## Policy Analysis Report: National Pharmaceutical Pricing Authority (NPPA) Order - June 15, 2021
**1. Executive Summary:**
This report analyzes an order issued by the National Pharmaceutical Pricing Authority (NPPA) on June 15, 2021, concerning the retail price fixation of specific drug formulations. This order directly impacts pharmaceutical manufacturers and marketing companies by establishing retail prices for certain drugs and outlining procedures for price display and notification. The key finding is that this order fixes retail prices for specific formulations and mandates compliance with the Drugs Prices Control Order (DPCO) 2013. This order supersedes previous price orders for the formulations listed within.
**2. Introduction:**
This report aims to provide a comprehensive analysis of the NPPA order issued on June 15, 2021, based solely on the provided policy text. The analysis focuses on the policy's objectives, key provisions, affected stakeholders, and potential impact on pharmaceutical manufacturers and retailers.
**3. Policy Overview:**
* This is a **New Policy** specifically regarding the listed drug formulations.
* **Core Objective(s):** The primary objective, as inferred from the text, is to fix the retail prices of specific drug formulations to regulate their cost. Secondary objectives include ensuring price transparency through mandatory display of price lists and adherence to the DPCO, 2013.
**4. Background and Rationale:**
* **Likely Problem/Issue Addressed:** The policy addresses the potential for unregulated pricing of pharmaceutical formulations. This is inferred from the core objective of price fixation. The NPPA likely aims to ensure affordability and accessibility of essential medicines by controlling their retail prices.
**5. Key Provisions / Changes:**
* **New Policy:**
* **Price Fixation:** The NPPA fixes the retail price for specific formulations listed in the table, explicitly excluding goods and services tax.
* **Manufacturer Responsibilities:** Manufacturers of these formulations are obligated to:
* Fix the retail price as specified by the NPPA.
* Add goods and services tax only if actually paid or payable to the government.
* Determine the retail price for a pack of the formulation according to DPCO 2013 paragraph 11.
* Issue a price list in Form V to NPPA through IPDMS and provide copies to the State Drug Controller and dealers, as per DPCO 2013 paragraph 24.
* **Retailer Responsibilities:** Retailers and dealers are required to display price lists and supplementary price lists in a conspicuous location accessible to customers.
* **Compliance:** Manufacturers and marketing companies failing to comply with the price notification and related regulations are liable to deposit the overcharged amount with interest under the DPCO 2013 and the Essential Commodities Act, 1955.
* **Supersession:** This order supersedes any prior orders fixing ceiling or retail prices for the formulations listed in the table.
**6. Target Audience and Stakeholders:**
Based on the provided text, the direct target audience and stakeholders are:
* Pharmaceutical Manufacturers and Marketing Companies (specifically those listed in column 5 of the table).
* Retailers and Dealers of pharmaceutical products.
* Consumers (indirectly, as they are intended to benefit from price regulation and transparency).
**7. Implementation Aspects (Inferred):**
* **Responsible Agency/Bodies:**
* National Pharmaceutical Pricing Authority (NPPA) is the primary body responsible for issuing and enforcing this order.
* State Drug Controllers are responsible for receiving price lists from manufacturers.
* Central/State Licensing Authorities are responsible for issuing manufacturing licenses.
* **Timelines/Procedures:**
* Manufacturers must issue a price list in Form V from the date of notification.
* Price lists must be submitted to the NPPA through IPDMS and to State Drug Controllers.
* Retailers must immediately display the price lists upon receipt.
**8. Expected Outcomes / Impact of Changes:**
* **Likely Intended Outcomes:**
* Price control of the specified drug formulations.
* Increased price transparency for consumers.
* Enforcement of the DPCO, 2013 and the Essential Commodities Act, 1955.
* Standardization of pricing across manufacturers and retailers for the listed formulations.
* Reduce out-of-pocket expenses for consumers purchasing the medicines impacted.
**9. Conclusion:**
The NPPA order issued on June 15, 2021, is a significant policy that directly impacts pharmaceutical manufacturers and retailers by fixing the retail prices of specific drug formulations. This order enforces price regulations, promotes price transparency, and ensures compliance with existing pharmaceutical regulations. Manufacturers and retailers must adhere to the requirements outlined in this order to avoid penalties under the DPCO 2013 and the Essential Commodities Act, 1955. This policy ensures the retail price of specific formulations is standardised to ensure that consumers purchase these drugs at a regulated price.
