Home India Ministry of Chemicals and Fertilizers In exercise of the powers conferred by paragraphs 5 11 and 1...
Date: 2019-12-18 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 2013 read with S O 1394 E

Issued by Ministry of Chemicals and Fertilizers · Department of Pharmaceuticals

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Executive Summary & Key Takeaways

Executive Summary: This document comprises three orders from the National Pharmaceutical Pricing Authority (NPPA), regarding the price fixation and revision of various pharmaceutical products and devices. It specifies retail prices for certain formulations, implements directions from the Department of Pharmaceuticals, and addresses pricing of inhaler devices with digital dose counters. It also includes a corrigendum to a previous notification. Key Points / Main Content: Order 1: S.O. 4535(E) * Price Fixation: Specifies retail prices for 44 formulations, exclusive of GST, as detailed in the table provided. * New Drug Definition: Manufacturers of new drugs under DPCO 2013, paragraph 2u, must adhere to the retail prices listed. * GST Addition: Manufacturers may add GST if actually paid or payable to the government. * Retail Price for Packs: Retail price for packs shall be determined based on the specified retail price as per DPCO 2013, paragraph 11. * Price List Issuance: Manufacturers must issue a price list in Form V to NPPA via IPDMS and provide copies to State Drug Controllers and dealers, as per DPCO 2013, paragraph 24. * Display of Price List: Retailers and dealers must display price lists as per DPCO 2013, paragraph 24(4). * Applicability: Retail prices apply only to manufacturers who applied for price fixation/revision via Form I under DPCO 2013. * Compliance: Non-compliance results in liability to deposit overcharged amounts with interest under DPCO 2013 and the Essential Commodities Act, 1955. * Supersession: Previous price orders for formulations in the notification are superseded. Order 2: S.O. 4536(E) * Price Fixation and Supersession: Fixes retail prices for Emtricitabine Tenofovir tablets, exclusive of GST, superseding previous orders, except for actions already taken. * Implementation of Directions: Implements directions per review orders issued by the Department of Pharmaceuticals under DPCO 2013, paragraph 31. * New Drug Definition: Manufacturers of new drugs under DPCO 2013, paragraph 2u, must adhere to the retail prices listed. * GST Addition: Manufacturers may add GST if actually paid or payable. * Retail Price for Packs: Retail price for packs shall be determined based on the specified retail price as per DPCO 2013, paragraph 11. * Price List Issuance: Manufacturers must issue a price list in Form V to NPPA via IPDMS and provide copies to State Drug Controllers and dealers, as per DPCO 2013, paragraph 24. * Display of Price List: Retailers and dealers must display price lists as per DPCO 2013, paragraph 24(4). * Applicability: Retail prices apply only to the listed manufacturers and similar generic formulations. * Compliance: Non-compliance results in liability to deposit overcharged amounts with interest under DPCO 2013 and the Essential Commodities Act, 1955. Order 3: S.O. 4537(E) - Corrigendum * Correction to S.O. 4062(E): Modifies the retail price for Vildagliptin Metformin tablets in the original notification dated November 8, 2019. * Revised Price: Changes the retail price for Vildagliptin Metformin from Rs. 19.54 to Rs. 19.64. * Notes and Contents: All other notes and content from the original order remain the same. Order 4: S.O. 4538(E) * Price Fixation for Synchrobreathe Inhaler Device: Fixes the price for Ms Cipla Ltd's Synchrobreathe Inhaler Device at Rs. 67.20 per unit, excluding GST. * Applicability: The set price is applicable to Synchrobreathe inhalers of specified strengths manufactured by Ms Cipla Ltd. * GST Addition: Ms Cipla Ltd. may add GST if actually paid or payable. * Fixed Price: The price of the Synchrobreathe Inhaler Device will remain fixed regardless of future changes in the ceiling price of the formulation. * Price List Issuance: Ms Cipla Ltd shall issue a price list in FormV. * Reporting Requirement: Ms Cipla Ltd must furnish quarterly returns regarding production, import, and sale. * Compliance: Non-compliance results in liability to deposit overcharged amounts with interest under DPCO 2013. Order 5: S.O. 4539(E) * Price Fixation for Digihaler Dose Counter: The price for Glenmark Pharmaceutical's Digihaler digital dose counter at Rs. 44.70 per unit, excluding GST. * Applicability: The set price is applicable to Digihaler digital dose counters of specified strengths manufactured by Glenmark Pharmaceuticals Ltd. * GST Addition: Glenmark Pharmaceuticals Ltd. may add GST if actually paid or payable. * Fixed Price: The price of the Digihaler digital dose counter will remain fixed regardless of future changes in the ceiling price of the formulation. * Price List Issuance: Glenmark Pharmaceuticals Ltd shall issue a price list in FormV. * Reporting Requirement: Glenmark Pharmaceuticals Ltd must furnish quarterly returns regarding production, import, and sale. * Compliance: Non-compliance results in liability to deposit overcharged amounts with interest under DPCO 2013. Impact Analysis: Manufacturers: Impact: Required to adhere to the fixed retail prices, issue price lists, and comply with reporting requirements. Action Required: Adjust pricing, ensure compliance with DPCO 2013, submit necessary forms and reports to NPPA, and inform NPPA of production discontinuation plans if applicable. Retailers and Dealers: Impact: Required to display updated price lists conspicuously. Action Required: Update and display price lists and supplementary lists as provided by manufacturers. National Pharmaceutical Pricing Authority (NPPA): Impact: Responsible for overseeing compliance and enforcing the orders. Action Required: Monitor price adherence, review submitted reports, and take action against non-compliant manufacturers. Consumers: Impact: Benefit from regulated prices of essential medicines and devices. Action Required: Be aware of the regulated prices to ensure fair transactions.

Key Entities Referenced

National Pharmaceutical Pricing Authority (NPPA): A regulatory body in India responsible for fixing and revising prices of pharmaceutical products, established in 1997. 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. Drugs Prices Control Order, 2013: An order issued by the Government of India to regulate the prices of essential drugs. Essential Commodities Act, 1955: An act of the Parliament of India that seeks to regulate the production, supply, and distribution of essential commodities. Cipla Limited: An Indian multinational pharmaceutical company. Glenmark Pharmaceuticals Ltd: An Indian multinational pharmaceutical company. Akums Drugs Pharmaceuticals Ltd: An Indian pharmaceutical company involved in manufacturing and marketing of pharmaceutical products New Delhi, Delhi: The capital of India, where the orders and notifications related to pharmaceutical pricing are issued.
