The central legal point established in the judgment is the uncertainty in the further imports of Tocilizumab to India and the efforts made by Roche India to import and supply the drug, as well as the Union of India's stand on licensing issues and the approval of an alternative antibody cocktail for COVID-19 treatment.

JUDGMENT

Prathiba M. Singh, J. - 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 the doses which are currently being received by tonight and by 15th May 2021, are concerned, the Union of India as also the GNCTD shall take immediate steps to ensure that the same are allocated to States/UTs and distributed transparently, efficiently and in a timely manner, so that they can be immediately administered to patients who are in need and have been duly prescribed with the same."

8. Further to the directions passed in the last order dated 10th May 2021, three affidavits