Guwahati: Like every scientist who has a dream to see his invented product reach the market from the lab after FDA approval, Mukut Gohain from Assam too had one, but it was not without making sacrifices and overcoming obstacles.
Interestingly Mukut Gohain is the co-inventor of Enmetazobactam (Exblifep) an antibiotic that was approved by the United States Food and Drug Administration last month to treat complicated urinary tract infections (cUTIs) including pyelonephritis. The antibiotic demonstrates remarkable efficacy in treating complicated urinary tract infections (UTI), pneumonia, and bacteremia caused by extended-spectrum beta-lactamase-producing pathogens.
Mukut Gohain is presently the Principal Investigator and head of the Research and Development Department of Chemical Process Technologies, South Africa.
“I sincerely applaud the entire team for having the courage, vision, ingenuity, and discovery to bring this first Indian antibiotic to the global market. This is a matter of pride to be an Indian! Entire team members had to make significant sacrifices and overcome many obstacles on the journey from the lab to the market,” Mukut Gohain told EastMojo.
” The process to get FDA approval is so tough that only a very few drugs get the approval,” he said.
“I worked very hard and dedicatedly on this project, and when I came to know that this product had finally received approval from the US Food and Drug Administration (FDA), I was very happy as one of the inventors. “The happiness increased by many folds from the fact that this is the first novel antibiotic from India that got US FDA approval. I am pleased to be one of the co-inventors of this novel antibiotic to save millions of lives. It is an immense pleasure for me that I could be able to contribute something to this world as an Assamese” he added.
“Orchid Pharma has initiated the process to make this antibiotic available in India, whereas in the US and Europe, other pharmaceutical companies will make it available in the market in days to come,” he said. The company has received a New Drug Approval (NDA) from the FDA for use in patients aged 18 years or older with complicated urinary tract infections (cUTIs) such as pyelonephritis.
He had his school education in the government-run Barchapari Primary School to attain PhD from NEIST, Jorhat, where he spent valuable years in Assam till shifting his workplace to Chennai then Spain, and finally to South Africa.
He was born in Gondhia Gaon, Panitola in upper Assam’s Tinsukia district. He did his high school at Panitola Higher Secondary School, HS from the Senairam Higher Secondary School, and then college from Tinsukia College in Chemistry. His wife Sangeeta Baruah is working as a Research Scientist at Chemical Process Technologies Pharma based in South Africa where he is leading the group of scientists.
COST EFFECTIVE AMODIAQUINE: Gohain told EastMojo that under his leadership a team of researchers are doing research work in many more life-saving drug projects to save lives. “A research team under my guidance has already developed cost-effective technology for the antimalarial drug Amodiaquine where we could be able to reduce the price of the prominent antimalarial drug to half of the current market price. This result was published in one of the American Chemical Society journals recently” he said.
THE ROAD TO GETTING FDA APPROVAL:
“It is a very difficult and lengthy process to reach the United States FDA approval through various rigorous processes. The novel drug has taken a long time to reach the clinical trial stage from laboratory innovation by overcoming all the related preclinical testing. Only very few molecules invented in the lab have reached the clinical trial stage. Despite careful planning, most drug candidates fail. Reasons for failure include poor solubility, life-threatening or other undesirable side effects, poor biodistribution by the proposed clinical route of administration, prohibitive scale-up and manufacturing costs, market competition, and poor efficacy in early clinical trials” he said.
The entire process took 16 years and was started in India in fact.
Preclinical drug development is often called the ‘Valley of Death,’ where good ideas often die through design flaws, lack of specialized expertise, and insufficient funding. Increasingly, public and private organizations are coming to the aid of investigators with outsourcing and funding support.
“If the preclinical laboratory assessments support the safety of the drug substance the researcher may submit an Investigational New Drug (IND) application to the FDA to request approval to begin human studies. Each year, the FDA reviews about 1,500 Investigational New Drug applications (IND). In addition to the FDA review, a local Institutional Review Board must approve a request for clinical trials. After approval, the researcher can begin clinical trials in humans” he said.
There are three phases and after the successful completion of a Phase 3 trial, a New Drug Application (NDA) can be submitted to the FDA to request review for approval. The FDA will then take 6-10 months to review all of the data submitted and either accept or deny the NDA. Once a medication is approved, the FDA requires the manufacturer to continue to monitor the safety of its drug. This ensures that any serious or rare side effects that may not have occurred in the clinical trials can be evaluated.
“On average, it takes almost 10 years and hundreds of millions of dollars to get a new medication approved by the FDA. Only about ten percent of potential drugs make it through the rigorous process to become FDA-approved. Despite these challenges, researchers remain hard at work to develop new safe and effective medications” he said.
Every scientist/researcher who works in the field of new products wants to see his product as a real success i.e. from lab to market, so I too had a dream to be one of the inventors who can see his invented product/drug from lab to market after FDA approval. “But to get to the market, an invented product has to go through various critical steps. For human use, it is very difficult to manage these necessary steps, from lab work to preclinical testing to final clinical testing and regulatory requirements, approval, and marketing,” he said.
It requires millions of dollars to complete all these steps successfully. So from lab to market, very few products succeed, which means very few scientists can see their product to that level. “Some scientists spend their entire lives trying to commercialize their invention after approval of regulatory agencies like the FDA/EMA, so it is very difficult to get approval at the FDA level,” he said.
Gohain is also involved and leading the Bill and Melinda Gates Foundation -funded projects (Development of Solutions to Improve Global Health) at Chemical Process Technologies API Plus Laboratory to develop cost-effective commercial process technologies for APIs of various life-saving drugs such as anti-malarial, antibacterial, anti-HIV, etc., in collaboration with “Medicine 4 All” of Virginia Commonwealth University, USA.
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