Delhi High Court Seeks Centre's Response On How It Intends To Obtain Supply Of Tocilizumab Drug

Observing that no assurance was given by Roche India, which enjoys the license of manufacturing Tocilizumab 400 mg, if any further stock can be supplied to India, the Delhi High Court on Thursday sought Centre's response on the demand of the said drug and how does the Centre intend to obtain the supplies of the said drug through Roche India and other global manufacturers.

A single judge bench comprising of Justice Pratibha M Singh sought Centre's response on the aforesaid three issues:

- Whether the demand for Tocilizumab 400 mg would be reduced, if the new antibody cocktail of Casirivimab and lmdevimab now approved for Emergency Use and Authorisation, is supplied by Roche and if so what quantities would be required of the said antibody cocktail?

- If Tocilizumab 400 mg is required for Covid-19 patients, how does it intend to obtain the supplies of the said drug through Roche India, or through its global manufacturers namely F. Hoffman- La Roche Ltd., Switzerland at M/s Chugai Seiyaku Kabushki Kaisha, Japan?

-When are the results for the Phase III trials for the drug Tocilizumab, which have now been approved on 12th May, 2021, in favour of two Indian companies - M/s Hetero Biopharma Ltd., and M/s JSS Medical Research India Pvt. Ltd., expected and details of the applicable guidelines?

The Court has directed the Centre to file an affidavit by 25 May i.e. two days before the next date of hearing which is scheduled to take place on 27 May.

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 direction came after the Court perused the affidavit filed by Roche India stating that there is no certainty in respect to the further imports of the said drug to be made to India.

"The global manufacturing figures of this drug have also not been filed before this Court despite specific directions. No assurance is being given as to further stocks that can be supplied to India." The Court observed.

The Court noted that the justification accorded by Roche India stating that the investigational antibody cocktail- Casirivimab and lmdevimab may be a better treatment for COVID-19 patients, the same shows that Roche's current focus is to supply the said antibody cocktail.

"The unequivocal stand of Roche India is clearly that more imports and supply of Tocilizumab in India would only be endeavoured upon, and there is no clear assurance or undertaking to meet the required market demand, despite there being patients who are willing to pay for the medicine." The Court observed at the outset.

During the previous course of hearing, the Court 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.

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