Pharma companies are scrambling to ramp up the production of antifungal drug Amphotericin B injection, which is critical in the treatment of mucormycosis, also called 'Black Fungus'.
Black Fungus is rare but rising, with India reporting about 140 cases per million people with a high mortality rate of 38 percent during pre-COVID times. The overuse of steroids in COVID-19 patients, especially in people with comorbidities like diabetes, is said to be the main reason for the current high number of Black Fungus cases in India. Hospitals are reporting 10-15 times more cases over normal times.
Industry sources told Moneycontrol that it would take at least 15-30 days for new production to hit the market, as the drug is complex to manufacture and would require a certain number of days of sterility data before the batch is released.
"There has been a sudden increase in demand for Liposomal Amphotericin B in India due to the rising cases of mucormycosis," a Sun Pharma spokesperson told Moneycontrol.
"We have ramped up production of Lambin 50 Inj (Liposomal Amphotericin B) to meet the additional demand. Because of the advanced technology we are using in our manufacturing process, we are confident of increasing our production rapidly," the spokesperson added.
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Amphotericin B is the primary drug required to treat Black Fungus that damages the nose, eyes, sinuses, and sometimes even the brain. The demand is especially acute for Amphotericin B of Liposomal formulation.
Sun Pharma, along with more than half a dozen companies including Mylan, Cipla, Bharat Serums and Vaccines, Intas and Abbott manufacture and distribute the drug in India. Moneycontrol learns that in normal times there was practically no demand for this product. Companies were manufacturing the drug only in limited quantities, not exceeding tens of thousands of vials.
Another major supplier Bharat Serums and Vaccines (BSV) told Moneycontrol that the primary focus of the company is to address the current demand for Liposomal Amphotericin B in the country due to the surge in fungal infection in post-COVID-19 cases.
"We are constantly updating government authorities on stock positions and allocations at critical locations. To further understand the requirements and provide timely support, we are constantly in touch with doctors, hospitals and stockists," a BSV spokesperson told Moneycontrol
For instance, Liposomal Amphotericin B, sold under the brand name Amphonex by BSV at MRP of Rs 6,890 per vial, is running out of stock. The same is the case with Sun Pharma's Lambin 50 Inj (Liposomal Amphotericin B) that costs about Rs 4,739.30 per vial, according to online pharmacy Netmeds.
Expensive and complex drug
The shortages have led to hoarding and black marketing of the drug, where the prices are quoted at 5-10 times the maximum retail price. The drug has to be administered for three weeks, through intravenous infusion to hospitalised patients. The number of vials would depend on the doctor's prescription and patient condition, but it would require 4-8 vials in a day, and the duration of the treatment would be 15-30 days. That makes it the most expensive drug. A patient would have to spend a minimum of Rs 3 lakh on the drug even if we assume the lowest number of vials and the lowest band of treatment days.
BSV said that the company is working with the government and suppliers of raw materials to expand production
"..the company is unceasingly working with the government authorities and suppliers to meet the increased demand of key input materials and developing various measures to assist the patients in every possible way,” the BSV spokesperson added.
Sun Pharma also has said that it is following the directive of the regulator and other government authorities for the distribution of Lambin 50 Inj to ensure that the product reaches patients at the approved prices.
Government takeover of distribution
Shortages and soaring prices in the black market have pressed the Centre and state governments into action.
Minister of State for Chemicals and Fertilisers Mansukh Mandaviya on May 18 reviewed the requirement and supply position of Amphotericin B.
He said the government has chalked out a strategy with manufacturers to increase domestic production as well as to import the drug from all over the world, and assured that the shortage is expected to be resolved at the earliest.
The central government said it has outlined the system for efficient distribution and supply chain management of Amphotericin B and urged states to use this drug judiciously by strictly following the prescribed guidelines.
The Maharashtra government said it will float a tender to procure one lakh Amphotericin-B injectionsDelhi and Telangana authorities have already taken over the allotment of Amphotericin-B injections in their respective states.