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REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-25032026-271287
EXTRAORDINARY
PART II-Section 3-Sub-section (ii)
PUBLISHED BY AUTHORITY
No. 1528]
NEW DELHI, WEDNESDAY, MARCH 25, 2026/CHAITRA 4, 1948
2210 GI/2026
MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals)
(NATIONAL PHARMACEUTICAL PRICING AUTHORITY)
ORDER
New Delhi, the 25th March, 2026
S.O. 1593(E)— Whereas 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).
2. And whereas the Ministry of Chemicals and Fertilizers vide S.O.1394 (E) dated the 30th May, 2013, in exercise of
the powers conferred by Section 3 and 5 of 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.
3. And whereas 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 Organisation (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).
4. And whereas 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 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".
5. Now, therefore, 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.
6. M/s 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.
7. M/s Wockhardt Limited, after the expiry of period of exemption granted under para 32(i) of DPCO, 2013, 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”.
[PN/276/144/2026/F/F. No. 8(144)/2026/D.P./NPPA-Div.-II]
BHIVA RAM YADAV, Assistant Director
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.
SARVESH KUMAR Digitally signed by SARVESH
SRIVASTAVA Date: 2026.03.25 22:52:23+05:30
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