Home India Ministry of Chemicals and Fertilizers In exercise of the powers conferred by paragraphs 4 6 10 11 ...
Date: 2017-04-27 Category: Extra Ordinary State: Union Government Country: India

In exercise of the powers conferred by paragraphs 4 6 10 11 14 16 17 and 18 of the Drugs

Issued by Ministry of Chemicals and Fertilizers · Department of Fertilizers

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Executive Summary & Key Takeaways

Executive Summary: This notification from the National Pharmaceutical Pricing Authority (NPPA) fixes ceiling prices for scheduled drug formulations as specified in the tables provided, superseding previous price orders. Manufacturers selling above the fixed ceiling price plus local taxes must revise prices downward. Manufacturers must also adhere to reporting requirements and display price lists. Key Points / Main Content: Ceiling Price Fixation: * The NPPA fixes ceiling prices for scheduled formulations, exclusive of local taxes, as listed in the tables. * Manufacturers selling at prices higher than the ceiling price plus local taxes must revise prices downward. * Existing manufacturers with MRP lower than the ceiling price plus local taxes must maintain the existing MRP. * Manufacturers can add local taxes only if they have paid or are liable to pay them to the government on the ceiling price. * Ceiling price for a pack shall be determined as per the Drugs Prices Control Order (DPCO) 2013, paragraph 11. * Previous price orders for the listed formulations are superseded by this notification. * NPPA also fixes retail prices for certain formulations as specified. Manufacturer Responsibilities: * Manufacturers must issue a price list in Form V to the NPPA through IPDMS and provide copies to the State Drug Controller and dealers. * Manufacturers launching a new drug with specified dosage or strength must apply to the NPPA for price approval in Form I. * Manufacturers must furnish quarterly returns on production, import, and sale of scheduled formulations to the NPPA in Form III through IPDMS. * Manufacturers intending to discontinue production or import of scheduled formulations must notify the NPPA in Form IV at least six months prior to discontinuation. * Manufacturers of new drugs shall fix retail prices. * Retail price is applicable only to individual manufacturers who applied for price fixation by submitting Form I. Retailer and Dealer Obligations: * Retailers and dealers must display the price list and supplementary price list, as furnished by the manufacturer, in a conspicuous location. Non-Compliance: * Manufacturers or marketing companies not complying with the ceiling or retail prices and specified conditions are liable to deposit the overcharged amount with interest under the DPCO 2013 and the Essential Commodities Act, 1955. Impact Analysis: Manufacturers: * Impact: Must adhere to the fixed ceiling prices, revise existing prices if necessary, comply with reporting requirements, and issue price lists. * Action Required: Review current pricing, adjust as needed, ensure compliance with reporting and notification requirements, and issue price lists. Retailers and Dealers: * Impact: Must display price lists and supplementary price lists. * Action Required: Ensure price lists are prominently displayed and accessible to customers. National Pharmaceutical Pricing Authority (NPPA): * Impact: Responsible for enforcing the fixed prices and overseeing compliance. * Action Required: Monitor manufacturer and retailer compliance, review submitted forms, and take action against non-compliant entities. Consumers: * Impact: Will benefit from regulated drug prices. * Action Required: Be aware of the prices.

