DCGI approves novel antibiotics discovered by Indian firmJanuary 20, 2020
The Indian drug regulator has cleared two novel antibiotics Emrok and Emrok-O by the Mumbai-based Wockharts to treat acute bacterial skin and skin structure infections including diabetic foot infections and concurrent bacteraemia.
Ths intravenous Emrok and oral pill Emrock O are broad-spectrum drugs that target superbug like methicillin-resistant Staphylococcus aureus (MRSA), which is a leading cause of antimicrobial resistance.
The drug shows potent bactericidal activity against gram-positive, quinalone susceptible gram-negative anaerobic and atypical bacteria.
The antibiotics have been researched and developed in India collaboratively with various foreign countries. The non-clinical and Phase 1 studies have been conducted in the US, Europe, and India while Phase 2 and Phase 3 clinical trials have been completed in India. The drug has been approved based on its Phase 3 trial which involved 500 patients from 40 different centres across the country.
Tackling AMR has become a high priority agenda today, globally. India is at the centre of several drug-resistant pathogens and has faced lack of concrete actions to build in the systems and practices to ensure the judicious use of antibiotics.
According to World Health Organisation (WHO) methicillin-resistant S. aureus (MRSA) has been enlisted in 2017 as a ‘high’ priority pathogen due to a high prevalence of resistance, mortality rate, the burden on community and health care settings.
In 2018, the Indian Council of Medical Research (ICMR) and Antimicrobial resistance surveillance network (AMRSN) group, based on their study, had alerted on the high prevalence of 38.6% of MRSA in India.
With its broad-spectrum activity against widely prevalent pathogens including MRSA, EMROK/EMROK-O offers superior safety over the currently available anti-MRSA agents, averred Dr. Habil Khorakiwala, Founder Chairman, Wockhardt Group in the release.