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Xyheis hjkbM $ iRz;ds vfyfir ckbyZ ;s MZ xkys h e%sa 1 xkys h 9.35 eVs QkfseuZ xkys h Xyheis hjkbM 4 fexzk-] elS lZ ,lVsa Qkek Z @elS l Z (XyhfeiDzs l ,e,Q eVs QkfseuZ gkbMªkDs yksjkbM 1000 fexzk- ¼izkys kWxM ,fjLVk s QkekZL;fwVdYl izk- QkVs sZ 4 ,Ma M;kfsiy 4 fjfyt QkWe Z e½sa fy- QkVs )sZ 41. Xyheis hjkbM $ iRz;ds vfyfir ckbyZ ;s MZ xkys h e%sa 1 xkys h 7.85 elS lZ ekbØks ycS l fy- eVs QkfseuZ xkys h Xyheis hjkbM vkbiZ h 3 fexzk-]4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] eVs QkfseuZ gkbMªDyksjkbM vkbiZ h 500 fexzk- ¼izkys kWxM fjfyt QkWe Z e½sa 42. Xyheis hjkbM $ iRz;ds vfyfir ckbyZ ;s MZ xkys h e%sa 1 xkys h 9.18 eVs QkfseuZ xkys h Xyheis hjkbM vkbiZ h 4 fexzk-] elS lZ ekbØks ycS l fy- eVs QkfseuZ gkbMªDyksjkbM vkbiZ h 500 fexzk- ¼lLVMsa fjfyt QkWe Z e½sa 43. flYuhMhikbu $ iRz;ds fyfir ckbyZ ;s MZ xkys h e%sa 1 xkys h 7.10 eVs kis zksykys lDlhuVs flYuhMhikbu vkbiZ h 10 fexzk-] xkys h eVs kis zksykys lDlhuVs vkbiZ h 23-75 fexzk d s cjkcj elS lZ ekbØks ycS l fy- eVs kis zksykys VkjVªVs 25 fexzk- ¼,DlVfsMM fjfyt½ 44. blflVkykis zke $ iRz;ds fQYe fyfir xkys h e%sa 1 xkys h 8.40 Dykus tke xkys h blflVkykis zke vkWDlkyVs vkbiZ h d s cjkcj elS lZ bjht ykbQlkbla ht blflVkykis zke 10 fexzk-] fy- Dykus tke vkbiZ h 0-25 fexzk- uksV % ¼d½ mi;qZDr nh xbZ fofufnZ"V QkWewZy's ku d s fofuekZrk vFkkZr tk s ÞubZ Mªxß Mhihlhvk]s 2013 d s iSjkxzkQ 2¼;½w d s rgr mi;qZDr nh xbZ lkj.kh d s LrHa k ¼6½ e sa fofufnZ"V [kqnjk eYw ; fu/kkZfjr djxsa As ¼[k½ vxj fuekZrkvk sa u s mi;qZDr lkj.kh d s LrHa k (6) e sa of.kZr vf/kdre dher ij ljdkj dk s okLro e sa Hkqxrku fd;k gS ;k ;g n;s gS rk s o s oLrq ,o a lsok dj dk s tkMs + ldr s gASa ¼x½ vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s iSjkxzkQ 11 e sa fn, x, izko/kkuk sa d s rgr fuekZrkvk sa dk s mi;qZDr lkj.kh d s LrHa k ¼6½ e sa fofufnZ"V [kqnjk eYw ; d s vk/kkj ij vuqlfwpr fofufeZfr;k sa d s iSdk sa d s fy, [kqnjk eYw ; fu/kkZfjr djAsa fuekZrk vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s iSjkxzkQ 24 d s rgr QkWeZ V e sa vf/klpw uk dh rkjh[k l s ,d eYw ; lpw h ,uihih, dk s vkbZihMh,e,l d s ek/;e l s tkjh dj sa rFkk mldh dkiWh jkT; vkS"kf/k fu;a=dk sa vkSj fofuekZr िवतरक(cid:6) को जारी कर(cid:12)A ¼?k½vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s 24 (4) d s mic/a kk sa d s vuqlkj izR;ds QqVdj fodzsrk vkSj forjd fofuekZrk }kjk fn, x, :i e sa ,sl s ifjlj] tgk a dkjckj dk s bl izdkj fd;k tk jgk gS fd mll s ijke'kZ d s bPNqd fdlh O;fDr d s fy, igpqa vklku gk]s ogk a mld s fdlh lgtn`’; Hkkx ij dher lpw h vkSj iwjd lpw h] ;fn dkbs Z gk]s dk s lia zn(cid:13)शत djxs kA ¼M-½ mi;qZDr xSj vf/kdre dher ¼[kqnjk eYw ;½ dsoy mi;qZDr fuekZrk@foi.ku d s fy, ykx w gS tSlk fd mUgkusa s vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s rgr vuqc) eYw ; fu/kkZj.k@l'a kk/s ku d s fy, QkWeZ I ij tek fd;k x;k Fkk vkSj ljdkj }kjk fu/kkfZjr lHkh ykx w oS/kkfud vko';drkvk sa dh ifwrZ d s v/khu izklfaxd fof/k;k@sa fu;ek sa d s vUrxZr tSlk fd dUs nzh;@jkT; ykblfslxa vkWFkkfsjVh d s l{ke izkf/kdkjh }kjk eUs ;Qw Ds pfjxa ykblsal eta wjh d s rgr lca fa/kr fofufeZr fuekZrk@foi.ku dEifu;k a tk s vuiq kyu djrh gAS ¼p½ fofuekZrk ;k foi.ku dEiuh] mijkDs r fofufeZfr;k as vkSj fofufnZ"V 'krks± dk ikyu ugh a djrh g Sa rk s o s vko';d oLr,q ¡ vf/kfu;e] 1955 d s lkFk ifBr Mhihlhvk]s 2013 d s izko/kkuk sa d s v/khu C;kt lfgr vf/kizHkkfjr jkf'k dk s tek dju s d s fy, nk;h gkxsa As ¼N½ bl vkn's k e sa mijkDs r lkj.kh d s LrHa k ¼2½ e sa dh rRLFkkuh izfof"V e sa fofufnZ"V fofufeZfr;k sa d s iSdk sa dh [kqnjk eYw ; fu;r gkus s d s ifj.kkeLo#i] vkn's k tk s fd bl vkn's k l s iwoZ tkjh g,q gS] Lor% gh fujLr gk s tk;xsa sA [dk-a l-a@203@71@2019@,Q@Qk- l-a 8¼71½@2019@Mhih@,uihih,&fMoh-II] izlus thr nkl] lgk;d fun's kd MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (National Pharmaceutical Pricing Authority) ORDER New Delhi, the18th December, 2019 S.O. 4535(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 in¹Hkkx IIµ[k.M 3(ii)] Hkkjr dk jkti=k % vlk/kj.k 5 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. Propranolol Each uncoated Bilayered Tablet contains: 5.28 Hydrochloride + Propranolol Hydrochloride IP 40mg (as M/s Akums Drugs & Flunarizine Tablet Sustained Release), 1 Tablet Pharmaceuticals Ltd. / Flunarizine Dihydrochloride eq. to M/s Cipla Limited Flunarizine 5mg 2. Propranolol Each uncoated Bilayered Tablet contains: 7.76 Hydrochloride + Propranolol Hydrochloride IP 40mg (as M/s Akums Drugs & Flunarizine Tablet Sustained Release), 1 Tablet Pharmaceuticals Ltd. / Flunarizine Dihydrochloride eq. to M/s Cipla Limited Flunarizine 10mg 3. Ibuprofen + Each 5ml suspension contains: M/s Shiva Biogenetic 0.35 Paracetamol Ibuprofen IP 100mg 1 ML Pharmaceuticals Pvt. Suspension Paracetamol IP 162.5mg Ltd. / M/s Sun Pharmaceutical Industries Limited 4. Atorvastatin + Each Hard Gelatin Capsule contains: M/s Synokem 14.62 Clopidogrel Atorvastatin Calcium IP Eq. to 1 Capsule Pharmaceuticals Capsule (Mactor Atorvastatin 20mg (As Pellets), Limited / M/s CV 20) Clopidogrel Bisulphate IP eq. to Macleods Clopidogrel 75mg (As Pellets) Pharmaceuticals Limited 5. Paracetamol + Each film coated tablet contains: M/s Synokem 14.00 Thiocolchicoside Paracetamol IP 325mg 1 Tablet Pharmaceuticals Ltd. / Tablet Thiocolchicoside IP 4mg M/s Apex Laboratories Pvt. Ltd. 6. Metformin + Each uncoated bilayered tablet contains: M/s Skymap 6.75 Glimepiride Metformin Hydrochloride IP 1000mg, 1 Tablet Pharmaceuticals Pvt. Tablet Glimepiride IP 1mg Tablet Ltd. 7. Metformin + Each uncoated bilayered tablet contains: M/s Skymap 9.84 Glimepiride Metformin Hydrochloride IP 1000mg, 1 Tablet Pharmaceuticals Pvt. Tablet Glimepiride IP 2mg Tablet Ltd. 8. Etoricoxib + Each film coated tablet contains: M/s Synokem 6.01 Paracetamol Etoricoxib IP 60mg, 1 Tablet Pharmaceuticals Ltd. / Tablet Paracetamol IP 325mg M/s Lupin Limited 9. Cefixime + Each 5ml of reconstituted suspension 2.39 Potassium contains: M/s Brooks Clavulanate Cefixime IP (As Trihydrate) eq. to Laboratories Ltd. / M/s 1 ML suspension Anhydrous Cefixime 50mg, Intas Pharmaceuticals Potassium Clavulanate Diluted IP eq. to Limited Clavulanic Acid 31.25mg 10. Vildagliptin + Each film coated tablet contains: 1 Tablet M/s Cadila 22.77 Metformin Tablet Vildagliptin 