Union Budget 2026: How Import Duty Exemption On Rare Disease Drugs Could Make Treatments Cheaper

In the Union Budget 2026-27, presented on February 1, 2026, by Finance Minister Nirmala Sitharaman, the Government of India expanded its healthcare relief measures by exempting customs duty on medicines and specialised foods for seven rare diseases when imported for personal use. This policy aligns with the National Policy for Rare Diseases (NPRD), 2021, aimed at reducing the cost burden on patients who often require niche therapies that are unavailable or prohibitively expensive in India. Rare diseases, conditions that affect small numbers of patients, typically require highly specialized drugs or Food for Special Medical Purposes (FSMP), which are frequently sourced from abroad due to limited domestic production.

These imported therapies have historically attracted basic customs duty and other levies, contributing to high landed costs and limited access for patients and families. By waiving import duties on life-saving drugs for seven specific rare diseases, the Budget seeks to make critical treatments more affordable, improving equity in care and reducing out-of-pocket expenses for vulnerable populations.

The customs duty exemption complements broader health initiatives including strengthening rare disease centres, subsidised care under NPRD, and fiscal incentives to bolster the availability of orphan drugs in India. This is expected to benefit not only patients but also support clinicians and caregivers in managing long-term treatment strategies for rare conditions.

Rare Diseases Newly Covered In Exemption List

The Budget has added the following seven rare diseases to the customs duty exemption list for personal imports of drugs, medicines, and FSMP: Congenital Hyperinsulinemic Hypoglycemia (CHI); Familial Homozygous Hypercholesterolemia; Alpha Mannosidosis; Primary Hyperoxaluria; Cystinosis; Hereditary Angioedema; and Primary Immune Deficiency Disorders. These conditions are part of the NPRD's recognised categories needing specialised care.

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1. Congenital Hyperinsulinemic Hypoglycaemia (CHI)

CHI is a genetic metabolic disorder where pancreatic beta cells secrete excess insulin, leading to dangerously low blood glucose especially in infants. Without rapid management, repeated hypoglycaemia can cause seizures, brain injury, or developmental delays. Treatment includes medications that control insulin secretion and, in some cases, surgical intervention.

2. Familial Homozygous Hypercholesterolemia (HoFH)

HoFH is a rare, severe form of high cholesterol caused by defective LDL receptor genes inherited from both parents. Individuals develop extremely high LDL cholesterol levels from early life, leading to premature cardiovascular disease, heart attacks, or stroke if untreated. Newer therapies like PCSK9 inhibitors and monoclonal antibodies (e.g., evinacumab) can significantly lower LDL levels but are costly.

3. Alpha Mannosidosis

This genetic lysosomal storage disorder stems from deficient alpha-mannosidase enzyme activity. The buildup of oligosaccharides within cells leads to recurrent infections, hearing loss, cognitive impairment, and weakness. Enzyme replacement therapy is a mainstay of treatment, which is expensive when imported.

4. Primary Hyperoxaluria

In Primary Hyperoxaluria, the liver overproduces oxalate, which combines with calcium to form kidney stones and renal damage. Without intervention, the condition can progress to kidney failure. Management includes hydration, diet changes, and specialised therapies to reduce oxalate levels.

5. Cystinosis

Cystinosis is a rare metabolic disease that causes accumulation of cystine crystals in cells, damaging kidneys, eyes, and other organs. Lifelong cystine-depleting treatments such as specialised drugs can preserve kidney function but are costly when imported.

6. Hereditary Angioedema (HAE)

HAE is a genetic condition marked by recurrent severe swelling of limbs, face, gastrointestinal tract, and airways due to C1-esterase inhibitor deficiency. Acute and prophylactic therapies, often protein concentrates or C1-inhibitor drugs, are specialised and expensive.

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7. Primary Immune Deficiency Disorders

This broad category includes conditions where components of the immune system are missing or dysfunctional, leading to recurrent, serious infections. Treatments include immunoglobulin replacement or gene therapies, which are often sourced from overseas.

By exempting basic customs duty on treatments for seven rare diseases, the Union Budget 2026-27 takes a significant step towards reducing treatment costs and improving access to highly specialised medicines and medical foods. This can ease financial hardship for patients and families, very often bearing high out-of-pocket expenses. While duty exemption alone cannot resolve all accessibility challenges, it supports equitable healthcare goals and complements long-term strategies to strengthen rare disease care infrastructure under the National Policy for Rare Diseases.

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