**Report on National Pharmaceutical Pricing Authority (NPPA) Order - February 9, 2021**
**1. Executive Summary:**
This report analyzes the National Pharmaceutical Pricing Authority (NPPA) Order issued on February 9, 2021. This is a new policy that establishes the retail prices for various drug formulations, as specified in the attached table. The order aims to regulate the prices of essential medicines, ensuring their availability and affordability. The report highlights the key provisions of the order, the affected stakeholders, and the expected outcomes of the new pricing regulations.
**2. Introduction:**
This report aims to provide an informative overview and analysis of the NPPA Order dated February 9, 2021, as published in the Gazette of India. The analysis is based solely on the provided text of the order and aims to clarify the key aspects of the policy for affected stakeholders.
**3. Policy Overview:**
* **Core Objective(s):** Based on the text, the core objective of this policy is to fix the retail prices of specific pharmaceutical formulations, ensuring they are available at regulated prices. This is stated through exercising the powers conferred by the Drugs Prices Control Order, 2013.
**4. Background and Rationale:**
* **New Policy:** This policy likely addresses the need to regulate pharmaceutical prices in India. Without price controls, the cost of essential medicines could become prohibitive for a significant portion of the population. By fixing the retail prices of specified formulations, the NPPA aims to ensure accessibility and affordability of these drugs. The reference to the Drugs Prices Control Order, 2013 further supports the notion of ongoing price regulation efforts.
**5. Key Provisions / Changes:**
* This new policy introduces a table specifying the retail price (exclusive of Goods and Services Tax) for a list of pharmaceutical formulations.
* The table includes the following information for each formulation:
* Sl. No.
* Name of the Formulation/Brand Name
* Strength
* Unit
* Manufacturer/Marketing Company
* Retail Price (Rs.)
* The formulations listed include various drugs such as Rosuvastatin, Moxifloxacin, Vitamin C, Telmisartan, Pantoprazole, Clopidogrel, Mefenamic acid, Paracetamol, Vildagliptin and Azathioprine.
* The order explicitly states that the manufacturer may add Goods and Services Tax (GST) only if they have actually paid it or if it is payable to the Government on the retail price.
* It mandates that the retail price for a pack of the formulation must be arrived at as per provisions contained in paragraph 11 of the DPCO, 2013.
* It is compulsory for manufacturers to issue a price list in Form V as per paragraph 24 of the DPCO, 2013 to NPPA through IPDMS and submit a copy to State Drug Controller and dealers.
* The order specifies that retailers and dealers must display the price list and supplementary price list in a conspicuous place on their business premises.
* The order also clarifies that the mentioned retail price applies only to the individual manufacturer/marketer who has applied for price fixation/revision by submitting Form I and fulfilling all statutory requirements.
* It mentions non-compliance will result in deposition of overcharged amount along with interest under the provisions of DPCO, 2013 read with the Essential Commodities Act, 1955.
* It supersedes any previous price orders fixing ceiling or retail price issued prior to the date of notification.
**6. Target Audience and Stakeholders:**
Based on the provided text, the primary target audience and stakeholders affected by this order include:
* Pharmaceutical Manufacturers: They are directly responsible for adhering to the fixed retail prices and for issuing price lists.
* Marketing Companies: Companies involved in marketing the listed formulations.
* Retailers and Dealers: Required to display the price lists prominently.
* Consumers: Ultimately benefit from regulated prices.
* National Pharmaceutical Pricing Authority (NPPA): Responsible for implementing and enforcing the order.
* State Drug Controllers: Responsible for monitoring compliance at the state level.
**7. Implementation Aspects (Inferred):**
* **Responsible agency:** The National Pharmaceutical Pricing Authority (NPPA) is the responsible agency for implementing and enforcing the order.
* **Timelines and Procedures:**
* Manufacturers are required to issue a price list in Form V from the date of notification.
* Retailers and dealers must display the price list as furnished by the manufacturer.
* Manufacturers are subject to penalties for non-compliance with the fixed retail prices.
**8. Expected Outcomes / Impact of Changes:**
* The likely intended outcomes of this policy include:
* Increased affordability of the listed pharmaceutical formulations.