50mg, Pharmaceuticals Metformin Hydrochloride 500mg Limited 11. Vildagliptin + Each film coated tablet contains: 1 Tablet M/s Intas 22.77 Metformin Tablet Vildagliptin 50mg, Pharmaceuticals Metformin Hydrochloride 500mg Limited 12. Vildagliptin + Each film coated tablet contains: 1 Tablet M/s Exemed 22.77 Metformin Tablet Vildagliptin 50mg, Pharmaceuticals / M/s (Vildaphage M) Metformin Hydrochloride 500mg Franco-Indian Pharmaceuticals Pvt. Ltd.6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 13. Vildagliptin + Each film coated tablet contains: 1 Tablet M/s Eris Lifesciences 22.77 Metformin Tablet Vildagliptin 50mg, Limited Metformin Hydrochloride 500mg 14. Vildagliptin + Each film coated tablet contains: 1 Tablet M/s Optimus Pharma 22.77 Metformin Tablet Vildagliptin 50mg, Pvt. Ltd. / M/s Lupin Metformin Hydrochloride 500mg Limited 15. Vildagliptin + Each film coated tablet contains: M/s Emcure 22.77 Metformin Tablet Vildagliptin 50mg, Pharmaceuticals 1 Tablet Metformin Hydrochloride 500mg Limited /M/s Zuventus Healthcare Limited 16. Vildagliptin + Each film coated tablet contains: M/s Optimus Pharma 22.77 Metformin Tablet Vildagliptin 50mg, Pvt. Ltd. / M/s Aristo 1 Tablet (Vildagard M Metformin Hydrochloride 500mg Pharmaceuticals Pvt. 500) Ltd. 17. Vildagliptin + Each film coated tablet contains: M/s Synokem 22.77 Metformin Tablet Vildagliptin 50mg, Pharmaceuticals Metformin Hydrochloride 500mg 1 Tablet Limited / M/s Alembic Pharmaceuticals Limited 18. Vildagliptin + Each film coated Tablet contains: 1 Tablet M/s Cadila 22.75 Metformin Tablet Vildagliptin 50mg, Pharmaceuticals Metformin Hydrochloride 850mg Limited 19. Vildagliptin + Each film coated Tablet contains: 1 Tablet M/s Intas 22.75 Metformin Tablet Vildagliptin 50mg, Pharmaceuticals Metformin Hydrochloride 850mg Limited 20. Vildagliptin + Each film coated tablet contains: 1 Tablet M/s Eris Lifesciences 22.75 Metformin Tablet Vildagliptin 50mg, Limited Metformin Hydrochloride 850mg 21. Vildagliptin + Each film coated tablet contains: 1 Tablet M/s Optimus Pharma 22.72 Metformin Tablet Vildagliptin 50mg, Pvt. Ltd. / M/s Lupin Metformin Hydrochloride 850mg Limited 22. Vildagliptin + Each film coated tablet contains: M/s Emcure 22.72 Metformin Tablet Vildagliptin 50mg, Pharmaceuticals 1 Tablet Metformin Hydrochloride 850mg Limited /M/s Zuventus Healthcare Limited 23. Vildagliptin + Each film coated tablet contains: M/s Synokem 22.72 Metformin Tablet Vildagliptin 50mg, Pharmaceuticals Metformin Hydrochloride 850mg 1 Tablet Limited / M/s Alembic Pharmaceuticals Limited 24. Vildagliptin + Each film coated tablet contains: M/s Optimus Pharma 22.72 Metformin Tablet Vildagliptin 50mg, Pvt. Ltd. / M/s Aristo 1 Tablet (Vildagard M Metformin Hydrochloride 850mg Pharmaceuticals Pvt. 850) Ltd. 25. Vildagliptin + Each film coated Tablet contains: 1 Tablet M/s Cadila 23.40 Metformin Tablet Vildagliptin 50mg, Pharmaceuticals Metformin Hydrochloride 1000mg Limited 26. Vildagliptin + Each film coated Tablet contains: 1 Tablet M/s Intas 23.40 Metformin Tablet Vildagliptin 50mg, Pharmaceuticals Metformin Hydrochloride 1000mg Limited 27. Vildagliptin + Each film coated Tablet contains: 1 Tablet M/s Exemed 23.40 Metformin Tablet Vildagliptin 50mg, Pharmaceuticals / M/s (Vildaphage M Metformin Hydrochloride 1000mg Franco-Indian Forte) Pharmaceuticals Pvt. Ltd. 28. Vildagliptin + Each film coated tablet contains: 1 Tablet M/s Eris Lifesciences 23.40 Metformin Tablet Vildagliptin 50mg, Limited Metformin Hydrochloride 1000mg 29. Vildagliptin + Each film coated tablet contains: 1 Tablet M/s Optimus Pharma 23.40 Metformin Tablet Vildagliptin 50mg, Pvt. Ltd. / M/s Lupin Metformin Hydrochloride 1000mg Limited¹Hkkx IIµ[k.M 3(ii)] Hkkjr dk jkti=k % vlk/kj.k 7 30. Vildagliptin + Each film coated tablet contains: M/s Emcure 23.40 Metformin Tablet Vildagliptin 50mg, Pharmaceuticals 1 Tablet Metformin Hydrochloride 1000mg Limited /M/s Zuventus Healthcare Limited 31. Vildagliptin + Each film coated tablet contains: M/s Optimus Pharma 23.40 Metformin Tablet Vildagliptin 50mg, Pvt. Ltd. / M/s Aristo 1 Tablet (Vildagard M Metformin Hydrochloride 1000mg Pharmaceuticals Pvt. 1000) Ltd. 32. Vildagliptin + Each film coated tablet contains: M/s Synokem 23.40 Metformin Tablet Vildagliptin 50mg, Pharmaceuticals Metformin Hydrochloride 1000mg 1 Tablet Limited / M/s Alembic Pharmaceuticals Limited 33. Pantoprazole + Each enteric coated tablet contains: 1 Tablet M/s Akums Drugs & 5.61 Domperidone Pantoprazole Sodium IP eq. to Pharmaceuticals Ltd. / Tablet Pantoprazole 40mg, M/s Emcure Domperidone IP 10mg Pharmaceuticals Ltd. 34. Telmisartan + Each uncoated bilayered tablet contains: 1 Tablet M/s WindlasBiotech 8.20 Chlorthalidone Telmisartan IP 40mg, Limited / M/s Indoco Tablet Chlorthalidone IP 12.5mg, Remedies Limited 35. Teneligliptin + Each uncoated bi-layered Tablet 10.24 Metformin Tablet contains: M/s Synokem (TENELIGAL-M Teneligliptin Hydrochloride Hydrate eq. Pharmaceuticals Ltd. / 1 Tablet 500) to Teneligliptin 20mg M/s Galpha Metformin Hydrochloride (As Sustained- Laboratories Limited release Form) 500mg 36. Teneligliptin + Each uncoated bi-layered Tablet 10.93 Metformin Tablet contains: M/s Synokem (TENELIGAL-M Teneligliptin Hydrochloride Hydrate eq. Pharmaceuticals Ltd. / 1 Tablet 1000) to Teneligliptin 20mg M/s Galpha Metformin Hydrochloride (As Sustained- Laboratories Limited release Form) 1000mg 37. Glimepiride + Each modified release bi-layered Tablet 7.96 M/s Anphar Organics Metformin Tablet contains: Pvt. Ltd. / M/s Aristo (Glimiprex MF 3 Glimepiride 3mg, 1 Tablet Pharmaceuticals Pvt. & Duopil 3 ) Metformin Hydrochloride 500mg (in Ltd. prolonged release form) 38. Glimepiride + Each uncoated bi-layered Tablet 8.61 M/s Accent Pharma / Metformin Tablet contains: M/s Aristo (Glimiprex MF Glimepiride 3mg, 1 Tablet Pharmaceuticals Pvt. Forte 3 & Duopil Metformin Hydrochloride 1000mg (in Ltd. 3 Forte) prolonged release form) 39. Glimepiride + Each modified release bi-layered Tablet 9.30 M/s Anphar Organics Metformin Tablet contains: Pvt. Ltd. / M/s Aristo (Glimiprex MF 4 Glimepiride 4mg, 1 Tablet Pharmaceuticals Pvt. & Duopil 4 ) Metformin Hydrochloride 500mg (in Ltd. prolonged release form) 40. Glimepiride + Each uncoated bi-layered Tablet 9.35 M/s Accent Pharma / Metformin Tablet contains: M/s Aristo (Glimiprex MF Glimepiride 4mg, 1 Tablet Pharmaceuticals Pvt. Forte 4 & Duopil Metformin Hydrochloride 1000mg (in Ltd. 4 Forte) prolonged release form) 41. Glimepiride + Each un coated bilayered tablet contains: 7.85 Metformin Tablet Glimepiride IP 3mg, M/s Micro Labs 1 Tablet Metformin Hydrochloride IP 500mg (As Limited Prolonged Release form) 42. Glimepiride + Each un coated bilayered tablet contains: 9.18 Metformin Tablet Glimepiride IP 4mg, M/s Micro Labs 1 Tablet Metformin Hydrochloride IP 500mg (As Limited sustained Release form)8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 43. Cilnidipine + Each film coated bilayerd Tablet 7.10 Metoprolol contains: Succinate Tablet Cilnidipine IP 10mg, M/s Micro Labs 1 Tablet Metoprolol Succinate IP 23.75mg eq. to Limited Metoprolol Tartrate 25mg (As Extended Release) 44. Escitalopram + Each film coated Tablet contains: 8.40 Clonazepam Escitalopram Oxalate IP eq. to M/s Eris Lifesciences 1 Tablet Tablet Escitalopram 10mg, Limited Clonazepam IP 0.25mg 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. [PN/203/71/2019/ F. No. 8(71)/2019/D.P./NPPA-Div.