## Policy Analysis Report: National Pharmaceutical Pricing Authority (NPPA) Order - November 28, 2022
**1. Executive Summary:**
This report analyzes the National Pharmaceutical Pricing Authority (NPPA) Order issued on November 28, 2022, regarding the retail price fixation of a specific formulation, Amoxycillin and Potassium Clavulanate Oral Suspension. This order, based on the Drugs Prices Control Order (DPCO) 2013, fixes the retail price for the specified formulation manufactured and marketed by Ms. Sun Pharmaceutical Industries Limited. The report details the price fixation, applicable conditions, and implications for manufacturers, retailers, and consumers. It highlights the amendment's focus on ensuring compliance with the set retail price and the mechanisms for addressing non-compliance.
**2. Introduction:**
This report aims to provide an informative analysis of the NPPA Order dated November 28, 2022, concerning the price regulation of pharmaceuticals. The analysis is based solely on the provided policy text and focuses on understanding the order's scope, key provisions, and potential implications for the pharmaceutical industry.
**3. Policy Overview:**
This order is issued under the authority of paragraphs 5, 11, and 15 of the Drugs Prices Control Order (DPCO), 2013, read with specified notifications (S.O. 1394E and S.O. 701E).
* **Core Objective(s):** The primary objective, as inferred from the text, is to regulate the retail price of Amoxycillin and Potassium Clavulanate Oral Suspension manufactured and marketed by Ms. Sun Pharmaceutical Industries Limited. This contributes to ensuring affordability and availability of essential medicines.
**4. Background and Rationale:**
* This order likely addresses the need to regulate the pricing of pharmaceutical formulations, ensuring that prices are fair and accessible to the public. The DPCO, 2013 provides the framework for this regulation, and this specific order focuses on a particular formulation, indicating a need for specific price control in this area.
**5. Key Provisions / Changes:**
* This order specifically concerns Amoxycillin and Potassium Clavulanate Oral Suspension.
* **New Rule/Provision:** The order fixes the retail price of Amoxycillin and Potassium Clavulanate Oral Suspension (Each 5ml of the reconstituted suspension contains: Amoxycillin Trihydrate IP eq. to Amoxycillin 600mg and Potassium Clavulanate diluted IP eq. to Clavulanic Acid 42.09mg per 50ml Vial) at Rs. 168.43 (exclusive of Goods and Services Tax) for Ms. Sun Pharmaceutical Industries Limited.
* The order clarifies that the manufacturer of the new drug under paragraph 21(u) of the DPCO, 2013 shall fix the retail price as specified.
* 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.
* The retail price for a pack of the formulation is to be calculated according to paragraph 11 of the DPCO, 2013.
* The manufacturer is required to issue a price list in Form V to NPPA through IPDMS, the State Drug Controller, and dealers, as per paragraph 24 of the DPCO, 2013.
* The order stipulates that retailers and dealers must display the price list and supplementary price list in a conspicuous location.
* The retail price is applicable only to the manufacturer mentioned in the order who has applied for price fixation/revision as per the DPCO, 2013 and fulfilled all statutory requirements.
* Non-compliance with the price notification can lead to the manufacturer being liable to deposit the overcharged amount along with interest under the DPCO, 2013 and the Essential Commodities Act, 1955.
* The order supersedes any prior price orders for the same formulation with the specified strength and manufacturer/marketing company.
**6. Target Audience and Stakeholders:**
The primary target audience includes:
* Ms. Sun Pharmaceutical Industries Limited (as the manufacturer and marketer)
* National Pharmaceutical Pricing Authority (NPPA)
* Pharmaceutical retailers and dealers
* State Drug Controllers
* Consumers of Amoxycillin and Potassium Clavulanate Oral Suspension.
**7. Implementation Aspects (Inferred):**
* **Responsible Agency:** The National Pharmaceutical Pricing Authority (NPPA) is the primary agency responsible for implementing and enforcing this order.
* **Timelines/Procedures:** The order is effective from the date of notification (November 28, 2022). The manufacturer is required to issue a price list in Form V immediately. Retailers and dealers must display the price list upon receipt. Non-compliance will trigger actions under the DPCO, 2013 and Essential Commodities Act, 1955.
**8. Expected Outcomes / Impact of Changes:**
The intended outcome of this order is to:
* Ensure that Amoxycillin and Potassium Clavulanate Oral Suspension is sold at the regulated price of Rs. 168.43 (exclusive of GST) for Ms. Sun Pharmaceutical Industries Limited.
* Promote transparency in pharmaceutical pricing by requiring price list displays.
* Protect consumers from overpricing of essential medicines.
* Enforce compliance with the DPCO, 2013.
**9. Conclusion:**
The NPPA Order issued on November 28, 2022, is a specific intervention to regulate the retail price of Amoxycillin and Potassium Clavulanate Oral Suspension for Ms. Sun Pharmaceutical Industries Limited. It mandates price adherence, transparency in pricing, and outlines consequences for non-compliance. This order reinforces the NPPA's role in ensuring access to affordable medicines and maintaining a regulated pharmaceutical market. This order is critical for manufacturers to understand their pricing obligations and for retailers to ensure compliance.
Key Entities Referenced
Drugs Prices Control Order, 2013: A legal order referenced for exercising powers related to drug pricing.
Ministry of Chemicals and Fertilizers: The government ministry issuing the order.
Department of Pharmaceuticals: The department within the Ministry of Chemicals and Fertilizers responsible for pharmaceutical matters.
National Pharmaceutical Pricing Authority: The authority (NPPA) responsible for fixing the price of drugs.
