Executive Summary:
This order, issued by the National Pharmaceutical Pricing Authority, fixes the retail prices of specific drug formulations, as detailed in the attached table, effective March 19, 2019. It outlines the responsibilities of manufacturers, marketers, retailers, and dealers concerning these prices and compliance with the Drugs Prices Control Order (DPCO) 2013. Previous price orders for these formulations are superseded.
Key Points / Main Content:
Pricing Fixation:
* Retail prices are fixed for formulations specified in column 2 of the table, as per column 6, excluding goods and services tax.
* The table includes the strength, unit, manufacturer, and marketing company for each formulation.
* Manufacturers of new drugs under paragraph 2(u) of DPCO 2013 shall fix retail prices as specified.
Tax and Price Calculation:
* Manufacturers may add goods and services tax if it has been paid or is payable to the government.
* Retail prices for packs of formulations must align with the retail prices specified in column 6, as per DPCO 2013 paragraph 11.
Responsibilities of Manufacturers:
* Manufacturers must 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.
Responsibilities of Retailers and Dealers:
* Retailers and dealers must display the price list and any supplementary list provided by the manufacturer conspicuously, as per DPCO 2013 paragraph 24(4).
Applicability and Compliance:
* The retail prices apply only to manufacturers/marketers who submitted Form I for price fixation/revision under DPCO 2013 and meet all statutory requirements.
* Failure to comply with the price notification may result in the manufacturer/marketing company being liable to deposit the overcharged amount with interest under the DPCO 2013 and the Essential Commodities Act, 1955.
* Existing price orders for formulations specified in the table are superseded by this notification.
Impact Analysis
Manufacturers:
* Impact: Required to adhere to the fixed retail prices, calculate pack prices accordingly, and issue price lists. Liable for overcharging.
* Action Required: Adjust pricing to comply with the order, issue price lists, and ensure compliance with DPCO 2013 and other regulations.
Retailers and Dealers:
* Impact: Must display the mandated price lists prominently.
* Action Required: Display the price list and any supplementary lists as provided by manufacturers.
Consumers:
* Impact: Benefit from regulated prices of essential drug formulations.
* Action Required: None.
Key Entities Referenced
National Pharmaceutical Pricing Authority: A government regulatory agency in India that fixes and revises prices of pharmaceutical products. It is abbreviated as NPPA in the document.
Drugs Prices Control Order, 2013: A legal order in India that empowers the NPPA to regulate drug prices. It is abbreviated as DPCO in the document.
Ministry of Chemicals and Fertilizers: A ministry of the Government of India responsible for the formulation and implementation of policies and programs for the chemical and fertilizer industries.
Department of Pharmaceuticals: A department under the Ministry of Chemicals and Fertilizers, Government of India, responsible for the growth and development of the pharmaceutical industry.
New Delhi: The capital city of India, where the order was issued.
Essential Commodities Act, 1955: An act of the Parliament of India to provide, in the interests of the general public, for the control of the production, supply, and distribution of, and trade and commerce in, certain commodities.
Ms Theon Pharmaceutical Ltd.: A manufacturer and marketing company of pharmaceutical products listed in the table.
Ms Jubilant Life Sciences Limited: A manufacturer and marketing company of pharmaceutical products listed in the table.
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MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals)
(NATIONAL PHARMACEUTICAL PRICING AUTHORITY)
ORDER
New Delhi, 19th March, 2019
S.O. 1395(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, 2016¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 3
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. Alpha Lipoic Acid 11.34
Each hard gelatine capsule
+
contains:
Methylcobalamin
Alpha Lipoic Acid USP 100mg,
+
Methylcobalamin 1500mcg, M/s Theon
Vitamin B6 IP +
Vitamin B6 IP 3mg, Pharmaceutical Ltd. /
Folic Acid IP + 1 Capsule
Folic Acid IP 1.5mg, M/s Jubilant Life
Benfotiamine +
Benfotiamine 50mg, Sciences Limited
Biotin USP +
Biotin USP 5mg, Chromium
Chromium
Picolinate USP eq. to Chromium
Picolinate Capsule
200mcg
(Jubinerv)
2. Alpha Lipoic Acid Each hard gelatine capsule 11.51
+ contains:
Methylcobalamin Alpha Lipoic Acid USP 200mg,
+ Methylcobalamin 1500mcg, M/s KonTest Chemicals
1 Capsule
Vitamin B6 + Vitamin B6 IP 3mg, Limited
Folic Acid + Folic Acid IP 1.5mg,
Benfotiamine + Benfotiamine 50mg,
Biotin Capsule Biotin USP 5mg,
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.4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC 3(ii)]
(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/195/63/2019/F/F. No. 8(63)/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
and Published by the Controller of Publications, Delhi-110054.