Executive Summary & Key Takeaways
Executive Summary:
This order issued by the National Pharmaceutical Pricing Authority (NPPA) fixes the retail prices of several drug formulations, as specified in the attached table, effective February 7, 2020. It outlines the responsibilities of manufacturers, retailers, and dealers concerning these price-controlled drugs, including price display and compliance with the Drugs Prices Control Order (DPCO) 2013. Previous price orders for these formulations are superseded.
Key Points / Main Content:
Price Fixation:
* The NPPA fixes the retail price of specified drug formulations, excluding goods and services tax, as listed in column 6 of the table.
* Manufacturers of new drugs, as defined in paragraph 2(u) of the DPCO, 2013, must adhere to the retail prices specified in column 6.
* Manufacturers can add goods and services tax to the retail price only if it is actually paid or payable to the government.
* Retail prices for packs of formulations must align with the retail prices specified in column 6, as per paragraph 11 of the DPCO, 2013.
Responsibilities of Manufacturers:
* Manufacturers must issue a price list in Form V to the NPPA through IPDMS from the date of notification, and provide copies to State Drug Controllers and dealers, as per paragraph 24 of the DPCO, 2013.
Responsibilities of Retailers and Dealers:
* Retailers and dealers must display the price list and any supplementary price list provided by the manufacturer in a visible location on their premises, as per paragraph 24(4) of the DPCO, 2013.
Applicability and Compliance:
* The specified retail prices apply only to manufacturers/marketers who have applied for price fixation/revision by submitting Form I under the DPCO, 2013.
* Manufacturers and marketing companies must meet all applicable statutory requirements.
* Failure to comply with the specified retail prices will result in liability to deposit the overcharged amount with interest, as per the DPCO, 2013, and the Essential Commodities Act, 1955.
Supersession:
* This notification supersedes any prior price orders for the formulations listed in column 2 of the table.
Impact Analysis:
Manufacturers:
* Impact: Must adhere to the retail prices fixed by the NPPA and ensure compliance with DPCO 2013 guidelines.
* Action Required: Fix retail prices as specified, issue price lists in Form V, and comply with all statutory requirements.
Retailers and Dealers:
* Impact: Required to display the price lists provided by manufacturers.
* Action Required: Display the price list and supplementary price list in a conspicuous part of the business premises.
Consumers:
* Impact: Benefit from fixed retail prices for essential drugs.
* Action Required: Be aware of the fixed prices and report any overcharging.
National Pharmaceutical Pricing Authority (NPPA):
* Impact: Responsible for ensuring compliance with the order and monitoring price adherence.
* Action Required: Monitor and enforce the price regulations outlined in the order.
Key Entities Referenced
Drugs Prices Control Order, 2013 : A legal order in India that regulates the prices of pharmaceutical drugs.
National Pharmaceutical Pricing Authority : An organization in India responsible for fixing and revising the prices of pharmaceutical products. It is referred to as NPPA.
Ministry of Chemicals and Fertilizers : A ministry of the Government of India.
Paclitaxel Protein Bound Human Albumin Injection : A formulation whose retail price is being fixed by this notification.
Essential Commodities Act, 1955 : An act of the Parliament of India which seeks to regulate the production, supply and distribution of essential commodities in order to ensure their availability to consumers and to protect them from exploitation.
New Delhi : The location where the order was issued.
State Drug Controller : The state level authority responsible for drug regulation.
Calcium Vitamin D3 Methylcobalamin : A formulation whose retail price is being fixed by this notification.