Key Entities Referenced

Drugs Prices Control Order, 2013: A legal order by the Government of India, which empowers NPPA to control prices of drugs. National Pharmaceutical Pricing Authority: A government regulatory agency in India responsible for fixing and revising prices of pharmaceutical products. Ministry of Chemicals and Fertilizers: A ministry of the Government of India responsible for policy formulation and regulation of the chemical and fertilizer industries. Essential Commodities Act, 1955: An act of the Parliament of India that ensures the supply of essential commodities. IPDMS: Integrated Pharmaceutical Database Management System, likely a digital platform used for submitting information to NPPA. State Drug Controller: A regulatory authority at the state level responsible for drug regulation and control. New Delhi: The location where the order was issued, New Delhi, NCT of Delhi Baljit Singh: Assistant Director in D.P.NPPA Div.II, signatory of the order
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REGD. NO. D. L.-33004/99 EXTRAORDINARY II— — (ii) PART II—Section 3—Sub-section (ii) PUBLISHED BY AUTHORITY 1180] No. 1180] NEW DELHI, THURSDAY, APRIL 27, 2017/VAISAKHA 7, 1939 ubZ fnYyh] 27 vizSy] 2017 dk-vk- 1333¼v½-&Hkkjr ljdkj ds jlk;u vkjS moZjd e=a ky; }kjk tkjh dk0 vk0 1394¼v½ rkjh[k 30 eb]Z 2013 vkSj dk0 vk0 701¼v½ rkjh[k 10 ekpZ] 2016 ds lkFk ifBr vkS"k/k ¼dher fu;a=.k½ vkn's k] 2013 d s iSjk 4] 6] 10] 11] 14] 16] 17 vkSj 18 }kjk iznRr 'kfDr;ks a dk iz;ksx djrs gq,] jk”Vªh; vkS”k/k eYw ; fu/kkjZ .k izkf/kdj.k ¼ftl s laf{kIr :i ls ,uihih, dgk tkrk gS½ uhp s dh lkj.kh d s LraHk ¼5½ esa fofufnZ”V vf/kdre dher dks mDr lkj.kh d s LraHk ¼3½ vkSj ¼4½ eas Øe’k% rRLFkkuh izfof”V;kas eas fofufn”ZV [kjq kd :i ,oa izcyrk vkSj bdkbZ lfgr ml lkj.kh ds LraHk ¼2½ eas dh rRLFkkuh izfof”V es a fofufnZ”V vuqlwfpr fofufeZfr;kas eas ls izR;sd dh] LFkkuh; dj] ;fn dkbs Z gS] dks NkMs +dj vf/kdre dher ds :i eas fu;r djrh gS% lkj.kh dz-la- vuqlwfpr fofufeZfr dk uke [kqjkd :i ,oa izcyrk bdkbZ vf/kdre dher ¼#-½ (1) (2) (3) (4) (5) 1. वनै कोमाइसीन इंजक्े शन के लिए पाउडर 250लमग्रा. प्रलि पैक 201.20 2. इटोपोसाइड कैप्सूि 50लमग्रा. 1 कैप्सूि 51.44 3 नोराड्रेनािाइन इंजेक्शन 2लमग्रा. /लमलि. 1लमलि. 24.38 4. बुडेसोनाइड नाक का स्प्प्रे 100एमसीजी/डोज 1 डोज 0.85 5. बुडेसोनाइड नाक का स्प्प्रे 50एमसीजी /डोज 1 डोज 0.96 6. 5-एलमनोसेिीलसलिक एलसड सुप्पोलजट्री 500लमग्रा. 1 सुप्पोलजट्री 15.99 ररटेंशन इनेमा 7. आईसोसोरबाइड-5-मोनोनाईट्रेट एसआर कैप्सूि 60लमग्रा. 1 कैप्सूि 3.29 8. आईसोसोरबाइड-5-मोनोनाईट्रेट एसआर कैप्सूि 30लमग्रा. 1 कैप्सूि 3.32 2807 GI/2017 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] uksV % ¼d½ ljdkj }kjk bl izdkj fu;r dh xbZ vkSj vf/klwfpr dh xbZ vf/kdre dher ¼/ku LFkkuh; dj] tks ykxw gksa½ ls vf/kd dher ij vuqlwfpr fofufeZfr;kas d s czkMa sM ;k tsufsjd ;k nkus kas :ikarjkas dks csp jgs vuqlwfpr fofufeZfr;kas d s lHkh fofuekZrk] mi;qZDr lkj.kh d s LraHk ¼5½ es a of.kZr vf/kdre dher ¼/ku LFkkuh; dj] tk s ykxw gksa½ ls vf/kd lHkh ,slh fofuferZ ;kas dh dher dk v/kkseq[kh iqujh{k.k djsaxsA ¼[k½ lHkh ekStwnk fuekZrkvks a dks mi;qZDr dfFkr vuqlwfpr fofufefZr;kas ds vf/kdre [knq jk dher mi;qZDr lkj.kh d s LraHk ¼5½ eas fofufnZ"V vf/kdre dher LFkkuh; dj lfgr ls de gS rk]s tgk a dgh Hkh ykxw gks] vkS"k/k ¼eYw ; fu;a=.k½ vkns'k] 2013 d s iSjkxzkQ 13¼2½ d s vuqlkj mldks ekStnw k vf/kdre [kqnjk dher dks cuk, j[kuk gksxkA ¼x½ vxj fuekZrkvks a us mi;qZDr lkj.kh d s LraHk ¼5½ eas of.kZr vf/kdre dher ij ljdkj dks okLro eas Hkqxrku fd;k gS ;k ;g ns; gS rk s os LFkkuh; djka s dks tksM+ ldr s gSaA ¼?k½ vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s iSjkxzkQ 11 es a fn, x, izko/kkukas d s rgr lEcfU/kr fuekZrkvks a dks mi;qZDr lkj.kh ds LraHk ¼5½ ea s fofufnZ"V vf/kdre dher ds vk/kkj ij vuqlwfpr fofufeZfr;kas d s iSdks a ds fy, vf/kdre dher fu/kkfZjr djsAa fuekZrk vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s iSjkxzkQ 24 d s rgr QkWe&Z V eas vf/klwpuk dh rkjh[k ls vkbiZ hMh,e,l d s ek/;e ls Hkjdj ,uihih, dks ,d eYw ; lwph tkjh djsAa rFkk mldh dkWih jkT; vkS”kf/k fu;a=dks a vkSj fofuekZrk forjd dks tkjh djsAa ¼M+½ vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s 24 ¼4½ d s mica/kka s d s vuqlkj izR;sd QVq dj fodszrk vkSj forjd fofuekZrk }kjk fn, x, :i es a ,sl s ifjlj] tgka dkjksckj dks bl izdkj fd;k tk jgk gS fd mlls ijke’k Z d s bPNqd fdlh O;fDr d s fy, igqap vklku gks] ogk a mld s fdlh lgtn’` ; Hkkx ij dher lwph vkSj iwjd lwph] ;fn dksb Z gks] dks lainz f’krZ djsxkA ¼p½ mi;qZDr lkj.kh ds LraHk ¼5½ eas fofufn"ZV vf/kdre dher ds fy, fofufn"ZV vuqlwfpr fofufeZfr;kas ds fofufn"ZV fofHkUu rjhds vkSj izcyrk ls fHkUu vxj ekStwnk fuekZrkvks a }kjk ,d ubZ vkS"kf/k dks ykap djrk gS rk s mls igy s vkS"k/k ¼eYw ; fu;a=k.k½ vkns'k] 2013 d s iSjkxzkQ 2¼;w½ d s vuqlkj vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 ds rgr lpw h II eas fofufn"ZV QkeZ I ds ek/;e ls ,uihih, es a ewY; fu/kkjZ .k gsrq vkons u djuk gksxkA ¼N½ mi;qZDr vuqlwfpr fofufeZfr;kas dh mRiknu@vk;kr vkSj fcØh d s lEcU/k eas fuekZrkvks a dks vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s lwph II ds QkWe Z III dks vkbiZ hMh,e,l d s ek/;e ls Hkjdj ,uihih, dks gj frekgh dh fjikVs Z izLrqr djsxkA mi;qZDr vuqlwfpr fofufeZfr;kas d s fuekZ.k dks dkbs Z fuekZrk mRiknu cUn djus dk bPNqd gks rk s bldh lwpuk ,uihih, dks voxr djk;xs kA bld s lEcU/k es a vxj vuqlwfpr fofufeZfr;kas ds mRiknu vkSj vk;kr dk s cUn djus dk bPNqd gS rk s cUn djus dh frfFk ls N% eghu s igy s lwph II d s QkWeZ IV eas Hkjdj ,uihih, dk s izLrqr djsxkA ¼Tk½ fofuekZrk ;k foi.ku dEiuh] mijkDs r dfFkr lkj.kh es a n'kkZ;s vf/kdre eYw ; vkSj 'krks± dk ikyu ugh a djrh gSa rk s os vko';d oLrq,¡ vf/kfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izko/kkuks a d s v/khu C;kt lfgr vf/kizHkkfjr jkf'k dks tek djus d s fy, nk;h gksaxsA ¼>½ bl vkn's k eas mijkDs r lkj.kh d s LraHk ¼2½ esa dh rRLFkkuh izfof"V eas fofufnZ"V ,slh fofufeZfr;kas d s iSdks a dh vf/kdre dher fu;r gksus d s ifj.kkeLo#i] vf/kdre ;k [knq jk eYw ; fu/kkfZjr vkn's k ;fn dksb Z gks] tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh vf/kØe.k gks tk;asxsA [dka-la-@176@44@2017@,Q@Qk- la- 8¼44½@2017@Mhih@,uihih,&fMoh&II] cythr flag] lgk;d funs'kd MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (NATIONAL PHARMACEUTICAL PRICING AUTHORITY) ORDER New Delhi, the 27th April, 2017 S.O. 1333(E).—In exercise of the powers conferred by paragraphs 4, 6, 10, 11, 14, 16, 17 and 18 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 prices as specified in column (5) of the table herein below as ceiling price exclusive of local tax applicable, if any, in respect of the Scheduled formulations specified in the corresponding entry in column (2) of the said Table with the dosage form & strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof: TABLE Sl. No. Name of the Scheduled FormulationD osage form & Strength Unit Ceiling Price (Rs.) (1) (2) (3) (4) (5) 1. Vancomycin Powder for Injection 250mg Each Pack 201.20II (ii) 3 2. Etoposide Capsule 50mg 1 Capsule 51.44 3 Noradrenaline Injection 2mg/ml 1ML 24.38 4. Budesonide Nasal Spray 100mcg/dose 1 Dose 0.85 5. Budesonide Nasal Spray 50mcg/dose 1 Dose 0.96 6. 