## Policy Analysis Report: National Pharmaceutical Pricing Authority (NPPA) Order, January 8, 2021
**1. Executive Summary:**
This report analyzes an order issued by the National Pharmaceutical Pricing Authority (NPPA) on January 8, 2021, regarding the retail pricing of specific pharmaceutical formulations. This order, issued under the authority of the Drugs Prices Control Order (DPCO) 2013, fixes the retail prices for twelve listed formulations. The key finding is that manufacturers must adhere to the specified retail prices, subject to permissible additions like Goods and Services Tax (GST). Retailers and distributors are also mandated to display these prices prominently. This order supersedes any prior price orders for the listed formulations.
**2. Introduction:**
The purpose of this report is to provide an informative analysis of the NPPA order issued on January 8, 2021, concerning the retail pricing of certain drugs, based solely on the content of the provided policy text. This analysis will outline the policy's objectives, key provisions, affected stakeholders, and likely outcomes.
**3. Policy Overview:**
This order is issued under the authority of paragraphs 5, 11, and 15 of the Drugs Prices Control Order (DPCO), 2013.
* **Core Objective(s) (inferred):** The core objective is to regulate and control the retail prices of specific pharmaceutical formulations within India to ensure affordability and accessibility.
**4. Background and Rationale:**
This is a pricing order that fixes the retail prices of specific pharmaceutical formulations under the Drugs Prices Control Order (DPCO), 2013. The underlying issue is likely to control the prices of essential drugs and prevent overcharging, thereby making them accessible to the public. This is suggested by the reference to the Essential Commodities Act, 1955.
**5. Key Provisions / Changes:**
* This order fixes the retail prices for twelve specific pharmaceutical formulations, as detailed in the table provided.
* The fixed prices are exclusive of Goods and Services Tax (GST). Manufacturers can add GST only if it is actually paid or payable to the government.
* Manufacturers of formulations that are considered new drugs under paragraph 2u of the DPCO 2013, must fix the retail price as specified.
* Manufacturers are required to issue a Price List in Form V to the NPPA through IPDMS, State Drug Controller, and dealers.
* Retailers and distributors are required to display the price list and any supplementary price lists in a conspicuous place within their business premises.
* The order explicitly states that the retail prices apply only to the individual manufacturer/marketer who applied for price fixation/revision under DPCO, 2013.
* Failure to comply with the pricing regulations will result in the manufacturer/marketing company being liable to deposit the overcharged amount, along with interest, under the provisions of the DPCO, 2013, read with the Essential Commodities Act, 1955.
* This order supersedes any prior price orders fixing the ceiling or retail price for the formulations listed.
**6. Target Audience and Stakeholders:**
The primary target audience and stakeholders are:
* **Pharmaceutical Manufacturers:** Specifically, those producing the twelve formulations listed in the order.
* **Marketing Companies:** Those involved in the marketing and distribution of the listed formulations.
* **Retailers and Distributors:** Those selling the formulations to the end consumers.
* **Consumers:** Although not directly addressed, they are the ultimate beneficiaries of the price control measures.
* **National Pharmaceutical Pricing Authority (NPPA):** The implementing and monitoring agency.
* **State Drug Controllers:** Responsible for overseeing implementation at the state level.
**7. Implementation Aspects (Inferred):**
* **Responsible Agency/Bodies:** The National Pharmaceutical Pricing Authority (NPPA) is the primary responsible agency. State Drug Controllers also play a role in overseeing implementation.
* **Timelines/Procedures:**
* Manufacturers must issue a Price List in Form V from the date of notification.
* Retailers and distributors must display the price list immediately upon receipt from the manufacturer.
* The order is effective from the date of publication.
* The NPPA utilizes the IPDMS (Integrated Pharma Database Management System) for communication and submission of price lists.
**8. Expected Outcomes / Impact of Changes:**
The likely intended outcomes of this price control order are:
* **Price Stabilization:** To prevent arbitrary price increases for the specified formulations.
* **Increased Affordability:** To make these medicines more accessible to patients by regulating their retail prices.
* **Compliance and Enforcement:** To ensure that manufacturers, marketers, retailers, and distributors comply with the pricing regulations.
* **Market Transparency:** Displaying price lists will improve transparency for consumers.
