COVID- Delhi High Court Issue Directions To Ensure Immediate Availability Of Tocilizumab For Critically Ill Patients

While observing that the lack of supplies from foreign shores and no local manufacturing of the covid drug Tocilizumab is completely unacceptable in the pandemic situation, the Delhi High Court on Monday issued slew of directions for its availability in India.

A single judge bench comprising of Justice Pratibha M Singh directed the Centre to inform the Court about the stock available for distribution of the said drug to various Hospitals and Medical Establishments in Delhi. It also directed the Centre to place on record details of entities to whom approvals have been granted of Tocilizumab for manufacturing, marketing, importing or selling in India.

The development came in 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.

Agarwal was diagnosed with multiple patchy areas in his lungs and with COVID-19 pneumonitis and was admitted in the hospital on 3rd May after his condition worsened. He was later prescribed Tocilizumab 400 mg, however, despite repeated efforts, the said drug/ injection has not been made available for its administration to Agarwal.

Noting that the Supreme Court while dealing with the suo moto writ petition titled In Re: Distribution of Essential Supplies and Services during the pandemic and also the Delhi High Court orders observed that there is a severe shortage of the drug Tocilizumab across the country, the Court observed thus:

"A reading of the above orders also shows that the issues relating to pricing, shortages and steps to be taken at the National level, including by the Central Government are being considered therein. In Delhi too there is shortage and several critical patients are being prescribed this drug."

Furthermore, the Court also went ahead to observe that there is an imminent need for the said drug in Delhi for critically ill patients who are being prescribed the same.

"From the publicly available records it is clear that certain patents are stated to have been granted in respect of this drug. The order of the Supreme Court clearly records that the drug is not being manufactured in India. Considering the demand for the drug, even to those patients who are willing to pay and purchase the same, it is clear that adequate quantities are not being made available. The rationing of critical medicines in this manner, owing to lack of supplies from foreign shores and no local manufacturing, is completely unacceptable in a pandemic situation, especially when the consumers are willing to purchase the drug." The Court observed at the outset.

In view of this, the Court issued the following directions to ensure immediate availability of the drug for administration to critically ill patients:

- The Union of India to inform this Court, on the next date of hearing, as to how much further stock of Tocilizumab is available for distribution to the hospitals/medical establishments in Delhi

- The UOI to also place on record the details of entities to whom approvals have been granted of Tocilizumab for manufacturing, marketing, importing or selling in India

- Qua the 500 vials of Tocilizumab, which were already allocated to the GNCTD by the Union of India, the GNCTD to inform this Court as to how much of the said stock has been consumed, and if any of the said stock is currently available for administration to any further patients who are being treated in smaller hospitals/ medical establishments, as also to the hospitals where the initial quantity of allocation could not be distributed.

- Place data before the Court as to: A. Whether immediate quantities of the drug Tocilizumab can be obtained from any of the manufacturing units engaged in manufacture of the said drug, and made available in India, for the purpose of administration to Covid-19 patients in India? B. The quantities of the drug Tocilizumab to be made available in India either through itself or through its licensee(s) in India on a monthly basis for the next four months. C. What is the total quantity of this drugTocilizumab, that has been imported/sold in India since March 2020 - either by the company itself or through its licensee(s) or approved importer(s) in India.

The matter will now be heard on 6th May 2021.

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