5-aminosalicylic Acid Suppository 500mg 1 Suppository 15.99 Retention Enema 7. Isosorbide-5-mononitrate SR Capsule 60mg 1 Capsule 3.29 8. Isosorbide-5-mononitrate SR Capsule 30mg 1 Capsule 3.32 Note : (a) All manufacturers of scheduled formulations, selling the branded or generic or both the versions of scheduled formulations at a price higher than the ceiling price (plus local taxes as applicable) so fixed and notified by the Government, shall revise the prices of all such formulations downward not exceeding the ceiling price specified in column (5) in the above table plus local taxes as applicable, if any. (b) All the existing manufacturers of above mentioned scheduled formulations having MRP lower than the ceiling price specified in column (5) in the above table plus local taxes as applicable, if any, shall continue to maintain the existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013. (c) The manufacturers may add local taxes only if they have paid actually or if it is payable to the Government on the ceiling price mentioned in column (5) of the above said table. (d) The ceiling price for a pack of the scheduled formulation shall be arrived at by the concerned manufacturer in accordance with the ceiling price specified in column (5) of the above table as per provisions contained in paragraph 11 of the Drugs (Prices Control) Order, 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. (e) 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. (f) Where an existing manufacturer of scheduled formulation with dosage or strength or both as specified in the above table launches a new drug as per paragraph 2 (u) of the DPCO, 2013 such existing manufacturer shall apply for prior price approval of such new drug to the NPPA in Form I as specified under Schedule-II of the DPCO, 2013. (g) The manufacturers of above said scheduled formulations shall furnish quarterly return to the NPPA, in respect of production / import and sale of scheduled formulations in Form-III of Schedule-II of the DPCO, 2013 through IPDMS. Any manufacturer intending to discontinue production of above said scheduled formulation shall furnish information to the NPPA, in respect of discontinuation of production and / or import of scheduled formulation in Form-IV of Schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation. (h) The manufacturers not complying with the ceiling price and notes specified hereinabove shall be liable to deposit the overcharged amount along with interest thereon under the provisions of the Drugs (Prices Control) Order, 2013 read with Essential Commodities Act, 1955. (i) 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/176/44/2017/F/F. No. 8(44)/2017/D.P./NPPA-Div.-II] BALJIT SINGH, Assistant Director ubZ fnYyh] 27 vizSy] 2017 Hkkjr ljdkj ds jlk;u vkSj moZjd ea=ky; }kjk tkjh dk- vk- 1394¼v½ rkjh[k 30 ebZ] 2013 vkSj dk- vk- 701¼v½ rkjh[k 10 ekpZ] 2016 ds lkFk ifBr vkS"k/k ¼dher fu;a=.k½ vkns'k] 2013 ds iSjk 4] 6] 10] 11] 14] 16] 17 vkSj 18 }kjk iznRr 'kfDr;ksa dk iz;ksx djrs gq, vkSj Hkkjr ljdkj es a jlk;u ,oa moZjd ea=ky; ¼jk”Vªh; vkS”k/k ewY; fu/kkZj.k izkf/kdj.k½ ds dk- vk- 1040¼v½ fnukad 01 vizSy] 2017 ds vkns'k ds vf/kdze.k es a tgka rd mldk laca/k uhps dh lkj.kh ds fofufeZfr iSd ls gS] mu ckrksa ds flok; vf/kØkUr djrs gq, ftUgas ,sls vf/kØe.k ds iwo Z fd;k x;k gS ;k dju s dk ykis fd;k x;k gS] uhps dh lkj.kh ds LraHk ¼5½ es a fofufnZ”V vf/kdre dher dks mDr lkj.kh ds LraHk ¼3½ vkSj ¼4½ es a Øe’k% rRLFkkuh izfof”V;ksa es a fofufn”V [kqjkd :i ,oa izcyrk vkSj bdkbZ lfgr ml lkj.kh ds LraHk ¼2½ es a dh rRLFkkuh izfof”V es a fofufn”V vulq wfpr fofufefZr;ksa es a ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NksM+dj vf/kdre dher ds :i esa fu;r djrh gS%4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] dz-la- vuqlwfpr fofufeZfr dk uke [kqjkd :i ,oa izcyrk bdkbZ vf/kdre dher ¼#-½ (1) (2) (3) (4) (5) 1. स्नेक वेनोम एन्टीसेरम-सोिूबि/ लिक्विड इंजेक्शन 10 लमलि. 