**9. Conclusion:**
The NPPA order issued on January 8, 2021, is a significant regulatory measure aimed at controlling the retail prices of twelve specific pharmaceutical formulations. It mandates specific actions for manufacturers, distributors, and retailers to ensure compliance and transparency. This policy aims to ultimately benefit consumers by ensuring the affordability and accessibility of essential medicines. The order's impact will depend on the effective enforcement by the NPPA and the compliance of the affected stakeholders.
Key Entities Referenced
Drugs Prices Control Order, 2013: A legal order that empowers the National Pharmaceutical Pricing Authority (NPPA) to regulate the prices of pharmaceutical products.
National Pharmaceutical Pricing Authority: A government regulatory agency responsible for fixing and revising prices of pharmaceutical products in India.
Ministry of Chemicals and Fertilizers: A ministry of the Government of India.
Department of Pharmaceuticals: A department within the Ministry of Chemicals and Fertilizers, Government of India, that deals with policy, research, and development related to the pharmaceutical sector.
Remogliflozin Etabonate: A pharmaceutical drug, with specific strengths (100mg) and manufacturers (Ms Glenmark Pharmaceuticals Ltd., Ms Torrent Pharmaceuticals Ltd.).
Metformin Hydrochloride: A pharmaceutical drug, with specific strengths (500mg, 1000mg) and manufacturers (Ms Glenmark Pharmaceuticals Ltd., Ms Torrent Pharmaceuticals Ltd.).
Goods and Services Tax: A tax levied on the supply of goods and services.
Form V: A form used for issuing a price list as per paragraph 24 of the DPCO, 2013.
IPDMS: A system through which the manufacturer shall issue a Price List in FormV from date of Notification as per paragraph 24 of the DPCO, 2013 to NPPA.
State Drug Controller: A regulatory authority at the state level responsible for drug control and regulation.
Form I: A form submitted for price fixation/revision under DPCO, 2013.
Essential Commodities Act, 1955: An act of the Parliament of India to provide, in the interests of the general public, for the control of the production, supply, and distribution of, and trade and commerce.
Aceclofenac: A pharmaceutical drug, with specific strengths (100mg) and manufacturers (Ms Pure and Cure Healthcare Pvt. Ltd., Ms Torrent Pharmaceuticals Ltd.).
Paracetamol: A pharmaceutical drug, with specific strengths (325mg) and manufacturers (Ms Pure and Cure Healthcare Pvt. Ltd., Ms Torrent Pharmaceuticals Ltd.).
Atorvastatin: A pharmaceutical drug (10mg) manufactured by Ms Pure and Cure Healthcare Pvt. Ltd. and Ms FDC Limited.
Aspirin: A pharmaceutical drug (75mg) manufactured by Ms Pure and Cure Healthcare Pvt. Ltd. and Ms FDC Limited.
Thiocolchicoside: A pharmaceutical drug (4mg) manufactured by Ms Akums Drugs and Pharmaceuticals Ltd. and Ms Torrent Pharmaceuticals Ltd..
Vildagliptin: A pharmaceutical drug (50mg) manufactured by Ms Exemed Pharmaceuticals and Ms Zydus Healthcare Limited or Ms Lupin Limited.
Metronidazole: A pharmaceutical drug (0.2gm) manufactured by Ms Aculife Healthcare Pvt. Ltd.
Dextrose: A pharmaceutical drug (5.0gm) manufactured by Ms Aculife Healthcare Pvt. Ltd.
Dapagliflozin: A pharmaceutical drug (5mg) manufactured by Ms Torrent Pharmaceuticals Limited.
New Delhi: The location where the order was issued.