-II] PRASENJIT DAS, Assistant Director vkns’k ubZ fnYyh] 18 fnlca j] 2019 dk-vk- 4536¼v½.—vkS"k/k foHkkx }kjk vkS’k/k ¼eYw ; fu;a=.k½] 2013 d s iSjk 31 d s varxZr ikfjr ble sa uhp s lkj.kh d s LrHa k ¼6½ e sa fofufnZ”V vkn's kk sa d s }kjk tkjh iqufoZykds u vkn's kk sa d s lna Hk Z e sa fn; s x, fun'sZ kk sa d s dk;kZUo;u e sa vkSj Hkkjr ljdkj d s jlk;u vkSj moZjd ea=ky; }kjk tkjh dk0 vk0 1394¼v½ rkjh[k 30 ebZ] 2013 vkSj dk0 vk0 701¼v½ rkjh[k 10 ekpZ] 2016 d s lkFk ifBr vkS"k/k ¼dher fu;a=.k½ vkn's k] 2013 d s iSjk 5 11 vkSj 15 }kjk iznRr 'kfDr;k sa dk iz;kxs djr s g,q ] lkj.kh d s LrHa k ¼7½ esa fofufn’ZV Hkkjr ljdkj d s jlk;u vkSj moZjd ea=ky;] (रा(cid:15)(cid:16) ीय vk"Sk/k eYw ; fu/kkZj.k izkf/kdj.k) d s vkn’skk sa d s vf/kdze.k e]sa tgk ¡ rd mldk lEcU/k uhp s dh lkj.kh d s fofufeZfr idS k sa l s gS] mu ckrk sa d s flok;] vf/kØkUr djr s gq, ftUg sa ,sl s vf/kØe.k d s iwo Z fd;k x;k gS ;k dju s dk ykis fd;k x;k gS] jk"Vªh; vkS"k/k eYw ; fu/kkZj.k izkf/kdj.k ¼ftldk s lfa{kIr :i e sa ,uihih, dgk tkrk gS½] uhp s dh lkj.kh d s LrHa k ¼5½ e as fofufnZ"V [kqnjk eYw ; dk s mDr lkj.kh d s LrHa k ¼3½] ¼4½] vkSj ¼8½ e as rRLFkkuh izfof"V;k sa e sa fofufnZ"V izcyrk] bdkbZ ¼;fwuV½ vkSj fofuekZrk vkSj foi.ku dEifu;k sa d s uke lfgr¹Hkkx IIµ[k.M 3(ii)] Hkkjr dk jkti=k % vlk/kj.k 9 LrHa k ¼2½ e sa dh rRLFkkuh izfof"V e sa l s izR;ds dh] oLrq ,o a lsok dj] ;fn dkbs Z gS] dk s NkMs d+ j vf/kdre [kqnjk eYw ; d s :i esa fu;r djrh gSA lkj.kh d-z vuqlfwpr [kqjkd :i ,oa icz yrk bdkbZ vf/kdre iuq foyZ kds u vkn’sk ektS nw k dk- vk- fofuekZrk vkSj l-a fofufefZr dk uke dher ¼#-½ l-a ,oa rkjh[k l-a ,oa rkjh[k foi.ku dia uh (1) (2) (3) (4) (5) (6) (7) (8) 1. beVªlhVkckbu $ iRz;ds fQYe fyfir xkys h e%sa 1 xkys h . 31015/10/2019- 4062(v) elS l Z gVs js k s ycS l 32 49 Vus kQs ksohj xkys h beVªlhVkckbu vkbiZ h 200 eYw ; fu/kkZj.k dh fnukda fy-@eSll Z ,eD;kjs fexzk-] Vus kQs ksohj fnukda 08.11.2019 QkekZL;fwVdYl fy- ,ykQus kekbM gfseQ;ew jVs d s 30.08.2019 (Ø-l-a 4) cjkcj Vus kQs ksohj ,ykQus kekbM 10 fexzk- uksV % ¼d½ mi;qZDr nh xbZ fofufnZ"V QkWewZy's ku d s fofuekZrk vFkkZr tk s ÞubZ Mªxß Mhihlhvk]s 2013 d s iSjkxzkQ 2¼;½w d s rgr mi;qDZ r nh xbZ lkj.kh d s LrHa k ¼5½ e sa fofufnZ"V [kqnjk eYw ; fu/kkZfjr djxsa As ¼[k½ vxj fuekZrkvk sa u s mi;qZDr lkj.kh d s LrHa k ¼5½ e sa of.kZr vf/kdre dher ij ljdkj dk s okLro e sa Hkqxrku fd;k g S ;k ;g n;s gS rk s o s oLrq ,o a lsok dj dk s tkMs + ldr s gASa ¼x½ vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s iSjkxzkQ 11 e sa fn, x, izko/kkuk sa d s rgr fuekZrkvk sa dk s mi;qZDr lkj.kh d s LrHa k ¼5½ e sa fofufnZ"V [kqnjk eYw ; d s vk/kkj ij vuqlfwpr fofufeZfr;k sa d s iSdk sa d s fy, [kqnjk eYw ; fu/kkZfjr djAsa fuekZrk vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s iSjkxzkQ 24 d s rgr QkWeZ V e sa vf/klpw uk dh rkjh[k l s ,d eYw ; lpw h ,uihih, dk s vkbZihMh,e,l d s ek/;e l s tkjh dj sa rFkk mldh dkWih jkT; vkS”kf/k fu;a=dk sa vkSj fofuekZrk forjdk sa dk s tkjh djAsa ¼?k½ vkS"k/k ¼eYw ; fu;a=.k½ vkns'k] 2013 d s 24 (4) d s mic/a kk sa d s vuqlkj iRz ;ds QqVdj fodzsrk vkSj forjd fofuekZrk }kjk fn, x, :i e sa ,sl s ifjlj] tgk a dkjckj dk s bl izdkj fd;k tk jgk gS fd mll s ijke'kZ d s bPNqd fdlh O;fDr d s fy, igpqa vklku gk]s ogk a mld s fdlh lgtn`’; Hkkx ij dher lpw h vkSj iwjd lpw h] ;fn dkbs Z gk]s dk s lia znf'kZr djxs kA ¼M-½ mi;qZDr xSj vf/kdre dher ¼[kqnjk eYw ;½ dsoy mi;qZDr fuekZrk@foi.ku d s fy, ykx w g S tSlk fd mi;DqZ r tus sjfd@leku lajpuk okyk dkbs Z Hkh czkMa @ lca fa/kr fofufeZfr;k sa dh izcyrk rFkk ljdkj }kjk fu/kkZfjr ykx w oS/kkfud vko';drkvk sa dh ifwrZ d s v/khu izklfaxd fof/k;k@sa fu;ek sa d s vUrxZr dUs nzh;@jkT; ykblfslxa vkWFkkfsjVh d s l{ke izkf/kdkjh }kjk eUs ;Qw Ds pfjxa ykblsal eta wjh d s rgr lca fa/kr fofufeZr fuekZrk@foi.ku dEifu;k a tk s vuqikyu djrh gSA ¼p½ fofuekZrk ;k foi.ku dEiuh] mijkDs r fofufeZfr;k as vkSj fofufnZ"V 'krks± dk ikyu ugh a djrh g Sa rk s o s vko';d oLr,q ¡ vf/kfu;e] 1955 d s lkFk ifBr Mhihlhvk]s 2013 d s izko/kkuk sa d s v/khu C;kt lfgr vf/kizHkkfjr jkf'k dk s tek dju s d s fy, nk;h gkxsa As [dk-a l-a@203@71/2019@,Q Qk- l-a 8¼71½@2019@Mhih@,uihih,&fMoh-II] izlus thr nkl] lgk;d fun's kd ORDER New Delhi, the 18th December, 2019 S.O. 4536(E).—In implementation of directions given in line with review orders issued by the Department of Pharmaceuticals (DOP) vide order(s) specified in column (6) of the table herein below passed by the Department of Pharmaceuticals under para 31 of Drugs (Prices Control) Order, 2013 and 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, and in supersession of the Order(s) of the Government of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority) specified in the Column (7) of the table, the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA), hereby fixes, the price as specified in column (5) 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 (8) thereof;10 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] TABLE Sl. Name of the Dosage form & Unit Retail Review Order Existing Manufacturer No. Formulation Strength Price number and SO & Marketing (Rs.) date number & Company date respectively (1) (2) (3) (4) (5) (6) (7) (8) 1. Emtricitabine Each film coated tablet 1 32.49 31015/10/2019- 4062(E) M/s Hetero Labs + Tenofovir contains: Tablet Pricing dated dated Ltd. / M/s tablet Emtricitabine IP 200 30.08.2019 08.11.2019 Emcure mg (at Sl. No. Pharmaceuticals Tenofovir 4) Ltd. Alafenamide Hemifumarate eq to Tenofovir Alafenamide 10 mg 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 (5) 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 (5) 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 (5) 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 prices are applicable only to the manufacturer / marketer as mentioned above for generic / any brand of the same composition / strength of the subject formulations, 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) 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. PN/203/71/2019/F. No. 8(71)/2019/D.P./NPPA-Div.