The Delhi High Court has directed the Centre to consider waiving customs duties and GST on the import of medicines for rare diseases, specifically in a plea concerning young victims. The case is an important part of the ongoing discussions about the affordability and availability of treatments for conditions like Spinal Muscular Atrophy ( SMA ) and other rare diseases in India.
The petitions were filed by the Petitioners who are mostly children suffering from rare diseases. These matters have been heard by the Court from time to time since 2020 and various directions have been issued for enabling treatment and making medicines available to the Petitioners.
It was the case of the Petitioners that the medicines and therapies for all these Rare Diseases are exorbitantly expensive, and directions ought to be issued to the Respondents i.e., the Union of India and its Ministry of Health and Family Welfare, All India Institute of Medical Science, as well as the GNCTD, to provide continuous and uninterrupted treatment to the Petitioners, free of cost.
During the hearings, it was emphasised that while patients can import medicines without taxes, companies importing these treatments face a substantial 11% customs duty and a 12% GST.
Complete Draft Replies of GST ITC Related Notices, Click Here
The Court also considered the submission of the Union of India that due to the constraint of governmental resources, and competing health priorities, it is not possible to fully finance the treatment of all high-cost Rare Diseases, but the gap could be bridged by seeking donations from prospective individuals or corporate donors, who are willing to support the cost of such diseases. Union of India recognised that Duchenne Muscular Dystrophy (hereinafter, ‘DMD’) was a ‘Rare Disease’ and the fact that patients, in general, may not be able to afford its treatment. It thus proposed that it shall explore ‘crowd-funding’ as an option to address affordability concerns.
It was also directed that, “Requisite notifications for granting customs, GST waivers and exemptions under Income Tax Act, 1961 in respect of imports of rare diseases medicines etc., shall be processed and issued within 30 days.”
Further, it was directed that, “Donations for rare diseases shall be added in Schedule VII of the Companies Act, 2013 to enable CSR contribution by companies, including PSUs.”
The Union of India shall direct the DCGI and the CDSCO to create a dedicated fast-track approval process for rare disease drugs and therapies within 60 days. All applications for rare disease therapies should be processed within 90 days from submission, it was also added.
The Union of India was also directed to consider extension of waiver of customs duty for all imports-individual use and imports for commercial purposes by companies, so that companies are incentivised to import larger quantities of drugs for rare diseases, to ensure robust supplies.
Complete Draft Replies of GST ITC Related Notices, Click Here
This direction from the Single Bench of Justice Prathiba M Singh came from the due judicial recognition that these financial burdens significantly increase the cost of life-saving treatments for patients suffering from rare diseases. Concrete steps were also directed to be taken to encourage PSUs and pharmaceutical companies to increase their contribution to CSR in rare diseases.
The Delhi High Court’s attention to detail in these issues signals a potential shift toward more supportive policies for patients requiring costly treatments, urging the government to take concrete steps in this direction.
Subscribe Taxscan Premium to view the JudgmentSupport our journalism by subscribing to Taxscan premium. Follow us on Telegram for quick updates
