**Report on Government Pharmaceutical Pricing Policy**
**1. Executive Summary:**
This report analyzes a notification from the National Pharmaceutical Pricing Authority (NPPA) concerning drug pricing. The notification addresses two distinct scenarios: first, it grants an exemption from certain pricing regulations to Torrent Pharmaceutical Limited for its Tapentadol Nasal Spray due to its patented status and status as a new drug; second, it implements a one-time 50% increase to the ceiling prices for nine scheduled formulations of three essential drugs in response to concerns about their continued availability. The core purposes are ensuring affordable access to essential medicines while also considering manufacturer viability and incentivizing innovation. The key findings are that the government is balancing price control with pharmaceutical company interests, particularly regarding patented drugs and essential medicines facing potential supply issues.
**2. Introduction:**
This report provides an informative analysis of a government policy notification regarding pharmaceutical pricing. The analysis is based solely on the provided text of the notification issued by the NPPA and aims to clarify its objectives, provisions, and potential impact.
**3. Policy Overview:**
This report analyzes what appears to be two separate actions documented in a single notification. The first action exempts a specific drug (Tapentadol Nasal Spray) from certain regulations. The second action amends existing pricing policies by increasing ceiling prices for specific drugs.
* **Core Objectives (Inferred):**
* To regulate the prices of drugs to ensure affordability and accessibility, as indicated by the NPPA's mandate.
* To encourage pharmaceutical innovation and protect intellectual property rights, as evidenced by the exemption granted to the patented drug.
* To ensure the continued availability of essential medicines, as indicated by the price revisions.
**4. Background and Rationale:**
* **Tapentadol Nasal Spray Exemption:** This exemption addresses the potential disincentive for pharmaceutical companies to invest in research and development of new drugs if they are immediately subjected to price controls. The exemption recognizes the patented status and innovative nature of Tapentadol Nasal Spray.
* **Ceiling Price Increase:** This increase addresses concerns about the economic viability of manufacturing certain essential drugs due to existing price controls. The text indicates that repeated price controls have made it difficult for manufacturers to sustain production, potentially leading to shortages or unavailability of these medicines. The measure is described as an "exceptional measure" advised by the Standing Committee on Affordable Medicines and Health Products (SCAMHP).
**5. Key Provisions / Changes:**
* **Tapentadol Nasal Spray Exemption:**
* **Specific Part of Original Policy Affected:** DPCO 2013, para 32 i.
* **New Rule/Provision:** Torrent Pharmaceutical Limited is exempted from the provisions of DPCO, 2013 under para 32 i for Tapentadol Nasal Spray 225mg/ml.
* **Difference/Effect:** Torrent Pharmaceutical Limited is allowed to price Tapentadol Nasal Spray without being immediately constrained by the standard price control mechanisms. This allows them to recoup R&D investments and potentially incentivize further innovation. The exemption is valid for five years from the commencement of commercial marketing or coterminus with the duration of the Indian Patent.
* **Ceiling Price Increase Amendment:**
* **Specific Part of Original Policy Affected:** DPCO 2013, para 19.
* **New Rule/Provision:** Ceiling prices for nine specific scheduled formulations of three drugs (Carbamazepine, Ranitidine, and Ibuprofen) are increased by 50%.
* **Difference/Effect:** The manufacturers of these specific drugs can now charge up to 50% more than the previous ceiling price. This is intended to improve their profitability and incentivize them to continue manufacturing these essential medicines.
**6. Target Audience and Stakeholders:**
* **Directly Affected:**
* Torrent Pharmaceutical Limited (regarding Tapentadol Nasal Spray).
* Manufacturers of Carbamazepine, Ranitidine, and Ibuprofen (specifically the formulations listed in the table).
* Consumers of these drugs (who may experience a price increase).
* NPPA (responsible for implementation and monitoring).
* **Indirectly Affected:** The broader pharmaceutical industry, healthcare providers, and patients who rely on affordable access to essential medicines.
**7. Implementation Aspects (Inferred):**
* **Responsible Agency/Bodies:** NPPA is responsible for overseeing the implementation of both the exemption and the price revisions.
* **Timelines/Procedures:**
* Torrent Pharmaceutical Limited must inform the NPPA of the date of commercial marketing and the Price to Retailer (PTR) and Maximum Retail Price (MRP) fixed for Tapentadol Nasal Spray.
* Torrent Pharmaceutical Limited must also seek retail price approval 3 months before the exemption's expiry.
* Manufacturers of the drugs with revised ceiling prices must revise their pricing accordingly.
* Manufacturers are required to furnish quarterly returns related to the production, import, and sale of scheduled formulations in Form III of Schedule II of the DPCO, 2013.
* Retailers and dealers must display the updated price lists.
**8. Expected Outcomes / Impact of Changes:**
* **Tapentadol Nasal Spray Exemption:**
* Likely Outcome: To incentivize Torrent Pharmaceutical Limited to commercialize the new drug and potentially foster further innovation in the pharmaceutical sector.
