With cases of mucormycosis or so-called black fungus mushrooming across the country alongside the coronavirus pandemic, a shortage of drugs to treat this rare infection has resulted in several deaths. Liposomal Amphotericin B is a lifesaving medication that helps patients overcome this deadly fungal disease. And the brains behind the development of this medicine in India, back in 2010-11, is B Srikantha Annappa Pai. Pai was the head of the research and development team at Bharat Serums and Vaccines Limited in Mumbai. Now, when that medicine is saving lives across the country, all that he feels is “grateful”.
Pai is a native of Gangolli village in Kundapura Taluk of Karnataka’s Udupi district. He got a degree of Bachelors in Pharma from the Government Pharmacy College in Bengaluru and completed his post-graduation from Manipal. “Job opportunities in Karnataka weren’t great. So I moved to Mumbai and stayed with my sister and started hunting for work. After several interviews, I landed a job with Bharat Serums," he recalled.
Pai served the company for 17 long years. Gilead Sciences, an American company, originally owned the patent to the drug for the treatment of mucormycosis. The patent expired in 2008. “India didn’t have the necessary technology to create an alternative and so lots of research and development was necessary. So it took two long years for the team to finally come up with an efficient product," said Pai. “There was no SoP (standard-operating procedure) for the redevelopment of the medicine. Only the basic formula of the drug is shared (by the company that created it) and they will only tell if the drug is made right or wrong. Hence, we had to do every other research and reach the clinical trial phase. We also had to get permissions from the FDA and European Medical Agency before the trials. After all this, the drug was finally released in 2010-11."
Mucormycosis, caused by a group of moulds called mucormycetes, is more common among people whose immunity has lowered due to Covid-19, diabetes, kidney disease, liver or cardiac disorders, age-related issues, or those on medication for auto-immune diseases like rheumatoid arthritis. The disease begins to manifest as a skin infection in the air pockets located behind the forehead, nose, cheekbones and in between the eyes and teeth. It then spreads to the eyes, lungs and can even spread to the brain. It leads to blackening or discoloration over the nose, blurred or double vision, chest pain, breathing difficulties and coughing of blood. Experts say that the use of steroids in the treatment of Covid-19 and the fact that many of these patients have diabetes as co-morbidity could be one of the reasons behind the spurt in black fungus cases.
“Mucormycosis majorly targets the lungs, liver and spleen," said Pai. “Amphotericin B is the source of injections that are available everywhere. Four different varieties of injections have been developed from this primary source. The first one is the traditional product. The second is the liposomal amphotericin injection, which is 75% more effective than normal jabs. The third is lipid complex, which is 20 times more effective than the second one. The last one is amphotericin emulsion, which is 150 times safer than regular jabs."
Pai has the patent for lipid complex and amphotericin in his name. He also holds 16 other patents including of protocol drugs used while administering anaesthesia while performing surgeries. He now leads a peaceful post-retirement life with his family in Mumbai.