New Delhi: The city where the order was issued.
Goods and Services Tax: A tax applicable to the retail price of formulations.
Amoxycillin and Potassium Clavulanate Oral Suspension: A specific drug formulation whose price is being fixed.
Ms Sun Pharmaceutical Industries Limited: The manufacturer of the Amoxycillin and Potassium Clavulanate Oral Suspension formulation.
State Drug Controller: The state-level authority responsible for drug regulation.
Essential Commodities Act, 1955: The act under which overcharged amounts may be deposited.
Government of India Press, Ring Road, Mayapuri, New Delhi-110064: The printing press for the document publication
Controller of Publications, Delhi-110054: The publisher of the document
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-28112022-240625
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CG-DL-E-28112022-240625
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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.ं 5281] नई ददल्ली, सोमर्ार, नर्म्ब र 28, 2022/अग्रहायण 7, 1944
No. 5281] NEW DELHI, MONDAY, NOVEMBER 28, 2022/AGRAHAYANA 7, 1944
रसायन और उर्रव क मत्रं ालय
(औषध जर्भाग राष्ट्रीय औषध मल्ू य जनधारव ण प्राजधकरण)
आदेि
नई ददल्ली, 28 नर्म्बर, 2022
का.आ. 5511(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 करत े हुए, राष्ट्रीय औषध मल्ू य जनधावरण प्राजधकरण (जिसको संजिप्त रूप
में एनपीपीए कहा िाता ह)ै नीर्े की सारणी के स्ट्तंभ (6) में 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) म ें की तत्सस्ट्थानी प्रजर्जष्ट म ें स े प्रत्सयेक की, र्स्ट्त ु एर्ं सर्े ा कर, यदद कोई ह,ै को छोड़कर अजधकतम खुदरा मूल्य के
रूप म ेंजनयत करती ह ै
ताजलका
क्रं जर्जनर्मजव त का प्रबलता इकाई जर्जनमातव ा और जर्पणन खदु रा
स.ं नाम/ब्ाडं का नाम कंपनी मल्ू य (रू.)
(1) (2) (3) (4) (5) (6)
1. एमोजससजसजलन प्रत्सयेक 5 जम.ली. रीकोंजस्ट्टट्यूटेड पर मैससव सन फामावस्ट्युठटकल 168.43
और पोटेजियम सस्ट्पेंिन म:ें र्ाईल इंडस्ट्रीि जलजमटेड
7889 GI/2022 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
क्रं जर्जनर्मजव त का प्रबलता इकाई जर्जनमातव ा और जर्पणन खदु रा
स.ं नाम/ब्ाडं का नाम कंपनी मल्ू य (रू.)
(1) (2) (3) (4) (5) (6)
सलार्ुलनेट ओरल एमोजससजसजलन राइहाइड्रेट आईपी (50
सस्ट्पेंिन आईपी अमोजससजसजलन 600 जमलीग्राम के जम.ली.
बराबर
पोटेजियम सलार्ुलनेट जडलूटेड आईपी
सलेर्ुलेजनक एजसड 42.9 जमलीग्राम के
बराबर
तालिका
V
I
ताजलका के कॉलम (3) और (5) में तत्सस्ट्थानी प्रजर्जष्टयों में जनर्दष्टव जर्जनमावण और जर्पणन
कंपजनयों की स्ट्रेंथ और नाम के साथ, उपरोि ताजलका के कॉलम (2) में जनर्दष्टव ऐसे फॉमूवलेिन के खुदरा मूल्य के जनधावरण
के पठरणामस्ट्र्रूप, कॉलम (2), (3) और (5) में तत्सस्ट्थानी प्रजर्जष्टयों म ें यथा जनर्दष्टव उस जर्जनमावण और जर्पणन कंपजनयों के
जलए जनर्दष्टव स्ट्रेंथ के साथ फॉमूवलेिन के खुदरा मूल्य को जनधावठरत करने र्ाल ेकोई मल्ू य आदेि यदद इस अजधसूर्ना से पहल े
िारी दकए गए हो, तो उसे इसका स्ट्थान जलया माना िाएगा
[पीएन/236/104/2022/एफ/फा. स.ं 8(104)/2022/डी.पी./एनपीपीए-डी.र्ी.-II]
महार्ीर सैनी, उप जनदेिक[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, the 28th November, 2022
S.O. 5511(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 / Marketing Company Price
Brand Name (Rs.)
(1) (2) (3) (4) (5) (6)
1. Amoxycillin Each 5ml of the M/s Sun 168.43
and Potassium reconstituted suspension Pharmaceutical
Clavulanate contains: Industries Limited
Oral Suspension Amoxycillin Trihydrate IP eq. Per Vial
IP to Amoxycillin 600mg (50ml)
Potassium Clavulanate
diluted IP eq. to Clavulanic
Acid 42.09mg
Note:
(a) The manufacturer of above-mentioned formulations i.e., “new drug” under paragraph 2(1)(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, 1955.4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
(g) Consequent to the fixation of retail price of such formulation as specified in column (2) of the
above table with the strength and name of Manufacturer & Marketing Companies specified in the
corresponding entries in Column (3) & (5) thereof, the price order(s) fixing the retail price of the
formulation with specified strength for that Manufacturer & Marketing Companies as specified in
corresponding entries in Column (2), (3) and (5) thereof, if any, issued prior to this notification,
stand(s) superseded.
[PN/236/104/2022/F/F. No. 8(104)/2022/D.P./NPPA-Div.-II]
MAHAVEER SAINI, 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.