* **Ceiling Price Increase Amendment:**
* Likely Outcome: To improve the profitability of manufacturing the specified essential drugs, thereby ensuring their continued availability in the market and preventing patients from having to switch to more expensive alternatives. It may also result in increased prices for the consumers.
**9. Conclusion:**
This notification from the NPPA reflects the government's attempt to balance competing objectives in the pharmaceutical sector: ensuring affordable access to essential medicines while also encouraging innovation and maintaining the viability of drug manufacturing. The exemption granted to Tapentadol Nasal Spray recognizes the value of patented drugs, while the price revisions for Carbamazepine, Ranitidine, and Ibuprofen address concerns about the potential unavailability of essential medicines due to price controls. The effectiveness of these measures will depend on careful monitoring and evaluation by the NPPA. The decision highlights the complexities of pharmaceutical pricing policy and the need for ongoing adjustments to ensure a stable and accessible drug market.
Key Entities Referenced
NEW DELHI: The city where the notification was issued.
Ministry of Chemicals and Fertilizers: The Government of India ministry that issued the order.
National Pharmaceutical Pricing Authority (NPPA): An authority established by the Government of India to fix and regulate drug prices.
Drugs Price Control Order (DPCO): An order related to the control of drug prices in India.
Essential Commodities Act, 1955: An act of the Indian Parliament regarding essential commodities.
Torrent Pharmaceutical Limited: A pharmaceutical company that applied for exemption from certain provisions of the DPCO 2013.
Tapentadol Nasal Spray 225mg/ml: A formulation manufactured by Torrent Pharmaceutical Limited, for which exemption from DPCO provisions was sought.
Tapentadol Hydrochloride: An ingredient of Tapentadol Nasal Spray.
Benzalkonium Chloride: An ingredient of Tapentadol Nasal Spray, used as preservative.
Central Drugs Standard Control Organisation India: The national regulatory body for pharmaceuticals and medical devices in India.
Drugs and Cosmetics Act, 1940: An act of the Indian Parliament regulating drugs and cosmetics.
Patents Act, 1970: An act of the Indian Parliament related to patents.
Patent Office, Government of India: The Indian government organization responsible for patents.
Standing Committee on Affordable Medicines and Health Products (SCAMHP): A committee of Niti Aayog, Government of India for guidance on the modalities methodology.
Niti Aayog: A policy think tank of the Government of India.
Inter-Ministerial Committee: A committee constituted for examination of cases under Para 19 of DPCO 2013.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
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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.ं 2462] नई दद ली, बृहस्ट्प जतर्ार, िुलाई 1, 2021/आषाढ़ 10, 1943
No. 2462] NEW DELHI, THURSDAY, JULY 1, 2021/ASHADHA 10, 1943
रसायन और उर्रव क मत्रं ालय
(औषध जर्भाग)
(राष्टर ीय औषध म य य जनधारव ण प्राजधकरण)
आदेि
नई दद ली, 1 िुलाई, 2021
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ds }kjk vko';d oLrq vf/kfu;e] 1955 dh /kkjk 3 rFkk 5 }kjk iznRr 'kfDr;ks a dk iz;kxs djrs gq,
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feyhxzke@fe-yh- ftle s çR;sd Lç s ¼0-1 fe-yh-½ es ViasVkMksy gkbMªkDs yksjkbM 22-5 feyhxzke castkYdkfsu;e
3646 GI/2021 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
Dykjs kbM ¼50%½ 0-02% MCY;w@oh ¼çtjosfVo½ tk s fd MªXl ,aM d‚LefsVDl vf/kfu;e 1940 vkSj fu;e
ds rgr dsæa h; MªXl LVSaMMZ daVªksy v‚xZsukbts'ku ¼Hkkjr½ }kjk fof/kor :i ls ubZ nok ds :i es a
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iVs sVa vf/kfu;e] 1970 ds rgr isVsVa vuqeksnu djk;k x;kA ¼iVs sVa la[;k 355890 vkjS vuqeksnu inz ku
djus dh frfFk 15-01-2021½A
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QkekZL;wfVdYl fy- dks vius mRikn QkWeZwys'ku ViasVkMksy usty Lizs 225 feyhxzke@fe-yh- ftles a izR;sd
Lizs ¼0-1 fe-yh-½ eas ViasVkMkys gkbMªkDs ykjs kbM 22-5 feyhxzke $ castkYdksfu;e Dykjs kbM ¼50%½ 0-02%
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हाइड्रोक्लोराइड 22-5 जमलीग्राम + बेंिा कोजनयम क्लोराइड ¼50 %½ 0-2 % डब्ल यय/र्ी (प्रिरर्ेटटर्) ds laca/k es a mDr
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nh xbZ gSA इसके अलार्ा पांच साल की अर्जध भारतीय पेटेंट की अर्जध के साथ सह-टर्मवनस ह।ै
6- मेसस व टोरन्ट फामावस्ट्युटटकल जलजमटेड एनपीपीए को फॉमयवलेिन टपेंटाडोल नेिल स्ट्प्रे 225 जमलीग्राम/जम.ली.