-II PRASENJIT DAS, Assistant Director 'kqf)i= ubZ fnYyh] 18 fnlca j] 2019 dk-vk- 4537¼v½.—jk"Vªh; vk"Sk/k eYw ; fu/kkZj.k izkf/kdj.k dh vf/klpw uk dk-vk- 4062¼v½] fnukda 8 uoca j] 2019 tk s 59 fofufeZfr;k sa d s [kqnjk eYw ; fu;r dju s l s lca fa/kr gS Hkkjr d s vklk/kj.k jkti= e sa rkfydk d s Øe l-a 37 dk fgna h vkSj vxa ts h nkus k sa dk :ikraj.k fuEukuqlkj i<+k tk,A¹Hkkx IIµ[k.M 3(ii)] Hkkjr dk jkti=k % vlk/kj.k 11 bld s LFkku ij dz-la- vuqlwfpr izcyrk bdkbZ fofuekZrk vkSj [kqnjk ewY; fofufeZfr dk foi.ku daiuh ¼#-½ uke@czkaM dk uke (1) (2) (3) (4) (5) (6) 37 foYMkXyhIVhu $ izR;sd fQYe fyfir xksyh esa% 1 xksyh eSllZ ,Ydse gsYFklkbal 19.54 esVQksfeZu xksyh esVQksfeZu gkbMªksDyksjkbM 500 @eSllZ ,Ydse ¼XywfoYMk ,e fexzk-] yscksjsVjht fy- 500@foXywdkst ,e foYMkXyhIVhu 50 fexzk- 500½ i<+k tk, dz-la- vuqlwfpr izcyrk bdkbZ fofuekZrk vkSj [kqnjk ewY; fofufeZfr dk foi.ku daiuh ¼#-½ uke@czkaM dk uke (1) (2) (3) (4) (5) (6) 37 foYMkXyhIVhu $ izR;sd fQYe fyfir xksyh esa% 1 xksyh eSllZ ,Ydse gsYFklkbal 19.64 esVQksfeZu xksyh esVQksfeZu gkbMªksDyksjkbM 500 @eSllZ ,Ydse ¼XywfoYMk ,e fexzk-] yscksjsVjht fy- 500@foXywdkst ,e foYMkXyhIVhu 50 fexzk- 500½ fnukda 8 uoca j] 2019 d s eyw vkn's k dk-vk- 4062 ¼v½ e sa mYyfs[kr lHkh ukVs l vkSj vU; lekxzh leku jgxs hA [dk-a l-a@203@71/2019@,Q@Qk- l-a 8¼71½@2019@Mhih@,uihih,&fMoh- II] izlus thr nkl] lgk;d fun's kd CORRIGENDUM New Delhi, the 18th December, 2019 S.O. 4537(E).—In the National Pharmaceutical Pricing Authority's notification S.O. 4062(E), dated 08th November, 2019 relating to the retail price fixation of 59 formulations, published in the Gazette of India, Extraordinary, the Entry at Sl. No. 37 of the Table, both in Hindi & English version, be read as follows : Instead of Sl. Name of the Strength Unit Manufacturer & Retail Price No. Scheduled Marketing Company (Rs.) Formulation / Brand Name (1) (2) (3) (4) (5) (6) 37 Vildagliptin + Each film coated tablet 1 Tablet M/s. Alkem 19.54 Metformin Tablet contains: Healthscience / M/s. (GLUVILDA M Metformin Hydrochloride IP Alkem Laboratories 500 / VIGLUCOZ 500mg, Ltd. M 500) Vildagliptin IP 50mg12 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] Read as Sl. Name of the Strength Unit Manufacturer & Retail Price No. Scheduled Marketing Company (Rs.) Formulation / Brand Name (1) (2) (3) (4) (5) (6) 37 Vildagliptin + Each film coated tablet 1 Tablet M/s. Alkem 19.64 Metformin Tablet contains: Healthscience / M/s. (GLUVILDA M Metformin Hydrochloride IP Alkem Laboratories 500 / VIGLUCOZ 500mg, Ltd. M 500) Vildagliptin IP 50mg All the notes and other contents mentioned in the original order S.O. 4062(E) dated 08th November 2019 shall remain same. [PN/203/71/2019/F/F. No. 8(71)/2019/D.P./NPPA-Div.-II] PRASENJIT DAS, Assistant Director आदेश ubZ fnYyh] 18 fnlEcj] 2019 ककककाााा....आआआआ.... 4444555533338888....————जब(cid:3)क रा(cid:8)ीय औषध मू(cid:16)य िनधा(cid:19)रण (cid:21)ािधकरण (एनपीपीए) क(cid:26) (cid:27)थ ापना (cid:3)दनांक 29 अग(cid:27)त, 1997 रसायन और उवर(cid:19) क मं%ालय क(cid:26) सं’या 33/7/97 /-पीआई-I म( भारत सरकार के संक(cid:16)प +ारा ,ई थी िजसम( अ.य बात/ के साथ-साथ ब(cid:16)क म( औषिध और िविन0मित के मू(cid:16)य / को िनयत करना और उसम( होने वाले बदलाव/ क(cid:26) अिधसूचना देना, य(cid:3)द कोई हो तो, और गैर-अनुसूिचत दवा5 और िविन0मितय/ के मू(cid:16)य / क(cid:26) िनगरानी करना तथा औषिध (म(cid:16)ू य िनधा(cid:19)रण), आदशे (डीपीसीओ) के (cid:21)ावधान/ के काया(cid:19).वयन क(cid:26) देखरेख करना शािमल ह।ै 2. और जब(cid:3)क (cid:3)दनांक 30 मई, 2013 को रसायन और उव(cid:19)रक मं%ालय के का.आ 1394 (अ) के मा9य म से, आव:यक व(cid:27)तु अिधिनयम, 1955 क(cid:26) धारा 3 और 5 +ारा (cid:21)द; शि=य/ का (cid:21)योग करते ,ए डीपीसीओ, 2013, के िविन@दA पैरा के संबंध म( शि=यां (cid:21)ाC त ह।D िजसम( क(F सरकार क(cid:26) ओर से एनपीपीए +ारा उ= आदेश के परै ा 11(3) का (cid:21)योग (cid:3)कया जाना शािमल ह।ै 3. और जब(cid:3)क एनपीपीए न े अपनी िविन0मित (ए) बुडेसोनाइड 200 एमसीजी + फॉमIटेरोल 6 एमसीजी (cid:21)ित खुराक इनहले र 120 एमडीआई (बी) बुडेसोनाइड 400 एमसीजी + फॉमIटेरोल 6 एमसीजी (cid:21)ित खरु ाक इनहले र 120 एमडीआई, के िलए ' िस.LोMीथ इ.हले र िडवाइस' क(cid:26) अलग से क(cid:26)मत के िलए मैसस (cid:19) िसपला िल. से एक आवदे न/अOय ावेदन (cid:21)ाCत (cid:3)कया था। 4. और जब(cid:3)क, (cid:3)दनांक 04.12.2019 को ब,िवषयक सिमित क(cid:26) 14 वP बैठक म ( िवशेषQ/ क(cid:26) ब,िवषयक सिमित के समR मैसस (cid:19) िसपला िलिमटेड के आवेदन रखे गए थे। सिमित म ( दो फामा(cid:19)कोकॉनोिमक िवशेषQ/ को सह-चुना गया। सिमित ने कहा (cid:3)क वृिTशील नवाचार को बढ़ावा देने के िलए एक अलग म(cid:16)ू य पर िवचार (cid:3)कया जा सकता ह।ै तदनुसार, इसने डीपीसीओ 2013 के पैरा 11 (3) के तहत मैसस (cid:19) िसCला िलिमटेड के िलए "िस.LोMीथ इनहले र िडवाइस" क(cid:26) िवशेष क(cid:26)मत क(cid:26) िसफाVरश क(cid:26)। 5. और जब(cid:3)क, jk"Vªh; vkS"k/k eYw ; fu/kkZj.k izkf/kdj.k ¼ftldk s lfa{kIr :i e sa ,uihih, dgk tkrk gS½ न े अपनी 71 वP बैठक म ( (cid:3)दनांक 09.12.2019 को मैसस (cid:19) िसCला िलिमटेड के आवेदन/ / अOयावेदन पर िवचार-िवमश (cid:19) (cid:3)कया और मैसस (cid:19) िसCला िलिमटेड के िलए "िस.LोMीथ इनहले र िडवाइस" क(cid:26) अलग से क(cid:26)मत दने े के िलए िवशेषQ/ क(cid:26) ब,-िवषयक सिमित क(cid:26) िसफाVरश/ को डीपीसीओ 2013 के पैरा 11 (3) के तहत (cid:27)वीकार कर िलया। 6. Hkkjr ljdkj d s jlk;u vkSj moZjd ea=ky; }kjk tkjh dk0 vk0 1394¼v½ rkjh[k 30 ebZ] 2013 d s lkFk ifBr vkS"k/k ¼dher fu;a=.k½ vkn's k] 2013 d s iSjk 11¼3½ }kjk inz Rr 'kfDr;k sa dk iz;kxs djr s gq,] jk"Vªh; vkS"k/k eYw ; fu/kkZj.k¹Hkkx IIµ[k.M 3(ii)] Hkkjr dk jkti=k % vlk/kj.k 13 izkf/kdj.k ¼ftldk s lfa{kIr :i e sa ,uihih, dgk tkrk gS½] uhp s dh lkj.kh d s LrHa k ¼5½ e as fofufnZ"V eYw ; dk s mDr lkj.kh d s LrHa k ¼3½ vkSj ¼4½ e as rRLFkkuh izfof"V;k sa esa fofufnZ"V czkMa ] bdkbZ ¼;fwuV½ vkSj dEiuh d s uke lfgr LrHa k ¼2½ e sa dh rRLFkkuh izfof"V e sa l s izR;ds dh] oLr q ,o a lsok dj] ;fn dkbs Z gS] dk s NkMs d+ j eYw ; fu;r djrh gAS सारणी (cid:17). सं. िडवाइस का नाम यूिनट कंपनी मू(cid:20)य ((cid:23).) (1) (2) (3) (4) (5) 1 िस(cid:27)(cid:17)ो(cid:28)ीथ इ(cid:27)हले र "ित यूिनट मैसस& िसपला िल. 67.20 िडवाइस ननननोोोोटटटट :::: (क) उपयु&* तािलका के कॉलम (2) म (cid:12) िविन+द- िडवाइस मैसस& िसपला िलिमटेड िजनके पास िडिजटल खुराक काउंटर ह,. िन/न िविन(cid:13)मित के िलए (ए) बुडेसोनाइड 200 एमसीजी + फॉम3टेरोल 6 एमसीजी "ित खुराक इनहेलर 120 एमडीआई और (बी) बुडेसोनाइड 400 एमसीजी + फॉम3टेरोल 6 एमसीजी "ित खुराक इनहले र 120 एमडीआई, लागू ह(cid:6)गे। (ख) मैसस &िसपला िलिमटेड िजनके पास उपयु&* तािलका के कॉलम (2) म (cid:12)िविन+द- िडवाइस है, वे उपयु&* तािलका के कॉलम (5) म (cid:12) िविन+द- मू(cid:20) य को िन/ न िविन(cid:13)मित के िलए (ए) बुडेसोनाइड 200 एमसीजी + फॉम3टेरोल 6 एमसीजी "ित खुराक इनहले र 120 एमडीआई और (बी) बुडेसोनाइड 400 एमसीजी + फॉम3टेरोल 6 एमसीजी "ित खुराक इनहले र 120 एमडीआई, अिधकतम मू(cid:20)य तक जोड़ सकते ह,. जैसा 9क लागू होता ह।