Budget cuts import costs of certain cancer & rare disease drugs. Why it offers little relief to patients

Cancer imposes catastrophic health expenditure in India, with medicines constituting over 60% of out-of-pocket expenditure. Research shows wide price variations, limited cost containment.

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New Delhi: Finance Minister Nirmala Sitharaman Sunday announced a full exemption from basic customs duty on 17 life-saving drugs including cancer drugs. She also included seven additional rare diseases that will now qualify for duty-free personal imports of medicines, drugs, and Foods for Special Medical Purpose (FSMP).

Presenting her 9th straight budget, Sitharaman said the government wanted to ease the financial burden on families that depend on imported drugs. “To provide relief to patients, particularly those suffering from cancer, I propose to exempt basic customs duty on 17 drugs or medicines,” she said. 

The 17 cancer drugs are: Ribociclib, Abemaciclib, Talycabtagene autoleucel, Tremelimumab, Venetoclax, Ceritinib, Brigatinib, Darolutamide, Toripalimab, Serplulimab, Tislelizumab, Inotuzumab ozogamicin, Ponatinib, Ibrutinib, Dabrafenib, Trametinib and Ipilimumab.

These are targeted therapies or immunotherapies used in breast cancer, brain tumours and melanoma.  

The new list adds to the 36 life-saving drugs and medicines which were fully exempt from basic customs duty in the budget last year. The 2014 list included drugs for rare diseases, other serious chronic illnesses, and three specific cancer drugs, including Trastuzumab Deruxtecan, Osimertinib, and Durvalumab.

Imported cancer drugs in India attract a basic customs duty of 10 percent, while some categories of lifesaving drugs/vaccines attract a concessional rate of 5 percent, which has now been made zero for these drugs.

Cancer is a major and growing public health challenge in India. The disease imposes catastrophic health expenditure in India, with medicines constituting more than 60 percent of out-of-pocket expenditure. 

Research has shown wide price variations and limited cost containment for cancer drugs. 

Last year, a parliamentary committee asked the government to impose price caps on certain cancer medicines. A Tata Memorial Centre study found that fewer than 3 percent of Indian cancer patients have access to newer, promising treatments. 

Dr Kanika Sood Sharma, Director of Radiation Oncology at Dharamshila Narayana Hospital, said that while the exemption could help more patients access newer cancer treatments, especially targeted therapies and immunotherapies, only a small segment of patients would benefit.

Over the last two decades, she said, cancer treatment has changed sharply with the arrival of these drugs.

“In a few malignancies, they have been life-changing,” Sharma said. She said that around 20 years ago, patients with metastatic lung cancer typically survived for nine to eleven months. Even for stage three disease, five-year survival rates were low despite aggressive chemotherapy and radiation. “Many drugs like durvalumab, which came as adjuvant therapy, have increased survival,” she said.

According to Sharma, the main barrier to using these drugs widely has been cost. She said that when customs duty is removed, a few more patients become eligible by virtue of their ability to afford that drug. 

Referring to the list of drugs exempted this year, she said that these are not basic medicines, but high-end drugs often used as second- or third-line treatment. 

“I do not think it would go to the grassroots level,” she said. “These are mostly tertiary care-based drugs, used in specialised, mostly private settings.”

Rare diseases

In her budget announcement, FM Sitharaman also said that seven additional rare diseases will now qualify for duty-free personal imports of medicines, drugs, and special medical foods (FSMP), making these essential treatments cheaper and easier for patients to bring into India.

The seven rare diseases added to the duty-exempt list are Congenital Hyperinsulinemic Hypoglycaemia (CHI), Familial Homozygous Hypercholesterolaemia, Alpha-Mannosidosis, Primary Hyperoxaluria, Cystinosis, Hereditary Angioedema, and Primary Immune Deficiency Disorders. 

All of these conditions are already covered under the National Policy for Rare Diseases (NPRD), 2021.

With this, a total of 58 diseases will now be considered for the exemption.

Prasanna Shirol, co-founder and executive director of Organisation for Rare Diseases India (ORDI), said, “No individual patient can afford to import these, even after the exemption,” he said. “If the drug costs Rs 75 lakh to Rs 1 crore per year, which patient will be able to afford it.” Shirol said the exemption on special formula diets and FSMPs may help some families, but only a limited section. 

“By reducing the import duty, the treatment may extend another one or two months,” Shirol said. 

He pointed out that similar exemptions have been announced in earlier budgets, with more drugs added each year, but the core problem remains. What patient groups are asking for, Shirol said, is not duty exemption but assured and consistent government funding.

(Edited by Ajeet Tiwari)