जिसमे प्रत्येक स्ट्प्रे (0.1 जम.ली.) मे टपेंटाडोल हाइड्रोक्लोराइड 22.5 जमलीग्राम + बेंिा कोजनयम क्लोराइड (50%)
0.02% डब्ल य/यर्ी (प्रिरर्ेटटर्) के व्यार्साजयक जर्पणन की तारीख और Mhihlhvks] 2013 ds rgr QkWeZ V es a eYw ;
lwph tkjh djds mDr vkS"kfèk ds ckjs eas dEiuh }kjk r; dh xbZ खुदरा जर्क्रेता को कीमत (पीटीआर) और
vf/kdre [kqnjk ewY; ,uihih, dk s lfwpr djsxhA
7. मेसस व टोरन्ट फामावस्ट्युटटकल जलजमटेड फॉमलयव ेिन टपेंटाडोल नेिल स्ट्प्रे 225 जमलीग्राम/जम.ली. जिसमे प्रत्येक स्ट्प्र े
(0.1 जम.ली.) मे टपेंटाडोल हाइड्रोक्लोराइड 22.5 जमलीग्राम + बेंिा कोजनयम क्लोराइड (50%) 0.02% डब्ल यय/र्ी
(प्रिरर्ेटटर्) के जलए खुदरा म य य अनुमोदन भी मांगगे ा डीपीसीओ 2013 के पैरा 32 (आई) के तहत दी गई छयट की
समाजि के तीन महीन े पहले।
[dka-l-a@221@89@2021@,Q Qk-l-a 8¼89½@2021@Mhih@,uihih,&fMoh-II]
izlsuthr nkl] mi funs'kd
MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals)
(NATIONAL PHARMACEUTICALS PRICING AUTHORITY)
ORDER
New Delhi, the 1st July, 2021
S.O. 2653(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).[भाग II—खण् ड 3(ii)] भारत का रािपत्र : असाधारण 3
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 received from M/s Torrent Pharmaceutical Limited, for exemption
from the provisions of DPCO, 2013 under para 32 (i) of the said order in respect of the formulation
“Tapentadol Nasal Spray 225mg/ml” in which each spray (0.1ml) contains Tapentadol Hydrochloride
22.5mg + Benzalkonium Chloride (50%) 0.02%w/v (As preservative) which was duly approved by the
Office of Central Drugs Standard Control Organisation (India) as ‘new drug’ under the Drugs and
Cosmetics Act, 1940 and Rules thereunder. Further, the Patent Office, Government of India has granted
Patent to M/s Torrent Pharmaceutical Limited for an invention entitled ‘Pharmaceutical invention of
Tapentadol’ for the term of 20 years from 19th July 2012 in accordance with the provisions of the Patents
Act, 1970 (Patent No. 355890 and Date of Grant: 15.01.2021).
4. And whereas the NPPA at its 89th meeting dated 28.06.2021 noted that M/s Torrent
Pharmaceutical Limited meets the requirement of Para 32(i) of DPCO 2013 and decided that exemption
may be granted to M/s Torrent Pharmaceutical Limited under Para 32(i) of DPCO, 2013 for their
formulation “Tapentadol Nasal Spray 225mg/ml” in which each spray (0.1ml) contains Tapentadol
Hydrochloride 22.5mg + Benzalkonium Chloride (50%) 0.02%w/v (As preservative).
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 Torrent Pharmaceuticals Limited is exempted from the provisions of DPCO,
2013 under para 32 (i) of the said order in respect of the formulation “Tapentadol Nasal Spray 225mg/ml”
in which each spray (0.1ml) contains Tapentadol Hydrochloride 22.5mg + Benzalkonium Chloride (50%)
0.02%w/v (As preservative) for a period of five years from the date of commencement of its commercial
marketing by the manufacturer in the country. Further, the period of five years is co-terminus with the
duration of Indian Patent.
6. M/s Torrent Pharmaceutical Ltd shall inform NPPA, the date of commercial marketing of the
formulation “Tapentadol Nasal Spray 225mg/ml” in which each spray (0.1ml) contains Tapentadol
Hydrochloride 22.5mg + Benzalkonium Chloride (50%) 0.02%w/v (As preservative) in the country and the
Price to Retailer (PTR) and Maximum Retail Price fixed by the company in respect of above said
formulation by issuing a price list in Form V under DPCO, 2013.
7. M/s Torrent Pharmaceutical Ltd shall also seek retail price approval for the formulation
“Tapentadol Nasal Spray 225mg/ml” in which each spray (0.1ml) contains Tapentadol Hydrochloride
22.5mg + Benzalkonium Chloride (50%) 0.02%w/v (As preservative), if applicable, three month before the
expiry of the exemption granted under Para 32(i) of DPCO 2013
[PN/221/89/2021/F F. No. 8(89)/2021/ DP/Div-II/NPPA]
PRASENJIT DAS, Dy. Director
आदेि
नई दद ली, 1 िुलाई, 2021
का.आ. 2654(अ).—िबदक राष्ट्रीय औषध म य य जनधावरण प्राजधकरण (एनपीपीए) की स्ट्थ ापना ददनांक 29 अगस्ट्त,
1997 रसायन और उर्वरक मत्रं ालय की संख्या 33/7/97 /-पीआई-I म ें भारत सरकार के सकं प द्वारा हुई थी जिसमें अन्य
बातों के साथ-साथ ब क में औषजध और जर्जनर्मवजत के म य यों को जनयत करना और उसम ें होने र्ाले बदलार्ों की अजधसयचना4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
देना, यदद कोई हो तो, और गैर-अनुसयजचत दर्ाओं और जर्जनर्मवजतयों के म य यों की जनगरानी करना तथा औषजध (मय य
जनधावरण), आदिे (डीपीसीओ) के प्रार्धानों के कायावन्र्यन की देखरेख करना िाजमल ह।ै
2. और िबदक ददनांक 30 मई, 2013 को रसायन और उर्वरक मत्रं ालय के का.आ 1394 (अ) के माध् यम स,े आर्श्यक
र्स्ट्तु अजधजनयम, 1955 की धारा 3 और 5 द्वारा प्रदत्त िजियों का प्रयोग करते हुए डीपीसीओ, 2013, के जर्जनर्दष्टव पैरा
के संबंध म ें िजियां प्राप् त ह।। जिसमें केंद्र सरकार की ओर स े एनपीपीए द्वारा उि आदेि के पैरा 19 का प्रयोग दकया िाना
िाजमल ह।ै
3. और िबदक जपछल े दो र्षों से अजधक स े उत्पादन लागत म ें र्ृजि, जर्जनमय दर के पटरणामस्ट्र्रूप जर्जभन् न
कंपजनयों से अजधकतम कीमतों में र्ृजि हते ु एनपीपीए म ें आर्देन प्राप् त हो रह े ह । जिसके र्िह से संबंजधत दर्ाओं के
उत्पादन और जर्पणन म ें अजस्ट्थरता आई ह।ै कंपजनयों का जनर्ेदन ह ै दक डीपीसीओ, 2013 के पैरा 19 के तहत संबंजधत
दर्ाओं की अजधकतम कीमत में र्ृजि की िाए।
4. और िबदक एनपीपीए न े ऐसे मामलों के बाद होने र्ाल े तौर-तरीकों/कायवप्रणाली पर मागवदिवन के जलए स्ट्थायी
र्हनीय दर्ाएं और स्ट्र्ास्ट््य उत्पाद सजमजत (एससीएएमएचपी), नीजत आयोग एर्ं भारत सरकार को मामला भेिा।
5. और िबदक एससीएएमएचपी ने ददनांक 07.11.2019 को आयोजित गटित सजमजत की दसय री बैिक म ें एनपीपीए
को कम कीमतों के कारण जर्जनमावण अव्यर्हायवता के मदों ु ों का सामना करने र्ाले फॉमलयव ेिन / अणओंु की िांच करने और
अजधकतम म य य स े50% की र्ृजि की अनुमजत देकर म य य संिोधन लाग यकरन े के जलए जसफाटरि की ह।ै
6. और िबदक, डीपीसीओ 2013 के पैरा 19 के तहत मामलों की िांच के जलए गटित एक अंतर-मंत्रालयी सजमजत न े
िांच की और पाया दक तीन दर्ाओं के अनुसयजचत फॉमयवलेिन सार्विजनक स्ट्र्ास्ट््य प्रबंधन के जलए आर्श्यक दर्ाएं ह । और
इनके मय य जनधावरण की कमी और अनुपलब्लधता का कारण नहीं होना चाजहए और इन दर्ाओं को तदनुसार डीपीसीओ
2013 के पैरा 19 के तहत कीमतों में र्ृजि के जलए जसफाटरि की गई।
