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Thursday, June 24, 2021

Challenging to procure drug for mucor treatment, high cost and low production main obstacles

"Whatever injections we could get will be used today, for tomorrow we have nothing," said his daughter Kusum Sachdeva. Her father's infection has slowly crept up his nose and is spreading towards his eyes in spite of two surgeries to cut it out.

Written by Tabassum Barnagarwala | Mumbai |
Updated: May 24, 2021 12:10:03 am
Black Fungus, DelhiDoctors treat a black fungus infected patient in a hospital. (Photo: PTI)

Each day that 64-year-old Dwarkadas Wadhwa (64) spends at PD Hinduja Hospital fighting off mucormycosis, the fungal infection brings forth a new set of challenges for his family.

“Whatever injections we could get will be used today, for tomorrow we have nothing,” said his daughter Kusum Sachdeva. Her father’s infection has slowly crept up his nose and is spreading towards his eyes in spite of two surgeries to cut it out.

Wadhwa is one of 1,500 patients suffering from Covid-associated mucormycosis or black fungus, in Maharashtra. While 90 have died so far, the extremely costly and rare antifungal medicine, liposomal amphotericin B injection, has emerged as a lifesaver for many. The procurement of the drug, however, has been a massive challenge for many like Wadhwa, who require anything between 90 and 120 vials that cost anything between Rs 6,000 and Rs 8,000 each.

Wadhwa, who recovered from Covid-19, was diagnosed with mucormycosis and prescribed 100 vials of amphotericin B on May 15 by Hinduja hospital. With the hospital pharmacy unable to procure the stock, the responsibility fell on the Wadhwas. They reached out to the BMC, visited the collector’s office and even travelled to Pune. “We have spent lakhs already and managed to buy just 30 injections. My father needs 100,” Sachdeva said.

When the family went to the Mumbai collector’s office, they were directed to the Thane collector since they resided there. Thane collector office redirected them to Mumbai collector. “Eventually, someone in Pune was ready to sell some injections at a higher price. I travelled there to buy them,” Sachdeva said, refusing to disclose the amount each lyophilised injection cost her. On Sunday, all the injections were exhausted.

Maharashtra’s monthly requirement for the drug has grown 100 times, from 3,000 during pre-pandemic days to three lakh injections, as of now. Pharmaceutical companies seem to be incapable of servicing this increased demand.

While the Wadhwa family can afford the injection, they are unable to source it. Several, like 29-year-old Samiya Mushtaq’s family, have run out of their savings to buy this drug. “After being infected with Covid, she was diagnosed with mucormycosis. We spent Rs 4 lakh on the injections to treat the infection at a private hospital, but have run out of money now,” said mother Sabiha. Samiya, who also suffers from a kidney ailment, was administered 80 injections and, subsequently, referred to KEM Hospital.

Like remdesivir, the state government has asked all collectors to control the supply of amphotericin B to hospitals to prevent black marketing and hoarding. D R Gahane, joint commissioner (drug) in Food and Drug Administration, said the state required three lakh injections a month, but had managed to procure only 8,500 in the last one week while the BMC procured another 1,000. The Centre allotted only 16,500 injections as Maharashtra’s quota, he said.

State health minister Rajesh Tope has urged the Centre to increase the allocation and allow manufacturers to sell directly to the state government, which has placed an order for 1.90 lakh amphotericin injections but is yet to get the supply.

The injections will be distributed based on hospital demands and prescriptions by the collector and district health department. Chemists will now find it hard to stock the antifungal drug.

The FDA estimates show that Maharashtra requires at least 10,000 injections per day. Bharat Serum, BDR Pharmaceuticals, Cipla and Mylan are major manufacturers of amphotericin B injection. There are three types: in plain powder, liquid form and lyophilised. Powder form, which costs Rs 300 per injection, is the cheapest and takes eight to 10 days to manufacture, but can affect the kidney and is not advised to all patients. Liquid form costs Rs 1,000 per vial and takes 10 to 15 days in production. Lyophilised takes 28 days in production, costs Rs 6,000 to Rs 8,000 for 50 mg and is in most demand. But its production is hampered by shortage in active pharmaceutical ingredients (API). It requires amphotericin, currently supplied by Gujarat-based Ambalal Sarabhai Enterprises.

Manufacturers are scouting for more options to buy API. Some have reached out to North China Pharmaceutical Group (NCPC) in China. “They assured us 40 to 50 kg by the end of June. We have also approached DCGI (Drugs Controller General of India) to approve another Chinese company to supply amphotericin. It has US FDA, but is yet to get approved in India,” Dharmesh Shah, chairperson and MD in BDR Pharmaceuticals.

Manufacturers said if raw material was available on time, India’s output could be five to eight lakh injections per month. Another hurdle is supply of a raw material from German company Lipoid GmbH. Manufacturers said the company was directing raw material to Pfizer for vaccine manufacturing, thus cutting down on India’s supply for amphotericin injections. They said orders placed in December were being shipped now, and Lipoid was in discussion with Indian manufacturers and has assured more supply in coming weeks.

“We have ramped up production since last year, but there has been an unprecedented surge in demand and we are working towards ensuring equitable patient access to the drug across India,” said a Cipla spokesperson.

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