In Madhya Pradesh, 100 doses were distributed among 218 patients admitted to 23 private hospitals in Indore on Monday. Attendants of the patients suffering from black fungus along with their kin, sat on a dharna in the hall of a government medical college, enraged over the unavailability of Amphotericin B injections. The drug is available only from the designated shops on the written recommendation of a three-member committee headed by the dean of the medical college.
The Gujarat High Court on Wednesday called the state government's notification on the distribution of Amphotericin-B injections to hospitals for the treatment of mucormycosis "quite vague and defective".
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Maharashtra filed a global tender for Amphorectin B to meet the demand in the state. Chandigarh alone ordered 2,000 vials of Liposomal Amphotericin B injection with Mylan company for a supply costing about ₹1.2 crores.
Drastic steps are required to bridge the gap between the demand and supply of Amphotericin B, the primary drug used for treating black fungus. The current production and supply and the projections of the same may fall well short of the requirement of the medicine to treat the patients all over the nation.
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This is what the Delhi High Court told the Centre as it heard the government’s status report on acquiring the anti-fungal drug for the rising cases of black fungus in the national capital.
The gap between the demand and supply is more than one-third.
As of May 25th, there are 11,717 patients under treatment for mucormycosis across the country.
The fungal infection affects the sinuses, brain and lungs and is particularly dangerous for immunocompromised people.
Early detection of the infection helps in the treatment which involves anti-fungals and in some cases, surgery.
There are only a few drugs available for treatment- liposomal Amphotericin B, Amphotericin B deoxycholate (plain), Isavuconazole and posaconazole.
Amphotericin B is the most common and primary drug used in the treatment. It is an intravenous injection which is given 4-6 weeks and requires 90-120 injections. The current cost of a single dose is between Rs 6000-9000 rupees and the treatment can cost ₹5-8 lakh or even more.
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A patient is administered around 6 injections in a day. On average, one patient requires 100 vials. With over 11,000 patients, India requires over 11 lakh. The number of cases are also expected to rise significantly.
Currently, there are only 5 manufacturers of this drug in the country- Bharat Serums & Vaccines, BDR Pharmaceuticals, Sun Pharma, Cipla, and Life Care Innovations. Mylan imports the drug and supplies.
Like in the case of Remdesivir, the Centre has taken over the supply and distribution of Amphotericin B to states, and the state is distributing the injections on the basis of criticality and seriousness.
The centre has given license to 5 more manufacturers to start production of the drug.
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The expected supply of the drug in May is 1.36 lakh vials, in June it would be 2.55 lakh vials. Besides the domestic production, there is an import order of 7.05 lakh vials and the government is trying to find out other avenues.
There’s also a shortage of two raw materials that is hindering the proaction capacity. The first is active pharmaceutical ingredient (API) Amphoterecin B. It is required for both liposomal form and plain form. The second is purified synthetic lipids. It is in demand globally for manufacturing of mRNA vaccines. There is only 1 lipid supplier in India.
The production of Amphoterecin B takes around 21 days besides the time taken for sterility test. Even with all the ramped up production, the domestic supply will not be enough to meet the demand. India is likely to remain dependent on imports.
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