Date: 2026-03-25Category: Extra OrdinaryState: Union GovernmentCountry: India
Notification for exemption to M/s Wockhardt Limited under para 32(i) of DPCO 2013 in respect of the formulation Nafithromycin Tablets Immediate release film coated tablets each film coated tablet containing Nafithromycin 400 mg
**Executive Summary**
The National Pharmaceutical Pricing Authority (NPPA) issued an order on March 25, 2026, granting M/s Wockhardt Limited an exemption from the price control provisions of DPCO, 2013, for its patented formulation, Nafithromycin 400 mg tablets. The exemption is valid for five years from the date of commercial marketing or until the expiry of the Indian patent, whichever is earlier. Wockhardt is required to inform the NPPA of the launch date and submit price lists in Form V.
**Key Points / Main Content**
**Exemption Grant and Duration**
* NPPA has granted an exemption to M/s Wockhardt Limited under Para 32(i) of the Drugs (Price Control) Order (DPCO), 2013.
* The exemption applies to the formulation: "Nafithromycin Tablets – Immediate release film-coated tablets – each film-coated tablet containing Nafithromycin 400 mg."
* The exemption period is five years starting from the date of the manufacturer’s commencement of commercial marketing in India, or until the expiry of the Indian patent, whichever occurs earlier.
**Legal and Regulatory Compliance**
* The formulation is covered under Indian Patent No. 415319, granted on December 23, 2022.
* The product received approval from the Central Drugs Standard Control Organisation (CDSCO) under the Drugs and Cosmetics Act, 1940.
* The decision was finalized during the 144th meeting of the NPPA held on March 24, 2026.
**Reporting and Pricing Requirements**
* Wockhardt must formally notify the NPPA of the specific date commercial marketing begins.
* The company must issue a price list in Form V under DPCO, 2013, specifying the Price to Retailer (PTR) and the Maximum Retail Price (MRP).
* Upon the expiry of the five-year exemption period, the manufacturer must adhere to the notified ceiling prices.
* If applicable, the manufacturer must seek retail price approval three months before the exemption period expires.
**Impact Analysis**
**M/s Wockhardt Limited**
**Impact**
The company is permitted to set prices for Nafithromycin 400 mg tablets without adhering to standard DPCO price ceilings for a period of five years or until patent expiry.
**Action Required**
The company must inform the NPPA of the commercial launch date, submit price data via Form V, and apply for price approvals or transition to ceiling prices three months before the exemption ends.
**National Pharmaceutical Pricing Authority (NPPA)**
**Impact**
The authority delegates its price-fixing powers to accommodate patented innovations as per statutory provisions but retains monitoring oversight.
**Action Required**
The NPPA must monitor the commercial launch notification and the subsequent price lists submitted by the manufacturer.
**Retailers and Consumers**
**Impact**
The pricing of this specific antibiotic formulation will be manufacturer-defined rather than government-regulated for the duration of the exemption.
**Action Required**
No specific action is required; however, retailers must adhere to the price lists issued by the company in Form V.
Key Entities Referenced
National Pharmaceutical Pricing Authority (NPPA): The primary regulatory body within the Ministry of Chemicals and Fertilizers responsible for fixing drug prices and implementing the DPCO.
Drugs (Prices Control) Order, 2013 (DPCO): The central regulation governing drug price control, specifically Para 32(i) which allows for exemptions for patented formulations.
M/s Wockhardt Limited: The pharmaceutical company granted a five-year price control exemption for its patented drug formulation.
Nafithromycin Tablets (400 mg): The specific drug formulation exempted from the provisions of DPCO, 2013 for five years or until patent expiry.
Patents Act, 1970: The law under which the formulation was granted a patent (Patent No. 415319), forming the legal basis for the price exemption.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-25032026-271287
