Covid-19: Shortage of black fungus drug Amphotericin-B looming
Rema Nagarajan / TNN / Updated: May 30, 2021, 12:29 IST
NEW DELHI: Union chemicals minister Sadananda Gowda on May 25 said over 11,700 cases of mucormycosis, commonly known as black fungus disease, had been identified in India. Going by this number, the required number of vials for the six-week therapy would be over 29 lakh. Even with imports and boost to domestic production, what will be available could be way below what is required, considering the fact that more cases are being added daily.
On May 22, there were 8,848 cases across India according to the central government. By May 26, the total number of cases went up to 11,717, an increase of 2,869 cases in just four days.
The treatment of mucormycosis needs 5-7 vials per patient per day over 42 days or six weeks, about 250 vials per patient. For 11,700 patients, about 70,200 vials would be needed each day. The government has procured and distributed over 1.5 lakh vials since May 22 and says production of just over 1.63 lakh vials in May is expected to go up to 2.55 lakh in June. It also plans to import 3.63 lakh vials in May and 3.15 lakh in June.
Gowda tweeted that 3.63 lakh vials of amphotericin-B will be imported in May, resulting in total availability of 5.27 lakh vials. “And 3.15 lakh vials will be imported in June 2021 making availability of 5.70 lakh vials in June 2021 inclusive of domestic production,” he added.
There are two kinds of amphotericin being used. Lyposomal amphotericin, the more expensive version, which is said to be slightly less toxic for kidneys, costs Rs 5,000-7,000 per vial. So, just the cost of amphotericin for treating one patient could be roughly Rs 15 lakh. Even the less expensive version, lipid complex or lipid emulsion amphotericin costs about Rs 2,000 per vial, which would mean Rs 5 lakh for just the drug without counting the cost of hospitalisation, tests, surgery etc. Clearly, the treatment would be unaffordable for many who might be forced to pay out of pocket.
Doctors involved in treating black fungus say the cheaper version is just as good and that the claims about kidney toxicity are mostly industry driven to sell the more expensive version.
While the government has stated that it is allocating amphotericin vials to states based on the number of cases, several states including Delhi, Punjab and Maharashtra have said they have more cases than the central government data is showing. Delhi CM Arvind Kejriwal stated that Delhi has reported 620 cases so far, nearly five times more than the number of cases (119) reported by the central government. On May 25, the Centre put the number of black fungus patients in Maharashtra at 2,770. But in the Bombay high court during a hearing, the state advocate general said that as of May 26 there were 3,200 such patients and the state needed at least 14,000 vials per day.
“We are getting 4,000-5,000 per day from the Centre,” he said. There are six domestic suppliers of amphotericin — Bharat Serums & Vaccines, BDR Pharmaceuticals, Sun Pharma, Cipla, Life Care Innovations and Mylan. Five new companies, Emcure Pharmaceuticals, Natco Pharma, Gufic Bioscience Ltd, Alembic Pharmaceuticals and Lyca Pharmaceuticals have been given approval to produce the drug amphotericin.
Rema Nagarajan / TNN / Updated: May 30, 2021, 12:29 IST
NEW DELHI: Union chemicals minister Sadananda Gowda on May 25 said over 11,700 cases of mucormycosis, commonly known as black fungus disease, had been identified in India. Going by this number, the required number of vials for the six-week therapy would be over 29 lakh. Even with imports and boost to domestic production, what will be available could be way below what is required, considering the fact that more cases are being added daily.
On May 22, there were 8,848 cases across India according to the central government. By May 26, the total number of cases went up to 11,717, an increase of 2,869 cases in just four days.
The treatment of mucormycosis needs 5-7 vials per patient per day over 42 days or six weeks, about 250 vials per patient. For 11,700 patients, about 70,200 vials would be needed each day. The government has procured and distributed over 1.5 lakh vials since May 22 and says production of just over 1.63 lakh vials in May is expected to go up to 2.55 lakh in June. It also plans to import 3.63 lakh vials in May and 3.15 lakh in June.
Gowda tweeted that 3.63 lakh vials of amphotericin-B will be imported in May, resulting in total availability of 5.27 lakh vials. “And 3.15 lakh vials will be imported in June 2021 making availability of 5.70 lakh vials in June 2021 inclusive of domestic production,” he added.
There are two kinds of amphotericin being used. Lyposomal amphotericin, the more expensive version, which is said to be slightly less toxic for kidneys, costs Rs 5,000-7,000 per vial. So, just the cost of amphotericin for treating one patient could be roughly Rs 15 lakh. Even the less expensive version, lipid complex or lipid emulsion amphotericin costs about Rs 2,000 per vial, which would mean Rs 5 lakh for just the drug without counting the cost of hospitalisation, tests, surgery etc. Clearly, the treatment would be unaffordable for many who might be forced to pay out of pocket.
Doctors involved in treating black fungus say the cheaper version is just as good and that the claims about kidney toxicity are mostly industry driven to sell the more expensive version.
While the government has stated that it is allocating amphotericin vials to states based on the number of cases, several states including Delhi, Punjab and Maharashtra have said they have more cases than the central government data is showing. Delhi CM Arvind Kejriwal stated that Delhi has reported 620 cases so far, nearly five times more than the number of cases (119) reported by the central government. On May 25, the Centre put the number of black fungus patients in Maharashtra at 2,770. But in the Bombay high court during a hearing, the state advocate general said that as of May 26 there were 3,200 such patients and the state needed at least 14,000 vials per day.
“We are getting 4,000-5,000 per day from the Centre,” he said. There are six domestic suppliers of amphotericin — Bharat Serums & Vaccines, BDR Pharmaceuticals, Sun Pharma, Cipla, Life Care Innovations and Mylan. Five new companies, Emcure Pharmaceuticals, Natco Pharma, Gufic Bioscience Ltd, Alembic Pharmaceuticals and Lyca Pharmaceuticals have been given approval to produce the drug amphotericin.
