The Delhi High Court has asked the Central government and the Delhi government to take immediate steps to ensure that COVID-19 drug Tocilizumab is allocated in a transparent and timely manner for the benefit of patients in need (Dharmendra Kumar v. GNCTD).
The order was passed by a Single Judge Bench of Justice Prathiba M Singh after pharmaceutical company Roche India informed the Court that in view of the COVID-19 situation in India, it has decided on its own to immediately supply 10,000 doses of Tocilizumab 400 MG.
The supply was a completely humanitarian gesture on behalf of Roche and would be free of cost, the company said.
“…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,” the Court ordered.
The Court was dealing with a petition seeking directions for urgent supply of the drug for a COVID-19 patient.
On an earlier occasion, the Court had directed that a high level meeting of government officials be held with the representatives of Roche India, the manufacturer, to assess the demand and modalities for supply of Tocilizumab, a drug being administered for COVID-19.
After perusing the minutes of the meeting, the Court noted that Roche was not able to meet the Indian demand on account of constraints on its global supply chain production units as the imports depended on its worldwide production capacity.
It recorded that Roche India supplies would only be about 43,000 doses over March-May, against the projected demand of 1,80,000 doses.
Looking at the numbers, the Court opined that although there had been some scaling up of supplies, the same would still be grossly insufficient.
The Court has now sought an affidavit from Roche India on whether any further supply of more quantities of Tocilizumab 400 MG doses could be made, and if so, within what timelines.
Information is also sought on figures of the global products of Tocilizumab for the period between January-April, 2021.
The Central government has been asked to place an affidavit on record on whether there were 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, and at what stage.
The Court has directed Deputy Controller of Patents to file a status report in respect of the details of the patents stated to be covering Tocilizumab 400 MG.
The matter will be heard next on May 13.
Additional Standing Counsel Anuj Aggarwal appeared for the Delhi government. Standing Counsel Anurag Ahluwalia appeared for the Centre. Roche was represented by Senior Advocate Neeraj Kishan Kaul and Advocate Ruby Singh Ahuja.