"DCGI (Drug Controller General of India) has approved Wockhardt's two new antibiotics, EMROK (IV) and EMROK 0 (Oral), for acute bacterial skin and skin structure infections including diabetic foot infections and concurrent bacteraemia...," the drug firm said in a regulatory filing.
The new drug will target superbug like Methicillin resistant Staphylococcus aureus (MRSA), which is a leading cause of rising antimicrobial resistance (AMR).
"By virtue of its broad spectrum activity against widely prevalent pathogens including MRSA, superior safety over currently available anti-MRSA agents and its unique properties, I believe EMROK/EMROK-O has a strong potential to effectively address the unmet medical need of the clinicians in the country thereby helping to reduce the morbidity and mortality," Wockhardt Group founder chairman Habil Khorakiwala said.
The size of Indian antibiotic market is around Rs 16,000 crore.
AMR is a major public health problem globally. India carries one of the largest burdens of drug-resistant pathogens worldwide.
Infections caused by drug-resistant organisms could lead to increased mortality and prolonged duration of hospitalisation, causing a huge financial burden to the affected persons, health-care systems, and hinder the goals of sustainable development.
Two million deaths are projected to occur in India due to AMR by the year 2050, the company said.
Currently available anti-MRSA agents have multiple side effects such as kidney damage, decrease in platelet cell counts and muscle pain, which limits their use for a longer period and compromise the safety of critically ill patients in the ICU. SID DRR