Mumbai-based Bharat Serums and Vaccines (BSV) gets OK to use sepsis drug for Covid clinical trials
                     Mumbai-based Bharat Serums and 
Vaccines (BSV) gets OK to use 
sepsis drug for Covid clinical trials
In another instance of ‘repurposing’ an existing therapy, Mumbai-based Bharat 
Serums and Vaccines (BSV) has received regulatory approval to initiate 
clinical trials of critical care drug, Ulinastatin, for Covid-19 patients.
According to Indian pharmaceutical industry news Ulinastatin is used in India for 
severe sepsis and other critical clinical conditions like acute pancreatitis. 
Managing director and chief executive officer Sanjiv Navangul told TOI that the 
company received approval from the drug regulator to conduct a clinical study on 
Ulinastatin, for mild-to-moderate acute respiratory distress syndrome (ARDS) 
patients with Covid-19.
The company joins other domestic firms including Glenmark, Sun Pharma, Biocon 
and NovaLead Pharma that are conducting trials of potential drugs for Covid-19. 
While there is no approved and proven treatment against SARS-CoV-2 virus yet, 
only experimental drugs are being used as supportive therapy.
According to Indian pharmaceutical industry news Clinical trials on 120 patients 
are expected to start at hospitals over the next three weeks, and results will be 
available by December. Though there is no scientific study on Ulinastatin yet, 
certain countries like China are believed to have used it for Covid-19 therapy.
Ulinastatin is a “well-researched, fairly old drug”, available in the country since 
2012 and manufactured by few companies including BSV. Around one million vials
have been used in the country. The company’s brand, U-TRYP had sales of Rs 24 
crore for the 12-month period ended April. The price of a vial is around Rs 1500 
each, with the therapy expected to cost around Rs 30,000-50,000 per patient for a
protocol of minimum seven days.
According to Indian pharmaceutical industry news “There’s a good chance of the 
drug working on hospitalised Covid-19 patients who have breathlessness,” he 
said, adding the company has done seven trials in India for other indications. 
Ulinastatin is manufactured at the company’s facility in Thane (Maharashtra).
The mortality risk is higher when an individual with Covid-19 infection develops 
ARDS and pneumonia. ARDS causes dry cough, heavy breathing, breathing 
difficulties and increased heart rate. Ulinastatin, in such cases, can be used as a 
remedy to combat the underlying inflammatory condition related to ARDS in 
Covid-19 patients.
According to Indian pharmaceutical industry news Meta-analysis of over 2,300 
ARDS patients globally treated with Ulinastatin has shown significant 
improvement in oxygenation index, shortening duration of mechanical 
ventilation, reduced mortality and ICU stay as compared to conventional 
therapies, the company said.
The Rs 1,000-crore portfolio of BSV includes drugs for hormones, monoclonals, 
equine human serums and plasma derivatives. It is one of the major products of 
Japan-based Mochida Pharmaceuticals, and is also manufactured in China and 
Korea.