Home India Ministry of Chemicals and Fertilizers In exercise of the powers conferred by paragraphs 5, 11 and ...
Date: 2019-03-19 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

Research with AI Agent Chat with Document Generate Summary Translate Helpful Share Add to Project Create Task

Executive Summary & Key Takeaways

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 Previous price orders for these formulations are superseded.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 * Existing price orders for formulations specified in the table are superseded by this notification.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.
Official Source Record View Original Source →
See Full Document Text
jftLVªh laö Mhö ,yö&33004@99 REGD. NO. D. L.-33004/99 vlk/kj.k EXTRAORDINARY Hkkx II—[k.M 3—mi&[k.M (ii) PART II—Section 3—Sub-section (ii) izkf/dkj ls izdkf'kr PUBLISHED BY AUTHORITY la- 1247] ubZ fnYyh] eaxyokj] ekpZ 19] 2019@iQkYxqu 28] 1940 No. 1247] NEW DELHI, TUESDAY, MARCH 19, 2019/PHALGUNA 28, 1940 jlk;u vkSj moZjd ea=ky; ¼vkS’k/k foHkkx½ ¼jk’Vªh; vkS’k/k ewY; fu/kkZj.k izkf/kdj.k½ vkns’k ub Z fnYyh] 19 ekpZ] 2019 dk-vk- 1395¼v½.—Hkkjr ljdkj d s jlk;u vkSj moZjd ea=ky; }kjk tkjh dk-vk- 1394¼v½ rkjh[k 30 eb]Z 2013 vkSj dk-vk- 701¼v½ rkjh[k 10 ekp]Z 2016 d s lkFk ifBr vkS"k/k ¼dher fu;a=.k½ vkn's k] 2013 d s iSjk 5, 11 vkSj 15 }kjk inz Rr 'kfDr;k sa dk i;z kxs djrs g,q ] jk"Vªh; vkS"k/k eYw ; fu/kkZj.k izkf/kdj.k ¼ftldk s lfa{kIr :i e sa ,uihih, dgk tkrk g½S] uhp s dh lkj.kh d s LrHa k ¼6½ e as fofufn"ZV [knq jk ewY; dk s mDr lkj.kh d s LrHa k ¼3½] ¼4½] vkSj ¼5½ e as rRLFkkuh ifzof"V;ksa e sa fofufn"ZV icz yrk] bdkb Z ¼;wfuV½ vkSj fofuekZrk vkSj foi.ku dEifu;k sa d s uke lfgr LrHa k ¼2½ e sa dh rRLFkkuh izfof"V es a l s iRz ;ds dh] oLr q ,o a lsok dj] ;fn dkbs Z gS] dk s NkMs d+ j vf/kdre [knq jk ewY; d s :i e sa fu;r djrh gSA lkj.kh Øz- vuqlwfpr fofufeZfr izcyrk bdkbZ fofuekZrk vkSj foi.ku daiuh [kqnjk la- dk uke@czkaM dk ewY; ¼#-½ uke (1) (2) (3) (4) (5) (6) 1. vYQk fyiksbd izR;sd gkMZ tsysfVu dSIlwy esa% 11.34 ,flM $ vYQk fyiksbd ,flM ;w,lih 100 feFkkbydksckyfeu fexzk-] $ foVkfeu ch6 $ feFkkbydksckyfeu 1500 ,elhth] Qksfyd ,flM $ foVkfeu ch6 vkbZih 3 fexzk-] eSllZ fFk;ksu QkekZL;wfVdYl csuQksfV;kekbu 1 dSIlwy fy-@eSllZ tqfcysaV ykbQ ck;ksfVu ;w,lih $ Qksfyd ,flM vkbZih 1-5 fexzk-] lkbalht fy- Djksfe;e csuQksfV;kekbu 50 fexzk-] fidksfyusV dSIlwy ck;ksfVu ;w,lih 5 fexzk-] ¼tqfcusoZ½ Djksfe;e fidksfyusV ;wih,l ds cjkcj Djksfe;e 200 ,elhth 1802 GI/2019 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC 3(ii)] 