Reduction of Customs Duty on Anticancer Drugs
In a significant move to make cancer treatment more affordable, the Department of Revenue under the Ministry of Finance has announced a reduction in Customs Duty to zero for three crucial anticancer drugs: Trastuzumab Deruxtecan, Osimertinib, and Durvalumab. This decision, formalized through Notification 30/2024 on July 23, 2024, aims to alleviate the financial burden on patients requiring these life-saving medications. Additionally, the Goods and Services Tax (GST) on these drugs has been lowered from 12% to 5%, as per Notification No. 05/2024 dated October 8, 2024. The National Pharmaceutical Pricing Authority (NPPA) has mandated that pharmaceutical companies adjust the Maximum Retail Price (MRP) of these drugs to reflect these tax reductions, ensuring that the benefits are passed on to consumers.
Impact of Reduced Customs Duty and GST
The reduction in Customs Duty and GST is expected to have a profound impact on the pricing of anticancer drugs. The NPPA has issued an Office Memorandum directing manufacturers to revise the MRP of these drugs in light of the new tax structure. This is in accordance with the Drugs (Prices Control) Order, 2013, which stipulates that the MRP of drugs must include all applicable taxes and duties. By lowering the MRP, manufacturers can help make these essential medications more accessible to patients.
As a result of these changes, companies have already begun to file the necessary information with the NPPA regarding the revised prices. This proactive approach ensures that patients can benefit from the reduced costs as soon as possible. The NPPA’s oversight will help maintain transparency in the pricing of these drugs, allowing consumers to make informed decisions about their treatment options.
Compliance by Pharmaceutical Companies
In response to the recent notifications, pharmaceutical companies have complied by reducing the MRP of the specified anticancer drugs. They have submitted the required information to the NPPA, detailing the changes in pricing. This compliance is crucial for ensuring that the benefits of the reduced taxes are effectively communicated to consumers.
The NPPA’s role in monitoring these changes is vital. It ensures that the revised prices are not only implemented but also that they reflect the actual cost reductions resulting from the tax changes. This oversight helps prevent any potential exploitation of the situation by manufacturers, ensuring that patients receive the intended financial relief.
New Regulations on Drug Packaging
In addition to the changes in pricing, the Ministry of Health & Family Welfare has also introduced new regulations regarding drug packaging. As of August 1, 2023, manufacturers of the top 300 drug formulation brands must include a Bar Code or Quick Response (QR) Code on their packaging. This requirement, outlined in the amended Drugs Rules, 1945, aims to enhance the traceability and authenticity of medications.
The inclusion of these codes will allow consumers and healthcare providers to verify the legitimacy of the drugs they are purchasing. This move is expected to bolster consumer confidence in the pharmaceutical market, particularly in the context of anticancer drugs, where the stakes are incredibly high. By facilitating easier authentication, these regulations aim to combat counterfeit medications and ensure that patients receive safe and effective treatments.
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