Delhi HC directs Centre to form policy on distribution of drug to treat black fungus patients

black fungus
Broad, wide-angle non-septate hyphae of the fungus Mucor, from the paranasal sinus of a patient with diabetes mellitus. Modified giemsa stain of frozen section. Photo: David A Litman/Shutterstock

New Delhi: The Delhi High Court Tuesday said it was passing with "a heavy heart" a direction for the Centre that a policy on distribution of Liposomal Amphotericin B drug for treating black fungus be made giving priority for patients of younger generation who can build and take the country forward.

It said the administration of drug has to be prioritised for those with better chances of survival as also the younger generation, having promise of future over the older ones who have lived their lives and added that this could at least save some lives, if not all.

The high court made it clear that it was not at all saying the lives of older people are not important as the emotional support which the elderly persons provide to a family cannot be discounted.

A bench of Justices Vipin Sanghi and Jasmeet Singh said the Centre may carve out an exception in the policy for those serving the nation in high position and whose safety and security is necessary because of the pivotal roles that they play.

"Why do you provide SPG cover to the Prime Minister of the country and not to others? Because that is what is required by his office. Similarly, you provide it first to those who are serving the society," the bench said.

"We need to protect our future, we need to protect our younger generation. You can't let them down. They will build the nation and take our country forward, it said, adding that we have made this order with a heavy heart but we have to do it".

If all patients cannot be treated it falls on the Centre to spell out its policy with regard to priority of patients so that at least some lives could be saved, if not all, the bench said, adding that the policy decision needs to be taken with inputs from medical experts.

It said while the younger generation holds a promise to the future of the nation, elderly people do not have dependents.

We are not discounting the emotional support which the older generation provides to the family, particularly in Indian families which are so closely bonded. However, in times like these, difficult choices have to be made and shall be made by the State, the bench said.

It said the drug is in shortage in the entire country including Delhi for the last two weeks and judicial cognisance can be taken that due to non-availability of the choice of drug, that is, Liposomal Amphotericin-B, and lack of information on the alternative medicine, a large number of fatalities are taking place.

The high court said it is high time that the Indian Council for Medical Research (ICMR), which is a statutory body constituted to lay down guidelines for medical treatment of patients suffering from various ailments, comes out with clear guidelines on the use of Liposomal Amphotericin-B, plain Amphotericin-B and Posaconazole, for black fungus treatment.

The high court, which was informed that steps are being taken by the Centre to procure 2.30 lakh vials of Liposomal Amphotericin-B from six countries, was not impressed with the explanation offered and said it appeared from the report that there is hardly any vials coming from the sources from where they were expected.

Mr. Kirtiman Singh (Centre's advocate) are you kidding us here? I am not understanding the exercise how is it panning out here. We are not getting your figure. It is a notional figure. One week has gone by and you have not given the information we wanted

You are completely vague and non committal. Tell us out of 2.30 lakh vials, how much my country India has received, Justice Singh said.

The high court said despite best efforts, availability of the drug remains acutely short and as per the data, there is a shortage of 66 per cent while cases of black fungus are showing an upward range.

The high court was informed that the number of active black fungus cases in Delhi were 753 on May 31 and 792 today.

The court said several questions are arising which can only be answered by medical experts committee like the ICMR and explained some of them including, whether it is medically prudent to administer two vials of medicine to a patient suffering from black fungus on daily basis even if the advised dosage is 6 vials per day.

The other questions are if due to shortage of medicine, a patient is given two vials per day, what are the other drugs he can be given to cure to disease and if there is loss of any body part and possibly eventual death, whether it is medically prudent to identify patients who should be given the dose first at the cost of others.

It noted that the Centre has been making efforts to procure the drugs by getting in touch with the primary manufacturer and the manufacturing capacity in India has been augmented and fresh licences issued.

However, the requirement of Liposomal Amphotericin-B is far in access of its availability. In this situation, in our view, it is fallen on the shoulders of the Centre to take a policy decision with regard to the manner in which the drug should be made available to patients.

The court directed the Centre and ICMR to file their respective status reports on these aspects and listed the matter for June 4.

Meanwhile, the court was informed by a patient's grand daughter, who was seeking direction to the government and Sir Ganga Ram Hospital to provide a sufficient number of vials of Amphotericin B to him, that his condition was stable and has been discharged from the hospital and she does not wish to pursue her plea.

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