See Full Document Text
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. NO. D. L.-33004/99
xxxGIDHxxx
सी.जी.-डी.एल.-अ.-07022020-216022
xxxGIDExxx
CG-DL-E-07022020-216022
असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (ii)
PART II—Section 3—Sub-section (ii)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 566] नई फिल्ली, िुक्रवार, फरवरी 7, 2020/माघ 18, 1941
No. 566] NEW DELHI, FRIDAY, FEBRUARY 7, 2020/MAGHA 18, 1941
ubZ fnYyh] 7 Qjojh] 2020
.—Hkkjr ljdkj ds jlk;u vkSj moZjd e=a ky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k
30 ebZ] 2013 vkSj dk-vk- 701¼v½ rkjh[k 10 ekpZ] 2016 ds lkFk ifBr vkS"k/k ¼dher fu;a=.k½ vkn's k] 2013 ds
iSjk 5, 11 vkSj 15 }kjk iznRr 'kfDr;ks a dk iz;ksx djr s gq,] jk"Vªh; vkS"k/k eYw ; fu/kkZj.k izkf/kdj.k ¼ftldk s laf{kIr
:i es a ,uihih, dgk tkrk gS½] uhp s dh lkj.kh ds LraHk ¼6½ esa fofufnZ"V [kqnjk eYw ; dk s mDr lkj.kh ds LraHk ¼3½]
¼4½] vkSj ¼5½ esa rRLFkkuh izfof"V;ks a eas fofufnZ"V izcyrk] bdkbZ ¼;wfuV½ vkSj fofuekZrk vkSj foi.ku dEifu;ks a ds uke
lfgr LraHk ¼2½ es a dh rRLFkkuh izfof"V eas ls izR;sd dh] oLrq ,oa lsok dj] ;fn dksbZ gS] dks NksM+dj vf/kdre [kqnjk
eYw ; ds :i eas fu;r djrh gSA
(1) (2) (3) (4) (5) (6)
1. पैजललटैलसेल + (पैजललटैलसेल प्रोटीन बाउंड पार्टिकल्स प्रत्येक पैक मैससि स्ट्पाल प्राइवेट जलजमटेड / 4795.27
मानव एल्बुजमन फॉर इंिेलटेबल सस्ट्पेन्िन 100 जमग्रा.) मैससि इनटास फामािस्ट्यूटटकल्स
इंिेलिन (पैजललटैलसेल प्रत्येक लयोफफलाइिड वायल में: प्रा. जलजमटेड
प्रोटीन बाउंड पार्टिकल्स पैजललटैलसेल आईपी 100 जमग्रा.,
फॉर इंिेलटेबल ह्युमन एल्बुजमन आईपी 900 जमग्रा.
सस्ट्पेन्िन 100 जमग्रा.) प्रजत 20 जमजल.
778 GI/2020 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
2. कैजल्ियम + जवटाजमन प्रत्येक फफल्म जलजपत गोली में: 1 गोली मैसस िमैस्ट्कॉट ेल्े ि सीरी़ प्रा. 11.48
डी 3 + कैजल्ियम जसरेट यूएसपी 1000 जमग्रा., जल. / मैससि ़ ाइडस ेल्े िकेयर
मेजिलकोबालाजमन + जवटाजमन डी3 200 आईयू, जलजमटेड
पाइटरडोलसीन + मेजिलकोबालाजमन आईपी 500
फॉजलक एजसड गोली एमसीिी,
पाइटरडोलसीन एचसीएल आईपी 10
जमग्रा.,
फॉजलक एजसड आईपी 5 जमग्रा.
3. जवल्डेजललजटटन + प्रत्येक फफल्म जलजपत गोली में: 1 गोली मैससि टयोर एंड लयोर ेल्े िकेयर 6.14
मेटफॉर्मिन गोली जवल्डेजललजटटन 50 जमग्रा., (पी) जलजमटेड / मैससि एंिस
(इनसुजवल-एम) मेटफॉर्मिन ेाइड्रोललोराइड आईपी फामािस्ट्यूटटकल्स प्राइवेट
500 जमग्रा. जलजमटेड
4. जवल्डेजललजटटन + प्रत्येक फफल्म जलजपत गोली में: 1 गोली मैसस िस्ट्काइमैप फामािस्ट्यूटटकल्स 6.14
मेटफोर्मिन गोली जवल्डेजललजटटन 50 जमग्रा., प्रा. जलजमटेड
मेटफोर्मिन ेाइड्रोललोराइड आईपी
500 जमग्रा.
5. जवल्डेजललजटटन + प्रत्येक फफल्म जलजपत गोली में: 1 गोली मैससि एटरस लाइफसाइंसेि 6.14
मेटफोर्मिन गोली जवल्डेजललजटटन 50 जमग्रा., जलजमटेड / मैससि एजपका
मेटफोर्मिन ेाइड्रोललोराइड आईपी ेल्े िकेयर प्रा. जलजमटेड
500 जमग्रा.