7. और िबदक एनपीपीए ने ददनाकं 28.06.2021 को अपनी 89 र्ीं बैिक म ें डीपीसीओ 2013 के पैरा 19 के तहत
इन दर्ाओं की फॉमयवलेिन के म य य र्ृजि के मामले पर जर्चार-जर्मि व दकया और कहा दक डीपीसीओ, 2013 के पैरा 19 के
तहत म य य र्ृजि करन े के जलए नौ अनुसयजचत फॉमयवलेिन पर जर्चार दकया िा रहा ह,ै िो दक कम कीमत र्ाली दर्ाए ं ह ।
और इनकी पुनरार्ृजत्त मय य जनयंत्रण म ें ह।ै इनम ें स े अजधकांि दर्ाओं का उपयोग उपचार की पहली पंजि के रूप म ें दकया
िाता ह ै और दिे के सार्विजनक स्ट्र्ास्ट््य कायवक्रम के जलए महत्र्पयणव ह।। इसके अलार्ा, एनपीपीए का अजधदेि सस्ट्ती
कीमतों पर दर्ाओं की उपलब्लधता सुजनजित करने के जलए ह ै और यह ध्यान ददया गया दक र्हनीयता सुजनजित करने के
जलए सुलभता को खतरे म ें नहीं डाला िा सकता ह ै और िीर्न बचाने र्ाली आर्श्यक दर्ाओं की बचत करके, आम िनता
के जलए हर समय उपलब्लध रखनी चाजहए। इसजलए, एनपीपीए का यह जर्चार ह ै दक इन जर्जनर्मवजतयों की अव्यर्हायवता
िैसी जस्ट्थजत नहीं होनी चाजहए, िहां ये दर्ाए ं बािार म ें अनपु लब्लध हो िाती ह । और िनता को महगं ा जर्क पों पर सोचन े
के जलए मिबरय दकया िाता ह।ै
8. और िबदक एनपीपीए के संज्ञान म ें ह ै दक मौियदा नीजत के अनसु ार लागत आधाटरत म य य जनधावरण संभर् नहीं ह।ै
बार-बार म य य जनयंत्रण के कारण उत्पन्न जस्ट्थजत का समाधान करन े के जलए, र्तवमान अजधकतम मय य स े 50% की एक बार
की मय य र्ृजि को सार्विजनक जहत म ें एक असाधारण उपाय के रूप में माना िा रहा है, िैसा दक एससीएएमएचपी द्वारा
सलाह दी गई ह।ै तद्नुसार एनपीपीए ने र्तवमान अजधकतम मय य स े 50% की एक समय र्ृजि देकर तीन दर्ाओं के नौ
अनुसयजचत फॉमयवलेिन की अजधकतम कीमतों म ें र्ृजि करने के जलए डीपीसीओ, 2013 के पैरा 19 के तहत सार्विजनक जहत
म ें असाधारण िजियों को िाजमल दकया था।
9. इसजलए, भारत सरकार के रसायन और उर्रव क मंत्रालय द्वारा िारी ददनांक 30 मई, 2013 को का.आ. 1394(अ)
के साथ पटित औषध (म य य जनयंत्रण) आदेि, 2013 के परै ा 19 द्वारा प्रदत्त असाधारण िजियों का प्रयोग करत े हुए
सार्विजनक जहत म ें और रसायन और उर्रव क मंत्रालय (राष्ट्रीय औषध मय य जनधारव ण प्राजधकरण) में भारत सरकार के आदेि
के अजधक्रमण म,ें नीच े की सारणी में उज ल जखत स्ट् तंभ स.ं 6(ए) और 6(बी) म ें जर्जनर्दष्टव ट का.आ. सं. और जतजथ दी गई ह,ै
राष्ट्रीय औषध मय य जनधावरण प्राजधकरण नीच े की सारणी के स्ट्त ंभ (5) म ें जर्जनर्दष्टव ट अजधकतम कीमत को उक्त सारणी के
स्ट् तंभ (3) और (4) क्रमि: तत्स्ट् थ ानी प्रजर्जष्टट यों म ें जर्जनर्दष्टव ट खुराक रूप एर् ं प्रबलता और इकाई सजहत उस सारणी के स्ट् तंभ[भाग II—खण् ड 3(ii)] भारत का रािपत्र : असाधारण 5
(2) में की तत्स्ट् थ ानी प्रजर्जष्टट में जर्जनर्दष्टव ट अनुसयजचत जर्जनर्मवजतयों में से प्रत् यके की, र्स्ट् तु एर्ं सेर्ा कर, यदद कोई ह,ै को
छोड़कर अजधकतम कीमत के रूप में जनयत करती ह।ै
सारणी
क्र.सं. अनुसयजचत जर्जनर्मवजत खुराक रूप और प्रबलता इकाई अजधकतम मौियदा का.आ. सं. और ददनांक
का नाम कीमत
(रु.)