351.44 पोिीविेन्ट पैक 2. हपे ाररन इंजेक्शन 1000 आईयू/लमलि. 1 लमलि. 14.80 3. ललिसराइि ट्राईनाट्रेट इंजेक्शन 5 लमग्रा./लमलि. 1 लमलि. 6.21 4. डाईगोक्सीन इंजेक्शन 0.25 लमग्रा./लमलि. 1 लमलि. 3.16 5. हारमोन ररलिजजग आईयूडी िेवोनोरजेस्प्टरेि की 52 लमग्रा. में 1 आईयूडी 3,509.95 uksV % ¼d½ ljdkj }kjk bl izdkj fu;r dh xbZ vkSj vf/klwfpr dh xbZ vf/kdre dher ¼/ku LFkkuh; dj] tks ykxw gksa½ ls vf/kd dher ij vuqlwfpr fofufeZfr;kas d s czkMa sM ;k tsufsjd ;k nkus ka s :ikarjkas dks csp jgs vuqlwfpr fofufeZfr;kas d s lHkh fofuekZrk] mi;qZDr lkj.kh d s LraHk ¼5½ es a of.kZr vf/kdre dher ¼/ku LFkkuh; dj] tk s ykxw gksa½ ls vf/kd lHkh ,slh fofuferZ ;kas dh dher dk v/kkseq[kh iqujh{k.k djsxa sA ¼[k½ lHkh ekStwnk fuekZrkvks a dks mi;qZDr dfFkr vuqlwfpr fofufefZr;kas ds vf/kdre [knq jk dher mi;qZDr lkj.kh d s LraHk ¼5½ eas fofufnZ"V vf/kdre dher LFkkuh; dj lfgr ls de gS rk]s tgk a dgh Hkh ykxw gks] vkS"k/k ¼eYw ; fu;a=.k½ vkns'k] 2013 d s iSjkxzkQ 13¼2½ d s vuqlkj mldks ekStnw k vf/kdre [kqnjk dher dks cuk, j[kuk gksxkA ¼x½ vxj fuekZrkvks a us mi;qZDr lkj.kh d s LraHk ¼5½ eas of.kZr vf/kdre dher ij ljdkj dks okLro eas Hkqxrku fd;k gS ;k ;g ns; gS rk s os LFkkuh; djka s dks tksM+ ldr s gSaA ¼?k½ vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s iSjkxzkQ 11 es a fn, x, izko/kkukas d s rgr lEcfU/kr fuekZrkvks a dks mi;qZDr lkj.kh ds LraHk ¼5½ ea s fofufnZ"V vf/kdre dher ds vk/kkj ij vuqlwfpr fofufeZfr;kas d s iSdks a ds fy, vf/kdre dher fu/kkfZjr djsAa fuekZrk vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s iSjkxzkQ 24 d s rgr QkWe&Z V eas vf/klwpuk dh rkjh[k ls vkbiZ hMh,e,l d s ek/;e ls Hkjdj ,uihih, dks ,d eYw ; lwph tkjh djsAa rFkk mldh dkWih jkT; vkS”kf/k fu;a=dks a vkSj fofuekZrk forjd dks tkjh djsAa ¼M+½ vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s 24 ¼4½ d s mica/kka s d s vuqlkj izR;sd QVq dj fodszrk vkSj forjd fofuekZrk }kjk fn, x, :i es a ,sl s ifjlj] tgka dkjksckj dks bl izdkj fd;k tk jgk gS fd mlls ijke’k Z d s bPNqd fdlh O;fDr d s fy, igqap vklku gks] ogk a mld s fdlh lgtn`’; Hkkx ij dher lwph vkSj iwjd lwph] ;fn dksb Z gks] dks lainz f’krZ djsxkA ¼p½ mi;qZDr lkj.kh ds LraHk ¼5½ eas fofufn"ZV vf/kdre dher ds fy, fofufn"ZV vuqlwfpr fofufeZfr;kas ds fofufn"ZV fofHkUu rjhds vkSj izcyrk ls fHkUu vxj ekStwnk fuekZrkvks a }kjk ,d ubZ vkS"kf/k dks ykap djrk gS rk s mls igy s vkS"k/k ¼eYw ; fu;a=k.k½ vkns'k] 2013 d s iSjkxzkQ 2¼;w½ d s vuqlkj vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 ds rgr lpw h II eas fofufn"ZV QkeZ I ds ek/;e ls ,uihih, es a ewY; fu/kkjZ .k gsrq vkons u djuk gksxkA ¼N½ mi;qZDr vuqlwfpr fofufeZfr;kas dh mRiknu@vk;kr vkSj fcØh d s lEcU/k eas fuekZrkvks a dks vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s lwph II ds QkWe Z III dks vkbiZ hMh,e,l ds ek/;e ls Hkjdj ,uihih, dks gj frekgh dh fjikVs Z izLrqr djsxkA mi;qZDr vuqlwfpr fofufeZfr;kas d s fuekZ.k dk s dksbZ fuekZrk mRiknu cUn djus dk bPNqd gks rk s bldh lwpuk ,uihih, dks voxr djk;xs kA bld s lEcU/k es a vxj vuqlwfpr fofufeZfr;kas ds mRiknu vkSj vk;kr dk s cUn djus dk bPNqd gS rk s cUn djus dh frfFk ls N% eghu s igy s lwph II d s QkWeZ IV eas Hkjdj ,uihih, dk s izLrqr djsxkA ¼Tk½ fofuekZrk ;k foi.ku dEiuh] mijkDs r dfFkr lkj.kh es a n'kkZ;s vf/kdre eYw ; vkSj 'krks± dk ikyu ugh a djrh gSa rk s os vko';d oLrq,¡ vf/kfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izko/kkuks a d s v/khu C;kt lfgr vf/kizHkkfjr jkf'k dk s tek djus d s fy, nk;h gksaxsA ¼>½ bl vkn's k eas mijkDs r lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V eas fofufnZ"V ,slh fofufeZfr;kas d s iSdks a dh vf/kdre dher fu;r gksus d s ifj.kkeLo#i] vf/kdre ;k [knq jk eYw ; fu/kkfZjr vkn's k ;fn dksb Z gks] tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh vf/kØe.k gks tk;asxsA [dka-la-@176@44@2017@,Q@Qk- la- 8¼44½@2017@Mhih@,uihih,&fMoh-II ] cythr flag] lgk;d funs'kd ORDER New Delhi, the 27th April, 2017 S.O. 1334(E).