**Executive Summary**
This order, issued by the National Pharmaceutical Pricing Authority (NPPA) on July 8, 2026, grants M/s Biological E Limited a price control exemption for its vaccine ‘PNEUBEVAX 14’. The exemption is valid for five years from the start of commercial production or marketing, or until the expiry of the Indian patent, whichever is earlier. Key requirements include notifying the NPPA of launch dates and submitting price lists in accordance with the Drugs (Prices Control) Order (DPCO), 2013.
**Key Points / Main Content**
**Legal Framework and Authority**
* The NPPA was established to fix drug prices, monitor non-scheduled drug prices, and implement the DPCO.
* The Ministry of Chemicals and Fertilizers delegated powers to the NPPA under the Essential Commodities Act, 1955, specifically regarding Para 32 of the DPCO, 2013.
**Exemption for PNEUBEVAX 14**
* M/s Biological E Limited applied for an exemption for its formulation ‘Pneumococcal Polysaccharide Conjugate Vaccine (PNEUBEVAX 14)’.
* The formulation received approval from the Central Drugs Standard Control Organisation (CDSCO) and holds Indian Patent No. 371406, granted on July 8, 2021.
* The NPPA determined during its 148th meeting on July 7, 2026, that the vaccine meets the criteria for exemption under Para 32(i) and 32(ii) of the DPCO, 2013.
**Conditions and Duration of Exemption**
* The exemption is effective for five years starting from the date of commercial marketing or production in India, or until the patent expires, whichever occurs first.
* The manufacturer is mandated to inform the NPPA of the specific dates when commercial production and marketing begin.
**Pricing and Reporting Requirements**
* M/s Biological E Limited must submit a price list in Form V under DPCO, 2013, detailing the Price to Retailer (PTR) and the Maximum Retail Price (MRP) fixed by the company.
* Once the exemption period expires, the company must follow the notified ceiling price for the vaccine.
* If applicable, the company must seek retail price approval three months before the exemption period concludes.
**Impact Analysis**
**Stakeholder: M/s Biological E Limited**
**Impact**
The company is permitted to set its own prices (MRP and PTR) for ‘PNEUBEVAX 14’ without adhering to standard DPCO price ceilings for a specified period.
**Action Required**
Must notify NPPA of commercial start dates, submit pricing details via Form V, and apply for price approvals or follow ceiling prices three months before the exemption expires.
**Stakeholder: National Pharmaceutical Pricing Authority (NPPA)**
**Impact**
The NPPA is responsible for monitoring the company’s compliance with the reporting requirements and the eventual transition of the vaccine back under price control.
**Action Required**
Must process the commencement dates and price lists submitted by the manufacturer and oversee the re-imposition of price controls post-exemption.
**Stakeholder: Retailers**
**Impact**
Retailers will receive official price lists for the vaccine directly from the manufacturer during the exemption period.
**Action Required**
Must ensure the vaccine is sold within the Maximum Retail Price (MRP) specified by M/s Biological E Limited in the issued price lists.
Key Entities Referenced
National Pharmaceutical Pricing Authority (NPPA): The primary regulatory body responsible for implementing the Drugs (Prices Control) Order and fixing prices for scheduled drugs and formulations.
Drugs (Prices Control) Order (DPCO), 2013: The specific regulatory order under which price-control exemptions are granted for patented drug formulations for a specified period.
M/s Biological E Limited: The pharmaceutical company granted a five-year price-control exemption for its patented Pneumococcal Polysaccharide Conjugate Vaccine.
Pneumococcal Polysaccharide Conjugate Vaccine (PNEUBEVAX 14): The specific drug formulation exempted from the pricing provisions of the DPCO, 2013, due to its status as a patented invention.
Essential Commodities Act, 1955: The parent legislation providing the central government and the NPPA the authority to regulate the pricing and distribution of drugs.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-09072026-274309