CG-DxLx-xEG-I2D5H0x3x2x0 26-271287
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असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (ii)
PART II—Section 3—Sub-section (ii)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 1528] नई दिल्ली, बधु वार, मार् च25, 2026/र्त्रै 4, 1948 13, 1947 26/पौष 17, 1947
No. 1528] NEW DELHI, WEDNESDAY, MARCH 25, 2026/CHAITRA 4, 1948 ss, 1947 /PAUSHA 17, 1947
रसायन और उर्रव क मत्रं ालय
(औषध वर्भाग)
(राष्ट्रीय औषध मल्ू य वनधारव ण प्रावधकरण)
आदेश
नई दिल्ली, 25 मार्च, 2026
का.आ. 1593(अ).— जबकक भारत सरकार के रसायन और उर्वरक मंत्रालय के किनांक 29 अगस्त, 1997 के
संकल्प स.ं 33/7/97-पी आई–I द्वारा राष्ट्रीय औषध मूल्य वनधारव ण प्रावधकरण (एनपीपीए) की स्थापना, अन्य बातों के साथ-
साथ थोक औषवधयों तथा वर्वनर्मववतयों के मल्ू य वनधावररत करन े और उनम ें पररर्तवन यकि कोई हो, को अवधसूवित करने,
अवनयंवत्रत औषवधयों और वर्वनर्मववतयों के मल्ू यों पर नजर रखने और औषध (मूल्य वनयंत्रण) आिेश (डीपीसीओ) के प्रार्धानों
का कायवन्र्यन करन े के वलए, की गई थी।
2. और जबकक, रसायन एर् ं उर्वरक मंत्रालय के किनांक 30 मई, 2013 के कायावलय आिशे स.ं 1394(अ) के द्वारा आर्श्यक
र्स्तु अवधवनयम, 1955 की धारा 3 तथा 5 द्वारा प्रित्त शवियों का प्रयोग करत े हुए डीपीसीओ, 2013 के वर्वशष्ट पैराग्राफ
के संबंध म ें उि आिेश के परै ाग्राफ 32 सवहत एनपीपीए को केंद्र सरकार की ओर स ेशवियां प्रत्यायोवजत की गई ह।ैं
3. और जबकक, मैससव र्ॉकहार्व वलवमर्ेड स े प्राप्त आर्ेिन द्वारा डीपीसीओ, 2013 के प्रार्धानों स े छूर् के वलए, पैराग्राफ
32(i) के अंतगवत उि आिेश म ें फॉमलुव ेशन “नैकफथ्रोमाइवसन र्ैबलेट्स – इमीवडएर् ररलीज कफल्म-कोर्ेड
र्ैबलेट्स – नैकफथ्रोमाइवसन 400 वम.ग्रा.” जो कक ड्रग्स एडं कॉस्मेरर्क्स अवधवनयम, 1940 और वनयम के तहत केंद्रीय ड्रग्स
स्र्ैंडड व कंट्रोल ऑगवनाइजेशन (भारत) द्वारा वर्वधर्त रूप स े अनुमोकित ककया गया था। इसके अलार्ा पेर्ेंर् कायावलय भारत
2210 GI/2026 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
ने मैससव र्ॉकहार्व वलवमर्ेड को “फामावस्यूरर्कल कंपोजीशन्स” के वलए पेर्ेंर् अवधवनयम, 1970 के तहत पेर्ेंर् प्रिान ककया गया
(पेर्ेंर् संख्या 415319 और अनमु ोिन प्रिान करन े की वतवथ 23.12.2022)।
4. और जबकक, एनपीपीए ने किनांक 24.03.2026 को अपनी 144र्ीं बैठक म ेंयह उल्लेख ककया कक मैससव र्ॉकहार्व वलवमर्ेड
डीपीसीओ, 2013 के पैरा 32(i) की आर्श्यकता को पूरा करत े ह ैं और यह फॉरमलु ेिन पेटेंट के अंतगचत आता ह।ै तिनुसार
यह वनणवय वलया ह ै कक डीपीसीओ, 2013 के पैरा 32(i) के अंतगवत मैससव र्ॉकहार्व वलवमर्ेड को उनके उि फॉमुवलशे न
“नैकफथ्रोमाइवसन र्ैबलेट्स – इमीवडएर् ररलीज कफल्म-कोर्ेड र्ैबलेट्स – नैकफथ्रोमाइवसन 400 वम.ग्रा.” के वलए छूर् िी जा
सकती ह।ै
5. अब इसवलए का.आ. 1394(अ), किनांक 30 मई, 2013 को रसायन एर् ं उर्वरक मंत्रालय, भारत सरकार द्वारा जारी
औषध (मूल्य वनयंत्रण) आिेश, 2013 के पैरा 32 के अंतगवत प्रित्त शवियों का प्रयोग करते हुए, मैससव र्ॉकहार्व वलवमर्ेड को
उि आिेश के परै ा 32(i) के अतं गवत डीपीसीओ, 2013 के प्रार्धानों स े फॉमुवलेशन “नैकफथ्रोमाइवसन र्ैबलेट्स – इमीवडएर्
ररलीज कफल्म-कोर्ेड र्ैबलेट्स – नैकफथ्रोमाइवसन 400 वम.ग्रा.” के संबंध म ेंिशे म ेंइसके र्ावणवययक वर्पणन की शरुु आत की
तारीख स े पांि र्ष व की अर्वध के वलए या भारतीय पेर्ेंर् की समावप्त, जो भी पहले हो, छूर् प्रिान की जाती ह।ै
6. मैससव र्ॉकहार्व वलवमर्ेड एनपीपीए को फॉमलुव ेशन “नैकफथ्रोमाइवसन र्ैबलेट्स – इमीवडएर् ररलीज कफल्म-कोर्ेड र्ैबलेट्स
– नैकफथ्रोमाइवसन 400 वम.ग्रा.” के व्यार्सावयक वर्पणन की तारीख और उि फॉमुवलेशन के सबं ंध म ें कंपनी द्वारा वनधावररत
खुिरा वर्क्रेता को कीमत (पीर्ीआर) और अवधकतम खुिरा मूल्य (एमआरपी) की जानकारी डीपीसीओ, 2013 के तहत प्रपत्र
V म ें मल्ू य सूिी जारी करके सूवित करेगा।
7. मैससव र्ॉकहार्व वलवमर्ेड, डीपीसीओ, 2013 के पैरा 32(i) के अंतगवत प्रिान की गई छूर् की अर्वध समाप्त होने के उपरांत,
उि फॉमुवलेशन “नैकफथ्रोमाइवसन र्ैबलेट्स – इमीवडएर् ररलीज कफल्म-कोर्ेड र्ैबलेट्स – नैकफथ्रोमाइवसन 400 वम.ग्रा.” के
वलए अवधसूवित अवधकतम मल्ू य का पालन करेगा अथर्ा छूर् की समावप्त स े तीन माह पूर्,व यकि लागू हो, खुिरा मूल्य
अनुमोिन प्राप्त करेगा।
[का.सं./276/144/2026/एफ़/फा.सं. 8(144)/2026/डीपी/एनपीपीए-जडवी-II]
भीवा राम यािव, सहायक जनििे क
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).[भाग II—खण् ड 3(ii)] भारत का रािपत्र : असाधारण 3
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.