ै (ग) मैसस & िसपला िलिमटेड व:तु एवं सेवा कर तभी जोड़ सकता है जब उ(cid:27)ह(cid:6)ने वा:तव म (cid:12) भुगतान 9कया हो या यह उ* तािलका के कॉलम (5) म (cid:12)उि(cid:20)लिखत मू(cid:20)य पर सरकार को दये हो। (घ) मैसस & िसपला िलिमटेड आईपीडीएमएस के मा<यम से डीपीसीओ, 2013 के पैरा=ाफ 24 के अनुसार अिधसूचना क> ितिथ से फॉम-& V म (cid:12)मू(cid:20)य सूची एनपीपीए को जारी करेगा और इसक> एक "ित रा?य औषध िनयं@क और िवतरक(cid:6) को ":तुत करेगा। (ड़) उपयु&* तािलका के कॉलम (5) म (cid:12) िविन+द- िडिजटल डोज काउंटर क> क>मत मैसस& िसपला िल.िजनके पास िडिजटल खुराक काउंटर ह . क> िन/ न िविन(cid:13)मित (ए) बुडेसोनाइड 200 एमसीजी + फॉम3टेरोल 6 एमसीजी "ित खुराक इनहेलर 120 एमडीआई और (बी) बुडेसोनाइड 400 एमसीजी + फॉम3टेरोल 6 एमसीजी "ित खुराक इनहले र 120 एमडीआई, क> अिधकतम क>मत म(cid:12) लगातार पBरवत&न के बावजूद :थाई रहगे ी। (च ) vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s iSjk 24 (4) ds mic/a kk sa d s vuqlkj izR;ds QqVdj fodzsrk vkSj forjd fofuekZrk }kjk fn, x, :i e sa ,sl s ifjlj] tgk a dkjkcs kj dk s bl izdkj fd;k tk jgk gS fd mll s ijke’kZ d s bPNqd fdlh O;fDr d s fy, igpqa vklku gk]s ogk a mld s fdlh lgtn`’; Hkkx ij dher lpw h vkSj iwjd lpw h] ;fn dkbs Z gk]s dk s lia znfशZr djxs kA (छ) िडवाइस का उपयु&* उ(cid:20) लिे खत मू(cid:20)य केवल मैसस& िसपला िलिमटेड के िलए लागू ह ै और सरकार Eारा िनधा&Bरत सभी लाग ू वैधािनक आवGयकताH क> पू(cid:13)त के अधीन "ासंिगक िविधय(cid:6)/िनयम(cid:6) के तहत, जैसा 9क क(cid:12)Iीय/रा?य लाइस(cid:12)Jसग "ािधकरण के सLम "ािधकारी Eारा मे(cid:27) यूफेM चOरग लाइस(cid:12)स मंजूरी के तहत संबंिधत िविन(cid:13)मित िनमा&ता/िवपणन कंपिनया ं जो अनुपालन करती ह . पर लाग ू हो सकता ह।ै (ज) mi;qZDr vuqlfwpr fofufeZfr;k sa dh mRiknu@vk;kr vkSj fcØh d s lEcU/k e sa मैसस& िसपला िलिमटेड dk s vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s lpw h II d s QkWeZ III dk s vkbiZ hMh,e,l d s ek/;e l s Hkjdj ,uihih, dk s gj frekgh dh fjikVs Z izLrqr djxs kA mi;qZDr vuqlfwpr fofufeZfr;k sa d s fuekZ.k dk s dkbs Z fuekZrk mRiknu cUn dju s dk bPNqd gk s rk s bldh lpw uk ,uihih, dk s voxr djk;xs kA bld s lEcU/k e sa vxj vuqlfwpr fofufeZfr;k sa d s mRiknu vkSj vk;kr dk s cUn dju s dk bPNqd gS rk s cUn dju s dh frfFk l s N% eghu s igy s vuqlpw h II d s QkWeZ IV e sa Hkjdj ,uihih, dk s izLrqr djxs kA14 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] (झ) य9द तQकाल मू(cid:20)य अिधसूचना और िविन+द- नोट के अनुसार िडवाइस क> क>मत का अनुपालन नहR 9कया जाता ह,ै तो मैसस & िसपला िलिमटेड आवG यक व: तएु ं अिधिनयम, 1955 के साथ पBठत डीपीसीओ, 2013 के "ावधान(cid:6) के अधीन Xय ाज सिहत अिध"भाBरत रािश को जमा करने के िलए उQ तरदायी ह(cid:6)गे। [dk-a l-a@203@71@2019@,Q@Qk- l-a 8¼71½@2019@Mhih@,uihih,&fMoh- II ] izlus thr nkl] lgk;d fun's kd ORDER New Delhi, the 18th December, 2019 S.O. 4538(E).—Whereas the National Pharmaceutical Pricing Authority (NPPA) was established vide the Resolution of the Government of India in the Ministry of Chemicals and Fertilizers No. 33/7/97-PI.I dated 29th August, 1997, inter-alia, to fix prices and notify the changes therein, if any, of bulk drugs and formulations, monitor the prices of non-scheduled drugs and formulations and oversee the implementation of the provisions of the Drugs (Price Control) Order (DPCO). 2. And whereas the Ministry of Chemicals and Fertilizers vide S.O.1394 (E) dated the 30th May, 2013, in exercise of the powers conferred by Section 3 and 5 of Essential Commodities Act, 1955 has delegated the powers in respect of specified paras of the DPCO, 2013, including para 11(3) of the said Order to be exercised by the NPPA on behalf of the Central Government. 3. And whereas NPPA had received an application from M/s Cipla Ltd for separate price of ‘Synchrobreathe Inhaler Device’ for its formulation (a) Budesonide 200mcg+ Formeterol 6mcg per dose Inhaler 120 MDI (b) Budesonide 400mcg+ Formeterol 6mcg per dose Inhaler 120 MDI. 4. And whereas, the application of M/s Cipla Limited was placed before the Multidisciplinary Committee of Experts in its 14th meeting dated 04.12.2019. Two Pharmacoeconomic experts were co-opted in the Committee. The Committee noted that a separate price could be considered to promote incremental innovation. Accordingly, it recommended special price of “Synchrobreathe Inhaler Device” for M/s Cipla Limited under para 11(3) of DPCO 2013. 5. And whereas, NPPA in its 71st meeting dated 09.12.2019 deliberated upon the applications/ representations of M/s Cipla Limited and accepted the recommendations of the Multidisciplinary Committee of Experts to give separate price of “Synchrobreathe Inhaler Device” for M/s Cipla Limited under para 11(3) of DPCO 2013. 6. Therefore, in exercise of powers, conferred by paragraph 11(3) of the Drugs (Prices Control) Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 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 (5) of the table herein below as the price, exclusive of goods and services tax, if any, in relation to the device specified in the corresponding entry in column (2) of the said Table with the unit and name of company, as specified in the corresponding entries in columns (3) and (4) thereof; TABLE Sl. No. Name of the device Unit Company Price (Rs.) (1) (2) (3) (4) (5) 1 Synchrobreathe Inhaler Device Per Unit M/s Cipla Ltd Rs. 67.20 Note: (a) The device as specified in column in (2) of the above said table would be applicable to the formulation (a) Budesonide 200mcg+ Formeterol 6mcg per dose Inhaler 120 MDI and (b) Budesonide 400mcg+ Formeterol 6mcg per dose Inhaler 120 MDI of M/s Cipla Ltd. (b) M/s Cipla Ltd may add the price as specified in column (5) of the above said table to the ceiling price, as applicable, of the formulation (a) Budesonide 200mcg+ Formeterol 6mcg per dose Inhaler 120 MDI (b) Budesonide 400mcg+ Formeterol 6mcg per dose Inhaler 120 MDI of M/s Cipla Ltd having the device as specified in column (2) of the above said table.¹Hkkx IIµ[k.M 3(ii)] Hkkjr dk jkti=k % vlk/kj.k 15 (c) M/s Cipla Ltd may add goods and services tax only if they have paid actually or it is payable to the Government on the price mentioned in column (5) of the above said table. (d) M/s Cipla Ltd 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) The price of the Synchrobreathe Inhaler Device as specified in column (5) of the above said table would remain fixed irrespective of the subsequent change in the ceiling price of the formulation (a) Budesonide 200mcg+ Formeterol 6mcg per dose Inhaler 120 MDI and (b) Budesonide 400mcg+ Formeterol 6mcg per dose Inhaler 120 MDI of M/s Cipla Ltd. (f) 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. (g) The above mentioned price of the device is applicable only to M/s Cipla Ltd 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. (h) M/s Cipla Ltd shall furnish quarterly return to the NPPA, in respect of production / import and sale of the device with the formulation as stated hereinabove 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. (i) In case the price of the device is not complied with, as per instant price notification and notes specified hereinabove, then M/s Cipla Ltd 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. [PN/203/71/2019/F/F. No. 8(71)/2019/ DP/Div-II/NPPA] PRASENJIT DAS, Asst. Director आदेश ubZ fnYyh] 18 fnlca j] 2019 ककककाााा....