CG-DxLx-xEG-I0D9H0x7x2x0 26-274309
xxxGIDExxx
असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (ii)
PART II—Section 3—Sub-section (ii)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 3549] नई ददल्ली, बुधर्ार, िुलाई 8, 2026/आषाढ 17, 1948
No. 3549] NEW DELHI, WEDNESDAY, JULY 8, 2026/ASHADHA 17, 1948
रसायन और उर्रव क मत्रं ालय
(औषध जर्भाग)
(राष्ट्रीय औषध मल्ू य जनधारव ण प्राजधकरण)
आदेि
नई ददल्ली, 8 िुलाई, 2026
का.आ. 3711(अ).— िबदक भारत सरकार के रसायन और उर्वरक मंत्रालय के ददनांक 29 अगस्ट्त, 1997 के
संकल्प स.ं 33/7/97-पी आई–I द्वारा राष्ट्रीय औषध मल्ू य जनधावरण प्राजधकरण (एनपीपीए) की स्ट्थापना, अन्य बातों के
साथ-साथ थोक औषजधयों तथा जर्जनर्ममजतयों के मूल्य जनधावररत करने और उनम ें पररर्तवन यदद कोई हो, को अजधसूजित
करन,े अजनयंजत्रत औषजधयों और जर्जनर्ममजतयों के मूल्यों पर निर रखन े और औषध (मल्ू य जनयंत्रण) आदेि (डीपीसीओ) के
प्रार्धानों का कायवन्र्यन करने के जलए, की गई थी।
2. और िबदक, रसायन एर् ं उर्वरक मंत्रालय के ददनांक 30 मई, 2013 के कायावलय आदिे स.ं 1394(अ) के द्वारा
आर्श्यक र्स्ट्त ु अजधजनयम, 1955 की धारा 3 तथा 5 द्वारा प्रदत्त िजियों का प्रयोग करत े हुए डीपीसीओ, 2013 के
जर्जिष्ट पैराग्राफ के संबंध म ें उि आदेि के परै ाग्राफ 32 सजहत एनपीपीए को केंद्र सरकार की ओर स े िजियां प्रत्यायोजित
की गई ह।ैं
5148 GI/2026 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
3. और िबदक, मैससव बायोलॉजिकल ई जलजमटेड से उि आदेि के पैरा 32(i), 32(ii) तथा 32(iii) के अंतगतव
डीपीसीओ, 2013 के प्रार्धानों स े छूट प्रदान दकए िाने हते ु फॉमुवलेिन ‘न्यूमोकोकल पॉलीसैकराइड कॉन्िुगेट र्ैक्सीन
(न्यूबेर्ैक्स 14)’ के संबंध म ें आर्ेदन प्राप्त हुआ, जिसे औषध एर् ं प्रसाधन सामग्री अजधजनयम, 1940 तथा उसके अधीन
बनाए गए जनयमों के अतं गतव केंद्रीय औषध मानक जनयंत्रण संगठन (भारत) द्वारा जर्जधर्त अनमु ोददत दकया गया ह।ै इसके
अजतररि, भारत सरकार के पटे ेंट कायावलय द्वारा पेटेंट अजधजनयम, 1970 के प्रार्धानों के अंतगतव ‘मल्टीर्ैलेंट न्यूमोकोकल
कॉन्िगु ेट र्ैक्सीन’ िीषवक र्ाल े आजर्ष्कार के जलए मैसस व बायोलॉजिकल ई जलजमटेड को पटे ेंट प्रदान दकया गया ह ै (पेटेंट
संख्या 371406 तथा पेटेंट प्रदान दकए िान े की जतजथ 08.07.2021)।
4. और िबदक, एनपीपीए ने ददनांक 07.07.2026 को आयोजित अपनी 148र्ीं बैठक म ें यह उल्लेख दकया दक
मैससव बायोलॉजिकल ई जलजमटेड डीपीसीओ, 2013 के परै ा 32(i) एर् ं 32(ii) की आर्श्यकताओं को परू ा करती ह ै तथा
उि फॉमलुव ेिन प्रदत्त पेटेंट के अंतगतव आच्छाददत ह।ै तदनुसार, प्राजधकरण न े यह जनणवय जलया दक मैसस व बायोलॉजिकल ई
जलजमटेड को उनके फॉमुवलिे न ‘न्यूमोकोकल पॉलीसैकराइड कॉन्िुगेट र्ैक्सीन (न्यूबेर्ैक्स 14)’ के संबंध म ें डीपीसीओ,
2013 के परै ा 32(i) एर् ं 32(ii) के अंतगतव छूट प्रदान की िा सकती ह।ै
5. अब, इसजलए, भारत सरकार के रसायन एर् ं उर्वरक मंत्रालय द्वारा ददनांक 30 मई, 2013 को िारी का.आ.
1394(अ) के माध्यम स े औषध (मूल्य जनयंत्रण) आदेि, 2013 के पैरा 32 के अंतगवत प्रत्यायोजित िजियों का प्रयोग करत े
हुए, मैसस व बायोलॉजिकल ई जलजमटेड को उि आदेि के पैरा 32(i) एर् ं 32(ii) के अतं गवत फॉमुवलेिन ‘न्यूमोकोकल
पॉलीसैकराइड कॉन्िगु ेट र्ैक्सीन (न्यूबेर्ैक्स 14)’ के संबंध म ें डीपीसीओ, 2013 के प्रार्धानों स े दिे म ें उसके र्ाजणजययक
जर्पणन के प्रारंभ होने की जतजथ अथर्ा जनमावता द्वारा दिे म ेंउसके र्ाजणजययक उत्पादन की जतजथ स े पााँि र्ष व की अर्जध के
जलए अथर्ा भारतीय पेटेंट की समाजप्त तक, िो भी पहल े ह,ै छूट प्रदान की िाती ह।ै
6. मैससव बायोलॉजिकल ई जलजमटेड फॉमलुव ेिन ‘न्यूमोकोकल पॉलीसैकराइड कॉन्िुगेट र्ैक्सीन (न्यूबेर्ैक्स 14)’ के
दिे म ें र्ाजणजययक जर्पणन तथा र्ाजणजययक उत्पादन की जतजथ तथा उि फॉमलुव ेिन के संबंध म ें कंपनी द्वारा जनधावररत
खुदरा जर्क्रेता को कीमत (पीटीआर) और अजधकतम खुदरा मल्ू य (एमआरपी) की िानकारी डीपीसीओ, 2013 के अंतगवत
प्रपत्र-V म ें मूल्य सूिी िारी करके एनपीपीए को सूजित करेगी।
7. मैससव बायोलॉजिकल ई जलजमटेड, डीपीसीओ, 2013 के पैरा 32(i) एर् ं 32(ii) के अंतगवत प्रदान की गई छूट की
अर्जध समाप्त होने के उपरातं , उि फॉमुवलिे न ‘न्यूमोकोकल पॉलीसैकराइड कॉन्िगु ेट र्ैक्सीन (न्यूबेर्ैक्स 14)’ के जलए
अजधसूजित सीललग मूल्य का पालन करेगी अथर्ा, यदद लाग ू हो, छूट की अर्जध समाप्त होन े स े तीन माह पूर् व खुदरा मूल्य
अनुमोदन प्राप्त करेगी।
[का.स.ं /280/148/2026/एफ़ /फा.स.ं 8(148)/2026/डीपी/एनपीपीए-जडर्ी-II]
भीर्ा राम यादर्, सहायक जनदेिक[भाग II—खण् ड 3(ii)] भारत का रािपत्र : असाधारण 3
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.