Wockhardt becomes India's first to get regulatory nod for novel antibiotics

The Mumbai-based drugmaker prepares to launch EMROK in the domestic market

Dr Habil Khorakiwala
Founder Chairman of the Wockhardt Group

Indian drug regulator DCGI has approved EMROK (IV) and EMROK O (Oral), two new antibiotics from Wockhardt, the Mumbai-based pharmaceutical company. The milestone approval set Wockhardt s the country's first to get the nod from the regulatory authority.

The medicine has been developed for the treatment of acute bacterial skin and skin structure infections, including diabetic foot infections and concurrent bacteraemia.

EMROK (IV) and EMROK O (Oral) contain a drug developed based on the Phase 3 study involving 500 patients in 40 centres across India. The drug targets "superbugs" such as Methicillin-resistant Staphylococcus aureus (MRSA), which is a leading cause of rising antimicrobial resistance (AMR).

Indian antibiotic market

For Wockhardt, the size of Indian antibiotic market is worth about 16,000 Crore (160 billion rupees; US$2.2bn), growing at 7%, and is one of the largest therapeutic segment, with a 12% market share of the Indian Pharmaceutical Market, as stated in IQVIA data.

“By virtue of its broad-spectrum activity against widely prevalent pathogens including MRSA, superior safety over the 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," said Dr Habil Khorakiwala, Founder Chairman of the Wockhardt Group.

Wockhardt said it has plans to launch EMROK/EMROK-O in India in due course.

According to Business Standard, a New Dehli-based newspaper, multinational companies have launched new antibiotics in the country, but novel drugs targeting gram-positive bacterial infections have not been introduced to the market in 15 years.

The newspaper has also reported that "Wockhardt plans to take these drugs to emerging markets and China soon".

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