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, 15880 of 2021
Decided On : 05-05-2021
Tocilizumab - Urgent Supply Petition - Patents Act, 1970, Sections 92, 100, 102 - The court discussed the severe shortage of Tocilizumab across the country, the provisions of the Patents Act allowing for compulsory licensing in circumstances of national emergency and extreme urgency, and the need for immediate availability of the drug for critically ill COVID-19 patients. The court issued directions to the Union of India and Roche Products (India) Pvt. Ltd. to provide information on the availability and distribution of Tocilizumab in India.
Fact of the Case:
The petitioner filed a petition seeking urgent supply of Tocilizumab injection for the treatment of a COVID-19 patient. The patient's condition was deteriorating, and the drug was urgently required.
Finding of the Court:
The court found a severe shortage of Tocilizumab across the country and issued directions to the Union of India and Roche Products (India) Pvt. Ltd. to provide information on the availability and distribution of the drug.
Issues: Shortage of Tocilizumab, provisions of the Patents Act for compulsory licensing, and the need for immediate availability of the drug for critically ill COVID-19 patients.
Ratio Decidendi: The court emphasized the need for immediate availability of Tocilizumab for critically ill COVID-19 patients and issued directions to ensure the same.
Final Decision: The court directed the Union of India and Roche Products (India) Pvt. Ltd. to provide information on the availability and distribution of Tocilizumab in India and listed the case for further hearing.
JUDGMENT
Prathiba M. Singh, J. - This hearing has been done through video conferencing.
2. The present petition has been 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 prayer in the petition is to issue directions to the Respondents in the petition, to urgently supply the Tocilizumab injection - Actemra 400 mg to the said hospital, so that the same can be administered to the patient urgently.
3. The patient was detected as positive for COVID-19 on 30th April 2021 and a CT scan is stated to have been conducted on him. He was diagnosed with multiple patchy areas in his lungs and with COVID-19 pneumonitis. On 3rd May, 2021, the medical condition of the patient deteriorated, and he was admitted to the said hospital. He is currently stated to be on high-flow oxygen as also BiPAP. The doctors at the said hospital, on 4th May, 2021, prescribed the drug- Tocilizumab 400 mg for being administered to the patient. However, despite repeated efforts, it is the case of the Petitioner, that the said drug/ injection has not been made available for its administration to the patient. He submits that the condition of the patient is continuously deteriorating, and the said drug is urgently required.
4. The matter was taken up on the morning session today, and the Petitioner has, thereafter, filed certain further documents on record during the lunch hour, as per which, the concerned doctor at the Malik Radix Health Care Hospital has also reported that the patient has not responded to the injection Bevacizumab 400mg and thus, requires injection Tocilizumab 400 mg for recovery.
5. Ld. Counsel for the Petitioner has emailed an amended memo of parties, during the lunch hour, wherein the Petitioner now seeks to implead the GNCTD, Drug Controller of Delhi, Union of India, Drugs Controller General of India and Roche Products (India) Pvt. Ltd. He orally also seeks the impleadment of the Union of India, through the Secretary, Department of Pharmaceuticals. Ordered accordingly. The amended memo of parties, be filed by 5 P.M today by the Petitioner's Counsel and emailed to the court master accordingly.
6. The Respondent no.5, Roche Products (India) Pvt. Ltd., ('Roche India') has been impleaded on the ground that it is the company dealing with the Tocilizumab injection Actemra, which has been prescribed for the patient. Ms. Ruby Singh Ahuja, ld. Counsel, has appeared for Roche India, before this Court, and submits that she was informed of the filing of the present writ petition and the impleadment of Roche Products (India) Pvt. Ltd., by ld. Counsel for the Petitioner during the lunch hour around 2 pm, and accordingly, she has entered appearance in the matter when it was taken up at 2.30pm.
7. The issues relating to the shortage of Tocilizumab injection have been highlighted previously by the Supreme Court in its order dated 30th April, 2021 in Suo Moto WP(C) No. 3/2021 titled In Re: Distribution of Essential Supplies and Services during the pandemic, as also by the ld. Division Bench of this Court in the order dated 20th April, 2021, in WP(C) 3031/2020 titled Rakesh Malhotra v. GNCTD.
8. The Supreme Court has, in Suo Moto WP(C) No. 3/2021 (supra) in paragraphs 42 to 46 as also 51 & 54 captured the position relating to various drugs such as Remdesivir and Favipiravir, as also Tocilizumab. The scheme of the Patents Act and the provisions relating to compulsory licensing etc., have also been considered in the said order of the Supreme Court. The relevant portion of the order of the Supreme Court is set out below:
"F. Potentiality of Compulsory Licensing for vaccines and essential drugs
42 Several drugs that are at the core of the COVID treatment protocol are under patents in India including Remdesivir, Tociluzumab and Favipiravir. On 2 October 2020, a communication was issued by the UOI, along with South Africa, to the Counci
The main legal point established is the need for immediate availability of essential drugs, such as Tocilizumab, for critically ill COVID-19 patients and the provisions of the Patents Act allowing fo....
During a national emergency, the government can exercise powers under the Patents Act to ensure the availability of essential drugs, emphasizing public health needs amid a pandemic.
Urgent assessment and supply of essential drugs in public health emergencies.
Court emphasizes urgency and coordinated efforts to ensure availability of critical medicine for COVID-19 patients while addressing broader supply chain issues.
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....
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....
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.
Court mandates government engagement to enhance drug supply for COVID-19 patients, emphasizing transparency and efficiency in distribution amidst a health crisis.
COVID-19 pandemic - frustration and harassment due to non-availability of Remdesivir, which is a prescribed drug for COVID-19 patients - Nodal Officer of GNCTD, who is dealing with Remdesivir, as als....
Covid -19 – Second wave – Directions issued to State and Central Government to make available Remdesivir, Oxygen and''RT-PCR'' and "Rapid Antigen" tests' - Every legal right has a corresponding legal....
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