(1) (2) (3) (4) (5) 6(ए) 6(बी)
1. dkckZektkikbu vkjs y fyD;wbZM 100 1 fefy- 0.29 25.03.2021
1330(E)
fexzk-@5 fefy-
क्र.सं. 139
2. dkckZektkikbu lhvkj xkys h 200 1 xkys h 2.34 25.03.2021
1330(E)
fexzk-
क्र.सं. 140
3. dkckZektkikbu lhvkj xkys h 400 1 xkys h 4.61 25.03.2021
1330(E)
fexzk-
क्र.सं. 141
4. dkckZektkikbu xkys h 100 fexzk- 1 xkys h 1.02 25.03.2021
1330(E)
क्र.सं. 142
5. jkfufVfMu vkjs y fyD;wbZM 75 1 fefy- 1.08 25.03.2021
1330(E)
fexzk-@5 fefy-
क्र.सं. 722
6. jkfufVfMu xkys h 150 fexzk- 1 xkys h 1.10 25.03.2021
1330(E)
क्र.सं. 723
7. jkfufVfMu batSD'ku 25 fexzk- 1 fefy- 2.43 25.03.2021
1330(E)
@fefy-
क्र.सं. 724
8. vkbZcqizksQqu xkys h 200 fexzk- 1 xkys h 0.59 25.03.2021
1330(E)
क्र.सं. 431
9. vkbZcqizksQqu xkys h 400 fexzk- 1 xkys h 1.04 25.03.2021
1330(E)
क्र.सं. 432
नोट:
¼d½ ljdkj }kjk bl idz kj fu;r dh xbZ vkSj vf/klwfpr dh xbZ vf/kdre dher ¼/ku oLrq ,o a lsok
dj] tks ykx w gksa½ ls vf/kd dher ij vuqlwfpr fofufeZfr;ks a ds czkaMsM ;k tsusfjd ;k nksukas :ikra jks a dk s
cps jg s vuqlwfpr fofufeZfr;ks a ds lHkh fofuekZrk] mi;qZDr lkj.kh ds LraHk ¼5½ eas of.kZr vf/kdre dher
¼/ku oLrq ,oa lsok dj] tk s ykx w gks½a ls vf/kd lHkh ,ls h fofufeZr;kas dh dher dk v/kkes q[kh iuq jh{k.k
djsxa As
(ख) डीपीसीओ, 2013 के पैरा 13 (2) के प्रार्धान क्रमि: कॉलम (2) और (3) म ें उज लजखत खुराक और प्रबलता के साथ
जर्जनर्मवजत के संबंध म ें कॉलम (5) म ें जनर्दष्टव अजधकतम मय य पर लाग य नहीं होंगे।
¼x½ vxj fuekZrkvkas us mi;qZDr lkj.kh ds LraHk ¼5½ eas of.kZr vf/kdre dher ij ljdkj dks okLro eas
Hkqxrku fd;k gS ;k ;g ns; gS rks o s oLrq ,oa lsok dj dk s tksM+ ldrs gSaA
¼?k½ vkS"k/k ¼eYw ; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 11 eas fn, x, izko/kkuks a ds rgr lEcfU/kr fuekrZ kvks a
dk s mi;qZDr lkj.kh ds LraHk ¼5½ esa fofufnZ"V vf/kdre dher ds vk/kkj ij vuqlwfpr fofufeZfr;ks a ds iSdkas
ds fy, vf/kdre dher fu/kkZfjr djsAa fuekZrk vkS"k/k ¼eYw ; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 24 ds6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
rgr QkWe&Z V es a vf/klwpuk dh rkjh[k ls vkbZihMh,e,l ds ek/;e ls Hkjdj ,uihih, dk s ,d ewY;
lwph tkjh djsa rFkk mldh dkWih jkT; vkS"kf/k fu;a=dkas vkSj fofuekZrk forjdkas dk s tkjh djsAa
¼M+½ vkS"k/k ¼eYw ; fu;a=.k½ vkns'k] 2013 ds iSjk 24 ¼4½ ds mica/kkas ds vuqlkj izR;sd QVq dj foØsrk vkSj
forjd fofuekZrk }kjk fn, x, :i es a ,ls s ifjlj] tgka dkjkcs kj dk s bl izdkj fd;k tk jgk gS fd
mlls ijke’kZ ds bPNqd fdlh O;fDr ds fy, igqap vklku gks] ogka mlds fdlh lgtn`'; Hkkx ij
dher lwph vkSj iwjd lwph] ;fn dksbZ gk]s dk s lia znf'krZ djsxkA
¼p½ mi;qZDr lkj.kh es a ;Fkk fofufnZ"V [kqnjk ;k izcyrk ;k nkus kas ds lkFk vuqlwfpr fofufeZfr dk dkbs Z
ekStnw k fofuekZrk vkS"k/k eYw ; fu;a=.k vkns'k] 2013 ds iSjk 2¼;½w ds vuqlkj dkbs Z ubZ vkS"kf/k dk s ykpa
djrk gS rks ,ls s ekStwnk fofuekZrk dh vkS"k/k ¼eYw ; fu;a=.k½ vkns'k 2013 dh vuqlwph&II ds varxZr ;Fkk
fofufnZ"V QkeZ&I es a ,uihih, dks ,ls h ubZ vkS"kf/k ds iwoZ ewY; vuqeksnu gsrq vkons u djuk gksxkA
¼N½ mi;qZDr vuqlwfpr fofufeZfr;ks a dh mRiknu@vk;kr vkSj fcØh ds lEcU/k eas fuekZrkvkas dk s vkS"k/k
¼eYw ; fu;a=.k½ vkns'k] 2013 ds lwph II ds QkWeZ III dk s vkbZihMh,e,l ds ek/;e ls Hkjdj ,uihih, dks
gj frekgh dh fjiksVZ izLrqr djsxkA mi;qZDr vuqlwfpr fofufeZfr;ks a ds fuekZ.k dk s dkbs Z fuekrZ k mRiknu
cUn djus dk bPNqd gks rks bldh lwpuk ,uihih, dk s voxr djk;sxkA blds lEcU/k es a vxj vuqlwfpr
fofufeZfr;ks a ds mRiknu vkSj vk;kr dk s cUn djus dk bPNqd gS rks cUn djus dh frfFk ls N% eghus
igys vuqlwph II ds QkWeZ IV eas Hkjdj ,uihih, dks izLrqr djsxkA
