A direction was also issued to Roche to file an affidavit confirming that it would be importing in India 50,000 and 25,000 vials of the medicine in mid-May and mid-June, respectively.
In view of the “acute shortage” of Tocilizumab which is prescribed to a large number of COVID-19 patients, the Delhi High Court has directed the Union Health Ministry and Department of Pharmaceuticals to hold a meeting with Roche India, which sells the drug here, to esnure immediate supplies of the medicine.
Justice Prathiba M Singh said the officials of the Ministry and the department shall hold a meeting with representatives of Roche India and its distributors here “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 court said in its May 6 order.
It passed the order after Roche told the court that it has no confirmed orders from the central government and was not aware of the actual demand in India.
The court said the minutes of the meeting, to be held on Friday afternoon, shall be placed before it by May 9 evening.
The court also directed central government standing counsel Anurag Ahluwalia, appearing for the ministry, to 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, if any, in relation to Tocilizumab along with the working statements filed in respect of the said patents.
A direction was also issued to Roche to file an affidavit confirming that it would be importing in India 50,000 and 25,000 vials of the medicine in mid-May and mid-June, respectively.
On this aspect Roche said that its distributor/licensee — Cipla Ltd. — would have better information regarding distribution and supplies and urged that it too be made a party in the matter.
The court allowed the request and made Cipla also a party in the matter and listed it for hearing on May 10.
The court was hearing a plea moved on behalf of two COVID-19 patients who were prescribed Tocilizumab by the doctors, but were unable to arrange the medicine from anywhere.
One of the patients, who moved the plea on May 5, was provided the medicine after the court intervened and in respect of the second, who approached the court on May 6, the lawyers for the Centre and Delhi government said they will make efforts to make the required dose available to her.
During the hearing on May 6, Roche told the court that the drug was not being manufactured in India and the sudden spurt in its demand was unexpected.
It said that in 2019, the demand for total consumption was only about 8,900 vials for the entire year. However, from March 2020 to April 2021, a total of 2,10,000 vials have been supplied to India.
“The latest batch of vials imported was of 11,000 vials on April 26, 2021. Out of the said batch, 9,900 vials were supplied to the central government for distribution to COVID-19 related institutions, and 1,100 vials were supplied to other government institutions for being administered to patients suffering from arthritis,” the company told the court.
It further told the court that an emergency approval has been obtained for an ‘Antibody Cocktail Treatment’ which would be distributed in India, and this would be a treatment meant specifically for COVID-19, unlike Tocilizumab which was originally a drug for arthritis and is only an investigational therapy for COVID-19.
Mr. Ahluwalia told the court that the central government does not have any stock of the drug with it as what it received was distributed to the states, union territories and other institutions.
Delhi government told the court that the entire stock of 500 vials of the drug which was received by it has already been distributed and there is no stock available with it.
It also told the court that it does not collect data relating to consumption of Tocilizumab from the hospitals or medical establishments to whom the vials were supplied.
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