* Greater transparency in pharmaceutical pricing.
* Reduced instances of overcharging by manufacturers and retailers.
* Improved access to essential medicines for the general public.
**9. Conclusion:**
The NPPA Order issued on February 9, 2021, represents a significant step in regulating pharmaceutical prices and ensuring the availability of essential medicines at affordable prices. The order establishes a framework for price control, impacting manufacturers, retailers, and consumers alike. Its successful implementation will depend on effective enforcement by the NPPA and compliance by all stakeholders.
Key Entities Referenced
Drugs Prices Control Order, 2013: A price control order related to drugs, referenced multiple times in the document.
Ministry of Chemicals and Fertilizers: The Indian government ministry under which the Department of Pharmaceuticals operates.
Department of Pharmaceuticals: A department operating under the Ministry of Chemicals and Fertilizers.
National Pharmaceutical Pricing Authority: The organization responsible for fixing and revising drug prices in India. Abbreviated as NPPA.
New Delhi: The city where the order was issued, also the location of Government of India Press, Ring Road, Mayapuri.
Rosuvastatin Calcium IP: An active pharmaceutical ingredient. IP likely stands for Indian Pharmacopoeia, a book of standards for drugs.
Sun Pharma Laboratories Limited: A pharmaceutical company manufacturing and marketing Rosuvastatin.
Aspirin IP: An active pharmaceutical ingredient. IP likely stands for Indian Pharmacopoeia, a book of standards for drugs.
East African India Overseas: A pharmaceutical company marketing Moxifloxacin.
Moxifloxacin hydrochloride IP: An active pharmaceutical ingredient. IP likely stands for Indian Pharmacopoeia, a book of standards for drugs.
Alkem Laboratories Ltd.: A pharmaceutical company manufacturing and marketing Moxifloxacin.
Ascorbic Acid IP: An active pharmaceutical ingredient. IP likely stands for Indian Pharmacopoeia, a book of standards for drugs. Also known as Vitamin C
Akums Drugs Pharmaceuticals Ltd.: A pharmaceutical company manufacturing Ascorbic Acid.
Koye Pharmaceuticals Pvt. Ltd.: A pharmaceutical company marketing Ascorbic Acid.
Zinc Citrate USP: An active pharmaceutical ingredient. USP likely stands for United States Pharmacopeia, a book of standards for drugs.
Synokem Pharmaceuticals Ltd.: A pharmaceutical company manufacturing Telmisartan, Cilnidipine and Chlorthalidone.
Telmisartan IP: An active pharmaceutical ingredient. IP likely stands for Indian Pharmacopoeia, a book of standards for drugs.
Cilnidipine IP: An active pharmaceutical ingredient. IP likely stands for Indian Pharmacopoeia, a book of standards for drugs.
Obsurge Biotech Ltd.: A pharmaceutical company marketing Telmisartan, Cilnidipine and Chlorthalidone.
Chlorthalidone IP: An active pharmaceutical ingredient. IP likely stands for Indian Pharmacopoeia, a book of standards for drugs.
Pantoprazole Sodium IP: An active pharmaceutical ingredient. IP likely stands for Indian Pharmacopoeia, a book of standards for drugs.
Alkem Healthscience: A pharmaceutical company marketing Pantoprazole.
Clopidogrel Bisulphate IP: An active pharmaceutical ingredient. IP likely stands for Indian Pharmacopoeia, a book of standards for drugs.
Pure and Cure Healthcare Pvt. Ltd.: A pharmaceutical company manufacturing and marketing Rosuvastatin and Clopidogrel.
Sun Pharmaceuticals Industries Ltd.: A pharmaceutical company marketing Rosuvastatin and Clopidogrel.
Mefanamic Acid IP: An active pharmaceutical ingredient. IP likely stands for Indian Pharmacopoeia, a book of standards for drugs.
Vivimed Labs Ltd: A pharmaceutical company manufacturing Mefanamic acid and Paracetamol.
Paracetamol IP: An active pharmaceutical ingredient. IP likely stands for Indian Pharmacopoeia, a book of standards for drugs.
