Wockhardt Gets 5-Year NPPA Price Control Exemption for Nafithromycin 400 mg Tablets

New Delhi: Through a recent notice, the National Pharmaceutical Pricing Authority (NPPA) has granted a five-year exemption from price control provisions under the Drugs (Prices Control) Order, 2013 (DPCO) to Wockhardt Limited for its patented formulation "Nafithromycin Tablets - Immediate release film-coated tablets containing Nafithromycin 400 mg" from the date of commencement of its commercial marketing by the manufacturer in the country or expiry of the Indian patent, whichever may be earlier.

Further, the notice stated that Wockhardt Limited shall inform NPPA, the date of commercial marketing of the formulation “Nafithromycin Tablets – Immediate release film-coated tablets – each film-coated tablet containing Nafithromycin 400 mg” in the country and the Price to Retailer (PTR) and Maximum Retail Price fixed by the company in respect of the said formulation by issuing a price list in Form V under DPCO, 2013.

This came as an application was received from M/s Wockhardt Limited seeking exemption from the provisions of DPCO, 2013 under para 32(i) of the said order in respect of the formulation “Nafithromycin Tablets – Immediate release film-coated tablets – each film-coated tablet containing Nafithromycin 400 mg," which was duly approved by the Office of Central Drugs Standard Control Organization (India) under the Drugs and Cosmetics Act, 1940 and Rules thereunder. Further, the Patent Office, Government of India, has granted Patent to M/s Wockhardt Limited for an invention titled “Pharmaceutical compositions” under the provisions of the Patents Act, 1970 (Patent No. 415319 and Date of Grant: 23.12.2022).

The National Pharmaceutical Pricing Authority (NPPA) was established vide the resolution of the Government of India in the Ministry of Chemicals and Fertilizers No. 33/7/97-PI. I dated 29th August, 1997, inter alia, to fix prices and notify the changes therein, if any, of bulk drugs and formulations; monitor the prices of non-scheduled drugs and formulations; and oversee the implementation of the provisions of the Drugs (Price Control) Order (DPCO).

Further, the Ministry of Chemicals and Fertilizers, vide S.O.1394 (E) dated the 30th of May, 2013, in exercise of the powers conferred by Sections 3 and 5 of the Essential Commodities Act, 1955 has delegated the powers in respect of specified paras of the DPCO, 2013, including para 32 of the said order to be exercised by the NPPA on behalf of the Central Government.

In addition the notice found that the NPPA in its 144th meeting dated 24.03.2026 noted that M/s Wockhardt Limited meets the requirement of para 32(i) of DPCO, 2013 and the formulation is covered under a patent granted.

Accordingly, the Authority decided that exemption may be granted to M/s Wockhardt Limited under para 32(i) of DPCO, 2013 for their formulation “Nafithromycin Tablets – Immediate release film-coated tablets – each film-coated tablet containing Nafithromycin 400 mg”.

In line with the above, the notice added,

"In exercise of the powers delegated under para 32 of the Drugs (Prices Control) Order, 2013 vide S.O.1394(E) dated 30th May, 2013 issued by the Government of India in the Ministry of Chemicals and Fertilizers, M/s Wockhardt Limited is exempted from the provisions of DPCO, 2013 under para 32(i) of the said order in respect of the formulation 'Nafithromycin Tablets – Immediate release film-coated tablets – each film-coated tablet containing Nafithromycin 400 mg” for a period of five years from the date of commencement of its commercial marketing by the manufacturer in the country or expiry of the Indian patent, whichever may be earlier."

In addition to the above, the notice stated that after the expiry of period of exemption granted under para 32(i) of DPCO, 2013, Wockhardt Limited shall follow the notified ceiling price or seek retail price approval three months before the expiry of the exemption, if applicable, for the formulation “Nafithromycin Tablets – Immediate release film-coated tablets – each film-coated tablet containing Nafithromycin 400 mg."

To view the official notice, click the link below: