Thursday, September 28, 2023

Covid treatment: Delhi HC asks Centre about Tocilizumab availability and an alternative cocktail

The questions were asked by the bench of Justice Prathiba M. Singh while hearing the petition by the brother of the patient in question.

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As a brother of a patient complains that he is not being able to get the drug Tocilizumab 400 MG for his brother suffering from SARS-Cov 2, the Delhi High Court sought a response from the central government on some questions in the matter of supply and availability of the drug. The drug Tocilizumab is in extremely short supply in the country and is one of the essential drugs being prescribed.

The questions are basically around when will the drug (it is now being imported) be authorised to be used and why India cannot manufacture the drug in India.

The questions are:

i) Whether the demand for Tocilizumab 400 mg would be reduced, if the new antibody cocktail of Casirivimab and Imdevimab now approved for emergency use and authorisation, is supplied by Roche? If so, what quantities would be required of the said antibody cocktail?
ii) 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?
iii) 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 questions were asked by the bench of Justice Prathiba M. Singh while hearing the petition by the brother of the patient in question. The patient is admitted in Malik Radix Health Care Hospital, Nirman Vihar, New Delhi. The petitioner is not getting a prescribed dose of Tocilizumab 400 MG despite of multiple efforts made by him. The court has asked the government why that drig cannot be manufactured in India.

Though the original petitioner was provided this drug by the government, later court had impleaded one more applicant/patient, Smt. Kamlesh Gupta as Petitioner No. 2, who was also prescribed Tocilizumab 400 MG, but despite repeated efforts, the same was not made available to her.

Counsel for UOI and GNCTD have assured the court that they will in their best effort provide medicine to the petitioner. Today, the counsel for Kamlesh Gupta has submitted that as Kamlesh Gupta is stable now and she is no more in the need of Tocilizumab.

Complying with the directions passed by the Court on May 10, three affidavits have been emailed to the court master-
• On behalf of Roche Products (India) Pvt. Ltd.
• On behalf of the Deputy Drugs Controller (India);
• On behalf of the Office of the Controller General of Patents, Designs and Trademarks,
And all these have been received, perused and taken on record by the court.

Senior Advocate Neeraj Kishan Kaul, Counsel for Roche India along with Ruby Singh Ahuja, had submitted that the consignment of 45,000 Tocilizumab 80 mg vials, to cater to 9,000 patients, have arrived in India last week, as assured to the court. This is in the form of a humanitarian aid that has been extended by Roche. In fact, as per the affidavit filed by Roche, 100,000 vials of Tocilizumab 80 mg, to cater to 20,000 doses, has already been imported by Roche India, prior to the stipulated date of May 15, and the same is scheduled to reach the distributor, M/s Cipla Ltd, today. This has been confirmed by Ms. Sahadev, ld. Counsel appearing for M/s Cipla Ltd.

Mr. Kaul, ld. Sr. counsel also highlights the fact that insofar as licensing issues of the said drug are concerned, the Union of India has taken a stand before the Supreme Court in Suo Moto Writ Petition (C) No. 3/2021 titled In Re : Distribution of Essential Supplies and Services during Pandemic that the question of voluntary or compulsory licences for the said drug, and the invocation of the provisions of the Patents Act, 1970 is a policy decision, and the Government of India is currently dealing with the said issue at a global level, through diplomatic channels. He submits that the Union of India’s stand in the said affidavit is that any invocation of these provisions, at this stage, would be counter-productive to the interests of India.

Mr. Kunal Tandon, ld. Counsel appearing for the Petitioner, points out that the Supreme Court’s order dated 30th April 2021, in In Re: Distribution of Essential Supplies and Services during Pandemic (supra), clearly upholds the power of granting licences which are to be resorted to by the Government, in public interest. He also submits that contrary to the last order dated 10th May 2021, passed by this court, the global manufacturing and production details of the drug- Tocilizumab have not been placed by record by Roche India. Mr. Tandon, ld. Counsel, further, highlights the fact that there is an enormous demand for Tocilizumab 400 mg, and doctors have been prescribing the same qua patients suffering from COVID-19, as is clear from the case of the two patients who are Petitioners before this Court itself. He finally submits that the shortage of the said drug has resulted in high prices as the drug is being sold in black market.

Ms. Archana Sahadeva, ld. Counsel appearing for Cipla Ltd., has pointed out that the Clinical Guidelines for the management of Adult COVID-19 patient protocol, that has been issued by ICMR on 22th April, 2021 has prescribed Remdesivir, Tocilizumab and Convalescent plasma as three drugs which can be used on a EUA/ Off label basis for the treatment/management of COVID-19 patients, in certain specific circumstances. The ICMR could consider revising the said Guidance protocols, in case of presence of an alternative for the said drugs, if required.

Mr. Kaul has further submitted that the said company has to also cater to the global demands of this drug, as this drug is also meant for treating Rheumatoid Arthritis. He has submitted that the next consignment of 1 lacs doses will be in India by the end of May.
On the question raised by Court that how many patients will get their complete dose of this drug from this 1 lacks doses of this consignment, Counsel for Roche India replied that it is for 1 lacks people.

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After going through all the affidavits filed and submissions made by the parties Court has observed that the stand of the importer M/s.Roche India, who enjoys the licence of the manufacturer, in India, is that there is no certainty in respect to the further imports of the said drug- Tocilizumab that are to be made to India. The unequivocal stand of Roche India is clearl 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.

Amended writ petition is taken on record by the court. Court has further instructed that UOI have to file affidavit atleast before two days of next day of hearing.

List this matter on May 27.

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