¼Tk½ fofuekZrk] mijkDs r dfFkr lkj.kh eas n'kkZ;s vf/kdre ewY; vkSj 'krks± dk ikyu ugha djrh gSa rk s o s
vko';d oLrq,¡ vf/kfu;e] 1955 ds lkFk ifBr Mhihlhvk]s 2013 ds izko/kkuks a ds v/khu C;kt lfgr
vf/kizHkkfjr jkf'k dks tek djus ds fy, mRrjnk;h gksaxAs
¼>½ bl vkns'k eas mijkDs r lkj.kh ds LraHk ¼2½ eas dh rRLFkkuh izfof"V eas fofufnZ"V ,slh fofufeZfr;ks a ds
iSdks a dh vf/kdre dher fu;r gksus ds ifj.kkeLo#i] vf/kdre ;k [kqnjk eYw ; fu/kkZfjr vkns'k ;fn
dkbs Z gks] tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh vf/kØe.k gks tk;asxsA
[dka-l-a@221@89@2021@,Q Qk-l-a 8¼89½@2021@Mhih@,uihih,&fMoh-II]
izlsuthr nkl] mi funs'kd
ORDER
New Delhi, the 1st July, 2021
S.O. 2654(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 19 of the said Order
to be exercised by the NPPA on behalf of the Central Government.
3. And whereas NPPA has been receiving applications for upward price revision under para 19 of
DPCO, 2013 since last more than two years citing various reasons like increase in cost of production,
exchange rates etc. resulting in unviability in sustainable production and marketing of the drugs.[भाग II—खण् ड 3(ii)] भारत का रािपत्र : असाधारण 7
4. And whereas NPPA referred the issue to the Standing Committee on Affordable Medicines and
Health Products (SCAMHP), Niti Aayog, Government of India for guidance on the modalities/
methodology to be followed for such cases.
5. And whereas SCAMHP in its 2nd meeting held on 07.11.2019 has recommended examination of
formulations/ molecules experiencing manufacturing unviability due to low prices and consider price
revision by allowing 50% increase from the ceiling price.
6. And whereas, the Inter-Ministerial Committee constituted for examination of cases under Para 19
of DPCO 2013 has examined the representations and observed that the formulations of the three drugs are
essential medicines for public health management and pricing of these should not be reason for shortage
and unavailability of these medicines, and accordingly recommended for upward revision of price under
Para 19 of DPCO 2013.
7. And whereas, NPPA in its 89th meeting dated 28.06.2021 deliberated upon the case of upward
price revision of the formulations of these drugs under para 19 of DPCO 2013 and noted that the scheduled
formulations being considered for upward price revision under para 19 of DPCO 2013 are low priced drugs
and have been under repeated price control. These drugs are used as first line of treatment and are
important to the public health program of the country. Further, the mandate of NPPA is to ensure
availability of drugs at affordable prices and it was noted that while ensuring affordability, access cannot be
jeopardized and the life saving essential drugs must remain available to the general public at all times.
Therefore, the NPPA is of the considered view that unviability of these formulations should not lead to a
situation, where these drugs become unavailable in the market and the public is forced to switch to costly
alternatives.
8. And whereas, NPPA is cognizant that as per the prevailing policy, cost based pricing is not feasible.
To address the situation arising due to repeated price control, one time price increase of 50% from the
present ceiling price is being considered in public interest as an exceptional measure as advised by
SCAMHP. Accordingly, NPPA invokes extra ordinary powers in public interest under para 19 of DPCO
2013 for upward revision of the ceiling prices of the nine scheduled formulations of 3 drugs by giving one
time increase of 50% from the present ceiling price.