6. जवल्डेजललजटटन + प्रत्येक फफल्म जलजपत गोली में: 1 गोली मैससि ेटे ेरो लैब्स जलजमटेड / 6.14
मेटफोर्मिन गोली जवल्डेजललजटटन 50 जमग्रा., मैससि ेटे ेरो ेल्े िकेयर जलजमटेड
(जवल्डोव एम 500) मेटफोर्मिन ेाइड्रोललोराइड आईपी
500 जमग्रा.
7. जवल्डेजललजटटन + प्रत्येक फफल्म जलजपत गोली में: 1 गोली मैससि इनोवा कैटटब जलजमटेड / 6.14
मेटफोर्मिन गोली जवल्डेजललजटटन 50 जमग्रा., मैससि गलफा लेबोरेटरीि
(वाल्डेपेन एम 500) मेटफोर्मिन ेाइड्रोललोराइड आईपी जलजमटेड
500 जमग्रा.
8. जवल्डेजललजटटन + प्रत्येक फफल्म जलजपत गोली में: 1 गोली मैसस ियूजनसन फामािस्ट्यूटटकल्स 6.07
मेटफोर्मिन गोली जवल्डेजललजटटन 50 जमग्रा., प्रा. जलजमटेड
(जवलासन एम 500) मेटफोर्मिन ेाइड्रोललोराइड आईपी
500 जमग्रा.
9. जवल्डेजललजटटन + प्रत्येक फफल्म जलजपत गोली में: 1 गोली मैससि स्ट्काइमैप फामािस्ट्यूटटकल्स 6.24
मेटफोर्मिन गोली जवल्डेजललजटटन 50 जमग्रा., प्रा. जलजमटेड
मेटफोर्मिन ेाइड्रोललोराइड आईपी
850 जमग्रा.
10. जवल्डेजललजटटन + प्रत्येक फफल्म जलजपत गोली में: 1 गोली मैससि एटरस लाइफसाइंसेि 6.24
मेटफोर्मिन गोली जवल्डेजललजटटन 50 जमग्रा., जलजमटेड/मैससि एजपका
मेटफोर्मिन ेाइड्रोललोराइड आईपी ेल्े िकेयर प्रा. जलजमटेड
850 जमग्रा.
11. जवल्डेजललजटटन + प्रत्येक फफल्म जलजपत गोली में: 1 गोली मैससि इनोवा कैटटब जलजमटेड/ 6.24
मेटफोर्मिन गोली जवल्डेजललजटटन 50 जमग्रा., मैससि गलफा लेबोरेटरीि
(वाल्डेपेन एम 850) मेटफोर्मिन ेाइड्रोललोराइड आईपी जलजमटेड
850 जमग्रा.
12. जवल्डेजललजटटन + प्रत्येक फफल्म जलजपत गोली में: 1 गोली मैससि स्ट्काइमैप फामािस्ट्यूटटकल्स 6.36
मेटफोर्मिन गोली जवल्डेजललजटटन 50 जमग्रा., प्रा. जलजमटेड
मेटफोर्मिन ेाइड्रोललोराइड आईपी
1000 जमग्रा.
13. जवल्डेजललजटटन + प्रत्येक फफल्म जलजपत गोली में: 1 गोली मैससि एटरस लाइफसाइंसेि 6.36
मेटफोर्मिन गोली जवल्डेजललजटटन 50 जमग्रा., जलजमटेड/मैससि एजपका
मेटफोर्मिन ेाइड्रोललोराइड 1000 जमग्रा. ेल्े िकेयर प्रा. जलजमटेडभाग II खण् ड (ii) भारत का रािपत्र : असाधारण 3
14. जवल्डेजललजटटन + प्रत्येक फफल्म जलजपत गोली में: 1 गोली मैससि ेटे ेरो लैब्स जलजमटेड / 6.36
मेटफोर्मिन गोली जवल्डेजललजटटन 50 जमग्रा., मैससि ेटे ेरो ेल्े िकेयर जलजमटेड
(जवल्डोव एम 1000) मेटफोर्मिन ेाइड्रोललोराइड आईपी
1000 जमग्रा.
15. जवल्डेजललजटटन + प्रत्येक फफल्म जलजपत गोली में: 1 गोली मैससि इनोवा कैटटब जलजमटेड / 6.36
मेटफोर्मिन गोली जवल्डेजललजटटन 50 जमग्रा., मैससि गलफा लेबोरेटरीि
(वाल्डेपेन एम 1000) मेटफोर्मिन ेाइड्रोललोराइड आईपी जलजमटेड
1000 जमग्रा.
