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The Single Judge Bench of Justice Prathiba M Singh while hearing a petition related to supply & availability of the drug Tocilizumab 400 MG for COVID-19 patients has directed the Union of India & GNCTD to take immediate steps to ensure transparent, efficient & timely distribution of the same to the States/UTs so that they can be immediately administered to patients who are in need and have been duly prescribed with the same.

The Court also directed the relevant department of the Union of India either the Department of Pharmaceuticals or the Drug Controller General of India to place an affidavit stating as to 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 & Mr. Sameer Kumar Swarup, the 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 working statements in respect thereof, including the date of filing, the term of patent etc. by 12th May, 2021. 

Ld Counsels appearing for Roche India were directed to take instructions from M/s Chugai Seiyaku Kabushiki Kaisha or any other entity involved in the supply chain to make submissions as to whether any further supply of more quantities of Tocilizumab 400 MG doses could be made, and if so within what timelines, in order to cater to the actual demand for patients in India & also to include in its affidavit the global products figures of Tocilizumab for the period January-April, 2021. 

The Court vide order dated May 6, 2021 had issued the following directions: 

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.

The said meeting shall be held tomorrow i.e. on 7th May , 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 will be emailed to the Court master by 6 pm on 9th May 2021.

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.

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.

In this regard, the Counsels appearing for the parties today, submitted that the first meeting was held on 7th May 2021 & another meeting was held on 8th May 2021 with respect to the projected demand made & the supplies that have come/ been imported of the  drug Tocilizumab 400 MG. The Counsel also informed the Bench that the same was attended by five senior officials from the Department of Pharmaceuticals and Ministry of Health, four officials of Roche India and three officials from Cipla Ltd were also present. 

Ld Counsel for Roche India submitted that considering the recent spike of CoVID 19 pandemic, the Company on its own decided to immediately supply 10,000 doses of Tocilizumab 400 MG free of cost & also supply 10,000 doses of Tocilizumab 400 MG by 15th May, 2021.

The matter is listed for further hearing on May 13, 2021 at 2:30 PM. 

Case Title: Dharmendra Kumar Aggarwal V. Govt. Of NCT Of Delhi Through The Secretary & Anr.| W.P.(C) 5173/2021