## Report on National Pharmaceutical Pricing Authority (NPPA) Order Regarding Retail Price Fixation of Vitamin D3 Formulation
**1. Executive Summary:**
This report analyzes a notification issued by the National Pharmaceutical Pricing Authority (NPPA) on September 15, 2021, concerning the retail price fixation of a specific Vitamin D3 (Cholecalciferol) orally disintegrating strip formulation. This notification appears to be an amendment or update to the Drug Prices Control Order (DPCO) 2013, superseding previous orders related to price regulation. The core purpose of this notification is to fix the retail price of the specified formulation, ensuring affordability and accessibility. Key findings include the determination of a retail price of Rs. 30.39 per strip, exclusive of GST, and outlining the responsibilities of manufacturers, retailers, and dealers in relation to price listing and compliance.
**2. Introduction:**
This report aims to provide a comprehensive overview of the NPPA notification published on September 15, 2021, regarding the retail price fixation of a specific Vitamin D3 formulation. This analysis is based solely on the information provided within the policy text.
**3. Policy Overview:**
* This order amends the Drugs Prices Control Order, 2013.
* **Core Objective:** To fix the retail price of a specific Vitamin D3 (Cholecalciferol) orally disintegrating strip formulation. This aims to regulate the price of essential medicines, ensuring affordability and accessibility to the public.
**4. Background and Rationale:**
This notification serves to update and potentially supersede previous orders related to drug pricing. The rationale appears to be a periodic review and adjustment of drug prices based on market dynamics, manufacturing costs, and government regulations. By fixing the retail price, the NPPA aims to prevent manufacturers from charging excessive prices and ensure that essential medicines are available at reasonable rates. The specific change likely addresses the need to set a price for this particular Vitamin D3 formulation due to its introduction into the market or a change in its market dynamics.
**5. Key Provisions / Changes:**
This notification introduces the following specific changes related to the Vitamin D3 formulation:
* **Specific Part of the Original Policy Changed:** This notification supersedes previous orders of the Government of India in the Ministry of Chemicals and Fertilizers National Pharmaceutical Pricing Authority specified in the Column 7 of the table, meaning that any price controls on this specific formulation are being updated with this order.
* **New Rule/Provision:** The NPPA fixes the retail price of Vitamin D3 (Cholecalciferol) orally disintegrating strips (60000 IU) manufactured and marketed by Ms. Zim Laboratories Ltd. and Ms. Cadila Pharmaceuticals Ltd. at Rs. 30.39 per strip, exclusive of Goods and Services Tax (GST).
* **Difference/Effect of the Change:** This change provides a clear and legally binding price for the specified formulation, ensuring that consumers are charged a regulated price. It affects the manufacturers, marketers, retailers, and consumers of this particular Vitamin D3 formulation. The specific amount of change from the previous price (before the new price) isn't available from the text.
**6. Target Audience and Stakeholders:**
The primary target audience and stakeholders directly affected by this notification include:
* **Manufacturers:** Ms. Zim Laboratories Ltd.
* **Marketing Companies:** Ms. Cadila Pharmaceuticals Ltd.
* **Retailers and Dealers:** All retailers and distributors of the specified Vitamin D3 formulation.
* **Consumers:** Individuals purchasing the specified Vitamin D3 formulation.
* **State Drug Controllers**
**7. Implementation Aspects (Inferred):**
* **Responsible Agency/Bodies:** The National Pharmaceutical Pricing Authority (NPPA) is the primary responsible agency for implementing and enforcing this notification. The Department of Pharmaceuticals (DOP) also plays a role by issuing directions. State Drug Controllers are involved in ensuring compliance at the state level.
* **Timelines/Procedures:**
* Manufacturers must issue a price list in Form V from the date of notification to NPPA through IPDMS and submit a copy to State Drug Controllers and dealers as per paragraph 24 of DPCO 2013.
* Retailers and dealers are required to display the price list and supplementary price list (if any) in a conspicuous part of their business premises, accessible to consumers, as per para 24(4) of DPCO 2013.
* **(Related to Specific Changes):** The implementation requires manufacturers to immediately adhere to the fixed retail price for the specific Vitamin D3 formulation and update their price lists accordingly. Retailers and dealers must display the updated price prominently.
**8. Expected Outcomes / Impact of Changes:**
* The likely intended outcome of this notification is to regulate the price of the specified Vitamin D3 formulation, ensuring affordability and preventing overcharging.