16. एमोजलसजसजलन + प्रत्येक फफल्म जलजपत गोली में: 1 गोली मैससि एलमस ड्रलस एंड 28.00
पोटेजियम ललैवुलनेट एमोजलसजसजलन रीेाइड्रेट आईपी के फामािस्ट्यूटटकल्स जलजमटेड /
गोली (पैनलैजलटक बराबर एमोजलसजसजलन 875 जमग्रा., मैससि मायलन फामािस्ट्यूटटकल्स
1000) पोटेजियम ललैवुलनेट जडलुटेड आईपी के प्राइवेट जलजमटेड
बराबर ललैवुलनेट एजसड 125 जमग्रा.
17. एमोजलसजसजलन + प्रत्येक फफल्म जलजपत गोली में: 1 गोली मैससि एलमस ड्रलस एंड 15.15
पोटेजियम ललैवुलनेट एमोजलसजसजलन रीेाइड्रेट आईपी के फामािस्ट्यूटटकल्स जलजमटेड /
टैबलेट (पैनलैजलटक बराबर एमोजलसजसजलन 250 जमग्रा., मैससि मायलन फामािस्ट्यूटटकल्स
375) पोटेजियम ललैवुलनेट जडलुटेड आईपी के प्राइवेट जलजमटेड
बराबर ललैवुलनेट एजसड 125 जमग्रा.
18. रेबीि ह्युमन प्रत्येक जमजल. इंिेलिन में: 856.65
प्रत्येक पैक
मोनोललोनल एंटीबॉडी रेबीि ह्युमन मोनोललोनल एंटीबॉडी मैससि सीरम इंस्ट्टीट्यूट ऑफ
1.25
इंिेलिन (राजविेल्ड- (आरडीएनए) 40आईयू इंजडया प्रा. जलजमटेड
जमजल.
50) (50आईयू/1.25 जमजल)
19. एमोजलसजसजलन + प्रत्येक ेाडि िेलेटाइन कैटसूल में: 1 कैटसूल मैससि स्ट्काइमैप फामािस्ट्यूटटकल्स 3.54
ललोलसाजसल्लीन + एमोजलसजसजलन रीेाइड्रेट आईपी के प्रा. जलजमटेड
लैलटीक एजसड बराबर एमोजलसजसजलन 250 जमग्रा.,
बाजसल्लूस कैटसूल ललोलसाजसल्लीन सोजडयम आईपी के
बराबर ललोलसाजसल्लीन 250 जमग्रा.,
लैलटीक एजसड बाजसल्लूस 2 जबजलयन
स्ट्पोर
20. मेटफॉर्मिन प्रत्येक फफल्म जलजपत जबलेयडि गोली में: 18.44
ेाइड्रोललोराइड + मेटफॉर्मिन ेाइड्रोललोराइड 1000
एवोजललजटटन टैबलेट जमग्रा. (सस्ट्टेंड टरजलि), मेससि अलकेम ेल्े िसाइंस /
1 गोली
(वेलेरा एम 1000 एवोजललजटटन टारेट 6.869 जमग्रा. आईपी मेससि अल्केम लेबोरेटरीि जल।
गोली) के बराबर एवोजललजटटन 5 जमग्रा.
