Delhi High Court: In the batch of petitions filed by the petitioners whose children were suffering from rare diseases, Prathiba M. Singh, J.*, took note of the press release dated 30-03-2023, published by Ministry of Finance and gazette notification dated 29-03-2023 released by Ministry of Finance, Department of Revenue, and observed that it included the rare diseases namely Gaucher Disease Type I and III, Hunter syndrome (MPS II), Pompe Disease, Duchenne Muscular Dystrophy (‘DMD’), and Spinal Muscular Atrophy. Thus, in addition to the press release and gazette notification issued by the Ministry of Finance, the Court clarified that custom duties and charges should not be levied on medicines, drugs and therapies for rare diseases, and further opined that whenever medicines were brought in respect of rare diseases, the custom authorities should ensure that the same were cleared expeditiously and no unnecessary impediments were caused in ensuring that the same reach the hospital concerned.
In the present case, where the children of the petitioners were suffering from rare diseases, the Court observed that these matters were heard by the Court from time to time and various directions were issued for enabling treatment and making medicines available to the petitioner. On 10-07-2023, this Court directed Hanugen Therapeutics/DART to proceed with clinical trials, and further, with regard to Sarepta Therapeutics, the Court noted the positive development that it had agreed to provide free treatment to fourteen patients.
The Court opined that one of the most important outstanding issues in the present petitions were related to the treatment of DMD. Considering the large number of DMD patients and the physical and mental health of the families involved in these cases, the Court directed that the National Research Development Corporation (‘NRDC’) to meet with Sarepta Therapeutics, and any information gained from Sarepta Therapeutics during these meetings should be kept confidential and to be submitted only to the Court. Further, Sarepta Therapeutics, should submit a report detailing the discussions and any further relevant details as also their recommendations, and this report should be submitted to the Court by the next date of hearing.
The Court further took note of the press release dated 30-03-2023, published by Ministry of Finance and gazette notification dated 29-03-2023 released by Ministry of Finance, Department of Revenue, and observed that it included the rare diseases namely Gaucher Disease Type I and III, Hunter syndrome (MPS II), Pompe Disease, DMD, and Spinal Muscular Atrophy.
Thus, in addition to the press release and gazette notification issued by the Ministry of Finance, the Court clarified that custom duties and charges should not be levied on medicines, drugs and therapies for rare diseases. The Court opined that whenever medicines were brought in respect of rare diseases, the custom authorities should ensure that the same were cleared expeditiously and no unnecessary impediments were caused in ensuring that the same reach the hospital concerned. The Court further stated that the present order to be communicated to o Central Board of Indirect Taxes and Customs (‘CBIC’) for compliance by the Registry.
The matter would next be listed on 22-03-2024.
[Master Arnesh Shaw v. Union of India, 2024 SCC OnLine Del 1517, decided on 26-02-2024]
*Judgment authored by- Justice Prathiba M. Singh
Advocates who appeared in this case:
