Promoting Affordable Cancer Treatment in India

What’s in today’s article?

• Why in News?
• 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

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 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 1.5 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. 54725.21 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 are widely expected to help reduce the financial burden on cancer patients and their families.

Q.1. What is the purpose of the National List of Essential Medicines (NLEM) in India?

The primary purpose of NLEM is to promote rational use of medicines considering the three important aspects i.e. cost, safety and efficacy. Furthermore, it promotes prescription by generic names.

Q.2. What is the National Pharmaceutical Pricing Authority (NPPA)?

NPPA is a government regulatory agency that controls the prices of pharmaceutical drugs in India. It was constituted in 1997 as an attached office of the Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers.

Source: Budget provides customs duty exemptions for three cancer treatment drugs | PIB | IE