It's living hell, we're helpless: Delhi HC on black fungus drug shortage.
“We are living this hell. Everyone is living this hell. It’s a situation where we want to help but we are helpless,” the Delhi High Court lamented on Friday while hearing pleas on the shortage of black fungus medicine and the problems being faced by the patients.
While the Centre placed a report giving the steps taken by it to source the medicine and overcome shortages, the high court directed it to give further details on current status of its imports and when the stocks are expected.
The court, which was hearing two pleas seeking medicine vials for two patients admitted here for black fungus infection, expressed helplessness over the situation and said it cannot pass any order that a particular patient should be given preference for treatment while denying it to others.
The issue of shortage of the medicine for treating black fungus was raised by advocate Rakesh Malhotra who said the black fungus cases, affecting COVID-affected people, are rising.
The 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, asked the government to explain the reason behind choosing this figure as the “today’s requirement of the medicine is much more”.
“The Union of India shall place a report giving the detailed current status of the said imports. It will be considered on Monday. It has to indicate how the figure of 2.30 lakh vials was arrived at and whether there is a greater availability of the drug which could be imported,” a bench of Justices Vipin Sanghi and Jasmeet Singh said, which heard for six hours the matter relating to various issues arising out of the COVID-19 pandemic.
The court asked the Centre to come back on May 31 with a definite statement as to what happened to these 2.30 lakh vials, where are they, what is the stage, when are they coming to India, has the order been placed or not.
When one of the Centre’s advocate said the order for the vials has been placed abroad, the bench said, “we are running against time. If you placed the order on May 24, today it should have been here”.
“We are only expressing out anxiety because of the proportions this thing is assuming. Every hour is assuming a new proportion,” the bench said, adding that “the effort here is to save lives and every hour matters”.
Additional Solicitor General Chetan Sharma said as per the information updated on the portal, the number of patients under treatment for mucormycosis (black fungus) in India are 14,872 on May 28 (9:00 AM) and this includes 423 patients in Delhi.
“Out of the sources that have been presently identified abroad, the Ministry of Health and Family Welfare (MoHFW) on May 24 has called upon Ministry of External Affairs (MEA) to take steps to procure 2,30,000 vials of Liposomal Amphotericin-B from Australia, Russia, Germany, Argentina, Belgium and China.
"MEA has also been called upon to procure 50,000 tablets of Isavuconazole. Steps in this regard are being taken by the MEA,” said the Centre’s report, filed through advocates Amit Mahajan, Kirtiman Singh and Nidhi Mohan Parashar.
The Centre said domestic production capacity of Amphotericin B Liposomal Injection has progressed as while in April it was 62,000, in May it was 1,40,000 and in June it is expected to be 3,25,114.
It said the main impediment in granting more licences for manufacture of Liposomal Amphotericin B is the shortage of the raw materials and excipients worldwide.
It said the MEA has been working on ensuring supplies of key excipients from sources abroad for production of Liposomal Amphotericin B (Amphonex) in India and added that imports are being made by Mylan Labs from Gilead Inc.USA and the government is working to increase the imports and for early delivery.
Regarding the medicine supplies made to Delhi, the Centre said 400 vials were allocated on May 24, 300 vials on May 26 and 1920 vials on May 27.
It said as per the tentative estimation of joint monitoring committee under the Directorate General of Health Services, 20 per cent of the total active COVID-19 cases are moderate to severe and may require hospitalisation. From these 20 percent of moderate and severe cases, 1:500 to 1:1000 cases may develop mucormycosis.
The court had earlier said the gap between demand and supply of Amphotericin B was “too wide to bridge” and drastic steps are required to be taken.
According to the Union Health Ministry, people catch mucormycosis by coming in contact with the fungal spores in the environment. It can also develop on the skin after the fungus enters the skin through a cut, scrape, burn, or other type of skin trauma.
The disease is being detected among patients who are recovering or have recovered from COVID-19. Moreover, anyone who is diabetic and whose immune system is not functioning well needs to be on the guard against this, the ministry has said.
