Wockhardt's Nafithromycin 400 mg May Get 5-Year Price Control Exemption

New Delhi: The National Pharmaceutical Pricing Authority (NPPA) Multidisciplinary Committee (MDC) has recommended granting exemption from price control to Nafithromycin Tablets 400 mg manufactured by Wockhardt Limited, under Para 32(i) of the Drugs (Prices Control) Order (DPCO), 2013.

This came after the Multidisciplinary Committee (MDC) of the National Pharmaceutical Pricing Authority (NPPA) reviewed the application for exemption of the patented non-scheduled formulation Nafithromycin Tablets under Para 32(i) of DPCO, 2013 by Wockhardt at 75th meeting of the Multidisciplinary Committee of Experts, which was held on 11.02.2026.

The Committee noted that M/s 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 also noted that NPPA vide letter dated 07.08.2025 sought the complete set of claims submitted to the Patent office by the company, as neither the patent certificate nor the claims filed with the Patent Office explicitly mention the name 'Nafithromycin.'

In response, the company, along with other documents furnished Summary of inventions & claims and the scientific publication from a peer-reviewed journal, “Chromatographia (2019) 82:1059-1068," as published in Springer Nature 2019.

The Committee in its 71st meeting held on 16.09.2025 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”.

The Committee directed that 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.

Office of the Controller General of Patents, Designs & Trade Marks (CGPDTM) vide email dated 02.01.2026 confirmed that “the CDSCO-approved Nafithromycin tablet formulation corresponds to the scope of the granted claims of Patent No. 415319, insofar as the claimed solid tablet composition is concerned.”

Accordingly, the matter was placed in the 75th MDC meeting. During the discussion the representative from CDSCO stated that as per the comments received from O/o CGPDTM, it is clear that the formulation approved by CDSCO is covered under the scope of Patent granted by Patent Office for Nafithromycin tablet 400 mg.

The Committee deliberated upon the matter and based on the inputs from O/o CGPDTM and CDSCO as above, noted,

"The applied formulation Nafithromycin Tablets – Immediate release film-coated tablets – each film-coated tablet containing Nafithromycin 400 mg is covered under patent granted. Accordingly, the committee recommended to grant exemption for tablet Nafithromycin 400 mg” under Para 32(i) of DPCO, 2013 to M/s Wockhardt Ltd for a period of five years from the date of commencement of its commercial marketing by M/s Wockhardt Ltd. in the country."