clinical input, new evidence and relevant recommendations to ensure its “continued clinical relevance”.

“These guidelines promote rational prescribing. They provide health professionals with updated information on drugs, their appropriate use, precautions and side effects,” said Dr Rajeev Jayadevan, public health expert and former president of the Indian Medical Association (Cochin). “While existing drug regulations continue to apply, rational prescribing requires physicians to select appropriate treatments and doses based on individual patient needs.”

Inquiries emailed to a Health Department spokesman Wednesday remained unanswered as of press time.

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