आआआआ.... 4444555533339999((((अअअअ)))).—जब(cid:3)क रा(cid:8)ीय औषध मू(cid:16)य िनधा(cid:19)रण (cid:21)ािधकरण (एनपीपीए) क(cid:26) (cid:27)थ ापना (cid:3)दनांक 29 अग(cid:27)त, 1997 रसायन और उवर(cid:19) क मं%ालय क(cid:26) सं’या 33/7/97 /-पीआई-I म( भारत सरकार के संक(cid:16)प +ारा ,ई थी िजसम( अ.य बात/ के साथ-साथ ब(cid:16)क म( औषिध और िविन0मित के मू(cid:16)य / को िनयत करना और उसम( होने वाले बदलाव/ क(cid:26) अिधसूचना देना, य(cid:3)द कोई हो तो, और गैर-अनुसूिचत दवा5 और िविन0मितय/ के मू(cid:16)य / क(cid:26) िनगरानी करना तथा औषिध (म(cid:16)ू य िनधा(cid:19)रण), आदशे (डीपीसीओ) के (cid:21)ावधान/ के काया(cid:19).वयन क(cid:26) देखरेख करना शािमल ह।ै 2. और जब(cid:3)क (cid:3)दनांक 30 मई, 2013 को रसायन और उव(cid:19)रक मं%ालय के का.आ 1394 (अ) के मा9य म से, आव:यक व(cid:27)तु अिधिनयम, 1955 क(cid:26) धारा 3 और 5 +ारा (cid:21)द; शि=य/ का (cid:21)योग करते ,ए डीपीसीओ, 2013, के िविन@दA पैरा के संबंध म( शि=यां (cid:21)ाC त ह।D िजसम( क(F सरकार क(cid:26) ओर से एनपीपीए +ारा उ= आदेश के परै ा 11(3) का (cid:21)योग (cid:3)कया जाना शािमल ह।ै 3. और जब(cid:3)क एनपीपीए न े अपनी िविन0मित (ए) बुडेसोनाइड 100 एमसीजी + फॉमIटेरोल 6 एमसीजी (cid:21)ित खुराक इनहले र 120 एमडीआई (बी) बुडेसोनाइड 200 एमसीजी + फॉमIटेरोल 6 एमसीजी (cid:21)ित खुराक इनहले र 120 एमडीआई और (सी) बुडेसोनाइड 400 एमसीजी + फॉमIटेरोल 6 एमसीजी (cid:21)ित खुराक इनहले र 120 एमडीआई, के िलए Mांड "िडजीहले र" के तहत 'िडिजटल डोज़ काउंटर' क(cid:26) अलग से क(cid:26)मत के िलए मैसस (cid:19) Wल ेनमाक(cid:19) फामा(cid:19)(cid:27)य ूVटक(cid:16)स िल. िजनके पास िडिजटल खुराक काउंटर ह,D से एक आवेदन/अO यावेदन (cid:21)ाCत (cid:3)कया था।16 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 4. और जब(cid:3)क, (cid:3)दनांक 04.12.2019 को ब,िवषयक सिमित क(cid:26) 14 वP बैठक म ( िवशेषQ/ क(cid:26) ब,िवषयक सिमित के समR मैसस (cid:19) Wलेनमाक(cid:19) फामा(cid:19)(cid:27)यूVटक(cid:16)स िलिमटेड के आवेदन रखे गए थे। सिमित म ( दो फामा(cid:19)कोकॉनोिमक िवशेषQ/ को सह- चुना गया। सिमित ने कहा (cid:3)क वृिTशील नवाचार को बढ़ावा देने के िलए एक अलग मू(cid:16)य पर िवचार (cid:3)कया जा सकता है। तदनुसार, इसने डीपीसीओ 2013 के पैरा 11 (3) के तहत मेसस (cid:19) Wलेनमाक(cid:19) फामा(cid:19)(cid:27)युVटक(cid:16)स िलिमटेड के िलए "िडजीहले र" Mांड के तहत 'िडिजटल डोज़ काउंटर' क(cid:26) िवशेष क(cid:26)मत क(cid:26) िसफाVरश क(cid:26)। 5. और जब9क, राZीय vkS"k/k eYw ; fu/kkZj.k izkf/kdj.k ¼ftldk s lfa{kIr :i e sa ,uihih, dgk tkrk gS½ ने अपनी 71 वP बैठक म (cid:12) 9दनांक 09.12.2019 को मैसस & [लेनमाक& फामा&:युBटक(cid:20)स िलिमटेड के आवेदन(cid:6)/अ\यावेदन पर िवचार-िवमश & 9कया और (cid:28)ांड के तहत 'िडिजटल खुराक काउंटर' क> अलग से क>मत दने े के िलए िवशेष^(cid:6) क> ब_-िवषयक सिमित क> िसफाBरश(cid:6) को डीपीसीओ 2013 के पैरा 11 (3) के तहत मेसस &[लेनमाक& फामा&:यूBटक(cid:20)स िलिमटेड के िलए :वीकार 9कया। 6. Hkkjr ljdkj d s jlk;u vkSj moZjd ea=ky; }kjk tkjh dk0 vk0 1394¼v½ rkjh[k 30 ebZ] 2013 d s lkFk ifBr vkS"k/k ¼dher fu;a=.k½ vkn's k] 2013 d s iSjk 11¼3½ }kjk inz Rr 'kfDr;k sa dk iz;kxs djr s gq,] jk"Vªh; vkS"k/k eYw ; fu/kkZj.k izkf/kdj.k ¼ftldk s lfa{kIr :i e sa ,uihih, dgk tkrk gS½] uhp s dh lkj.kh d s LrHa k ¼6½ e as fofufnZ"V eYw ; dk s mDr lkj.kh d s LrHa k ¼3½] ¼4½] vkSj ¼5½ e as rRLFkkuh izfof"V;k sa e sa fofufnZ"V czkMa ] bdkbZ ¼;fwuV½ vkSj dEiuh d s uke lfgr LrHa k ¼2½ e sa dh rRLFkkuh izfof"V e sa l s izR;ds dh] oLrq ,o a lsok dj] ;fn dkbs Z gS] dk s NkMs d+ j eYw ; fu;r djrh gAS सारणी L. सं. िडवाइस का नाम Mांड यूिनट कंपनी मू(cid:16)य (X.) (1) (2) (3) (4) (5) (6) 1 िडिजटल खुराक काउंटर िडजीहले र (cid:21)ित यूिनट मैसस (cid:19) Wल ने माक(cid:19) 44.70 फामा(cid:19)(cid:27)य ूVटक(cid:16)स िल. ननननोोोोटटटट:::: (क) उपयु(cid:19)= तािलका के कॉलम (2) म ( िविन@दA िडवाइस मैसस(cid:19) Wलेनमाक(cid:19) फामा(cid:19)(cid:27)यूVटक(cid:16)स िलिमटेड िजनके पास िडिजटल खुराक काउंटर ह,D िनY न िविन0मित के िलए (ए) बुडेसोनाइड 100 एमसीजी + फॉमIटेरोल 6 एमसीजी (cid:21)ित खुराक इनहले र 120 एमडीआई (बी) बुडेसोनाइड 200 एमसीजी + फॉमIटेरोल 6 एमसीजी (cid:21)ित खुराक इनहले र 120 एमडीआई और (सी) बुडेसोनाइड 400 एमसीजी + फॉमIटेरोल 6 एमसीजी (cid:21)ित खरु ाक इनहले र 120 एमडीआई, लाग ूह/गे। (ख) मैसस(cid:19) Wलेनमाक(cid:19) फामा(cid:19)(cid:27)यूVटक(cid:16)स िलिमटेड िजनके पास िडिजटल खरु ाक काउंटर ह,D व े उपय=ु(cid:19) तािलका के कॉलम (6) म ( िविन@दA मू(cid:16) य को िनY न िविन0मित के िलए (ए) बडु ेसोनाइड 100 एमसीजी + फॉमIटेरोल 6 एमसीजी (cid:21)ित खुराक इनहले र 120 एमडीआई (बी) बुडेसोनाइड 200 एमसीजी + फॉमIटेरोल 6 एमसीजी (cid:21)ित खुराक इनहले र 120 एमडीआई और (सी) बुडेसोनाइड 400 एमसीजी + फॉमIटेरोल 6 एमसीजी (cid:21)ित खुराक इनहले र 120 एमडीआई, अिधकतम मू(cid:16)य तक जोड़ सकते ह,D जैसा (cid:3)क लाग ू होता ह।ै (ग) मैसस(cid:19) Wलेनमाक(cid:19) फामा(cid:19)(cid:27)यूVटक(cid:16)स िलिमटेड व(cid:27)तु एव ं सेवा कर तभी जोड़ सकता ह ैजब उ.ह/न ेवा(cid:27)तव म ( भगु तान (cid:3)कया हो या यह उ= तािलका के कॉलम (6) म (उि(cid:16)लिखत म(cid:16)ू य पर सरकार को देय हो। (घ) मैसस(cid:19) Wलने माक(cid:19) फामा(cid:19)(cid:27)यूVटक(cid:16)स िलिमटेड आईपीडीएमएस के मा9यम स े डीपीसीओ, 2013 के परै ा[ाफ 24 के अनुसार अिधसूचना क(cid:26) ितिथ से फॉम-(cid:19) V म ( मू(cid:16)य सूची एनपीपीए को जारी करेगा और इसक(cid:26) एक (cid:21)ित रा\य औषध िनयं%क और िवतरक/ को (cid:21)(cid:27)तुत करेगा। (ड़) उपयु(cid:19)= तािलका के कॉलम (6) म ( िविन@दA िडिजटल डोज काउंटर क(cid:26) क(cid:26)मत मैसस(cid:19) Wलने माक(cid:19) फामा(cid:19)(cid:27)यूVटक(cid:16)स िलिमटेड िजनके पास िडिजटल खरु ाक काउंटर ह D क(cid:26) िनYन िविन0मित (ए) बुडेसोनाइड 100 एमसीजी + फॉमIटेरोल 6 एमसीजी (cid:21)ित खुराक इनहले र 120 एमडीआई (बी) बुडेसोनाइड 200 एमसीजी + फॉमIटेरोल 6 एमसीजी (cid:21)ित खुराक इनहले र 120 एमडीआई और (सी) बुडेसोनाइड 400 एमसीजी + फॉमIटेरोल 6 एमसीजी (cid:21)ित खुराक इनहले र 120 एमडीआई, क(cid:26) अिधकतम क(cid:26)मत म( लगातार पVरवत(cid:19)न के बावजूद (cid:27)थाई रहगे ी।¹Hkkx IIµ[k.M 3(ii)] Hkkjr dk jkti=k % vlk/kj.k 17 (च) vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s iSjk 24 (4) ds mic/a kk sa d s vuqlkj izR;ds QqVdj fodzsrk vkSj forjd fofuekZrk }kjk fn, x, :i e sa ,sl s ifjlj] tgk a dkjkcs kj dk s bl idz kj fd;k tk jgk gS fd mll s ijke’kZ d s bPNqd fdlh O;fDr d s fy, igpqa vklku gk]s ogk a mld s fdlh lgtn`’; Hkkx ij dher lpw h vkSj iwjd lpw h] ;fn dkbs Z gk]s dk s lia znf'kZr djxs kA (छ) िडवाइस का उपयु(cid:19)= उ(cid:16)ल िे खत मू(cid:16)य केवल मैसस(cid:19) Wलेनमाक(cid:19) फामा(cid:19)(cid:27)यूVटक(cid:16)स िलिमटेड के िलए लाग ू ह ै और सरकार +ारा िनधा(cid:19)Vरत सभी लागू वधै ािनक आव:यकता5 क(cid:26) पू0त के अधीन (cid:21)ासंिगक िविधय// िनयम/ के तहत, जैसा (cid:3)क क(Fीय / रा\य लाइस(]सग (cid:21)ािधकरण के सRम (cid:21)ािधकारी +ारा मे.