Meanwhile, the Delhi High Court has asked the Centre to explain why the drug is in shortage.
Black fungus infection: India has been reporting an increasing number of black fungus cases from several states, and about 9,000 cases have been reported so far. However, amid this rise in cases, the primary drug used to treat the mucormycosis fungal infection – Liposomal Amphotericin B – is in short supply. There have been numerous reports stating that this drug is being hoarded and black marketed in recent times. Meanwhile, the Delhi High Court has asked the Centre to explain why the drug is in shortage, as per an IE report.
Mucormycosis is a rare fungal infection. However, a paper published in Journal of Fungi in 2019 had estimated that in India and Pakistan, the incidence of the infection was 140 per million people, which was the highest among all the countries which were taken into account in this estimation. Earlier this month, AIIMS director Dr Randeep Guleria had said that many parts of India were reporting an increase in the number of cases of a supplementary fungal infection called Covid-Associated Mucormycosis (CAM). He linked this infection with the “irrational” way in which steroids were being used for treating COVID-19 patients.
On May 20, the Union Ministry of Health and Family Welfare made black fungus infection notifiable, which meant that states had to mandatorily report suspected as well as confirmed cases of the infection. The highest number of cases of the infection are being reported from Gujarat, followed by Maharashtra, the report added.
As per doctors, the infection has to be treated quickly and aggressively. It is also a big help if the infection is detected early, and to treat it, doctors have to mostly use anti-fungals. But in some cases, surgery is required to scrape off the fungus, the report added.
Liposomal Amphotericin B injection is the most common anti-fungal used for such cases, after which doctors opt for Amphotericin B deoxycholate (plain) injection, but it can cause some issues to the kidney and hence is only used among young patients who do not have any kidney problems. The third choice is Pfizer’s isavuconazole, which is available as an injectable vial as well as a tablet. The report added that the fourth option is generic posaconazole, which is also available in both injectable and tablet forms.
The treatment of the infection using Amphotericin can go for 4 to 6 weeks. During this period, a patient can require 90 to 120 injections of the drug, and the cost can come up to Rs 5 lakh to Rs 8 lakh, or even beyond that. However, the main obstacle right now is the shortage of the drug,
At the moment, with simple calculations, India needs at least 9 to 10 lakh injections of the drug and the requirement is expected to go up in the upcoming days. Currently in India, Mylan is importing the drug and supplying it, while BDR Pharmaceuticals, Cipla, Bharat Serums & Vaccines, Life Care Innovations, and Sun Pharma are manufacturing the drug. However, the production volume of the drug has remained on the low side always due to the low number of cases.
Once the reported cases began to increase, it was estimated that with the help of the government, these companies would collectively be able to produce 1.63 lakh vials of the drug in May, while another 3.63 lakh vials were being imported. But, the report citing Centre’s data said that for the period between May 10 and 31, only 67,930 injections have been allocated to the different states, which is significantly lower than their requirement.
Even though the state had last week licenced five other manufacturers to produce the drug, they are only expected to begin production in July while collectively supplying about 1.11 lakh vials only, which means that for the foreseeable future, the country would have to depend on imports for meeting most of the requirement.
There is an issue in production of the drug largely due to a shortage of two raw materials, the report added. One of them is the active pharmaceutical ingredient (API) Amphotericin B, and the second is purified synthetic lipids to produce liposomal Amphotericin B. The situation regarding the supply of these materials is expected to ease within the next 4 to 6 weeks for all manufacturers, but even then, it takes 21 days for the production of the drug, the report added.