New Delhi: A decision by the Modi government, as announced by finance minister Nirmala Sitharaman in her budget speech Tuesday, to waive off basic customs duty on three crucial anti-cancer drugs has been widely hailed as a patient-friendly move.
But the move, which will make these prohibitively expensive drugs marginally cheaper — by 10 percent — has also led to concerns, mainly by the opposition which has pointed out that the drugs given the waiver are all by a single drugmaker.
The anti-cancer medicines on which the government has announced concessions include immune and targeted therapies trastuzumab deruxtecan, osimertinib and durvalumab by British-Swedish pharma giant AstraZeneca.
“If one looks at the specific concessions on basic customs duty given to three cancer drugs, it turns out that they were made by the same pharmaceutical company,” senior Congress parliamentarian Shashi Tharoor said in the Lok Sabha Wednesday.
“Why would various other costly life-saving drugs being imported into the country be overlooked for this exemption?” he had asked.
This fact was also noted by some cancer experts.
Dr Ravi Mehrotra, a cancer researcher who is also associated with the WHO’s International Agency for Research on Cancer, underlined that while these three drugs have shown to improve clinical outcomes for patients, the common thread is that they are manufactured by the same company.
ThePrint has reached out to AstraZeneca over email for a comment on the issue. This report will be updated if and when a response is received.
Welcoming the government’s decision, Dr C.S. Pramesh, director of the country’s top cancer hospital, Tata Memorial Centre (TMC), in Mumbai, said he hoped the pharmaceutical industry ensures that this benefit is passed on to patients requiring these drugs.
“Also, I would urge the government to continue to reduce or exempt taxes on life-saving drugs to make healthcare more affordable for patients,” he told ThePrint.
Several new immunotherapy and targeted therapies for treating various cancers have dramatically improved the quality of life and survival rates in patients, but their costs remain unaffordable for the majority of cancer patients in India.
These patented drugs, whose prices may go as high as over Rs 50 lakh per year, are mostly offered by companies through their patient access programme, and are not formally launched in the country primarily due to limited business opportunities.
Less than 3 percent of cancer patients in India have access to promising treatment immunotherapy, mainly due to exorbitant costs, a landmark study by TMC researchers that came out in 2022 had shown.
“It is good that the government has offered custom duty concessions on a few drugs — but this basket needs to be extended. There are 50 — or more — such drugs, including ribociclib, nivolumab and ipilimumab, among others, which should be put on that list,” said an oncologist with the All India Institute of Medical Sciences (AIIMS) in New Delhi.
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Waivers granted to other medicines
The latest concession for the three drugs comes in the backdrop of duty waivers granted to certain other drugs last year.
In March 2023, the finance ministry had announced that there would be no basic customs duties on pembrolizumab (Keytruda) — used to treat 17 types of malignancies — by US-based pharma giant Merck.
In addition, an exemption from customs duties was also granted for other drugs or food for special medical purposes imported for personal use for treating rare diseases as listed under the National Policy for Rare Diseases, 2021.
Before that, there was an exemption on custom duties for specified drugs used in treating only one rare disease — spinal muscular atrophy or Duchenne muscular dystrophy.
Drugs and medicines — which are not registered in India but are imported by patients individually — not under the exemption generally attract basic customs duties of 10 percent, with some categories of life-saving drugs or vaccines attracting a concessional rate of 5 percent.
Three drugs whose prices go down
Trastuzumab deruxtecan, sold under the brand name Enhertu, is a variant of cancer drug trastuzumab that is in India’s National List of Essential Medicine (NLEM) and was initially used for HER2-positive breast cancer, a particularly aggressive type of breast cancer.
Earlier this year, the Drug Controller General of India also granted AstraZeneca approval to import and distribute the drug for HER2-low metastatic breast cancer — another aggressive and fast-growing subtype of breast cancer — and locally advanced or metastatic gastric cancer.
According to the National Cancer Registry Programme maintained by the Indian Council of Medical Research (ICMR), almost 2 lakh breast cancer cases are detected in India every year. Also, cases of this cancer have surged by almost 40 percent over the past 25 years.
Dr Arjun Singh, a surgical oncologist with TMC, pointed out that breast cancer is the most common cancer among Indian women.
“This drug has improved survival and provided a balance of toxicity as well,” he said.
Gastric cancer, on the other hand, ranks as the sixth most prevalent cancer affecting men in India, and poses a considerable challenge with a five-year survival rate of less than 7 percent for those diagnosed at an advanced stage.
As of now, Enhertu costs Rs 1.6 lakh per vial in India even though the government has set a ceiling price of Rs 54,725.21 per vial for trastuzumab, as prices of drugs in the NLEM — also known as scheduled drugs — are regulated by the government.
Osimertinib, sold under the brand name of Tagrisso, is a targeted therapy drug used to treat non-small cell lung cancer (NSCLC) with specific mutations in the epidermal growth factor receptor (EGFR) gene.
Clinical trials have shown that osimertinib is effective in shrinking tumours and prolonging progression-free survival in patients with EGFR-mutant NSCLC, Dr Singh said.
A strip of ten pills of this drug costs Rs 1.5 lakh and, according to data available with the National Pharmaceutical Pricing Authority (NPPA), the annual turnover of osimertinib in the country for the year 2023-24 was Rs 52.26 crore.
This drug was in the list of 42 anti-cancer drugs for which trade margin was regulated under the trade margin rationalisation approach by the government in 2019.
The third drug in the list, durvalumab, sold as Imfinzi, is an immunotherapy drug, specifically a monoclonal antibody that targets PD-L1, used primarily in the treatment of non-small cell lung cancer and certain types of urinary bladder cancer.
Durvalumab has demonstrated durable responses in patients, particularly in the treatment of locally advanced, unresectable NSCLC. The responses tend to be long-lasting, which is a significant improvement over some traditional therapies.
Every 10 ml vial of this drug costs Rs 1.5 lakh for Indian patients. “This immunotherapy drug becoming more affordable will be very advantageous for patients with various types of cancer,” said Dr Amit Rauthan, senior medical oncologist with Manipal Hospital in Bengaluru.
The annual turnover of durvalumab for the year 2023-24 was Rs. 28.8 crore, according to the NPPA.
(Edited by Nida Fatima Siddiqui)
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