9. Therefore, in exercise of extra ordinary powers in public interest, conferred by paragraph 19 of the
Drugs (Prices Control) Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 issued by the
Government of India in the Ministry of Chemicals and Fertilizers, and in supersession of the Order(s) of the
Government of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing
Authority) S.O. Number and date specified in column no. 6(a) & 6(b) mentioned in the table below, the
National Pharmaceutical Pricing Authority, hereby fixes the prices as specified in column (5) of the Table
below as ceiling prices exclusive of Goods and Services Tax applicable, if any in respect of the Scheduled
formulations specified in the corresponding entry in column (2) of the said Table with the dosage form &
strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof:
TABLE
Sl. Name of the Dosage form & Unit Ceiling Existing S.O. No. & Date
No. Scheduled Strength Price
Formulation (Rs.)
(1) (2) (3) (4) (5) 6(a) 6(b)
1. Carbamazepine Oral Liquid 100 1 ml 0.29 1330(E) 25.03.2021
mg/5ml Sl. No. 139
2. Carbamazepine CR Tablet 200 mg 1 tablet 2.34 1330(E) 25.03.2021
Sl. No. 140
3. Carbamazepine CR Tablet 400 mg 1 tablet 4.61 1330(E) 25.03.2021
Sl. No. 1418 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
4. Carbamazepine Tablet 100 mg 1 tablet 1.02 1330(E) 25.03.2021
Sl. No. 142
5. Ranitidine Oral Liquid 75 1 ml 1.08 1330(E) 25.03.2021
mg/5ml Sl. No. 722
6. Ranitidine Tablet 150 mg 1 tablet 1.10 1330(E) 25.03.2021
Sl. No. 723
7. Ranitidine Injection 25mg/ml 1 ml 2.43 1330(E) 25.03.2021
Sl. No. 724
8. Ibuprofen Tablet 200 mg 1 tablet 0.59 1330(E) 25.03.2021
Sl. No. 431
9. Ibuprofen Tablet 400 mg 1 tablet 1.04 1330(E) 25.03.2021
Sl. No. 432
Note:
(a) All manufacturers of scheduled formulation, selling the branded or generic or both the versions of
scheduled formulations at a price higher than the ceiling price (plus Goods and Services Tax as
applicable) so fixed and notified by the Government, shall revise the prices of all such formulations
downward not exceeding the ceiling price specified in column (5) in the above table plus Goods and
Services Tax as applicable, if any.
(b) The provisions of para 13(2) of DPCO 2013 would not be applicable on the ceiling price specified in
column (5) in respect of the formulations with dosage & strength mentioned in column (2) and (3)
respectively.
(c) The manufacturers may add Goods and Services Tax only if they have paid actually or if it is payable
to the Government on the ceiling price mentioned in column (5) of the above said table.
(d) The ceiling price for a pack of the scheduled formulation shall be arrived at by the concerned
manufacturer in accordance with the ceiling price specified in column (5) of the above table as per
provisions contained in paragraph 11 of the Drugs (Prices Control) Order, 2013. The manufacturer
shall issue a price list in Form–V from date of Notification as per paragraph 24 of the DPCO, 2013 to
NPPA through IPDMS and submit a copy to State Drug Controller and dealers.
(e) As per para 24(4) of DPCO 2013, every retailer and dealer shall display price list and the
supplementary price list, if any, as furnished by the manufacturer, on a conspicuous part of the
premises where he carries on business in a manner so as to be easily accessible to any person wishing
to consult the same.
(f) Where an existing manufacturer of scheduled formulation with dosage or strength or both as specified
in the above table launches a new drug as per paragraph 2 (u) of the DPCO, 2013 such existing
manufacturer shall apply for prior price approval of such new drug to the NPPA in Form I as specified
under Schedule-II of the DPCO, 2013.
(g) The manufacturers of above said scheduled formulations shall furnish quarterly return to the NPPA, in
respect of production / import and sale of scheduled formulations in Form-III of Schedule-II of the
DPCO, 2013 through IPDMS. Any manufacturer intending to discontinue production of above said
scheduled formulation shall furnish information to the NPPA, in respect of discontinuation of
production and / or import of scheduled formulation in Form-IV of Schedule-II of the DPCO, 2013 at
least six months prior to the intended date of discontinuation.
(h) The manufacturers not complying with the ceiling price and notes specified hereinabove shall be liable
to deposit the overcharged amount along with interest thereon under the provisions of the Drugs
(Prices Control) Order, 2013 read with Essential Commodities Act, 1955.[भाग II—खण् ड 3(ii)] भारत का रािपत्र : असाधारण 9
(i) Consequent to the issue of ceiling price of such formulation as specified in column (2) of the above
table in this notification, the price order(s) fixing ceiling or retail price, if any, issued prior to the above
said date of notification, stand(s) superseded.
[PN/221/89/2021/F F. No. 8(89)/2021/ DP/Div-II/NPPA]
PRASENJIT DAS, Dy. 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.