Key Entities Referenced
NEW DELHI: Location where the notification was issued.
Drugs Prices Control Order, 2013: A legal document that empowers the National Pharmaceutical Pricing Authority (NPPA) to regulate drug prices in India.
National Pharmaceutical Pricing Authority: The regulatory body in India responsible for fixing and revising the prices of pharmaceutical products.
Government of India: The governing authority of India that issued notifications related to drug pricing.
Ministry of Chemicals and Fertilizers: The Indian government ministry responsible for the Department of Pharmaceuticals and related regulations.
Essential Commodities Act, 1955: An act of the Parliament of India that ensures the supply of certain commodities or products, the supply of which if obstructed would affect the people adversely.
Ms. Archimedis Healthcare Pvt. Ltd.: A pharmaceutical manufacturer/marketer mentioned in the notification.
Ms. Lupin Limited: A pharmaceutical manufacturer/marketer mentioned in the notification.
Ms. Hetero Labs Ltd.: A pharmaceutical manufacturer/marketer mentioned in the notification.
Cipla limited: A pharmaceutical manufacturer/marketer mentioned in the notification.
Ms. Roche Products India Pvt. Ltd: A pharmaceutical manufacturer/marketer mentioned in the notification.
Cipla Ltd: A pharmaceutical manufacturer/marketer mentioned in the notification.
State Drug Controller: Authority responsible for drug regulation at the state level.
CentralState Licensing Authority: Authority responsible for issuing manufacturing licenses.
Department of Pharmaceuticals: A department under the Ministry of Chemicals and Fertilizers, Government of India
Mayapuri, New Delhi: Location of the Government of India Press
Delhi: Location of the Controller of Publications
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-15062021-227617
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CG-DL-E-15062021-227617
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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.ं 2170] नई ददल्ली, मगं लर्ार, िनू 15, 2021/ज्य ष्े ि 25, 1943
No. 2170] NEW DELHI, TUESDAY, JUNE 15, 2021/JYAISTHA 25, 1943
रसायन और उर्रव क मत्रं ालय
(औषध जर्भाग)
( राष्ट्रीय औषध मल्ू य जनधारव ण प्राजधकरण)
आदेि
नई ददल्ली, 15 िून, 2021
का. आ. 2334 (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 मार्,व 2016 के साथ पठित औषध (कीमत जनयंत्रण) आदिे , 2013 के पैरा
5,11 और 15 द्वारा प्रदत्त िजियों का प्रयोग करते हुए, राष्ट्रीय औषध मूल्य जनधावरण प्राजधकरण (जिसको संजिप्त रूप म ें
एनपीपीए कहा िाता ह)ै नीर् े 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 म ें स े प्रत्सयेक की, र्स्ट्तु एर् ं सेर्ा कर, यदद कोई ह,ै को छोड़कर अजधकतम खुदरा मूल्य के रूप म ें
जनयत करती ह।ै
सारणी
क्रं जर्जनर्मजवत का नाम/ब्ाडं का प्रबलता इकाई जर्जनमातव ा और जर्पणन खदु रा
सं नाम कंपनी मूल्य (रु.)
(1) (2) (3) (4) (5) (6)
1. इर्ाब्ैजडन हाइड्रोक्लोराइड +
प्रत्सयेक दिल्म जलजपत गोली में: मैसस वआर्कवजमजडस
20.68
इर्ाब्ैजडन हाइड्रोक्लोराइड इर्ाब्ैजडन 7.5 1 गोली हल्े थकेयर प्रा. जलजमटेड /
मेटोप्रोलोल टारेट गोली
जमलीग्राम के बराबर + मेटोप्रोलोल टारेट 25 मैसस वल्यूजपन जलजमटेड
3240 GI/2021 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
क्रं जर्जनर्मजवत का नाम/ब्ाडं का प्रबलता इकाई जर्जनमातव ा और जर्पणन खदु रा
सं नाम कंपनी मूल्य (रु.)
