In a significant move aimed at making life-saving cancer treatments more affordable, the Department of Revenue, Ministry of Finance, has reduced Customs Duty to nil on three anticancer drugs—Trastuzumab Deruxtecan, Osimertinib, and Durvalumab. This exemption was notified under Notification 30/2024 dated July 23, 2024. Additionally, the Goods and Services Tax (GST) on these drugs has been slashed from 12% to 5% under Notification 05/2024 dated October 8, 2024.
Impact on Drug Prices
Under the Drugs (Prices Control) Order, 2013 (DPCO, 2013), the Maximum Retail Price (MRP) of drugs is inclusive of applicable taxes and duties. In light of the reduced Customs Duty and GST, the National Pharmaceutical Pricing Authority (NPPA) has directed pharmaceutical companies to reduce the MRPs of these drugs to pass on the benefit of lower taxes to consumers. Manufacturers have already complied by adjusting prices and submitting the revised MRPs in accordance with regulatory requirements.
This measure is expected to significantly reduce the financial burden on patients requiring these essential anticancer drugs, which are widely used in the treatment of advanced and metastatic cancers.
Barcoding for Enhanced Transparency
In a related update, the Drugs Rules, 1945 were amended in 2022, with provisions effective from August 1, 2023, requiring manufacturers of the top 300 drug brands listed under Schedule H2 to include Bar Codes or Quick Response (QR) Codes on packaging. This technology facilitates the authentication of drugs and ensures transparency in the pharmaceutical supply chain.
Boosting Access to Cancer Treatment
The dual measures of tax reductions and enhanced packaging regulations underscore the government’s commitment to improving accessibility and ensuring the quality of critical medicines. The collaborative efforts of the Ministry of Finance, the NPPA, and the Ministry of Health & Family Welfare reflect a proactive approach to addressing the economic and health-related challenges faced by patients battling cancer.
These initiatives align with the broader goals of enhancing healthcare affordability and accessibility while safeguarding the interests of consumers through regulatory oversight and technological integration.
For detailed information on price changes and compliance, refer to the annexure provided by the NPPA.
Information filed by the Companies with NPPA regarding reduction in MRP on account of reduction in Custom Duty and GST
Durvalumab
S. No | Formulation | Company | Uunit | Pre Revised MRP (in Rs) (including taxes) | Revised MRP (in Rs) (including taxes) |
1 | Imfinzi 120 Mg Injection 2.4ML(1.00 Vial) (Durvalumab INJECTION) | AstraZeneca Pharma India Limited | per vial | 45500 | 40790.96 |
2 | Imfinzy 500 Mg Injection 10 ML(1.00 Vial) (Durvalumab INJECTION) | AstraZeneca Pharma India Limited | per vial | 189585 | 171324.27 |
Osimertinib
S. No | Formulation | Company | Unit | Pre Revised MRP (in Rs) (including taxes) | Revised MRP (in Rs) (including taxes) |
1* | Tagrisso 40 Mg Tablet 10 | AstraZeneca Pharma India Limited | per 10 tablets | 150154 | 140769.38 |
2 | Tagrisso 80 Mg Tablet 30 | AstraZeneca Pharma India Limited | per 30 tablets | 455010 | 416492.48 |
3 | Tagrisso 80 Mg Tablet 10 | AstraZeneca Pharma India Limited | per 10 tablets | 151670 | 138830.83 |
Trastuzumab Deruxtecan
S. No | Formulation | Company | Unit | Pre Revised MRP (in Rs) (including taxes) | Revised MRP (in Rs) (including taxes) |
1 | Enhertu 100mg/5ml Inj. Vial(1.00 Vial) (Trastuzumab VIAL) | AstraZeneca Pharma India Limited | per vial | 187000 | 167069.17 |
*As informed by the company vide letter dated 19.11.2024, downward revision on account of BCD becoming Nil shall be implemented when the stocks benefitting from BCD relief are released for commercial sales in the market.
This information was given by the Union Minister of State for Chemicals and Fertilizers Smt Anupriya Patel in Lok Sabha in written reply to a question yesterday.