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REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-09072026-274309
EXTRAORDINARY
PART II-Section 3-Sub-section (ii)
PUBLISHED BY AUTHORITY
No. 3549]
NEW DELHI, WEDNESDAY, JULY 8, 2026/ASHADHA 17, 1948
MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals)
(NATIONAL PHARMACEUTICAL PRICING AUTHORITY)
ORDER
New Delhi, the 8th July, 2026
S.O. 3711(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
(Prices 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 Biological E Limited seeking exemption from the provisions of
DPCO, 2013 under Para 32(i), 32(ii) and 32(iii) of the said order in respect of the formulation 'Pneumococcal
Polysaccharide Conjugate Vaccine (PNEUBEVAX 14)', 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 Biological E Limited for an invention titled “Multivalent
Pneumococcal Conjugate Vaccine' under the provisions of the Patents Act, 1970 (Patent No. 371406 and Date of
Grant: 08.07.2021).
4. And whereas the NPPA in its 148th meeting dated 07.07.2026 noted that M/s Biological E Limited meets the
requirement of Para 32(i) & 32(ii) of DPCO, 2013 and the formulation is covered under patent granted. Accordingly,
the Authority decided that exemption may be granted to M/s Biological E Limited under Para 32(i) & 32(ii) of DPCO,
2013 for their formulation 'Pneumococcal Polysaccharide Conjugate Vaccine (PNEUBEVAX 14)'.
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 Biological E Limited is exempted from the provisions of DPCO, 2013 under Para 32(i) & 32(ii) of the said order
in respect of the formulation ‘Pneumococcal Polysaccharide Conjugate Vaccine (PNEUBEVAX 14)' for a period of
five years from the date of the commencement of its commercial marketing or date of the commercial production by
the manufacturer in the country or expiry of the Indian patent, whichever is earlier.
6. M/s Biological E Limited shall inform NPPA, the date of commercial marketing and commercial production of the
formulation 'Pneumococcal Polysaccharide Conjugate Vaccine (PNEUBEVAX 14)' in the country and the Price to
Retailer (PTR) and Maximum Retail Price (MRP) fixed by the company in respect of the said formulation by issuing a
price list in Form V under DPCO, 2013.
7. M/s Biological E Limited, after the expiry of period of exemption granted under Para 32(i) & 32(ii) 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 'Pneumococcal Polysaccharide Conjugate Vaccine (PNEUBEVAX 14)'.
[PN/280/148/2026/F/ F. No. 8(148)/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. SRIVASTAVA
SARVESH KUMAR SARVESH
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