Delhi HC Directs Centre, Delhi Govt To Take Immediate Steps To Ensure Transparent Allocation, Distribution Of Tocilizumab Doses To States/UTs

The Delhi High Court on Monday directed the Centre and the Delhi Government to take immediate steps to ensure that the Tocilizumab doses received by tonight and May 15 are allocated and distributed transparently in a timely and efficient manner to all States and Union Territories for administration of patients who are in dire need of the same.

A single judge bench comprising of Justice Pratibha Singh also directed the Centre and the Department of Pharmaceuticals or the Drug Controller General of India, to 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.

Moreover, the Bench also directed counsel for Roche India, only importers of the drug, to take instructions 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 Court was dealing with a petition filed by brother of one Sudhir Kumar Agarwal, a covid 19 patient admitted in Malik Radix Health Care Hospital, Nirman Vihar, New Delhi praying for directions on GNCTD and Union of India to urgently supply the Tocilizumab injection - Actemra 400 mg to the said hospital, so that the same can be administered to the patient urgently.

The Court had on previous hearing called for a high level meeting for assessing the demand for Tocilizumab in India and also to discuss the modalities for import and supply of the drug as per the expected demand and further logistics for its placing orders.

During the course of hearing on Monday, Minutes of the Meetings between senior officials of the UOI along with functionaries of Roche India and its distributors were placed on record wherein it was mentioned that the representatives of Roche expressed their inability to give a timeframe in which the quantity demanded by Cipla could be confirmed as they are only importers and were fully dependent on global supply chain.

The Court was apprised by Roche India that the total number of doses which shall be supplied by the end of week would be 10,000 doses of Tocilizumab 400 MG, which shall be received by tonight and that further 10,000 doses of Tocilizumab 400 MG will be received by 15th May, 2021 making a total of 20,000 doses of Tocilizumab 400 MG.

Noting the aforesaid submissions, the Court opined thus:

"Even if in addition, the 10,000 Tocilizumab 400 MG doses, which are expected to arrive in India tonight, as a humanitarian aid, along with the 10,000 doses of Tocilizumab 400 MG to be supplied by 15th May 2021 (already considered in the table above), are added, the total supply would still amount to approximately 43,000 doses, as against a projected demand of 1,80,000 doses over the last three months. Thus, this would only constitute less than 25% of the required demand of Tocilizumab 400 MG projected for patients in India."

Observing that however there has been a scaling up in supplies by Roche India but the same will be "grossly insufficient", the Court asked Roche India to obtain instructions on Court's suggestion that the manufacturer can be impleaded in order to ascertain as to how the demand of patients in India, who are willing to pay for the medicine, can be met,

Directions of the Court

- 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.

- Union of India and 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 a status report be filed by Deputy Controller of Patents, 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.

- 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.

Giving time till May 12 for filing of all the affidavits and status report in the matter, the Court posted the matter for further hearing on May 13.

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