2. vYQk fyiksbd izR;sd gkMZ tsysfVu dSIlwy esa% 11.51 ,flM $ vYQk fyiksbd ,flM ;w,lih 200 feFkkbydksckyfeu fexzk-] $ foVkfeu ch6 $ feFkkbydksckyfeu 1500 ,elhth] Qksfyd ,flM $ csuQksfV;kekbu $ foVkfeu ch6 vkbZih 3 fexzk-] 1 dSIlwy eSllZ dkWuVsLV dsfedYl fy- ck;ksfVu dSIlwy Qksfyd ,flM vkbZih 1-5 fexzk-] csuQksfV;kekbu 50 fexzk-] ck;ksfVu ;w,lih 5 fexzk-] uksV % ¼d½ mi;qZDr nh xbZ fofufnZ"V QkWewZys'ku ds fofuekZrk vFkkZr~ tks ÞubZ Mªxß Mhihlhvks] 2013 ds iSjkxzkQ 2¼;w½ ds rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼6½ esa fofufnZ"V [kqnjk ewY; fu/kkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (6) esa of.kZr vf/kdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os oLrq ,oa lsok dj dks tksM+ ldrs gSaA ¼x½ vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼6½ esa fofufnZ"V [kqnjk ewY; ds vk/kkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fu/kkZfjr djsaA fuekZrk vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 24 ds rgr QkWeZ V esa vf/klwpuk dh rkjh[k ls ,d ewY; lwph ,uihih, dks vkbZihMh,e,l ds ek/;e ls tkjh djsa rFkk mldh dkiWh jkT; vkS"kf/k fu;a=dksa vkSj fofuekZrk forjdksa dks tkjh djsaA ¼?k½ vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds 24 (4) ds mica/kksa ds vuqlkj izR;sd QqVdj fodzsrk vkSj forjd fofuekZrk }kjk fn, x, :i esa ,sls ifjlj] tgka dkjckj dks bl izdkj fd;k tk jgk gS fd mlls ijke’kZ ds bPNqd fdlh O;fDr ds fy, igqap vklku gks] ogka mlds fdlh lgtn`’; Hkkx ij dher lwph vkSj iwjd lwph] ;fn dksbZ gks] dks laiznf’kZr djsxkA ¼M-½ mi;qZDr xSj vf/kdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds rgr vuqc) ewY; fu/kkZj.k@la'kks/ku ds fy, QkWeZ I ij tek fd;k x;k Fkk vkSj ljdkj }kjk fu/kkZfjr lHkh ykxw oS/kkfud vko';drkvksa dh iwfrZ ds v/khu izklafxd fof/k;ksa@fu;eksa ds vUrxZr tSlk fd dsUnzh;@jkT; ykblsflax vkWFkksfjVh ds l{ke izkf/kdkjh }kjk esU;wQsDpfjax ykblsal eatwjh ds rgr lacaf/kr fofufeZr fuekZrk@foi.ku dEifu;ka tks vuqikyu djrh gSA ¼p½ fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa vkSj fofufnZ"V 'krks± dk ikyu ugha djrh gSa rks os vko';d oLrq,¡ vf/kfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izko/kkuksa ds v/khu C;kt lfgr vf/kizHkkfjr jkf'k dks tek djus ds fy, nk;h gksaxsA ¼N½ bl vkns'k esa mijksDr lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V fofufeZfr;ksa ds iSdksa dh [kqnjk ewY; fu;r gksus ds ifj.kkeLo:i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA [dka- la-@195@63/2019@,Q@Qk- la- 8¼63½@2019@Mhih@,uihih,&fMoh-II] izlsuthr nkl] lgk;d funs'kd 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.

Continue your research