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The National Pharmaceutical Pricing Authority (NPPA) has directed all manufacturers and marketing companies selling the three anti-cancer drugs that were exempted from customs duty and Goods and Services Tax (GST) earlier this year, to revise the maximum retail price (MRP) of these drugs and submit the details regarding the revision with the regulators.
The move is in line with the Centre's announcement in the Union Budget 2024-25 to fully exempt cancer drugs namely, trastuzumab deruxtecan, osimertinib and durvalumab from customs duty. The 54th GST Council meeting in September, this year, has also recommended reduction of GST rates on these drugs from 12 per cent to five per cent.
The Authority, in a latest communication, observed that as per Drugs Prices Control Order, 2013, MRP of drugs or formulations is inclusive of taxes and duties, as applicable. Hence, any downward change in duties and taxes should be reflected in the MRP and benefit of nil duty, or reduction in duties or taxes should be passed on to consumers.
"In view of the above, all the manufacturers and marketing companies selling the above-mentioned drugs/formulations are required to revise the MRP of drugs/formulations on which Custom duty has been made nil and GST has been reduced," said NPPA in an office memorandum.
Information about the revision is required to be submitted through Form II/Form V and the manufacturers shall issue a price list or supplementary price list to the dealers, State Drugs Controllers and the Government indicating changes, it added.
The ministry of health in July said that it has requested duty exemption for trastuzumab deruxtecan used for the treatment of breast cancer, osimertinib used for the treatment of lung cancer; and durvalumab for the treatment of lung cancer and biliary tract cancer, to support 27 lakh cancer patients in the country.
Trastuzumab injection 440mg/50ml is a scheduled drug under National List of Essential Medicines, 2022 and National Pharmaceutical Pricing Authority (NPPA) has fixed the ceiling price of the medicine. Current applicable ceiling price is Rs. 54,725.21 per vial, through a notification on March 26, 2024.
However, its other strength variants are not under the schedules list. trastuzumab comes in different strengths and dosages with a combined annual turnover of more than Rs. 276 crore.
The other two medicines, osimertinib and durvalumab are non-scheduled medicines under 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 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 through a notification on February 27, 2019. As per the data available with NPPA, the annual turnover of osimertinib for the year 2023-24 was Rs. 52.26 crore.
It may be noted that the GST Council in its 50th meeting has recommended IGST exemption of dinutuximab (Quarziba), another cancer drug, when imported for personal use.
As per the Indian Council of Medical Research (ICMR) - National Cancer Registry Programme (ICMR-NCRP), under the ministry of health & family welfare, the estimated number of incidence of cancer cases in the country for the year 2024 was 15.33 lakh, as compared to 14.26 lakh in 2021, according to a statement tabled by the ministry of chemicals and fertilisers on July 26, 2024.
It said that the NPPA has fixed the ceiling prices of 131 anti-cancer scheduled formulations included in Scheduled-I of the Drugs (Prices Control) Order, 2013 (DPCO, 2013) under National List of Essential medicines (NLEM) 2015 and 2022. Of the 131 anti-cancer drugs for which ceiling prices were fixed, 120 formulations are under NLEM 2022. This has resulted in the reduction of around 20 per cent in the ceiling prices from the existing ceiling price under NLEM, 2015 leading to annual savings of around Rs. 294 crore to the patients.
NPPA has also fixed retail price of 28 anti-cancer formulations as on July 22, 2024 which are applicable to the applicant manufacturing and marketing company.
In February, 2019, the Authority has put a cap of 30 per cent on trade margin on 42 selected non-schedules anti-cancer medicines under the Trade Margin Rationalisation approach and through this, maximum retail price of 526 brands of these medicines were reduced by average of 50 per cent, resulting in annual savings or around Rs. 984 crore to the patients, added the Ministry.
Besides, 83 products for cancer treatments have been brought under the basket of drugs offered by Jan Aushadhi Kendras under the Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP), which sells drugs cheaper by at least 50 per cent and in some cases by 80-90 per cent of the market price.
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