Home India Ministry of Chemicals and Fertilizers In exercise of the powers conferred by paragraphs 5 11 and 1...
Date: 2019-02-05 Category: Extra Ordinary State: Union Government Country: India

In exercise of the powers conferred by paragraphs 5 11 and 15 of the Drugs Prices Control Order

Issued by Ministry of Chemicals and Fertilizers · Department of Pharmaceuticals

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Executive Summary & Key Takeaways

**Executive Summary:** This order, issued by the National Pharmaceutical Pricing Authority (NPPA), fixes the retail price of a specific formulation of Abacavir Lamivudine tablet. It specifies the price, manufacturer, and applicable conditions. It also defines the responsibilities of manufacturers, retailers, and dealers regarding price lists and compliance. The order supersedes any prior price orders for the specified formulation. **Key Points / Main Content:** * **Price Fixation:** * The NPPA fixes the retail price of Abacavir Lamivudine tablet (brand name Dolutegravir) at Rs. 157.96, excluding GST. * This price applies to the manufacturer, M/s Emcure Pharmaceuticals Ltd. * **Manufacturer Responsibilities:** * Manufacturers can add GST if it is actually paid or payable to the government. * Retail prices for packs must be determined according to DPCO 2013, paragraph 11. * A price list in Form V must be issued to NPPA through IPDMS from the date of notification, with copies to the State Drug Controller and dealers, as per DPCO 2013, paragraph 24. * **Retailer and Dealer Responsibilities:** * Retailers and dealers must display the price list and supplementary price list (if any) in a conspicuous location, easily accessible to customers, as per DPCO 2013, para 24(4). * **Applicability and Compliance:** * The fixed retail price applies only to manufacturers who have applied for price fixation/revision by submitting Form I under DPCO 2013. * Manufacturers must fulfill all statutory requirements, including manufacturing license permissions. * Failure to comply with the price notification and specified notes will result in liability to deposit the overcharged amount with interest under the Essential Commodities Act, 1955, read with DPCO 2013. * **Supersession:** * This order supersedes any prior price orders for the specified formulation. **Impact Analysis** * **Manufacturers (M/s Emcure Pharmaceuticals Ltd):** * *Impact:* Must adhere to the fixed retail price of Rs. 157.96 (exclusive of GST) for the specified formulation. * *Action Required:* Ensure compliance with pricing regulations, issue price lists, and meet all statutory requirements. * **Retailers and Dealers:** * *Impact:* Required to sell the specified formulation at or below the fixed retail price. * *Action Required:* Display the manufacturer's price list conspicuously and ensure easy access for customers. * **Consumers:** * *Impact:* Ensures price control on Abacavir Lamivudine tablet, potentially making it more affordable. * *Action Required:* Be aware of the fixed price and report any overcharging. * **National Pharmaceutical Pricing Authority (NPPA):** * *Impact:* Responsible for enforcing the price control order. * *Action Required:* Monitor compliance and take action against any violations.

Key Entities Referenced

National Pharmaceutical Pricing Authority: A government regulatory agency in India that controls the prices of pharmaceutical drugs. Referred to as NPPA. Drugs Prices Control Order, 2013: A legal order in India that regulates the prices of essential drugs. Referred to as DPCO, 2013. Ministry of Chemicals and Fertilizers: A ministry in the Government of India responsible for the development and regulation of the chemical and fertilizer industries. Abacavir: An antiretroviral medication used to treat HIV/AIDS. Lamivudine: An antiretroviral medication used to treat HIV and hepatitis B. Emcure Pharmaceuticals Ltd.: A pharmaceutical company that manufactures and markets Abacavir and Lamivudine. Essential Commodities Act, 1955: An act of the Parliament of India which seeks to ensure the delivery of certain commodities to consumers at fair prices. New Delhi, Delhi: The capital city of India, where the order was issued.
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O. 703(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;¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 3 TABLE Sl. Name of the Strength Unit Manufacturer & Retail No. Formulation / Marketing Company Price Brand Name (Rs.) (1) (2) (3) (4) (5) (6) 1. Abacavir + Each film coated tablet contains: Tablet M/s Emcure 157.96 Dolutegravir + Abacavir Sulphate IP eq. to Abacavir Pharmaceuticals Ltd. Lamivudine tablet 600 mg Dolutegravir Sodium eq. to Dolutegravir 50 mg Lamivudine IP 300 mg Note: (a) The manufacturer of above mentioned formulation 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 / marketeer 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 formulation 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/194/62/2019/F/F. No. 8(62)/2019/D.P./NPPA-Div.-II] PRASENJIT DAS, Asstt. 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.

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