—In exercise of the powers conferred by paragraphs 4, 6, 10, 11, 14, 16, 17 and 18 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 of the Government of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority)II (ii) 5 No. S.O. 1040(E), dated 1st April, 2017, in so far as it relates to formulation packs mentioned in the table below, except in respect of things done or omitted to be done before such supersession, the National Pharmaceutical Pricing Authority, hereby fixes the price as specified in column (5) of the table herein below as ceiling price exclusive of local tax applicable, if any in respect of the Scheduled formulations specified in the corresponding entry in column (2) of the said Table with the dosage from & strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof: TABLE Sl. No. Name of the Scheduled Dosage form & Strength Unit Ceiling Formulation Price (Rs.) (1) (2) (3) (4) (5) 6. Snake venom antiserum - Injection 10 ML Pack 351.44 Soluble/liquid polyvalent 7. Heparin Injection 1000 IU/ml 1 ML 14.80 8. Glyceryl Trinitrate Injection 5 mg/ml 1 ML 6.21 9. Digoxin Injection 0.25 mg/ml 1 ML 3.16 10. Hormone Releasing IUD Contains 52 mg of Levonorgestrel 1 IUD 3,509.95 Note: (a) All manufacturers of scheduled formulations, selling the branded or generic or both the versions of scheduled formulations at a price higher than the ceiling price (plus local taxes as applicable) so fixed and notified by the Government, shall revise the prices of all such formulations downward not exceeding the ceiling price specified in column (5) in the above table plus local taxes as applicable, if any. (b) All the existing manufacturers of above mentioned scheduled formulations having MRP lower than the ceiling price specified in column (5) in the above table plus local taxes as applicable, if any, shall continue to maintain the existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013. (c) The manufacturers may add local taxes only if they have paid actually or if it is payable to the Government on the ceiling price mentioned in column (5) of the above said table. (d) The ceiling price for a pack of the scheduled formulation shall be arrived at by the concerned manufacturer in accordance with the ceiling price specified in column (5) of the above table as per provisions contained in paragraph 11 of the Drugs (Prices Control) Order, 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. (e) 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. (f) Where an existing manufacturer of scheduled formulation with dosage or strength or both as specified in the above table launches a new drug as per paragraph 2 (u) of the DPCO, 2013 such existing manufacturer shall apply for prior price approval of such new drug to the NPPA in Form I as specified under Schedule-II of the DPCO, 2013. (g) The manufacturers of above said scheduled formulations shall furnish quarterly return to the NPPA, in respect of production / import and sale of scheduled formulations in Form-III of Schedule-II of the DPCO, 2013 through IPDMS. Any manufacturer intending to discontinue production of above said scheduled formulation