“The exemption of customs duty on rare disease drugs was already announced earlier as per court order, but without price caps, these treatments remain out of reach for most patients,” said Prasanna Shirol, Co-founder and Executive Director of Organization for Rare Diseases India.

Beyond tax exemptions: Rare disease patients await comprehensive policy support

While the Union Budget’s customs duty exemption for 36 life-saving drugs offers some relief, patients and advocacy groups say deeper challenges in rare disease treatment remain unaddressed, from exorbitant costs to lack of institutional support.

Chetana Belagere

Published Feb 02, 2025 | 7:00 AM ⚊ Updated Feb 02, 2025 | 7:00 AM

Union Finance Minister Nirmala Sitharaman announced a full customs duty exemption for 36 life-saving medicines for cancer and rare and chronic diseases during her Union Budget 2025-26 address in the Parliament on Saturday, 1 February. She also announced that six other drugs will have a concessional customs duty of 5 percent as part of efforts to increase accessibility to expensive advanced medicines for a larger section of patients.

“To provide relief to patients, particularly those suffering from cancer, rare diseases, and other severe chronic diseases, I propose to add 36 life-saving drugs and medicines to the list of medicines fully exempted from Basic Customs Duty,” she said in her speech.

Dr Deepa Bhat, Genetic Counsellor at JSS Medical College in Mysuru, who has worked extensively on rare diseases, appreciated the move. “It is a positive step by the government to prioritise internationally available rare disease drugs, eight years after the National Policy for Rare Diseases (NPRD) was introduced. However, with the high disease burden in India, much more needs to be done to ensure these treatments reach those in need,” she said.

List of exempted drugs:

  • Tepotinib for non-small cell lung cancer
  • Avelumab, a monoclonal antibody for certain types of cancer
  • Asciminib for white blood cell cancer
  • Alglucosidase Alfa for Pompe disease
  • Mepolizumab for severe asthma
  • Onasemnogene abeparvovec
  • Pegylated Liposomal Irinotecan
  • Daratumumab
  • Daratumumab subcutaneous
  • Teclistamab
  • Amivantamab
  • Alectinib
  • Risdiplam
  • Obinutuzumab
  • Polatuzumab vedotin
  • Entrectinib
  • Atezolizumab
  • Spesolimab
  • Velaglucerase Alpha
  • Agalsidase Alfa
  • Rurioctocog Alphas Pegol
  • Idursulfase
  • Alglucosidase Alfa
  • Laronidase
  • Olipudase Alfa
  • Tepotinib
  • Avelumab
  • Emicizumab
  • Belumosudil
  • Miglustat
  • Velmanase Alfa
  • Alirocumab
  • Evolocumab
  • Cystamine Bitartrate
  • CI-Inhibitor injection
  • Inclisiran
  • Agalsidase Beta
  • Imiglucerase
  • Eptacog alfa activated recombinant coagulation factor VIIa

The high cost of rare disease treatment

One of the biggest hurdles in treating rare diseases is the astronomical cost of medicines. Many treatments, including enzyme replacement therapies and gene therapies, cost crores of rupees annually, making them unaffordable for most families. For example, therapies for conditions like Spinal Muscular Atrophy (SMA) and Pompe disease can cost between ₹4-16 crores per patient per year.

While tax exemptions slightly lower costs, no regulatory mechanism exists to cap the prices of these high-cost drugs, which are often produced by a handful of global pharmaceutical companies.

“The exemption of customs duty on rare disease drugs was already announced earlier as per court order, but without price caps, these treatments remain out of reach for most patients,” said Prasanna Shirol, Co-founder and Executive Director of Organization for Rare Diseases India.

A price control mechanism under the the National Policy for Rare Diseases (NPRD) 2021 could be a viable solution. However, the 2025 budget did not mention this.

Underutilised previous funds and insurance unavailability

In 2022, the government announced a ₹974 crore fund to support rare disease treatment under the NPRD. However, bureaucratic inefficiencies, lack of clarity in implementation, and limited outreach have left a significant portion of these funds unutilised.

Patient advocacy groups have urged the government to expedite the allocation of this fund, but the latest budget did not mention it. Shirol expressed disappointment and said that the group had requested the Prime Minister and Health Minister to expedite the process of allocating ₹974 crores announced earlier. “It is disappointing to see there is no mention of this anywhere in the budget,” he said.

This inaction leaves many families without financial assistance, forcing them to crowdfund treatment or rely on inconsistent Corporate Social Responsibility (CSR) contributions.

Meanwhile, most private and public health insurance schemes do not cover rare diseases, citing high treatment costs and the prolonged nature of therapy. Even government insurance schemes like Ayushman Bharat do not provide coverage for most rare disease treatments.

This forces families to pay out of pocket, often leading them into financial ruin. Without a clear insurance policy for rare diseases, tax exemptions alone will not ease the financial burden on patients.

The Karnataka government, however, announced in November 2024 that 50 children diagnosed with SMA will receive lifelong, free access to Risdiplam, an oral treatment for the disorder, as part of a financial assistance and free medicine programme. Care and Protection of Children Trust (CPCT), a Non-Governmental Organisation (NGO) supporting rare disease treatment, has partnered with Roche Pharma India to supply this drug for SMA treatment.

Infrastructure and long term policy

Rare disease treatment requires specialised diagnostic centres, trained geneticists, and medical professionals. However, India has very few specialised centres for rare diseases, leading to delayed diagnoses and treatment.

Many patients must travel to metro cities like Bengaluru, Delhi, or Mumbai for diagnosis and treatment, adding to the overall financial strain. The budget lacks provisions for expanding rare disease research, diagnostic labs, and medical training programmes to address this issue.

Currently, India’s rare disease policy focuses on one-time financial assistance rather than a sustainable long-term treatment plan. Unlike developed countries where governments negotiate drug prices with pharmaceutical companies or fund research for indigenous therapies, India’s approach remains fragmented.

Experts say a holistic rare disease policy should include:

  • Government-negotiated pricing with pharmaceutical companies
  • Increased funding for research on indigenous therapies
  • Comprehensive insurance schemes
  • Infrastructure development for early diagnosis and treatment

(Edited by Dese Gowda)

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Beyond tax exemptions: Rare disease patients await comprehensive policy support

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