Wockhardt's Nafithromycin Faces NPPA Pricing Exemption Hurdle Over Patent Validity Questions
Key Insights
India's first indigenous antibiotic nafithromycin faces regulatory scrutiny as the NPPA's expert committee questions whether the patent covers the approved formulation.
The Multidisciplinary Committee of Experts has directed verification from CDSCO and patent authorities to confirm alignment between the granted patent and approved drug formulation.
Wockhardt seeks five-year pricing exemption under DPCO 2013 for the groundbreaking antibiotic that targets drug-resistant Community-Acquired Bacterial Pneumonia (search).
Wockhardt Limited's application for pricing exemption of its breakthrough antibiotic nafithromycin has encountered regulatory complications, with India's National Pharmaceutical Pricing Authority (search) (NPPA) expert committee raising questions about patent validity and formulation alignment.
The Multidisciplinary Committee of Experts, which advises NPPA on pricing matters, has directed that inputs be obtained from both the Central Drugs Standard Control Organization (search) (CDSCO) and the Office of the Controller General of Patents, Designs and Trade Marks (CGPDTM) to verify whether the formulation approved by CDSCO corresponds to the one covered under the granted patent.
Patent-Approval Discrepancy Emerges
During the 71st meeting held on September 16, 2025, the committee identified a critical discrepancy in Wockhardt's application. While the CDSCO approval (Approval No. IND/MA/24/00001 dated January 1, 2025) pertains specifically to "Nafithromycin Tablets—Immediate release film-coated tablets—each film-coated tablet containing Nafithromycin 400 mg," the patent documents tell a different story.
Patent No. 415319, granted on December 23, 2022, is registered in Wockhardt Limited's name for an invention titled "Pharmaceutical compositions." However, the committee noted that neither the patent certificate nor the claims filed with the Patent Office explicitly mention the name 'Nafithromycin'.
Regulatory Framework and Exemption Sought
Wockhardt submitted its application on July 14, 2025, seeking exemption for the non-scheduled formulation under Para 32(i) of the DPCO, 2013. This provision states that DPCO pricing norms shall not apply to a manufacturer producing a new drug patented under the Indian Patent Act, 1970, for a period of five years from the date of commencement of its commercial marketing in the country.
Under normal DPCO regulations, the government monitors the maximum retail price (MRP) of all drugs, including non-scheduled formulations, ensuring that no manufacturer increases the MRP more than 10% during the preceding 12 months.
Clinical Significance and Development Background
Nafithromycin, marketed as "Miqnaf," represents a significant milestone as the country's first indigenous Macrolide antibiotic. The drug was officially launched on November 20, 2024, by Union Minister Dr Jitendra Singh, following extensive development supported by the Biotechnology Industry Research Assistance Council (BIRAC).
BIRAC provided Rs. 8 crore funding under the Biotech Industry Programme for phase 3 clinical trials. The overall development required an investment of Rs. 500 crore, with clinical trials conducted across the US, Europe, and India.
The antibiotic targets Community-Acquired Bacterial Pneumonia (search) (CABP) caused by drug-resistant bacteria, which disproportionately affects vulnerable populations such as children, the elderly, and those with compromised immune systems. According to the Ministry of Chemicals and Fertilisers, the drug is "ten times more effective than current treatments like azithromycin and offers a three-day treatment regimen, significantly shortening the recovery time while improving patient outcomes."
Addressing Antimicrobial Resistance
Nafithromycin is designed to treat both typical and atypical drug-resistant bacteria, positioning it as a crucial tool in addressing the global health crisis of antimicrobial resistance (search) (AMR). The drug boasts superior safety, minimal side effects, and no significant drug interactions.
The Ministry emphasized that "Nafithromycin's development marks a historic milestone as the first new antibiotic in its class to be introduced globally in over 30 years."
Next Steps in Regulatory Process
Following the NPPA's request for complete claims documentation on August 7, 2025, Wockhardt submitted additional materials including a summary of inventions and claims, along with a scientific publication from the peer-reviewed journal Chromatographia (2019) 82:1059-1068, published in Springer Nature 2019.
The committee has instructed that the application, along with the required clarifications from CDSCO and CGPDTM, be placed before the Committee again for further consideration. The outcome will determine whether Wockhardt can secure the five-year pricing exemption for this groundbreaking antibiotic that represents a significant advancement in India's pharmaceutical innovation capabilities.