Executive Summary:
This order, issued by the National Pharmaceutical Pricing Authority (NPPA) on August 23, 2019, fixes the retail prices of specific drug formulations, namely Emtricitabine and Dolutegravir. It outlines the responsibilities of manufacturers, retailers, and dealers concerning these prices, including compliance with the Drugs Prices Control Order (DPCO) 2013. This order supersedes any previous price orders for the specified formulations.
Key Points / Main Content:
* **Price Fixation:**
* Retail prices are fixed for Emtricitabine and Dolutegravir formulations, as specified in the table within the order (column 6).
* Prices are exclusive of goods and services tax (GST).
* **Manufacturer Responsibilities:**
* Manufacturers of new drugs must fix retail prices as specified in column 6 of the table.
* Manufacturers may add GST if actually paid or payable to the government.
* Retail price for a pack shall be fixed based on the retail price specified in column 6 of the table as per DPCO 2013.
* Manufacturers must issue a price list in Form V to NPPA through IPDMS, State Drug Controller and dealers, as per DPCO 2013.
* **Retailer and Dealer Responsibilities:**
* Retailers and dealers must display the price list and supplementary price list (if any) furnished by the manufacturer in a visible location.
* **Applicability:**
* The fixed retail price is applicable only to the manufacturer/marketer who applied for price fixation/revision by submitting Form I under DPCO 2013.
* Applicable subject to fulfilment of all statutory requirements and manufacturing license permissions from the Competent Authority.
* **Non-Compliance:**
* Manufacturers/marketers not complying with the price notification and specified notes will be liable to deposit the overcharged amount with interest under the Essential Commodities Act, 1955 and DPCO 2013.
* **Supersession:**
* This order supersedes any prior orders fixing ceiling or retail prices for the formulations specified.
Impact Analysis:
* Manufacturers:
* Impact: Required to adhere to the fixed retail prices for the specified formulations. Subject to penalties for non-compliance.
* Action Required: Fix retail prices accordingly, issue price lists, and ensure compliance with DPCO 2013 and other relevant regulations.
* Retailers and Dealers:
* Impact: Must sell the formulations at or below the fixed retail price.
* Action Required: Display the price list prominently for customer access.
* Consumers:
* Impact: Ensures price control and transparency in the pricing of essential medicines.
* Action Required: Be aware of fixed prices and report discrepancies.
* National Pharmaceutical Pricing Authority (NPPA):
* Impact: Responsible for monitoring and enforcing compliance with the order.
* Action Required: Oversee implementation, address non-compliance, and update price lists as needed.
Key Entities Referenced
Drugs Prices Control Order, 2013: A legal order issued by the Government of India to regulate the prices of drugs.
Ministry of Chemicals and Fertilizers: A government ministry responsible for the chemical and fertilizer industries.
National Pharmaceutical Pricing Authority: A government regulatory agency that fixes and revises prices of pharmaceutical products.
New Delhi: The location where the order was issued, New Delhi, Delhi
Emtricitabine: An antiretroviral medication used to treat HIV/AIDS.
Tenofovir Alafenamide: An antiretroviral medication used to treat HIV/AIDS and chronic hepatitis B.
Dolutegravir: An antiretroviral medication used to treat HIV/AIDS.
Essential Commodities Act, 1955: An act of the Parliament of India to ensure the supply of certain essential commodities.
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MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals)
(NATIONAL PHARMACEUTICAL PRICING AUTHORITY)
ORDER
New Delhi, the 23rd August, 2019
S.O. 3032(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. Emtricitabine + Each film coated tablet contains: 51.34
M/s Hetero Labs Ltd. /
Tenofovir Tablet Emtricitabine IP 200mg.
1 Tablet M/s Emcure
Tenofovir Alafenamide Hemifumarate
Pharmaceuticals Ltd.
eq. to Tenofovir Alafenamide 25mg¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 3
2. Dolutegravir + Each film coated tablet contains: 130.61
Emtricitabine + Dolutegravir Sodium eq. to
M/s Emcure
Tenofovir Dolutegravir 50mg,
1 Tablet Pharmaceuticals
Alafenamide Tablet Emtricitabine IP 200mg,
Limited
Tenofovir Alafenamide Fumarate eq.
to Tenofovir Alafenamide 25mg.
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.
[P.N./201/69/2019/F/F. No. 8(69)/2019/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
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