* The specific changes introduced by the amendment are expected to stabilize the price of this specific formulation and improve access for patients requiring it.
* It may also lead to increased price transparency and better compliance with drug pricing regulations.
* Manufacturers have to adhere to the pricing or face penalties.
**9. Conclusion:**
The NPPA notification of September 15, 2021, regarding the retail price fixation of a specific Vitamin D3 formulation represents a key regulatory measure to ensure affordability and accessibility of essential medicines. The notification fixes the retail price, outlines compliance responsibilities, and aims to promote transparency in drug pricing. This order underscores the NPPA's commitment to regulating the pharmaceutical industry and protecting consumer interests.
Key Entities Referenced
NEW DELHI: Location of publication.
Department of Pharmaceuticals: Issuing department under the MINISTRY OF CHEMICALS AND FERTILIZERS
Ministry of Chemicals and Fertilizers: The Indian government ministry under which the NATIONAL PHARMACEUTICAL PRICING AUTHORITY operates.
National Pharmaceutical Pricing Authority: The regulatory body (NPPA) responsible for fixing drug prices in India.
Drugs Prices Control Order, 2013: Indian law (DPCO, 2013) that empowers the NPPA to regulate drug prices.
Essential Commodities Act, 1955: The Act under which companies are liable to deposit the overcharged amount along with interest.
Ms. Zim Laboratories Ltd.: Manufacturer of Vitamin D3 oral strips.
Ms. Cadila Pharmaceuticals Ltd.: Marketing company for Vitamin D3 oral strips.
Vitamin D3: The drug formulation whose price is being regulated by this order.
State Drug Controller: Authority to which a price list copy must be submitted
IPDMS: The system through which the price list in Form V must be issued to NPPA
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
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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.ं 3471] नई दिल्ली, बुधिार, जसतम्ब र 15, 2021/भाद्र 24, 1943
No. 3471] NEW DELHI, WEDNESDAY, SEPTEMBER 15, 2021/BHADRA 24, 1943
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1. प्रत्येक ओरल्ली प्रत्येक 30.39 31015/06/2021- 1724(अ) मैससा ज़िम
जिटाजमनडी 3 जडससटेग्रटटग्स जस्ट्रप्स: जस्ट्रप् मूल् य जनधाारण दिनांक लेबोरेटरीि जल. /
(कोलेक्लजसफेरोल) जिटाजमनडी 3 (16530) का दिनांक 30.04.2021 मैससा कैजडला
ओरल्ली (कोलेक्लजसफेरोल) 08.09.2021 (क्र. सं. 20) फामाास्ट्यूटटकल्स
जडससटेग्रटटग्स जस्ट्रप्स जलजमटेड
आईपी 60000 आईयू
5185 GI/2021 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
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MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals)
(NATIONAL PHARMACEUTICAL PRICING AUTHORITY)
ORDER
New Delhi, the 15th September, 2021
S.O. 3783(E).—In line with the directions given by the Department of Pharmaceuticals (DOP) vide letters
specified in column (6) of the table herein below and 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, and in supersession
of the Order(s) of the Government of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical
Pricing Authority) specified in the Column (7) of the table, the National Pharmaceutical Pricing Authority (hereinafter
referred as NPPA), hereby fixes, the price as specified in column (5) 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 (8) thereof;
TABLE
Sl. Name of the Dosage form & Strength Unit Retail DoP Letter no. Existing S.O. Manufacturer &
No. Formulation Price and Date number & Marketing
(Rs.) date Company
respectively
(1) (2) (3) (4) (5) (6) (7) (8)
1. Vitamin D3 Each orally disintegrating Per 30.39 31015/06/2021- 1724(E) M/s. Zim
strips contains: Strip Pricing (16530) dated Laboratories
(Cholecalciferol)
Vitamin D3 dated 08.09.2021 30.04.2021
orally Ltd. / M/s. Cadila
(Cholecalciferol)
(at Sl. No. 20)
disintegrating strips IP 60000 IU Pharmaceuticals
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 (5) of the table hereinabove.[भाग II—खण् ड 3(ii)] भारत का रािपत्र : असाधारण 3
(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 (5) 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 (5) 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 prices are applicable only to the manufacturer / marketer as mentioned above for
generic / any brand of the same composition / strength of the subject formulations, subject to fulfillment 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 manufacturers/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.
[P.N./223/91/2021/F/F. No. 8(91)/2021/DP./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.