21. पैराजसटामोल + कैफीन प्रत्येक अजलजपत गोली में: मेससि टरवपा फॉर्मयुिलेिन प्रा। 1.25
टैबलेट (सारबाइना पैराजसटामोल आईपी 500 जमग्रा., 1 गोली जलजमटेड / मेससि डाबर इंजडया
स्ट्रॉग) कैफीन एनेाइड्रोि आईपी 50 जमग्रा. जलजमटेड
¼d½ mi;qZDr nh xbZ fofufnZ"V QkWewyZ 's ku ds fofuekZrk vFkkZr tk s ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼;w½
ds rgr mi;qZDr nh xbZ lkj.kh ds LrHa k ¼6½ es a fofufnZ"V [kqnjk eYw ; fu/kkZfjr djasxsA
¼[k½ vxj fuekZrkvks a u s mi;qZDr lkj.kh ds LraHk ¼6½ eas of.kZr vf/kdre dher ij ljdkj dks okLro eas Hkqxrku
fd;k gS ;k ;g ns; gS rks os oLrq ,oa lsok dj dks tksM+ ldr s gSaA
¼x½ vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 ds iSjkxzkQ 11 eas fn, x, izko/kkuks a ds rgr fuekZrkvks a dks mi;qZDr
lkj.kh ds LraHk ¼6½ eas fofufnZ"V [kqnjk eYw ; ds vk/kkj ij vuqlwfpr fofufeZfr;ks a ds iSdkas ds fy, [kqnjk
eYw ; fu/kkZfjr djsAa fuekZrk vkS"k/k ¼eYw ; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 24 ds rgr QkWeZ V es a
vf/klwpuk dh rkjh[k ls ,d ewY; lwph ,uihih, dks vkbZihMh,e,l ds ek/;e ls tkjh djs a rFkk mldh
dkWih jkT; vkS"kf/k fu;a=dks a vkSj fofuekZrk forjdkas dks tkjh djsAa4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
¼?k½ vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds 24 ¼4½ ds mica/kks a ds vuqlkj izR;sd QqVdj foØsrk vkSj forjd
fofuekZrk }kjk fn, x, :i eas ,sl s ifjlj] tgka dkjckj dk s bl izdkj fd;k tk jgk gS fd mlls ijke'kZ
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MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals)
(NATIONAL PHARMACEUTICAL PRICING AUTHORITY)
ORDER
New Delhi, the 7th February, 2020
S.O. 619(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. Name of the Strength Unit Manufacturer & Retail Price
No. Formulation/Brand Marketing Company (Rs.)
Name
(1) (2) (3) (4) (5) (6)
1. Paclitaxel + Paclitaxel Protein Bound Each M/s. SPAL Private 4795.27
Human Albumin Injection Particles for Injectable Pack Limited / M/s. Intas
(Paclitaxel Protein Bound suspension 100mg Pharmaceuticals Pvt.
Particles for Injectable Each Lyophilized vial contains: Ltd.
suspension 100mg) Paclitaxel IP 100mg
Human Albumin IP 900mg per
20ml
2. Calcium + Vitamin D3 + Each film coated tablet contains: 1 Tablet M/s. Mascot Health 11.48
Methylcobalamin + Calcium Citrate USP 1000mg, Series Pvt. Ltd. /
Pyridoxine + Folic Acid Vitamin D3 200IU, M/s. Zydus Healthcare
Tablet Methylcobalamin IP 500mcg, Limited
Pyridoxine HCI IP 10mg,
Folic Acid IP 5mg,
3. Vildagliptin + Metformin Each film coated tablet contains: 1 Tablet M/s. Pure & Cure 6.14
Tablet (INSUVIL-M) Vildagliptin 50mg, Healthcare (P) Ltd. /
Metformin Hydrochloride IP M/s. Anthus
500mg, Pharmaceuticals Pvt.
Ltd.भाग II खण् ड (ii) भारत का रािपत्र : असाधारण 5
4. Vildagliptin + Metformin Each film coated tablet contains: 1 Tablet M/s. Skymap 6.14
Tablet Vildagliptin 50mg, Pharmaceuticals Pvt.
Metformin Hydrochloride IP Ltd.
500mg,
5. Vildagliptin + Metformin Each film coated tablet contains: 1 Tablet M/s. Eris Lifesciences 6.14
Tablet Vildagliptin 50mg, Limited / M/s. Aprica
Metformin Hydrochloride IP Healthcare Pvt. Ltd.
500mg,
6. Vildagliptin + Metformin Each film coated tablet contains: 1 Tablet M/s. Hetero Labs 6.14
Tablet (VILDOV M 500) Vildagliptin 50mg, Limited / M/s. Hetero
Metformin Hydrochloride IP Healthcare Limited
500mg,
7. Vildagliptin + Metformin Each film coated tablet contains: 1 Tablet M/s Innova Captab 6.14
Tablet (Valdepain M 500) Vildagliptin 50mg, Ltd. / M/s Galpha
Metformin Hydrochloride IP Laboratories Limited
500mg,
8. Vildagliptin + Metformin Each film coated tablet contains: 1 Tablet M/s. Unison 6.07
Tablet (Vilason M 500) Vildagliptin 50mg, Pharmaceuticals Pvt.
Metformin Hydrochloride IP Ltd.
500mg,
9. Vildagliptin + Metformin Each film coated tablet contains: 1 Tablet M/s. Skymap 6.24
Tablet Vildagliptin 50mg, Pharmaceuticals Pvt.
