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 to respond as to 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 by way of an affidavit to be filed two days before the next date of hearing.
Along with this, the court has also directed the Union of India to respond as to:
- 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
- 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 upon hearing the parties took note of the fact that the importer M/s.Roche India having the licence of the manufacturer, in India, did not provide any certainty with regards to the further imports of Tocilizumab.
“No assurance is being given as to further stocks that can be supplied to India. One of the justifications for the same by Roche is that the investigational antibody cocktail- Casirivimab and lmdevimab, as mentioned in paragraph 10 of the affidavit filed by Roche India, may be a better treatment for COVID-19 patients. According to Roche India, its current focus is to supply the said antibody cocktail. According to counsels, 1,00,000 doses of the said investigative antibody cocktail, which is stated to have been approved for emergency use and authorization in India, is likely to be sent to India by the end of May. The unequivocal stand of Roche India is clearly that more imports and supply ofTocilizumab 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 also observed.
The matter is listed for further hearing on May 27, 2021.
Case Title: Dharmendra Kumar Aggarwal V. Govt. Of NCT Of Delhi Through The Secretary & Anr.| W.P.(C) 5173/2021