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2021 Supreme(Del) 2155

IN THE HIGH COURT OF DELHI AT NEW DELHI
Prathiba M.Singh, J.
Dharmendra Kumar Aggarwal - Appellant
Versus
Govt Of NCT Of Delhi & Anr. - Respondents
W.P. (C) No. 5173 of 2021; C.M. Appls No. 15878 of 2021, 15879 of 2021, 15880 of 2021
Decided On : 10-05-2021

Advocates appeared:
Kunal Tandon, Advocate, Niti Jain, Advocate, Kanika Jain, Advocate, Anuj Aggarwal, Advocate, Ayushi Bansal, Advocate, Anurag Ahluwalia, Advocate, Abhigyan Siddhant, Advocate, Nitnem Singh Ghuman, Advocate, Neeraj Kishan Kaul, Advocate, Ruby Singh Ahuja, Advocate, Vishal Gehrana, Advocate, Shravan Sahny, Advocate, Toshi, Advocate, Archana Sahadeva, Advocate

The main legal point established is the court's intervention to address the shortage of Tocilizumab 400 MG for COVID-19 patients in India, emphasizing the need for the manufacturer to meet the demand and ensuring transparent distribution of the available doses.

Headnote:

Tocilizumab - Supply and Availability - Drugs and Cosmetics Act, 1940 - [Drugs and Cosmetics Act, 1940, Section 26A] - The court discussed the supply and availability of Tocilizumab 400 MG for COVID-19 patients and issued directions to assess the demand, import and supply modalities, and to obtain information on patents and working statements. The court noted the shortage of the drug due to production constraints and urged the manufacturer to meet the demand in India.

Fact of the Case:

The petition concerns the supply and availability of Tocilizumab 400 MG for COVID-19 patients. The patient was prescribed the drug but faced difficulty in procuring it, leading to the filing of the petition. The court issued directions to assess demand, import and supply modalities, and obtain information on patents and working statements.

Finding of the Court:

The court found that there was a shortage of Tocilizumab 400 MG in India due to production constraints, leading to inadequate supply to meet the projected demand for COVID-19 patients.

Issues: The main issue was the shortage of Tocilizumab 400 MG for COVID-19 patients in India, despite the projected demand.

Ratio Decidendi: The court's decision was influenced by the inadequate supply of the drug, attributed to production and supply constraints in the global supply chain. The court urged the manufacturer to meet the demand in India and issued directions to assess the supply modalities and obtain information on patents.

Final Decision: The court directed the parties to file affidavits and status reports regarding the supply, patents, and working statements of Tocilizumab 400 MG. It also urged immediate steps for transparent and efficient distribution of the received doses to patients in need.

JUDGMENT

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

2. 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.

3. This petition was filed by the brother of Shri Sudhir Kumar Agarwal, who is a COVID-19 patient (hereinafter, "patient"), and is currently admitted in Malik Radix Health Care Hospital, Nirman Vihar, New Delhi. The patient was prescribed a dose of Tocilizumab 400 MG, however after multiple efforts, he was not able to procure the same. Hence the present writ petition was filed by the Petitioner. On 5 th May 2021, the Court had recorded the submission of ld. counsels appearing for the UOI and GNCTD that they would use their good offices to make the same available to the Petitioner. The matter was then adjourned to 6th May 2021.

4. As recorded in the last order dated 6th May 2021, Mr. Kunal Tandon, submits that the said dose of Tocilizumab 400 MG has been made available for the Petitioner's brother and was administered to the patient. Mr. Tandon further submits that the patient's medical condition is better.

5. On the last date, this court had also impleaded another Applicant/patient, Smt. Kamlesh Gupta as Petitioner No. 2, who was also prescribed Tocilizumab 400 MG, but despite repeated efforts, the same was not made available to her. 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. The same is submitted to not have been made available yet, but Mr. Tandon submits that she is currently stable and if the medicine is needed, he would contact the counsels for UOI and GNCTD.

6. Vide order dated 6th May 2021, this court had also impleaded M/s. Cipla Ltd. Ld. counsel for the Petitioner has filed an amended memo of parties in terms of the last order. The same is taken on record.

7. After hearing the parties on the said date, this court had issued the following directions:

    (i) A high level meeting shall be called by the official(s) of the Department of Pharmaceuticals and the Ministry of Health and Family Welfare, Government of India. Mr. Rajiv Wadhawan and Mr. Navdeep Rinwa and/or any of their team members, shall accordingly hold a meeting with the representatives of Roche Products (India) Pvt. Ltd. and its distributors in India, in order to communicate and assess the demand for this drug in India. They shall also discuss the modalities for import and supply of the drug as per the expected demand and further logistics for placing orders for the same.

      (ii) The said meeting shall be held tomorrow i.e. on 7th April, 2021 at about 12:30 P.M. The meeting shall be minuted, and the agreed minutes of the said meeting, shall be placed before this Court, by ld. Counsel for the UOI/Roche India. The minutes be emailed to the Court master by 6 pm on 9th May 2021.

        (iii) Mr. Ahluwalia, ld. CGSC, representing the Union of India, shall also obtain instructions from the Office of the Controller General of Patents, and place on record the documents relating to the Patents that have been granted/ applicable, if any, in relation to the said drug, Tocilizumab, along with the working statements filed in respect of the said patents, if any.

          (iv) An affidavit shall also be placed on record by Roche India confirming the import, distribution and supply of 50,000 vials and 25,000 vials into India, as per the submissions made above.

            As directed above, a meeting was to be called by senior officials of the UOI along with functionaries of Roche India and its distributors. The agreed minutes of meeting was to be placed on record.

            8. Pursuant to the above directions dated 6th May 2021, the minutes of the meetings which were held on 7th and 8th May, 2021, have been placed on record by Mr. Ahluwalia, ld. Counsel appearing for the Union of Ind

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