Wockhardt Misses NPPA Clearance for Nafithromycin, Faces Questions on Patent Validity
New Delhi: In a temporary setback to Wockhardt, the National Pharmaceutical Pricing Authority (NPPA) has sought further clarifications from the drugmaker on its application seeking exemption for the patented, non-scheduled formulation Nafithromycin Tablets under Paragraph 32(i) of the Drugs (Prices Control) Order, 2013 (DPCO, 2013).
The Committee also directed that inputs be obtained from both the Central Drugs Standard Control Organization (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. It further instructed that the application, along with the required clarifications, be placed before the Committee again for further consideration.
The recommendation came during the 71st meeting of the Multidisciplinary Committee of Experts held on 16.09.2025, where the committee reviewed the application for exemption of patented non-scheduled formulation Nafithromycin Tablets under Para 32(i) of DPCO, 2013 by Wockhardt Limited.
Nafithromycin, the country’s first indigenous Macrolide antibiotic was officially launched on November 20, 2024, by Union Minister Dr Jitendra Singh.
Developed by Wockhardt with support from the Biotechnology Industry Research Assistance Council (BIRAC), Nafithromycin, marketed as "Miqnaf," targets Community-Acquired Bacterial Pneumonia (CABP) caused by drug-resistant bacteria, which disproportionately affects vulnerable populations such as children, the elderly, and those with compromised immune systems.
Nafithromycin is designed to treat both typical and atypical drug-resistant bacteria, making it a crucial tool in addressing the global health crisis of AMR (Anti-microbial Resistance). It boasts superior safety, minimal side effects, and no significant drug interactions.
The Multidisciplinary Committee of Experts noted that Wockhardt Limited submitted an application on 14.07.2025 seeking exemption for the non-scheduled formulation Nafithromycin Tablets under Para 32(i) of the DPCO, 2013.
The company had submitted the permission of the formulation granted by the Central Drugs Standard Control Organization (CDSCO) and the Patent Certificate (Patent No. 415319, granted on 23.12.2022) under the Patent Act, 1970.
The Committee further observed that Nafithromycin is a non-scheduled formulation. During its deliberations, the Committee noted that Patent No. 415319, granted on 23.12.2022 is registered in the name of Wockhardt Limited for an invention titled “Pharmaceutical compositions.”
However, the drug approval from CDSCO (Approval No. IND/MA/24/00001 dated 01.01.2025) pertains specifically to “Nafithromycin Tablets—Immediate release film-coated tablets—each film-coated tablet containing Nafithromycin 400 mg.”
It was also noted that neither the patent certificate nor the claims filed with the Patent Office explicitly mention the name ‘Nafithromycin’. Accordingly, NPPA vide letter dated 7.08.2025 sought the complete set of claims as submitted to the Patent office by the company.
In response, the company, along with other documents furnished Summary of inventions and claims and the scientific publication from a peer reviewed journal “Chromatographia (2019) 82:1059-1068,” as published in Springer Nature 2019.
In line with the above, the Committee directed,
"Inputs be obtained from CDSCO and the Office of the Controller General of Patents, Designs & Trade Marks (CGPDTM) to verify whether the formulation approved by CDSCO corresponds to the one for which the patent was granted.The committee further directed that the application along with the necessary clarifications may be placed before the Committee for further consideration."
