Montelukast in India: friend, or the enemy we refuse to name?

A drug that the U.S. FDA now reserves for patients who fail every other option has become, in India, the most casually prescribed respiratory molecule in the country.

Read that sentence again. In March 2020, the FDA placed a Boxed Warning — its strongest possible safety alert — on montelukast after recording 82 completed suicides in patients on the drug between 1998 and 2019, including 19 in children and adolescents. The agency went further, restricting its use in allergic rhinitis to patients “who have not responded adequately to, or cannot tolerate, alternative therapies.” In plain English: last line, not first reach.

In India, we read that memo and did the opposite.

A category, not a drug

PharmaTrac data show that in FY 2023–24, sales of plain montelukast in India fell by roughly 14%, while sales of montelukast combinations grew by 25%. More than 193 brands of just the montelukast + levocetirizine combination compete on the same prescription pad. Add the bambuterol, acebrophylline, ambroxol, fexofenadine and doxofylline variants and the count comfortably crosses a thousand SKUs.

The molecule has stopped being a drug. It has become a category — pushed through chemists, RMPs and, in too many towns, the local quack — because the unit margins are generous and the question “is this even indicated here?” is conveniently never asked.

What the irrational use is hiding

India already carries 34.3 million asthmatics — the world’s largest pool — and an indefensible 42.4% of the planet’s asthma deaths despite holding only 12.9% of the cases (Global Asthma Network, Lung India, 2022). Daily inhaled corticosteroid (ICS) use sits at less than 2.5% of patients with current wheeze. Total ICS sales in India equal just 6.8% of what guideline-based treatment of the asthma pool would require. Only one-third of diagnosed asthmatics use any inhaler at all; half are still on oral medication.

Into that diagnostic vacuum walks a sweet, chewable tablet that promises to “cover everything” — asthma, allergic rhinitis, urticaria, post-viral cough, “wheezing.” Montelukast combinations are routinely dispensed as a 5- or 10-day course, because that is what the chemist understands and what the patient is willing to pay for. The drug it should be — a controller, used for months under specialist supervision in a narrowly defined add-on role — is nowhere on that strip.

The clinical cost is exactly what one would predict. Combinations damp symptoms just enough that the patient feels “better,” postpones the GP visit, postpones the spirometry that would never have been done anyway, and presents months later with a full-blown exacerbation in the ER. The Global Asthma Network already tells us that 82% of current wheezers in India are never formally diagnosed. We are not under-treating asthma in this country. We are pharmacologically hiding it.

The safety story we keep soft-pedalling

The UK MHRA issued a fresh neuropsychiatric advisory on montelukast in November 2024. GINA 2025 now explicitly asks clinicians to engage in shared decision-making with the patient before adding a leukotriene receptor antagonist, citing the same concerns — agitation, mood change, sleep disturbance, suicidal ideation. The Indian label, by contrast, still carries softer language than the FDA boxed warning, which means a paediatrician in Mumbai is prescribing the same molecule to a six-year-old that her counterpart in Boston would only reach for after exhausting alternatives — and without the same disclosure of risk to the parent.

The Drugs Technical Advisory Board banned 156 irrational FDCs in 2024. The montelukast combination cohort — which any unbiased reading of the evidence places squarely on that list — survived.

Whose problem is this, really?

It is fashionable to lay this entirely at the prescriber’s door, or entirely at the chemist’s counter. Neither is honest. Pharma companies — including market leaders who know exactly what GINA says, exactly what the FDA boxed warning says, and exactly what their own medical-affairs decks say in private — keep launching montelukast variants because the unit economics are extraordinary and the regulatory friction is near zero. A molecule originally licensed as a narrow add-on is being promoted as a frontline cough-and-cold answer. Nobody is meaningfully pushing back.

The reset is neither complicated nor dependent on new science:

• Pharma leadership: stop launching new montelukast FDCs. The molecule has earned its restraint.

• CDSCO: harmonise the Indian label with the FDA boxed warning. An Indian parent deserves the same information a parent in any other country gets.

• Specialists and superspecialists: speak louder. Our pulmonology and allergy societies have the credibility to make “dispense an inhaler before reaching for a leukotriene tablet” the new default of GP practice. Today, that voice is too soft.

• Chemists and RMPs: a prescription-only molecule carrying a global boxed warning has no business sitting on the counter next to chewable vitamin C.

Montelukast is not the enemy. It has a real, narrow, evidence-based role. The enemy is what we have allowed an add-on drug to become — a substitute for diagnosis, a substitute for inhaler training, a substitute for the harder conversation about asthma in this country.

That is the next article.