Black Fungus- "Responsibility Falls On Centre's Shoulders To Spell Out Policy For Priority Of Patients To Be Administered Amphotericin-B": Delhi High Court

Observing that younger patients may have to be prioritized in comparison with the older generation "which has lived its life", the Delhi High Court has directed the Centre to spell out its policy with regard to the priority of patients who should be administered the said drug, to maximize the lives that could be saved, amongst patients suffering from Mucormycosis also known as black fungus.

A division bench comprising of Justice Vipin Sanghi and Justice Jasmeet Singh observed thus:

"The responsibility has fallen on the shoulders of the UOI to take a policy decision with regard to the manner in which the said drug should be made available to the suffering patients, till such time as the shortage of Liposomal Amphotericin-B continues, or an alternate equally effective and safe medicine is found for treatment of the said disease. If all patients suffering from the said disease cannot be treated on account of non-availability of the said drug in sufficient quantity, the responsibility falls on the UOI to spell out its policy with regard to the priority of patients who should be administered the said drug, to maximize the lives that could be saved, amongst patients suffering from Mucormycosis (Black Fungus)."

The Court further observed thus:

"Administration of the said drug on patients who have better chances of survival may have to be prioritized. Similarly, within the group of patients who have same or similar chances of survival, patients who are younger and who hold the promise to run the nation in future, may have to be prioritized in comparison with the older generation which has lived its life and on whom others may not be as dependent financially. While so observing, we are, not for a moment, discounting the emotional and psychological support that the older generation provides to families, particularly, the Indian families who are so closely bonded. However, in times like these, practical choices have to be made, and should be made by the State."

In view of this, the Court further directed the Centre to frame a policy with regards to the administration of the drug to the patients and how allocation should be made by the Centre since its calling for information on its portal from all over the country of all the patients who are suffering from the said disease.

Taking into account the two status reports filed by the Centre dated 31st May and 1st June, the Court observed that the probable sources from which 2,30,000 Vials of Liposomal Amphotericin B were to be sourced "have proved to be of no avail, and it appears that there are hardly any Vials coming from the sources from which it was expected that 2,30,000 Vials would be received."

In view of the submissions made during the course of hearing, the Court raised some pertinent questions to be answered by ICMR including:

- Whether it is medically prudent to administer, to a patient suffering from Mucormycosis (Black Fungus), two Vials of the said medicine on a daily basis, if the advised dosage is six Vials per day, i.e. 300 mg per day?

- If a patient – due to shortage of the said medicine, is allocated only two Vials per day, what are the other medications which he could be administered in combination, if at all, to tide over the shortage, and cure the disease?

- Whether a patient – who is not administered the full required dosage of Liposomal Amphotericin B, is exposed to progress of the disease leading to loss of one, or the other, body part such as eyes and jaws, and possibly, eventual death?

- Whether it would be medically prudent to identify patients who should be given the full doses of Liposomal Amphotericin B, so that their lives could be saved, even if it is to be at the expense of denying the said drug to another patient who may need the same? If so, what should be the basis for medical categorisation/ prioritization of the patients?

Observing that shortage of the drug for treating black fungus is there not only in Delhi but all over the country, the Court ordered thus:

"It is high time that the ICMR – which is statutory body constituted to lay down policy guidelines with regard to the medical treatment of patients suffering from various diseases, comes out with clear guidelines on the use of Liposomal Amphotericin-B, Plain Amphotericin-B, Posaconazole, etc. for treatment of Mucormycosis(Black Fungus), and also advises the Central Government on the classification of cases which should be prioritized for the purpose of administration of the various drugs, such as Liposomal Amphotericin-B, Plain Amphotericin-B, Posaconazole ."

With the aforesaid observations, the Court asked the Centre to file status repot in the matter before the next date of hearing.

The matter will be considered next on Friday.

Title: RAKESH MALHOTRA v. GOVERNMENT OF NATIONAL CAPITAL TERRITORY OF INDIA AND ORS

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