Government of India Press, Ring Road, Mayapuri, New Delhi: Location of the Dte. of Printing
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
xxxGIDHxxx
सी.जी.-डी.एलxx.x-GअI.D-E0x9x0x 12021-224306
CG-DL-E-09012021-224306
असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (ii)
PART II—Section 3—Sub-section (ii)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 81] नई ददल्ली, िुक्रर्ार, िनर्री 8, 2021/पौष 18, 1942
No. 81] NEW DELHI, FRIDAY, JANUARY 8, 2021/PAUSHA 18, 1942
रसायन और उर्रव क मत्रं ालय
(औषध जर्भाग)
( राष्ट्रीय औषध मूल्य जनधावरण प्राजधकरण)
आदिे
नई ददल्ली, 08 िनर्री 2021
का. आ. 95(अ).— भारत सरकार के रसायन और उर्वरक मत्रं ालय द्वारा िारी का. आ. 1394 (अ) तारीख 30
मई, 2013 और का. आ. 701(अ) तारीख 10मार्,व 2016 के साथ पठित औषध (कीमत जनयंत्रण) आदेि, 2013 के पैरा
5,11 और 15 द्वारा प्रदत्त िजियों का प्रयोग करते हुए, राष्ट्रीय औषध मल्ू य जनधारव ण प्राजधकरण(जिसको संजिप्त रूप म ें
एनपीपीए कहा िाता ह)ै नीर्े की सारणी के स्ट्तंभ(6) म ें जर्जनर्ददष्ट खुदरा मल्ू य को उि सारणी के स्ट्तंभ(3),(4) और (5) म ें
तत्सस्ट्थानी प्रजर्जष्टयों म ें जर्जनर्ददष्ट प्रबलता, इकाई (यूजनट) और जर्जनमावता और जर्पणन कंपजनयों के नाम सजहत स्ट्तंभ(2) म ें
की तत्सस्ट्थानी प्रजर्जष्ट म ें से प्रत्सयेक की,र्स्ट्त ु एर् ं सेर्ा कर, यदद कोई ह,ै को छोड़कर अजधकतम खुदरा मल्ू य के रूप म ें जनयत
करती ह ै
सारणी
क्रं जर्जनर्ममजत का प्रबलता इकाई जर्जनमातव ा और जर्पणन खुदरा
स ं नाम/ब्ाडं का नाम कंपनी मल्ू य
(रू.)
(1) (2) (3) (4) (5) (6)
1. रेमोजललफ्लोज़िन प्रत्सयेक दिल्म जलजपत गोली में: मैससव ललेनमाकव 11.44
रेमोजललफ्लोज़िन एटाबोनेट 100 जम.ग्रा 1 गोली िामावस्ट्यूठटकल्स जलजमटेड
एटाबोनेट 100 जम.ग्रा
/ मैससव टोरेंट
128 GI/2021 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
क्रं जर्जनर्ममजत का प्रबलता इकाई जर्जनमातव ा और जर्पणन खुदरा
स ं नाम/ब्ाडं का नाम कंपनी मल्ू य
(रू.)
(1) (2) (3) (4) (5) (6)
+ मेटिॉर्ममन हाइड्रोक्लोराइड आईपी 500 िामावस्ट्यूठटकल्स जलजमटेड
मेटिॉर्ममन जम.ग्रा
हाइड्रोक्लोराइड 500
जम.ग्रा गोजलयााँ
2. रेमोजललफ्लोज़िन प्रत्सयेक दिल्म जलजपत गोली में: 13.18
एटाबोनेट 100 जम.ग्रा रेमोजललफ्लोज़िन एटाबोनेट 100 जम.ग्रा
मैससव ललेनमाकव
+ मेटिॉर्ममन हाइड्रोक्लोराइड आईपी 1000 िामावस्ट्यूठटकल्स जलजमटेड
1 गोली
मेटिॉर्ममन जम.ग्रा / मैससव टोरेंट
हाइड्रोक्लोराइड िामावस्ट्यूठटकल्स जलजमटेड
1000 जम.ग्रा गोजलयााँ
3. प्रत्सयेक दिल्म जलजपत गोली में: मैससव प्योर एंड क्योर 4.23
एजसक्लोिेनाक
एजसक्लोिेनाक
हल्े थकेयर प्रा. जलजमटेड /
+ पैराजसटामोल 1 गोली
आईपी 100 जमलीग्राम
मैससव टोरेंट
टैबलेट
पैराजसटामोल आईपी 325 जमलीग्राम िामावस्ट्यूठटकल्स जलजमटेड
4. प्रत्सयेक हाडव जिलेठटन कैप्सूल में: 2.59
एटोरर्ास्ट्टेठटन कैजल्ियम आईपी
मैससव प्योर एंड क्योर
एटोरर्ास्ट्टेठटन 10 जमलीग्राम के बराबर
एटोरर्ास्ट्टेठटन +
1 कैप्सूल हल्े थकेयर प्रा. जलजमटेड /
एजस्ट्पठरन कैप्सूल (दिल्म जलजपत टैबलेट के रूप में)
मैससव एिडीसी जलजमटेड
एजस्ट्पठरन आईपी 75 जमलीग्राम (एंटठरक