Alembic Pharmaceuticals MF Lmited: A pharmaceutical company marketing Mefanamic acid and Paracetamol.
Vildagliptin: An active pharmaceutical ingredient
Exemed Pharmaceuticals: A pharmaceutical company manufacturing Vildagliptin and Metformin Hydrochloride.
Metformin Hydrochloride IP: An active pharmaceutical ingredient. IP likely stands for Indian Pharmacopoeia, a book of standards for drugs.
Torrent Pharmaceuticals Limited: A pharmaceutical company marketing Vildagliptin and Metformin Hydrochloride.
Mascot Health Series Pvt. Ltd.: A pharmaceutical company manufacturing and marketing Vildagliptin and Metformin Hydrochloride.
Azathioprine IP: An active pharmaceutical ingredient. IP likely stands for Indian Pharmacopoeia, a book of standards for drugs.
RPG Life Sciences Limited: A pharmaceutical company manufacturing Azathioprine.
Essential Commodities Act, 1955: An act of the Parliament of India to ensure the delivery of certain commodities or products, the supply of which if obstructed owing to hoarding or black-marketing would affect the normal life of the people.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-09022021-225018
xxxGIDHxxx
CG-DL-E-09022021-225018
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.ं 523] नई ददल्ली, मगं लर्ार, फरर्री 9, 2021/माघ 20, 1942
No. 523] NEW DELHI, TUESDAY, FEBRUARY 9, 2021/MAGHA 20, 1942
रसायन और उर्रव क मत्रं ालय
(औषध जर्भाग)
(राष्ट्रीय औषध मल्ू य जनधारव ण प्राजधकरण)
आदेि
नई ददल्ली, 9 फ़रर्री, 2021
का.आ. 575(अ).—भारत सरकार के रसायन और उर्वरक मंत्रालय द्वारा िारी का.आ. 1394(अ) तारीख
30 मई, 2013 और का.आ. 701(अ) तारीख 10 मार्व, 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 जनधावरण प्राजधकरण (जिसको संजिप्त रूप
में एनपीपीए कहा िाता ह)ै नीर्े की सारणी के स्ट्तंभ (6) म ें जर्जनर्दष्टव खुदरा मूल्य को उि सारणी के स्ट्तंभ (3), (4) और
(5) में तत्सस्ट्थानी प्रजर्जष्टयों म ें जर्जनर्दष्टव प्रबलता, इकाई (यूजनट) और जर्जनमावता और जर्पणन कंपजनयों के नाम सजहत
स्ट्तंभ (2) में की तत्सस्ट्थानी प्रजर्जष्ट में से प्रत्सयेक की, र्स्ट्तु एर्ं सर्े ा कर, यदद कोई ह,ै को छोड़कर अजधकतम खुदरा मल्ू य के
रूप म ेंजनयत करती ह ै
सारणी
क्रं जर्जनर्मजवत का प्रबलता इकाई जर्जनमातव ा और जर्पणन खुदरा मल्ू य
स ं नाम/ब्ाडं का नाम कंपनी (रू.)
(1) (2) (3) (4) (5) (6)
प्रत्सयेक कैप्सूल में : 8.09
रोसुर्ास्ट्टेठटन + मेससव सन फामाव
1. रोसुर्ास्ट्टेठटन कैजल्ियम आईपी 1 कैप्सूल
एजस्ट्पठरन कैप्सूल लेबोरेटरीि जलजमटेड
रोसुर्ास्ट्टेठटन 20 जमलीग्राम के बराबर
790 GI/2021 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
क्रं जर्जनर्मजवत का प्रबलता इकाई जर्जनमातव ा और जर्पणन खुदरा मल्ू य
स ं नाम/ब्ाडं का नाम कंपनी (रू.)
(1) (2) (3) (4) (5) (6)
एजस्ट्पठरन आईपी 150 जमलीग्राम के
बराबर (इंटेठरक कोटेड)
घटक: मैससव ईस्ट्ट अफ्रीकन 21.87
मोक्सीफ्लोक्साजसन मोक्सीफ्लोक्साजसन हाइड्रोक्लोराइड (इंजडया) ओर्रसीि /
2. 1 एमएल
आई ड्रॉप्स आईपी मोक्सोफ्लोक्साजसन 0.5% मैससव अल्केम लेबोरेटरीि
डब्लू/र्ी के बराबर जल.
