Why in News?

In her Budget 2024-25 speech, the Finance Minister announced customs duty (which was earlier ~10%) exemptions on 3 targeted cancer drugs - trastuzumab deruxtecan, osimertinib, and durvalumab.

The decision is likely to make these drugs more accessible to Indian patients, and reduce the overall cost of cancer therapies.

What’s in Today’s Article?

• What is the Cancer Profile in India?
• What are Some of the Targeted Cancer Therapies?
• About the 3 Custom Duty Exempted Targeted Cancer Drugs
• Regulation of Prices of These Cancer Drugs in India
• What will be the Impact of the Customs Duty Exemptions

What is the Cancer Profile in India?

• Cancer is a disease in which some of the body’s cells grow uncontrollably and spread to other parts of the body.
  • When cells grow old or become damaged, they die, and new cells take their place.
  • Sometimes this orderly process breaks down, and abnormal or damaged cells grow and multiply.
  • These cells may form tumors, which are lumps of tissue and can be cancerous or not cancerous.
• The number of cancer cases in India is on the rise. According to the National Cancer Registry data,
  • An estimated 14.6 lakh new cancer cases were detected in 2022, up from 14.2 lakh in 2021 and 13.9 lakh in 2020.
  • The number of deaths due to cancer increased to an estimated 8.08 lakh in 2022, up from 7.9 lakh in 2021 and 7.7 lakh in 2020.
• The incidence of cancer cases in India:
  • According to the Indian Council of Medical Research (ICMR), 1 in 9 Indians will develop cancer during their lifetime.
  • The incidence is higher among women - 103.6 per 100,000 population in 2020 compared to 94.1 among men.
  • The most common cancers among men were of the lung, mouth, prostate, tongue and stomach; for women, they were breast, cervix, ovary, uterus and lung.

What are Some of the Targeted Cancer Therapies?

• Targeted cancer drugs:
  • These drugs are designed to attack only the cancer cells, leaving the normal cells unaffected.
  • They target specific genetic changes in cancer cells that help them grow, divide and spread.
  • These drugs have better outcomes and fewer side effects compared to traditional chemotherapy drugs that indiscriminately target all cells.
• Immunotherapy: Immunotherapy does not target the cancer itself by using any drug. Instead, they train the patient’s immune system to find and attack the cancer cells.

About the 3 Custom Duty Exempted Targeted Cancer Drugs:

• Trastuzumab deruxtecan:
  • It is an antibody-drug conjugate developed by Daiichi Sankyo and marketed by Astrazeneca as Enhertu.
  • It is a second-line treatment, which costs around Rs 1.6 lakh per vial and is used when traditional therapies have failed. In 2019, the drug was approved for the treatment of breast cancers.
  • In 2024, it became the first drug in its class to receive “tissue-agnostic approval” (from the US FDA) - meaning it can be used to treat any cancer with HER-2 receptor regardless of where it originates.
• Osimertinib:
  • It is the most commonly used of the three cancer drugs in India and it is quite expensive as it costs 5 lakh per strip of ten pills, and has to be taken every day.
  • Marketed as Tagrisso by AstraZeneca, the drug is used to treat lung cancers.
• Durvalumab:
  • An immunotherapy treatment, it is used for the treatment of certain lung cancers, biliary tract cancers, bladder cancer, and liver cancer.
  • Sold as Imfinzi, durvalumab costs around Rs 1.5 lakh for every 10ml vial.

Regulation of Prices of These Cancer Drugs in India:

• Trastuzumab Injection is a scheduled drug under National List of Essential Medicines (NLEM) 2022 and National Pharmaceutical Pricing Authority (NPPA) has fixed the ceiling price (Rs. 54725 per vial) of the same.
• The other two medicines i.e., Osimertinib and Durvalumab are non-scheduled medicines under Drug Prices Control Order (DPCO), 2013.
  • Hence, NPPA monitors the maximum retail price (MRP) of the non-scheduled formulation to ensure that the same does not increase by more than 10% of MRP during the preceding 12 months.

What will be the Impact of the Customs Duty Exemptions?

• In India, one in 68 men will develop lung cancer, and one in 29 women will develop breast cancer.
• This means, around one lakh patients need rastuzumab deruxtecan, osimertinib, and durvalumab in India, as they are useful for the treatment of lung and breast cancers.
• Hence, the customs duty exemptions on these drugs is widely expected to help reduce the financial burden on cancer patients and their families.