Metformin Hydrochloride IP Ltd.
850mg,
10. Vildagliptin + Metformin Each film coated tablet contains: 1 Tablet M/s. Eris Lifesciences 6.24
Tablet Vildagliptin 50mg, Limited / M/s. Aprica
Metformin Hydrochloride IP Healthcare Pvt. Ltd.
850mg,
11. Vildagliptin + Metformin Each film coated tablet contains: 1 Tablet M/s. Innova Captab 6.24
Tablet (Valdepain M 850) Vildagliptin 50mg, Ltd. / M/s. Galpha
Metformin Hydrochloride IP Laboratories Limited
850mg,
12. Vildagliptin + Metformin Each film coated tablet contains: 1 Tablet M/s. Skymap 6.36
Tablet Vildagliptin 50mg, Pharmaceuticals Pvt.
Metformin Hydrochloride IP Ltd.
1000mg,
13. Vildagliptin + Metformin Each film coated tablet contains: 1 Tablet M/s. Eris Lifesciences 6.36
Tablet Vildagliptin 50mg, Limited / M/s. Aprica
Metformin Hydrochloride IP Healthcare Pvt. Ltd.
1000mg,
14. Vildagliptin + Metformin Each film coated tablet contains: 1 Tablet M/s. Hetero Labs 6.36
Tablet (VILDOV M 1000) Vildagliptin 50mg, Limited / M/s. Hetero
Metformin Hydrochloride IP Healthcare Limited
1000mg,
15. Vildagliptin + Metformin Each film coated tablet contains: 1 Tablet M/s. Innova Captab 6.36
Tablet (Valdepain M Vildagliptin 50mg, Ltd. / M/s. Galpha
1000) Metformin Hydrochloride IP Laboratories Limited
1000mg,
16. Amoxycillin + Potassium Each film coated tablet contains: 1 Tablet M/s. Akums Drugs 28.00
Clavulanate Tablet Amoxycillin Trihydrate IP eq. to and Pharmaceuticals
(Panlactic 1000) Amoxycillin 875mg, Ltd. / M/s. Mylan
Potassium Clavulanate Diluted Pharmaceuticals
IP eq. to Clavulanic Acid 25mg, Private Limited
17. Amoxycillin + Potassium Each film coated tablet contains: 1 Tablet M/s. Akums Drugs 15.15
Clavulanate Tablet Amoxycillin Trihydrate IP eq. to and Pharmaceuticals
(Panlactic 375) Amoxycillin 250mg, Ltd. / M/s. Mylan
Potassium Clavulanate Diluted Pharmaceuticals
IP eq. to Clavulanic Acid Private Limited
125mg,
18. Rabies Human Each ml injection contains: Each M/s. Serum Institute 856.65
Monoclonal Antibody Rabies Human Monoclonal pack of of India Pvt. Ltd.
Injection (Rabishield – Antibody (rDNA) 40IU 1.25ml
50) (50IU/1.25ml)6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
19. Amoxicillin + Cloxacillin Each hard gelatine capsule 1 M/s. Skymap 3.54
+ Lactic Acid Bacillus contains: Capsule Pharmaceuticals Pvt.
Capsule Amoxicillin Trihydrate IP eq. to Ltd.
Amoxicillin 250mg,
Cloxacillin Sodium IP eq. to
Cloxacillin 250mg,
Lactic Acid Bacillus 2 billion
spore
20. Metformin Hydrochloride Each film coated bilayered 1 Tablet M/s. Alkem 18.44
+ Evogliptin Tablet Tablet contains: Healthscience /
(Valera M 1000 Tablet) Metformin Hydrochloride IP M/s. Alkem
1000mg (Sustained Release), Laboratories Ltd.
Evogliptin Tartrate 6.869mg eq.
to Evogliptin 5mg Tablet
21. Paracetamol + Caffeine Each uncoated tablets contains: 1 Tablet M/s. Rivpra 1.25
Tablet (SARBYNA Paracetamol IP 500mg Formulation Pvt. Ltd. /
STRONG) Caffeine Anhydrous IP 50mg M/s. Dabur India Ltd
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/204/72/2020/F./F. No. 8(72)/2020/D.P./NPPA-Div.-II]
PRASENJIT DAS, 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.