कोटेड टैबलेट िॉमव के रूप में)
5. प्रत्सयेक दिल्म जलजपत गोली में: 1 गोली 14.99
मैससव अकुम ड्रलस एंड
थायोकोलेकोसाइड + थायोकोलेकोसाइड आईपी 4 जमलीग्राम
िामावस्ट्यूठटकल्स जलजमटेड
एसक्लोिेनाक +
एसक्लोिेनाक आईपी 100 जमलीग्राम / मैससव टोरेंट
पैराजसटामोल टैबलेट
िामावस्ट्यूठटकल्स जलजमटेड
पैराजसटामोल आईपी 325 जमलीग्राम
6. मेटिॉर्ममन प्रत्सयेक अजलजपत बाईलेयर गोली में: 1 गोली 6.58
हाइड्रोक्लोराइड मेटिॉर्ममन हाइड्रोक्लोराइड आईपी (सस्ट्टेंड मैससव एजक़्िमेड
(सस्ट्टेंड ठरली़ि रूप में) फामावस्ट्यूठटकल्स / मैससव
ठरली़ि रूप में) 500 जमलीग्राम,
और ़िाइडस हल्े थकेयर
जर्डालजललजप्टन 50 जमलीग्राम,
जर्डालजललजप्टन जलजमटेड
गोजलयााँ
7. मेटिॉर्ममन प्रत्सयेक अजलजपत बाईलेयर गोली में: : 1 गोली 7.07
हाइड्रोक्लोराइड मेटिॉर्ममन हाइड्रोक्लोराइड आईपी (सस्ट्टेंड मैससव एजक़्िमेड
(सस्ट्टेंड ठरली़ि रूप में) फामावस्ट्यूठटकल्स / मैससव
ठरली़ि रूप में) 1000 जमलीग्राम,,
और ़िाइडस हल्े थकेयर
जर्डालजललजप्टन 50 जमलीग्राम,
जर्डालजललजप्टन जलजमटेड
गोजलयााँ
8. मेटिॉर्ममन प्रत्सयेक अजलजपत बाईलेयर गोली में: : 1 गोली 6.58
हाइड्रोक्लोराइड मेटिॉर्ममन हाइड्रोक्लोराइड आईपी (सस्ट्टेंड
मैससव एजक़्िमेड
(सस्ट्टेंड ठरली़ि रूप में)
ठरली़ि रूप में) 500 जमलीग्राम,, फामावस्ट्यूठटकल्स / मैससव
और
जर्डालजललजप्टन 50 जमलीग्राम, ल्यूजपन जलजमटेड
जर्डालजललजप्टन
गोजलयााँ
9. मेटिॉर्ममन प्रत्सयेक अजलजपत बाईलेयर गोली में: : 1 गोली मैससव एजक़्िमेड 7.07
हाइड्रोक्लोराइड फामावस्ट्यूठटकल्स / मैससव[भाग II—खण् ड 3(ii)] भारत का रािपत्र : असाधारण 3
क्रं जर्जनर्ममजत का प्रबलता इकाई जर्जनमातव ा और जर्पणन खुदरा
स ं नाम/ब्ाडं का नाम कंपनी मल्ू य
(रू.)
(1) (2) (3) (4) (5) (6)
(सस्ट्टेंड ठरली़ि रूप में) मेटिॉर्ममन हाइड्रोक्लोराइड आईपी (सस्ट्टेंड ल्यूजपन जलजमटेड
और ठरली़ि रूप में) 1000 जमलीग्राम,,
जर्डालजललजप्टन
जर्डालजललजप्टन 50 जमलीग्राम,
गोजलयााँ
10. प्रत्सयेक 100 जम.ली में.: 79.29
मेरोजनडािोल आईपी 0.2ग्राम
मेरोजनडािोल और प्रजत 500 मैससव एक्यूलाइि
डेक्सरोि इंिेक्िन डेक्सरोि आईपी (एनहाईड्रस रूप में) 5.0 जमली पैक हल्े थकेयर प्रा. जलजमटेड
ग्राम
इंिेक्िन आईपी के जलए पानी
11. डापाजललफ्लोजिन + प्रत्सयेक दिल्म जलजपत गोली में: 1 गोली 6.97
मेटिॉर्ममन डापाजललफ्लोजिन 5जमलीग्राम,
मैससव टोरेंट
हाइड्रोक्लोराइड मेटिॉर्ममन हाइड्रोक्लोराइड आईपी
िामावस्ट्यूठटकल्स जलजमटेड
जर्स्ट्ताठरत ठरली़ि (एक्स्ट्टेंडेड ठरलीि िॉमव में) 500 जमलीग्राम
गोली में
12. डापाजललफ्लोजिन + प्रत्सयेक दिल्म जलजपत गोली में: 1 गोली 8.35
डापाजललफ्लोजिन 5जमलीग्राम,
मेटिॉर्ममन
मैससव टोरेंट
हाइड्रोक्लोराइड मेटिॉर्ममन हाइड्रोक्लोराइड आईपी
िामावस्ट्यूठटकल्स जलजमटेड
जर्स्ट्ताठरत ठरली़ि (एक्स्ट्टेंडेड ठरलीि िॉमव में) 1000
गोली में जमलीग्राम
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lkj.kh ds LrHak ¼6½ es a fofufn"ZV [kqnjk ewY; fu/kkZfjr djasxsA
¼[k½ vxj fuekZrkvksa us mi;ZDq r lkj.kh ds LrHak (6) es a of.kZr vf/kdre dher ij ljdkj dks okLro e sa Hkqxrku fd;k gS ;k ;g ns; gS
rks os oLrq ,oa lsok dj dks tksM+ ldr s gSaA
