Delhi HC Asks Centre to Import Drug Amphotericin-B from ‘Wherever Available’ Before Precious Lives Lost
The Delhi High Court on Thursday asked the Centre to take steps to import Amphotericin-B used for treating Mucormycosis, also known as ‘black fungus’, from wherever it is available in the world to bridge its shortage “before we lose more precious lives” even as a Union minister said Indian companies have placed orders for importing 6 lakh vials of this key anti-fungal drug. Minister Mansukh Mandaviya also said 11 pharma firms in the country will produce the drug with five more approvals being given.
“You have to get the medicine from wherever in the world. You have to take steps right now. Wherever it is available in the world get it,” said a bench of Justices Vipin Sanghi and Jasmeet Singh which was assured by the Centre that it has already started taking steps to import the medicine.
The court said the Centre should inform it about the steps taken to import the medicine, the shortfall of which was coming in the way of the treatment of this fungal infection which has been on the rise in the national capital and elsewhere in the country. The infection that affects the nose, eyes, sinuses, and sometimes even the brain is being detected among patients who are recovering or have recovered from COVID-19.
As cases of ‘black fungus’ among COVID-19 patients in the country crossed 7,000, a number of states, including Tamil NAdu, Rajasthan and Odisha declared it as a notifiable disease under the Epidemic Diseases Act to ensure mandatory surveillance to tackle the “new challenge”. The Centre has urged all states and union territories to do the same.
Central government standing counsel Kirtiman Singh and Amit Mahajan informed the court that as on May 19, there are 7,251 patients of black fungus in the country and this includes 200 in Delhi. Some states have also reported fatalities due to this disease with Maharashtra recording 90 deaths. The issue of shortage of the medicine for treating black fungus was raised by advocate Rakesh Malhotra.
Minister Mandaviya said the shortage of the anti-fungal drug will be resolved soon. “Black Fungus (Mucormycosis) curing drug #AmphotericinB’s shortage will be resolved soon! Within three days, 5 more Pharma companies have got New Drug Approval for producing it in India, in addition to the existing 6 pharma companies,” he said in a tweet.
Mandaviya, who is the Minister of State for Chemicals and Fertilizers, also said that existing pharma companies have already started ramping up the production of the drug. “Indian Companies have also placed orders for importing 6 lakh vials of #AmphotericinB. We are leaving no stone unturned to smoothen the situation,” he noted.
In a letter to the states and the UTs, the Union Health Ministry said that in the recent times a “new challenge” in the form of a fungal infection Mucormycosis has emerged, and is leading to prolonged morbidity and mortality amongst COVID-19 patients. The letter said the disease is reported from many states amongst COVID-19 patients, especially those on steroid therapy and deranged sugar control.
“You are requested to make Mucormycosis a notifiable disease under the Epidemic Diseases Act, 1897, wherein all government and private health facilities, medical colleges will follow guidelines for screening, diagnosis, management of mucormycosis, issued by the Ministry of Health and Family Welfare (Gol) and the Indian Council of Medical Research (ICMR). “And, make it mandatory for all these facilities to report all suspected and confirmed cases to health department through district-level chief medical officer and subsequently to Integrated Disease Surveillance Programme (IDSP) surveillance system,” said Lav Agarwal, Joint Secretary in the health ministry, in the letter.
Some states like Rajasthan, Telangana and Karnataka have already declared Mucormycosis as a notifiable disease. Delhi Chief Minister Arvind Kejriwal said dedicated centres will be set up for treatment of the disease at three city government-run hospitals.
The treatment of the fungal infection requires multidisciplinary approach involving eye surgeons, ENT specialists, general surgeon, neurosurgeon and dental maxillo facial surgeon, among others, and administration of Amphotericin-B injection. The Indian Medical Association (IMA) also wrote a letter to Prime Minister Narendra Modi, urging him to allow eligible pharmaceutical companies to manufacture Amphotericin-B drugs in the country.
At the high court, the two-judge bench said there are two things premium here, that is, time and human lives and if the supplies of the drug are not proper, it would be neither here nor there and it would not serve the purpose as the shortage is by two-third of the total demand. You need to import this to bridge the gap between your plan to enhance the capacity and completing manufacture before we lose more precious lives. So act fast on this, it said, and asked the Centre to file a status report on present production capacity of the medicine, details of producers licensed to produce it, and by when it would be manufactured with the increased capacity.
Maharashtra Health Minister Rajesh Tope said he told Prime Minister Modi that Mucormycosis is a matter of prime concern for the state at present, and the government needs more supply of the medicine used for its treatment. “I have informed the Centre that Mucormycosis is the prime concern before the state government. I insisted that we need more allocation and supply of Amphotericin-B as the number of cases in the state is higher,” Tope told reporters in Mumbai after a virtual meeting convened by the prime minister.
Tope had earlier said that Maharashtra faces a shortage of Amphotericin- B and the state needs 1.50 lakh to two lakh vials of the medicine, but has received only 16,000 vials from the Centre. Of the 1,500 patients of black fungus detected so far in the state, some 850 were undergoing treatment in hospitals, while 90 COVID-19 survivors have died so far, he said.
According to an advisory issued by the ICMR, conditions such as uncontrolled diabetes, weakening of immune system due to use of steroids, prolonged ICU/hospital stay, co-morbidities/post-organ transplant/cancer, voriconazole therapy (used to treat serious fungal infections) in COVID-19 patients increase the risk of mucormycosis infection. In addition, COVID patients undergoing oxygen therapy in the ICU, where humidifier is used, are prone to fungal infection because of exposure to moisture, it said.
But this does not mean that every COVID patient will get infected by Mucormycosis. The disease is uncommon in those not having diabetes but can be fatal if not treated promptly. Chances of recovery depend upon early diagnosis and treatment, it added.
(With PTI inputs)