For the Petitioners: Rahul Malhotra, Advocate; Shyel Trehan, Rohan Poddar & Shivalika Rudrabatla, Advocates; Asif Ahmed, Advocate; Ashok Agarwal, Kumar Utkarsh & Manoj Kumar, Advocates; Aditya Chatterjee and Ishaan Karki, Advocates; Anurag Ojha and Deepak Somani, Advocate; Deepak Somani, Advocate; Sonia Sharma, Neha Chugh, Vijay Chandra Jha, Adv. Purva Chugh & Tushant, Advocates;
For the Respondents: Kirtiman Singh CGSC, Waize Ali Noor, Vidhi Jain & Anvi Garg Advocates; Ripudaman Bhardwaj CGSC and Kushagra Kumar, Manaswini Kondepudi, Advocate; Tanveer Oberoi & Jaswinder Singh, Advocates; Dharmender Verma and Vishal Singh, Advocates; Dr. Sheffali Gulati, (AIIMS); Dharmender Verma Advocate, Vishal Singh Advocate, Shantanu Garg Advocate; Sudarshan Rajan, Hitain Bajaj and Mahesh Kumar, Advocates; Dinesh Kumar and Prakash Raj Thakur, Advocates; Divyam Nandrajog, Panel Counsel, GNCTD with Mayank Kamra, Advocate; Ripudaman Bhardwaj CGSC with Kushagra Kumar Advocate; Sameer Vashisht, ASC (Civil), GNCTD and Vanshay Kaul, Advocate; Vijay Joshi, Sr. Panel Counsel, Pravin Anand, Shrawan Chopra, Prachi Agrawal, Achyut Tewari, Advocates; Anuj Aggarwal, ASC, GNCTD, Ayushi Bansal, Sanyam Suri and Arshya Singh, Siddhant Dutt, Advocates; Neeraj, Sahaj Garg, Deepanshu Badiwal & Vedansh Anand, Advocates; Anurag Ahluwalia, CGSC, Abhigyan Siddhant, Advocate; Abhishek Sharma, Kritya Sinha, Pranshul Kulshreshtha, Advocates; Amrita Prakash, CGSC and Vishal Ashwani Mehta, Advocates; Ajay Digpaul and Ishita Pathak, Kamal Digpaul with Swati Kwatra, Advocates; Rishabh Sahu, Central Govt Sr. Counsel with Sameer Sharma, Advocates; Ghanshyam Mishra, and Priyanka Verma, Advocate with Babli Chauhan, Advocate; Bharathi Raju, Sr. Panel Counsel with Mr. Rohit Singh, Advocate; Anuj Aggarwal, ASC, GNCTD, Ayushi Bansal, Sanyam Suri and Arshya Singh, Siddhant Dutt, Advocates; T.P. Singh, Sr. Central Govt. Counsel; Sanjeev Uniyal and Dhawal Uniyal with Satyam Pandey Advocates; Sanjib Kumar Mohanty, Sr. Panel Counsel with Anushka Jakhodia, Subesh K. Sahood, Advocate; Siddharth Khatana, Advocate; Ranvir Singh (CGSC); Anuj Aggarwal, ASC, GNCTD with Ayushi Bansal, Sanyam Suri and Arshya Singh Advocates; Sanjeev Sabharwal, Sr. Panel Counsel with Shweta, Advocate; Harish Kumar Garg and Palak Gupta, Ms. Khushboo Sharma, Advocates; Satya Ranjan, (Sr. Panel Counsel) with Kautilya Birat, Advocates; Avnish Singh, SPC along with Mahendra Vikram Singh & Kanchan Kumari, Advocate; Niraj Kumar, Sr. Central Govt. Counsel; Parth Goyal, Advocate for Jawahar Raja, ASC(C) GNCTD; Rishikesh Kumar ASC-GNCTD, with Aditya Raj, Muhammad Zaid, Sheenu Priya, Sudhir Kumar Shukla & Sumit Choudhary, Advocates; Dr. Nabendu Sekhar Chatterjee, ICMR; Nitinjya Chaudhry, Sr Panel Counsel with Abhishek, GP, Rahul Mourya, Advocate; Abhishek Khanna, Advocate; Raj Kumar, Advocate; Raj Kumar Yadav, Nitya Sharma, Jasmine Sheikh Advocate; Virender Pratap Singh Charak and Shubhra Parashar Advocates; Yash Hari Dixit, Akshay Kumar, Pushpender Singh Charak, Pinky Yadav, Advocates; Sushil Raaja, Advocate with Arani Chaudhary, Advocate; Mukul Singh (CGSC) with Ira Singh, Advocates; Monika Arora (CGSC), Kushal, Subhrodeep Saha, Yash Tyagi , Advocate, Subhrodeep, Advocate; Ritu Reniwal (SPC UOI); Prerna Dhall & Ripu Dhiman, Advocates; Rudra Paliwal Advocate; Sudarshan Rajan, Hitain Bajaj and Mahesh Kumar, Advocates; Atul Sai Krishna Senior Panel Counsel, Hardik Bedi GP; Vineet Dhanda, CGSC with Durga D. Vashist, Advocate; Shashank Garg, CGSC for UOI with Vanshul Pali, Advocate; Seema Singh, Advocate; Pratima N Lakra CGSC with Vanya Bajaj, Advocates; Kashish G Baweja, Advocate.
