Orchid Pharma Gains DCGI Nod for Advanced Antibiotic Drug

Orchid Pharma has obtained approval from the Drug Controller General of India (DCGI) to manufacture and market an antibiotic drug aimed at treating complex urinary tract infections. The approval extends to the manufacturing and marketing of Cefepime and Enmetazobactam as a dry powder injectable formulation. The move is seen as a significant step in combating anti-microbial resistance.

In a significant development, Orchid Pharma announced on Thursday that it has received regulatory approval from the Drug Controller General of India (DCGI) to manufacture and market an antibiotic specifically designed to treat complicated urinary tract infections.

The drug will be available in the form of a dry powder injectable and combines Cefepime and Enmetazobactam, according to a company statement. This formulation is also indicated for the treatment of acute Pyelonephritis, hospital-acquired pneumonia, ventilator-associated pneumonia (VAP), and bacteremia.

Orchid Pharma's Managing Director, Manish Dhanuka, hailed the approval as a milestone for the company, emphasizing its commitment to providing advanced and affordable treatment options for patients in India. The firm is eager to launch and distribute the new drug to enhance the treatment landscape for severe infections.

Importantly, anti-microbial resistance (AMR) is identified as a silent pandemic by both the UN and WHO, accounting for nearly 5 million deaths in 2019 alone. The economic implications are equally staggering, with the World Bank estimating potential healthcare costs to surge by USD 1 trillion by 2050, and GDP losses potentially ranging between USD 1 trillion to USD 3.4 trillion per year by 2030.

(This story has not been edited by Devdiscourse staff and is auto-generated from a syndicated feed.)