प्रत्सयेक अजलजपत जर्उअबल गोली में: 3.82
एस्ट्कॉर्बवक एजसड आईपी 100 जमलीग्राम मैससव अकुम ड्रग्स एंड
एस्ट्कॉर्बवक एजसड सोजडयम एस्ट्कॉबेट आईपी 450 फामावस्ट्यूठटकल्स जलजमटेड
3. (जर्टाजमन सी) + जिंक जमलीग्राम के बराबर एस्ट्कॉर्बवक एजसड 1 गोली / मैससव कोए
र्ेर्ेबल गोली 400 जमलीग्राम फामावस्ट्यूठटकल्स प्राइर्ेट
जलजमटेड
जिंक साइरेट यूएसपी मौजलक जिंक 5
जमलीग्राम के बराबर
प्रत्सयेक दफल्म लेजपत गोली में: मैससव जसंकोम 11.36
टेजल्मसटवन,
टेजल्मसटवन आईपी 40 जमलीग्राम, फामावस्ट्युठटकल्स जलजमटेड
4. जसजल्नजडजपन और 1 गोली
जसजल्नजडजपन आईपी 10 जमलीग्राम, / मैससव ऑब्सिव बायोटेक
क्लोटावजलजडडोन गोली
क्लोटावजलजडडोन आईपी 6.25 जमलीग्राम जल.
प्रत्सयेक दोहरी-ठरलीज गैस्ट्रो-प्रजतरोधी 16.48
पैंटोप्राजोल दोहरी- मैससव अल्केम स्ट्र्ास्ट््य
गोली में :
5. ठरलीज गैस्ट्रो-प्रजतरोधी 1 गोली जर्ज्ञान / मैससव अल्केम
पैंटोप्राजोल सोजडयम आईपी
गोली लेबोरेटरीि जलजमटेड.
पेन्टोप्रािोल 80 जम.ग्रा के बराबर
प्रत्सयेक दफल्म लेजपत गोली में: 16.97
मैससव प्योर एंड क्योर
रोसुर्ास्ट्टेठटन कैजल्ियम आईपी
रोसुर्ास्ट्टेठटन + हल्े थकेयर प्रा. जल. /
6. रोसुर्ास्ट्टेठटन को 20 जम.ग्रा के बराबर, 1 गोली
क्लोजपडोग्रेल गोली मैससव सन फामा व
क्लोजपडोग्रेल जबसुलफेट आईपी
लेबोरेटरीि जल.
क्लोजपडोग्रेल 75 जम.ग्रा के बराबर
प्रत्सयेक दफल्म लेजपत गोली में: मैससव प्योर एंड क्योर 16.97
रोसुर्ास्ट्टेठटन कैजल्ियम आईपी हल्े थकेयर प्रा. जल. /
रोसुर्ास्ट्टेठटन +
7. रोसुर्ास्ट्टेठटन को 20 जम.ग्रा के बराबर, 1 गोली मैससव सन
क्लोजपडोग्रेल गोली
क्लोजपडोग्रेल जबसुलफेट आईपी फामावस्ट्युठटकल्स इंडस्ट्रीि
क्लोजपडोग्रेल 75 जम.ग्रा के बराबर जल.