य ूफे^च _रग लाइस(स मंजरू ी के तहत संबंिधत िविन0मित िनमा(cid:19)ता/िवपणन कंपिनयां जो अनपु ालन करती ह D पर लाग ू हो सकता ह।ै (ज) mi;qZDr vuqlfwpr fofufefZr;k sa dh mRiknu@vk;kr vkSj fcØh d s lEcU/k e sa मैसस& [लेनमाक& फामा&:यूBटक(cid:20)स िलिमटेड dk s vkS"k/k ¼eYw ; fu;a=.k½ vkn's k] 2013 d s lpw h II d s QkWeZ III dk s vkbiZ hMh,e,l d s ek/;e l s Hkjdj ,uihih, dk s gj frekgh dh fjikVs Z izLrqr djxs kA mi;qZDr vuqlfwpr fofufefZr;k sa d s fuekZ.k dk s dkbs Z fuekZrk mRiknu cUn dju s dk bPNqd gk s rk s bldh lpw uk ,uihih, dk s voxr djk;xs kA bld s lEcU/k e sa vxj vuqlfwpr fofufeZfr;k sa d s mRiknu vkSj vk;kr dk s cUn dju s dk bPNdq gS rk s cUn dju s dh frfFk l s N% eghu s igy s vuqlpw h II d s QkWeZ IV e sa Hkjdj ,uihih, dk s izLrqr djxs kA (झ) य(cid:3)द त‘काल म(cid:16)ू य अिधसूचना और िविन@दA नोट के अनुसार िडवाइस क(cid:26) क(cid:26)मत का अनुपालन नहP (cid:3)कया जाता ह,ै तो मैसस(cid:19) Wलने माक(cid:19) फामा(cid:19)(cid:27)यूVटक(cid:16)स िलिमटेड आव: यक व(cid:27)त एु ं अिधिनयम, 1955 के साथ पVठत डीपीसीओ, 2013 के (cid:21)ावधान/ के अधीन h याज सिहत अिध(cid:21)भाVरत रािश को जमा करन े के िलए उ‘त रदायी ह/गे। [dk-a l-a@203@71@2019@,Q@Qk- l-a 8¼71½@2019@Mhih@,uihih,&fMoh- II] izlus thr nkl] lgk;d fun's kd ORDER New Delhi, the 18th December, 2019 S.O. 4539(E).—Whereas the National Pharmaceutical Pricing Authority (NPPA) was established vide the Resolution of the Government of India in the Ministry of Chemicals and Fertilizers No. 33/7/97-PI.I dated 29th August, 1997, inter-alia, to fix prices and notify the changes therein, if any, of bulk drugs and formulations, monitor the prices of non-scheduled drugs and formulations and oversee the implementation of the provisions of the Drugs (Price Control) Order (DPCO). 2. And whereas the Ministry of Chemicals and Fertilizers vide S.O.1394 (E) dated the 30th May, 2013, in exercise of the powers conferred by Section 3 and 5 of Essential Commodities Act, 1955 has delegated the powers in respect of specified paras of the DPCO, 2013, including para 11(3) of the said Order to be exercised by the NPPA on behalf of the Central Government. 3. And whereas NPPA had received an application/ representation from M/s Glenmark Pharmaceuticals Ltd for separate price of ‘digital dose counter’ under the brand “Digihaler” for its formulation (a) Budesonide 100mcg+ Formeterol 6mcg per dose Inhaler 120 MDI (b) Budesonide 200mcg+ Formeterol 6mcg per dose Inhaler 120 MDI and (c) Budesonide 400mcg+ Formeterol 6mcg per dose Inhaler 120 MDI having digital dose counter. 4. And whereas, the application of M/s Glenmark Pharmaceuticals Ltd was placed before the Multidisciplinary Committee of Experts in its 14th meeting dated 04.12.2019. Two Pharmacoeconomic experts were co-opted in the Committee. The Committee noted that a separate price could be considered to promote incremental innovation. Accordingly, it recommended special price of ‘digital dose counter’ under the brand “Digihaler” for M/s Glenmark Pharmaceuticals Ltd under para 11(3) of DPCO 2013. 5. And whereas, NPPA in its 71st meeting dated 09.12.2019 deliberated upon the applications/ representations of M/s Glenmark Pharmaceuticals Ltd and accepted the recommendations of the Multidisciplinary Committee of Experts to give separate price of ‘digital dose counter’ under the brand “Digihaler” for M/s Glenmark Pharmaceuticals Ltd under para 11(3) of DPCO 2013. 6. Therefore, in exercise of powers, conferred by paragraph 11(3) of the Drugs (Prices Control) Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 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 price, exclusive of goods and services tax, if any, in relation to the device specified in the corresponding entry in column (2) of the said Table with the brand, unit and name of company, as specified in the corresponding entries in columns (3), (4) and (5) thereof;18 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] TABLE Sl. No. Name of the device Brand Unit Company Price (Rs.) (1) (2) (3) (4) (5) (6) 1 Digital Dose Counter Digihaler Per Unit M/s Glenmark Rs. 44.70 Pharmaceuticals Ltd Note: (a) The device as specified in column in (2) of the above said table would be applicable to the formulation (a) Budesonide 100mcg+ Formeterol 6mcg per dose Inhaler 120 MDI (b) Budesonide 200mcg+ Formeterol 6mcg per dose Inhaler 120 MDI and (c) Budesonide 400mcg+ Formeterol 6mcg per dose Inhaler 120 MDI of M/s Glenmark Pharmaceuticals Ltd having digital dose counter. (b) M/s Glenmark Pharmaceuticals Ltd may add the price as specified in column (6) of the above said table to the ceiling price, as applicable, of the formulation (a) Budesonide 100mcg+ Formeterol 6mcg per dose Inhaler 120 MDI (b) Budesonide 200mcg+ Formeterol 6mcg per dose Inhaler 120 MDI and (c) Budesonide 400mcg+ Formeterol 6mcg per dose Inhaler 120 MDI of M/s Glenmark Pharmaceuticals Ltd having digital dose counter. (c) M/s Glenmark Pharmaceuticals Ltd may add goods and services tax only if they have paid actually or it is payable to the Government on the price mentioned in column (6) of the above said table. (d) M/s Glenmark Pharmaceuticals Ltd 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) The price of the digital dose counter as specified in column (6) of the above said table would remain fixed irrespective of the subsequent change in the ceiling price of the formulation (a) Budesonide 100mcg+ Formeterol 6mcg per dose Inhaler 120 MDI (b) Budesonide 200mcg+ Formeterol 6mcg per dose Inhaler 120 MDI and (c) Budesonide 400mcg+ Formeterol 6mcg per dose Inhaler 120 MDI of M/s Glenmark Pharmaceuticals Ltd having digital dose counter. (f) 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. (g) The above mentioned price of the device is applicable only to M/s Glenmeark Pharmaceuticals Ltd 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. (h) M/s Glenmark Pharmaceuticals Ltd shall furnish quarterly return to the NPPA, in respect of production / import and sale of the device with the formulation as stated hereinabove 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. (i) In case the price of the device is not complied with, as per instant price notification and notes specified hereinabove, then M/s Glenmark Pharmaceuticals Ltd 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. [PN/203/71/2019/F/F. No. 8(71)/2019/ DP/Div-II/NPPA] PRASENJIT DAS, Asst. 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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