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IN THE HIGH COURT OF DELHI
Prathiba M. Singh, J.
Dharmendra Kumar Aggarwal - Appellant
Versus
Govt. of NCT of Delhi - Respondent
W.P.(C) 5173 of 2021
Decided On : 13-05-2021




The court asserted the need for government accountability in drug distribution and ordered comprehensive reporting on the supply capabilities of Tocilizumab amid urgent demand due to COVID-19.

Headnote:(A) The Drugs and Cosmetics Act, 1940 - Availability and supply of Tocilizumab for COVID-19 patients - The petitioner sought intervention for the drug’s availability amidst shortages exacerbated by demand due to the pandemic. The court noted the need for comprehensive reporting of global supply capabilities and the urgent requirement of the drug within India. (Paras 4, 5, 11, 20)

(B) Role of the Government - The court emphasized the government's responsibility in ensuring equitable drug distribution and monitoring compliance with emergency use regulations. (Paras 17, 21)

(C) Manufacturing Capabilities - The acknowledgment by Roche India regarding its inability to meet demand necessitated judicial scrutiny into patent and supply chain dynamics. (Paras 10, 11, 20)

Facts of the case:
The petition involved requests for the drug Tocilizumab, with prior efforts yielding limited success. The court had recognized the urgency due to pandemic-related demand, especially after patient prescriptions.

Findings of Court:
The court highlighted the lack of certainty from Roche India regarding further supplies, despite ongoing patient needs and black-market pricing issues.

Issues: The main issues included government accountability for drug supply, Roche India's manufacturing capacity, and the implications of alternative COVID-19 treatments.

Ratio Decidendi: The court ruled that both Roche India and the government must provide clear actionable reports on drug availability and take necessary steps to ensure public health needs are met.

Result: The case was adjourned with directions to the Government of India to file detailed affidavits addressing the outlined issues.

Table of Content
1. availability of tocilizumab for patients (Para 4 , 5 , 6)
2. court's directions on drug supply and information (Para 7 , 8 , 9)
3. affidavit on manufacturing and clinical trials (Para 10 , 11)
4. roche's import status and government licensing stance (Para 12 , 13)
5. observations on the necessity of tocilizumab (Para 15 , 17)
6. inquiry into future supplies and trials (Para 20 , 21)
7. order for follow-up and next hearing (Para 22 , 24 , 25)

JUDGMENT

Prathiba M. Singh, J. (Oral)--This hearing has been done through video conferencing.

CM APPL. 15878/2021(for exemption)

2. Allowed, subject to all just exceptions. Application is disposed of.

CM APPLs. 15879-80/2021(exemption from filing court fee and attested affidavits)

3. These are applications seeking exemption from filing court fee and duly notarized affidavits. Binding the deponent of the affidavit to the contents of the application, the exemption is granted. Insofar as the court fee is concerned, the same be deposited within one week. Applications are disposed of. Registry to submit a report in case the court fees is not filed after a month.

W.P.(C) 5173/2021

4. The present petition is concerned with the supply and availability of the drug Tocilizumab 400 MG for COVID-19 patients who are prescribed the same.

5. Vide order dated 6th May 2021, this court had recorded that Tocilizumab 400 MG had been made available for the Petitioner's brother and was administered to the patient. Mr. Tandon, ld. Counsel for the Petitioner further submitted, as recorded in order dated 10th May 2021, that the patient's medical condition is better.

6. On 6th May 2021, this court had also impleaded another patient Smt. Kamlesh Gupta as Petitioner No. 2, who was also prescribed Tocilizumab 400 MG, however despite repeated efforts could not get access to the same. Ld. Counsels for the GNCTD and the Union of India had assured the court that they would through their good offices try and make the medicine available. Today, however, Mr. Kunal Tandon, ld. Counsel for the Petitioner No.2, submits that the Petitioner No.2 is now stable, and she does not require the said dose of Tocilizumab 400 MG, for the time being.

7. On the issue of availability of Tocilizumab 400 MG, on the last date i.e., 10th May 2021, this court had issued the following directions:

    "17. Accordingly, ld. Counsels appearing for Roche India to take instructions from M/s Chugai Seiyaku Kabushiki Kaisha or any other entity involved in the supply chain and make submissions as to whether any further supply of more quantities of Tocilizumab 400 MG doses can be made, and if so within what timelines, in order to cater to the actual demand for patients in India. The affidavit, if possible, shall also indicate the global products figures of Tocilizumab for the period January-April, 2021. Let an affidavit in pursuance of the same be filed on behalf of Roche India, by 12th May, 2021 at 4:30 PM. The same may be emailed to the Court Master.

    18. Further, insofar as the Union of India is concerned, the relevant department, i.e., either the Department of Pharmaceuticals or the Drug Controller General of India, shall place an affidavit on record, stating as to whether there are any other applications for manufacture/import/sale of Tocilizumab 400 MG, with the Drug Controller General of India, under the Drugs and Cosmetics Act, 1940. The said affidavit to comprehensively specify the status/stage of the said applications as well, if any. Let the affidavit of UOI be also filed by 12th May, 2021 through email to the Court Master.

    19. Mr. Sameer Kumar Swarup, the Deputy Controller of Patents, has joined the proceedings. Let a status report be filed by him, in respect of the details of the patents stated to be covering Tocilizumab 400 MG, as also the working statements in respect thereof, including the date of filing, the term of patent etc., The same be also emailed by 12th May, 2021 through email to the Court Master.

    20. Insofar as

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