shall furnish information to the NPPA, in respect of discontinuation of production and / or import of scheduled formulation in Form-IV of Schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation. (h) The manufacturers not complying with the ceiling price and notes specified hereinabove shall be liable to deposit the overcharged amount along with interest thereon under the provisions of the Drugs (Prices Control) Order, 2013 read with Essential Commodities Act, 1955. (i) Consequent to the issue of ceiling prices of such formulations 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/176/44/2017/F/F. No. 8(44)/2017/D.P./NPPA-Div.-II] BALJIT SINGH,Assistant Director6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] vkns’k ubZ fnYyh] 27 vizSy] 2017 dk- vk- 1335 ¼v½- Hkkjr ljdkj d s jlk;u vkSj moZjd e=a ky; }kjk tkjh dk0 vk0 1394¼v½ rkjh[k 30 eb]Z 2013 vkSj dk0 vk0 — 701¼v½ rkjh[k 10 ekpZ] 2016 d s lkFk ifBr vkS"k/k ¼dher fu;a=.k½ vkns'k] 2013 ds iSjk 5, 11 vkSj 15 }kjk iznRr 'kfDr;ks a dk iz;kxs djrs gq,] rFkk Hkkjr ljdkj ds jlk;u vkSj moZjd e=a ky;] jk"Vªh; vkS"k/k eYw ; fu/kkjZ .k izkf/kdj.k ¼ftldk s laf{kIr :i eas ,uihih, dgk tkrk gS½] uhps dh lkj.kh d s LraHk ¼6½ esa fofufn"ZV [knq jk eYw ; dks mDr lkj.kh ds LraHk ¼3½] ¼4½] vkSj ¼5½ esa Øe'k% rRLFkkuh izfof"V;kas esa fofufnZ"V izcyrk] bdkbZ ¼;wfuV½ vkSj fofuekZrk vkSj foi.ku dEifu;kas ds uke lfgr Øe'k% LraHk ¼2½ eas dh rRLFkkuh izfof"V eas ls izR;sd dh] LFkkuh; dj] ;fn dksbZ gS] dks NkMs +dj vf/kdre [knq jk eYw ; d s #i eas fu;r djrh gSA lkj.kh dz-la- vuqlwfpr fofufeZfr dk izcyrk bdkbZ fofuekZrk vkSj foi.ku daiuh [knq jk uke@czkMa dk uke dez ’k% eYw ; ¼#-½ (1) (2) (3) (4) (5) (6) 1- iSjkflVkekys lLVsMa fjfyt izR;sd vfyfir ck;ys;MZ xkys h eas% 1 xkys h eSllZ fyudksu 3-28 1000 fexzk- xkys h iSjkflVkekys 300 fexzk ¼bEehMVs fjfyt eas½ QkekZL;wfVdYl fy- vkSj iSjkflVkekys 700 fexzk ¼llVsUM fjyht eas½ eSllZ dfsMyk gsYFkds;j fy- 2- buMjky 20 fexzk- xkys h izR;sd vfyfir xkys h es:a izkis zkuksykys 1 xkys h eSllZ ,CcksV gSYFkds;j izk- 2-03 ,plh,y 20 fexzk- fy- uksV % ¼d½ mi;qZDr nh xbZ fofufn"V QkWeZwy's ku d s fofuekZrk vFkkZr tks ÞubZ Mªxß Mhihlhvk]s 2013 d s iSjkxzkQ 2¼;½w d s rgr mi;qZDr nh xbZ lkj.kh ds LraHk ¼6½ esa fofufnZ"V [kqnjk eYw ; fu/kkZfjr djsxa sA ¼[k½ vxj fuekZrkvks a us mi;qZDr lkj.kh d s LraHk ¼6½ eas of.kZr vf/kdre dher ij ljdkj dks okLro es a Hkxq rku fd;k gS ;k ;g ns; gS rks os LFkkuh; djka s dks tksM+ ldr s gSaA ¼x½ vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s iSjkxzkQ 11 eas fn, x, izko/kkukas d s rgr fuekZrkvks a dks mi;qZDr lkj.kh d s LraHk ¼6½ eas fofufnZ"V [knq jk eYw ; d s vk/kkj ij vuqlwfpr fofufeZfr;kas d s iSdks a ds fy, [knq jk eYw ; fu/kkfZjr djsAa fuekZrk vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s iSjkxzkQ 24 ds rgr QkWe Z V eas vf/klwpuk dh rkjh[k ls ,d eYw ; lwph ,uihih, dk s vkbZihMh,e,l d s ek/;e ls tkjh djsAa ¼?k½ vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s 24 ¼4½ d s mica/kks a d s vuqlkj izR;sd QVq dj fodszrk vkSj forjd fofuekZrk }kjk fn, x, :i es a ,sls ifjlj] tgka dkjckj dks bl izdkj fd;k tk jgk gS fd mlls ijke’k Z d s bPNqd fdlh O;fDr d s fy, igqap vklku gks] ogka mld s fdlh lgtn`’; Hkkx ij dher lwph vkSj iwjd lwph] ;fn dksb Z gk]s dks lainz f’krZ djsxkA ¼M-½ mi;qZDr xSj vf/kdre dher ¼[knq jk eYw ;½ dos y mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksau s vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s rgr vuqc) eYw ; fu/kkjZ .k@la'kks/ku d s fy, QkWe Z I ij tek fd;k x;k Fkk vkSj ljdkj }kjk fu/kkfZjr lHkh ykxw oS/kkfud vko';drkvks a dh iwfrZ d s v/khu izklafxd fof/k;kas@fu;eka s d s vUrxZr tSlk fd dsUnzh;@jkT; ykblsflax