¼x½ vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxkzQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvks a dks mi;qZDr lkj.kh ds LraHk ¼6½ es a
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vkns'k] 2013 ds iSjkxkzQ 24 ds rgr QkWeZ V es a vf/klwpuk dh rkjh[k l s ,d ewY; lpw h ,uihih, dks vkbZihMh,e,l ds ek/;e ls
tkjh djs a rFkk mldh dkiWh jkT; vkS"kf/k fu;a=dksa vkSj fofuekZrk forjdks a dks tkjh djsAa
¼?k½ vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds 24 (4) ds mica/kksa ds vulq kj izR;sd QqVdj fodzsrk vkSj forjd fofuekZrk }kjk fn, x,
:i esa ,sls ifjlj] tgka dkjckj dks bl izdkj fd;k tk jgk gS fd mlls ijke'kZ ds bPNqd fdlh O;fDr ds fy, igqpa vklku gks]
ogka mlds fdlh lgtn`'; Hkkx ij dher lwph vkSj iwjd lwph] ;fn dksb Z gks] dks lainz f'kZr djxs kA
¼M-½ mi;qZDr xSj vf/kdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykx w gS tSlk fd mUgkusa s vkS"k/k ¼ewY; fu;a=.k½
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[पीएन@214/82/2020/एि@िा.न.8(82)/2020/डी-पी-@एनपीपीए&डी.र्ी-&II]
izlus thr nkl] mi funs'kd4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals)
(National Pharmaceutical Pricing Authority)
ORDER
New Delhi, 08 January, 2021
S. O. 95(E).— In exercise of the powers conferred by paragraphs 5, 11 and 15 of the Drugs (Prices Control)
Order, 2013, read with S.O. 1394(E) dated the 30th May, 2013 and S.O. 701(E) dated 10th March, 2016 issued by the
Government of India in the Ministry of Chemicals and Fertilizers, the National Pharmaceutical Pricing Authority
(hereinafter referred as NPPA), hereby fixes, the price as specified in column (6) of the table herein below as the retail
price, exclusive of Goods and Services Tax, if any, in relation to the formulation specified in the corresponding entry
in column (2) of the said Table with the strength, unit and name of manufacturer & marketing company, as specified
in the corresponding entries in columns (3), (4) and (5) thereof;
Table
Sl. No. Name of the Strength Unit Manufacturer & Retail
Formulation / Brand Marketing Company Price
Name (Rs.)
(1) (2) (3) (4) (5) (6)
1. Remogliflozin Each film coated tablet contains: M/s Glenmark 11.44
Etabonate + Remogliflozin Etabonate 100mg, Pharmaceuticals Ltd. /
1 Tablet
Metformin Metformin Hydrochloride IP 500mg M/s Torrent
Hydrochloride Tablet Pharmaceuticals Ltd.
2. Remogliflozin Each film coated tablet contains: M/s Glenmark 13.18
Etabonate + Remogliflozin Etabonate 100mg, Pharmaceuticals Ltd. /
1 Tablet
Metformin Metformin Hydrochloride IP M/s Torrent
Hydrochloride Tablet 1000mg Pharmaceuticals Ltd.
3. Each film coated tablet contains: M/s Pure and Cure 4.23
Aceclofenac + Aceclofenac IP 100mg Healthcare Pvt. Ltd. /
1 Tablet
Paracetamol Tablet Paracetamol IP 325mg M/s Torrent
Pharmaceuticals Ltd.