(1) (2) (3) (4) (5) (6)
जमलीग्राम
2.
प्रत्सयेक दिल्म जलजपत गोली में:
190.44
दारुनर्ीर + ठरटोनार्ीर दारुनर्ीर इथेनॉलोलेट दारुनर्ीर आईपी 800 मैसस वहटे ेरो लैब्स जलजमटेड /
1 गोली
गोली जमलीग्राम ठरटोनार्ीर आईपी 100 जमलीग्राम के मैसस वजसप्ला जलजमटेड
बराबर
3.
रस्ट्टूज़ुमेब कोंसन्ट्रेट िोर प्रत्सयेक र्ायल में:
प्रत्सयेक
मैसस वरोर् प्रोडक्ट (इंजडया)
15526.
सोल्युसन िोर इंफ्युिन रस्ट्टूज़ुमेब 150 जमलीग्राम जलजमटेड / मैसस वजसप्ला प्रा.
र्ायल 97
र्ायल जलजमटेड
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;g n;s gS rks os oLrq ,oa lsok dj dks tksM+ ldr s gSaA
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forjdkas dks tkjh djasA
¼?k½ vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 ds 24 ¼4½ ds mica/kks a ds vuqlkj izR;sd QqVdj fodzsrk vkSj forjd fofuekZrk }kjk
fn, x, :i es a ,sl s ifjlj] tgka dkjckj dks 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 gks] dks
laiznf'kZr djsxkA
¼M-½ mi;qZDr xSj vf/kdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksua s vkS"k/k
¼eYw ; fu;a=.k½ vkn's k] 2013 ds rgr vuqc) eYw ; fu/kkZj.k@la'kks/ku ds fy, QkWeZ I ij tek fd;k x;k Fkk vkSj
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fd dsUnzh;@jkT; ykblsflax vkWFkksfjVh ds l{ke izkf/kdkjh }kjk eUs ;wQsDpfjxa ykblsla eta wjh ds rgr lacaf/kr
fofufeZr fuekZrk@foi.ku dEifu;ka tks vuqikyu djrh gSA
¼p½ fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ks a vkSj fofufnZ"V 'krks± dk ikyu ugh a djrh gSa rks os vko';d oLrq,¡
vf/kfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izko/kkuks a ds v/khu C;kt lfgr vf/kizHkkfjr jkf'k dks tek dju s
ds fy, nk;h gksxa sA
¼N½ bl vkns'k eas mijksDr lkj.kh ds LraHk ¼2½ es a dh rRLFkkuh izfof"V es a fofufnZ"V fofufeZfr;ks a ds iSdks a dh [kqnjk ewY;
fu;r gksus ds ifj.kkeLo#i] vkn's k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;sxa sA
[पीएन/219/87/2021/एि िा. न. 8(87)/2021/डी.पी./एनपीपीए-डी.र्ी.-II]
izlsuthr nkl] mi funs'kd[भाग II—खण् ड 3(ii)] भारत का रािपत्र : असाधारण 3
MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals)
(NATIONAL PHARMACEUTICAL PRICING AUTHORITY)
ORDER
New Delhi, 15th June, 2021
S. O. 2334(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
No. Formulation / Brand Marketing Price
Name Company (Rs.)
(1) (2) (3) (4) (5) (6)
1 Ivabradine Each film coated tablet contains: 20.68
M/s. Archimedis
Hydrochloride + Ivabradine Hydrochloride eq. to
1 Tablet Healthcare Pvt. Ltd. /
Metoprolol Tartrate Ivabradine 7.5 mg + Metoprolol
M/s. Lupin Limited
Tablet Tartrate 25 mg
2. Each film coated tablet contains: 190.44
Darunavir + Ritonavir Darunavir Ethanolate eq. Darunavir M/s. Hetero Labs Ltd.
1 Tablet
Tablet IP 800mg / M/ Cipla limited
Ritonavir IP 100mg
3. Trastuzumab Each vial contains: M/s. Roche Products 15526.97
Each
Concentrate for solution (India) Pvt. Ltd/ M/s
Trastuzumab 150 mg vial
for Infusion in vials Cipla 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 the4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
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/219/87/2021/F F. No. 8(87)/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.