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Breast and lung cancers account for 3L new cases/year; an explainer on the exempted drugs

Trastuzumab Deruxtecan, Osimertinib, and Durvalumab are used to treat breast, lung and biliary tract cancer

Breast cancer is the commonest cancer in women in india, accounting for an estimated quarter of all new cancer cases detected every year. Lung cancer is the 4th most common cancer accounting for 5.9% of all cancers detected in the overall population. Biliary tract cancer is less common in India. Every year an estimated 1.5 lakh cases of each of these two cancers are detected in India.

That is why the exemption given to the three cancer drugs – Trastuzumab Deruxtecan, Osimertinib, and Durvalumab – has been hailed by the industry as a game changer. The three drugs are primarily used to treat breast, lung and biliary tract cancer. The last is relatively less common in India and is found largely in the west or in China and Thailand in our part of the world.

In a statement Wednesday the Union ministry of health said: “The request (for duty exemption) was forwarded by the Ministry of Health and Family Welfare (MoHFW) to the Ministry of Finance in view of the 27 lakh cancer patients in the country. To improve the affordability of these drugs, Ministry of Finance has exempted them from the customs duty.”

What are these drugs?

Trastuzumab Injection 440mg/50ml is a scheduled drug under National List of Essential Medicines 2022. This means that the ceiling price of the drug has been fixed by the National Pharmaceutical Pricing Authority (NPPA). Current applicable ceiling price is Rs. 54725.21 per vial, fixed in March this year. However, its other strength variants are not under the scheduled list. Trastuzumab comes in different strengths and dosages with a combined annual turnover of more than Rs. 276 crores.

The other two medicines i.e., Osimertinib and Durvalumab are non-scheduled medicines under the Drug Price Control Order, 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 twelve months.  The Annual turnover of Durvalumab for the year 2023-24 was Rs. 28.8 crore

Osimertinib is covered under the list of 42 anti-cancer drugs for which trade margin was regulated under Trade Margin Rationalisation.  As per the data available with NPPA, the annual turnover of Osimertinib for the year 2023-24 was Rs. 52.26 crore.

MediBulletin Bureau
MediBulletin Bureau
A team of experienced and committed journalists. Working under guidance of Dr. O. P. Choudhury. You can reach us at: bureau@medibulletin.com
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