vkWFkksfjVh d s l{ke izkf/kdkjh }kjk eUs;wQsDpfjax ykblasl eta jw h ds rgr lacfa/kr fofuferZ fuekZrk@foi.ku dEifu;k a tks vuqikyu djrh gSA ¼p½ mi;qZDr fofufeZfr;kas dh mRiknu@vk;kr vkSj fcØh d s lEcU/k eas lEcfU/kr fuekZrkvks a dks vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s lwph II ds QkWe Z III dks vkbiZ hMh,e,l ds ek/;e ls Hkjdj ,uihih, dks gj frekgh dh fjikVs Z izLrqr djsxkA mi;qZDr fofufeZfr;kas ds fuekZ.k dks dksbZ fuekZrk mRiknu cUn djus dk bPNqd gks rks bldh lwpuk ,uihih, dks voxr djk;xs kA bld s lEcU/k eas vxj fofufefZr;kas ds mRiknu vkSj vk;kr dks cUn djus dk bPNqd gS rk s cUn djus dh frfFk ls N% eghu s igy s lwph II ds QkWe Z IV esa Hkjdj ,uihih, dk s izLrqr djsxkA ¼N½ fofuekZrk ;k foi.ku dEiuh] mijkDs r fofufeZfr;kas vkSj fofufn"ZV 'krks± dk ikyu ugh a djrh gSa rk s os vko';d oLrq,¡ vf/kfu;e] 1955 d s lkFk ifBr Mhihlhvks] 2013 d s izko/kkuksa d s v/khu C;kt lfgr vf/kizHkkfjr jkf'k dk s tek djus ds fy, nk;h gksaxsA ¼t½ bl vkn's k eas mijkDs r lkj.kh ds LraHk ¼2½ eas dh rRLFkkuh izfof"V es a fofufn"ZV fofufeZfr;kas ds iSdks a dh [kqnjk eYw ; fu;r gksus d s ifj.kkeLo#i ,sl s vkn's k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gk s tk;sxa sA [dka-la-@176@44@2017@,Q@Qk- la0 8¼44½@2017@Mhih@,uihih,&fMoh&II] cythr flag] lgk;d funs'kdII (ii) 7 ORDER New Delhi, the 27th April, 2017 S.O. 1335(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 local taxes, 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 respectively, as specified in the corresponding entries in columns (3), (4) and (5) thereof; TABLE Sl. Name of the Strength Unit Manufacturer & Marketing Retail No. Scheduled Company respectively Price Formulation / Brand (Rs.) Name (1) (2) (3) (4) (5) (6) 1. Paracetamol sustained Each uncoated bilayered 1 Tablet M/s Lincoln Pharmaceuticals 3.28 release 1000mg tablet tablet contains: Ltd./ M/s Cadila Healthcare Paracetamol 300mg (as Ltd. immediate release) Paracetamol 700mg (as sustained release) 2. Inderal 20mg tablet Each uncoated tablet 1 Tablet M/s Abbott Healthcare Pvt. 2.03 contains: Ltd. Propranolol HCL 20mg Note: (a) The manufacturers 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 manufacturers may add local taxes 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 manufacturers 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 manufacturers 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 manufacturers/marketeers 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 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) The concerned manufacturers of above said formulations shall furnish quarterly return to the NPPA, in respect of production / import and sale of product in Form-III of Schedule-II of the DPCO, 2013 through IPDMS. Manufacturers, in case intending to discontinue above said formulations, shall furnish information to the NPPA, in respect of discontinuation of the production and/or import of above said formulation in Form-IV of Schedule- II of the DPCO, 2013 at least six months prior to the intended date of discontinuation.8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] (g) 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. (h) Consequent to the issue of retail price of the aforesaid formulations as specified in column (2) of the above mentioned table in this notification, the price order(s) if any, issued for concerned manufacturer / marketer prior to the above said date of notification, stand(s) superseded. [PN/176/44/2017/F/F. No. 8(44)/2017/D.P./NPPA-Div.-II ] BALJIT SINGH, 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.

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