प्रत्सयेक 5 जमलीलीटर में िाजमल ह:ैं मैससव जर्जर्मेड लैब्स 0.66
मेफेनैजमक एजसड +
मेफेनैजमक एजसड आईपी 100 जम.ग्रा जलजमटेड / मैससव
8. पैराजसटामोल सस्ट्पेंिन 1 एमएल
एलेजबबक फामावस्ट्यूठटकल्स
पैराजसटामोल आईपी 250 जमलीग्राम
(जप्रमोल-एमएफ)
जलजमटेड
जर्डालजग्लजप्टन + प्रत्सयेक अलजपत जबलायडव गोली में: मैससव एजक्जमेड 6.86
मेटफॉर्मवन जर्ल्डेजग्लजप्टन 50 जमलीग्राम, फ़ामावस्ट्यूठटकल्स / मैससव
9. 1 गोली
हाइड्रोक्लोराइड मेटफॉर्मवन हाइड्रोक्लोराइड आईपी 500 टोरेंट फ़ामावस्ट्यूठटकल्स
(एसआर) टैबलेट जमलीग्राम (सस्ट्टैन्ड ठरलीि के रूप में) जलजमटेड[भाग II—खण् ड 3(ii)] भारत का रािपत्र : असाधारण 3
क्रं जर्जनर्मजवत का प्रबलता इकाई जर्जनमातव ा और जर्पणन खुदरा मल्ू य
स ं नाम/ब्ाडं का नाम कंपनी (रू.)
(1) (2) (3) (4) (5) (6)
प्रत्सयेक अलजपत जबलायडव गोली में: 7.51
जर्डालजग्लजप्टन + मैससव एजक्जमेड
जर्ल्डेजग्लजप्टन 50 जमलीग्राम,
मेटफॉर्मवन फ़ामावस्ट्यूठटकल्स / मैससव
10. मेटफॉर्मवन हाइड्रोक्लोराइड आईपी 1 गोली
हाइड्रोक्लोराइड टोरेंट फ़ामावस्ट्यूठटकल्स
1000 जमलीग्राम (सस्ट्टैन्ड ठरलीि के रूप
(एसआर) टैबलेट जलजमटेड
में)
जर्डालजग्लजप्टन + प्रत्सयेक अलजपत जबलायडव गोली में: मैससव मैस्ट्कॉट हल्े थ 6.86
मेटफॉर्मवन जर्ल्डेजग्लजप्टन 50 जमलीग्राम, सीरीज प्रा. जलजमटेड /
11. 1 गोली
हाइड्रोक्लोराइड मेटफॉर्मवन हाइड्रोक्लोराइड आईपी 500 मैससव अल्केम लेबोरेटरीि
(एसआर) टैबलेट जमलीग्राम (सस्ट्टैन्ड ठरलीि के रूप में) जलजमटेड
प्रत्सयेक अलजपत जबलायडव गोली में: 7.51
जर्डालजग्लजप्टन + मैससव मैस्ट्कॉट हल्े थ
जर्ल्डेजग्लजप्टन 50 जमलीग्राम,
मेटफॉर्मवन सीरीज प्रा. जलजमटेड /
12. मेटफॉर्मवन हाइड्रोक्लोराइड आईपी 1 गोली
हाइड्रोक्लोराइड मैससव अल्केम लेबोरेटरीि
1000 जमलीग्राम (सस्ट्टैन्ड ठरलीि के रूप
(एसआर) टैबलेट जलजमटेड
में)
अजैथोप्रीन प्रत्सयेक दफल्म लेजपत गोली में: मैससव आरपीिी लाइफ 14.17
13. 1 गोली
गोली अजथै ोप्रीन आईपी 75 जमलीग्राम साइंसेस जलजमटेड
(6)
V
(4)
I4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
[ II]
MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals)
(NATIONAL PHARMACEUTICAL PRICING AUTHORITY)
ORDER
New Delhi, the 9th February, 2021
S.O. 575(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
Name of the Strength Unit Manufacturer & Retail
Sl.
Formulation / Marketing Company Price
No.
Brand Name (Rs.)
(1) (2) (3) (4) (5) (6)
Each Capsule contains: 8.09
Rosuvastatin Calcium IP eq. to
Rosuvastatin + M/s Sun Pharma
1. Rosuvastatin 20mg 1 Capsule
Aspirin Capsule Laboratories Limited
Aspirin IP 150mg (as enteric
coated)
Composition: M/s East African 21.87
Moxifloxacin Eye Moxifloxacin hydrochloride IP (India) Overseas / M/s
2. 1 ML
Drops eq. to Moxifloxacin 0.5%w/v Alkem Laboratories
Ltd.