4. Each Hard Gelatin Capsule 2.59
Contains:
Atorvastatin Calcium IP eq to M/s Pure and Cure
Atorvastatin + Aspirin
Atorvastatin 10mg (As Film coated 1 Capsule Healthcare Pvt. Ltd. /
Capsule
tablet form) M/s FDC Limited
Aspirin IP 75mg (As Enteric Coated
tablet form)
5. Each film coated tablet contains: 1 Tablet M/s Akums Drugs and 14.99
Thiocolchicoside +
Thiocolchicoside IP 4mg Pharmaceuticals Ltd. /
Aceclofenac +
Aceclofenac IP 100mg M/s Torrent
Paracetamol Tablet
Paracetamol IP 325mg Pharmaceuticals Ltd.
6. Each uncoated bilayered tablet 1 Tablet 6.58
Metformin M/s Exemed
contains:
Hydrochloride (As Pharmaceuticals / M/s
Metformin Hydrochloride IP (As
sustained release) and Zydus Healthcare
sustained release) 500mg,
Vildagliptin Tablets Limited
Vildagliptin 50mg,
7. Each uncoated bilayered tablet 1 Tablet 7.07
Metformin M/s Exemed
contains:
Hydrochloride (As Pharmaceuticals / M/s
Metformin Hydrochloride IP (As
sustained release) and Zydus Healthcare
sustained release) 1000mg,
Vildagliptin Tablets Limited
Vildagliptin 50mg,
8. Each uncoated bilayered tablet 1 Tablet 6.58
Metformin
contains: M/s Exemed
Hydrochloride (As
Metformin Hydrochloride IP (As Pharmaceuticals / M/s
sustained release) and
sustained release) 500mg, Lupin Limited
Vildagliptin Tablets
Vildagliptin 50mg,
9. Each uncoated bilayered tablet 1 Tablet 7.07
Metformin
contains: M/s Exemed
Hydrochloride (As
Metformin Hydrochloride IP (As Pharmaceuticals / M/s
sustained release) and
sustained release) 1000mg, Lupin Limited
Vildagliptin Tablets
Vildagliptin 50mg,
10. Metronidazole and Each 100ml contains: Per 500ml M/s Aculife Healthcare 79.29[भाग II—खण् ड 3(ii)] भारत का रािपत्र : असाधारण 5
Sl. No. Name of the Strength Unit Manufacturer & Retail
Formulation / Brand Marketing Company Price
Name (Rs.)
(1) (2) (3) (4) (5) (6)
Dextrose Injection Metronidazole IP 0.2gm Pack Pvt. Ltd.
Dextrose IP (as anhydrous) 5.0gm
Water for injection IP
11. Dapagliflozin + Each film-coated tablet contains: 1 Tablet 6.97
Metformin Dapagliflozin 5mg,
M/s Torrent
Hydrochloride Metformin Hydrochloride IP (In
Pharmaceuticals Limited
Extended-Release Extended release form) 500mg
Tablet
12. Dapagliflozin + Each film-coated tablet contains: 1 Tablet 8.35
Metformin Dapagliflozin 5mg,
M/s Torrent
Hydrochloride Metformin Hydrochloride IP (In
Pharmaceuticals Limited
Extended-Release Extended release form) 1000mg
Tablet
Note:
(a) The manufacturer of above mentioned formulations i.e. ―new drug‖ under paragraph 2(u) of the DPCO, 2013
shall fix the retail price as specified in column (6) of the table hereinabove.
(b) The manufacturer may add Goods and Services Tax only if they have paid actually or it is payable to the
Government on the retail price mentioned in column (6) of the above said table.
(c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in
accordance with the retail price specified in column (6) of the above table as per provisions contained in
paragraph 11 of the DPCO, 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.
(d) 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.
(e) The above mentioned retail price is applicable only to the individual manufacturer / marketer as mentioned
above i.e. who have applied for the same by submitting Form-I for price fixation / revision as stipulated
under DPCO, 2013 and subject to fulfilment of all the applicable statutory requirements as laid down by the
Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent
Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned
manufacturer/marketing companies.
(f) In case the retail price of any of the aforesaid formulations is not complied with, as per instant price
notification and notes specified hereinabove, then the concerned manufacturer/marketing company shall be
liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO,
2013 read with the Essential Commodities Act, 1955.
(g) 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/214/82/2020/F/F. No. 8(82)/2020/D.P./NPPA-Div.-II]
PRASENJIT DAS, Deputy 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.