Each uncoated Chewable tablet 3.82
contains: M/s Akums Drugs &
Ascorbic Acid Ascorbic Acid IP 100mg Pharmaceuticals Ltd. /
3. (Vitamin C) + Zinc Sodium Ascorbate IP 450mg eq. 1 Tablet M/s Koye
Chewable Tablet to Ascorbic Acid 400mg Pharmaceuticals Pvt.
Zinc Citrate USP eq. to Elemental Ltd.
Zinc 5mg
Each film coated tablet contains: M/s Synokem 11.36
Telmisartan,
Telmisartan IP 40mg, Pharmaceuticals Ltd.
4. Cilnidipine and 1 Tablet
Cilnidipine IP 10mg, / M/s Obsurge Biotech
Chlorthalidone Tablet
Chlorthalidone IP 6.25mg Ltd.
Each Dual-release Gastro- M/s Alkem 16.48
Pantoprazole Dual-
resistant tablet contains: Healthscience / M/s
5. Release Gastro- 1 Tablet
Pantoprazole Sodium IP eq. to Alkem Laboratories
Resistant Tablet
Pantoprazole 80mg Ltd.
Rosuvastatin + Each Film coated tablet contains: M/s Pure and Cure 16.97
6. 1 Tablet
Clopidogrel Tablet Rosuvastatin Calcium IP eq. to Healthcare Pvt. Ltd. /[भाग II—खण् ड 3(ii)] भारत का रािपत्र : असाधारण 5
Name of the Strength Unit Manufacturer & Retail
Sl.
Formulation / Marketing Company Price
No.
Brand Name (Rs.)
(1) (2) (3) (4) (5) (6)
Rosuvastatin 20mg, M/s Sun Pharma
Clopidogrel Bisulphate IP eq. to Laboratories Limited
Clopidogrel 75mg
Each Film coated tablet contains: M/s Pure and Cure 16.97
Rosuvastatin Calcium IP eq. to Healthcare Pvt. Ltd. /
Rosuvastatin +
7. Rosuvastatin 20mg, 1 Tablet M/s Sun
Clopidogrel Tablet
Clopidogrel Bisulphate IP eq. to Pharmaceuticals
Clopidogrel 75mg Industries Ltd.
Mefanamic acid + Each 5ml contains: M/s Vivimed Labs 0.66
Paracetamol Mefanamic Acid IP 100mg Ltd. /M/s Alembic
8. 1 ML
Suspension (Pyremol- Paracetamol IP 250mg Pharmaceuticals
MF) Lmited
Each uncoated bilayered tablet 6.86
M/s Exemed
Vildagliptin + contains:
Pharmaceuticals / M/s
Metformin Vildagliptin 50mg,
9. 1 Tablet Torrent
Hydrochloride (SR) Metformin Hydrochloride IP
Pharmaceuticals
Tablet 500mg (As sustained release
Limited
form)
Each uncoated bilayered tablet 7.51
M/s Exemed
Vildagliptin + contains:
Pharmaceuticals / M/s
Metformin Vildagliptin 50mg,
10. 1 Tablet Torrent
Hydrochloride (SR) Metformin Hydrochloride IP
Pharmaceuticals
Tablet 1000mg (As sustained release
Limited
form)
Each uncoated bilayered tablet 6.86
Vildagliptin + contains: M/s Mascot Health
Metformin Vildagliptin 50mg, Series Pvt. Ltd. / M/s
11. 1 Tablet
Hydrochloride (SR) Metformin Hydrochloride IP Alkem Laboratories
Tablet 500mg (As sustained release Limited
form)
Each uncoated bilayered tablet 7.51
Vildagliptin + contains: M/s Mascot Health
Metformin Vildagliptin 50mg, Series Pvt. Ltd. / M/s
12. 1 Tablet
Hydrochloride (SR) Metformin Hydrochloride IP Alkem Laboratories
Tablet 1000mg (As sustained release Limited
form)
Each film coated Tablet contains: M/s RPG Life 14.17
13. Azathioprine Tablet 1 Tablet
Azathioprine IP 75mg Sciences Limited
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 the6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
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/215/83/2021/F/F. No. 8(83)/2021/D.P./NPPA-Div.-II]
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.