Home India Ministry of Chemicals and Fertilizers In exercise of the powers conferred by paragraphs 5 11 and 1...
Date: 2019-11-14 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

Issued by Ministry of Chemicals and Fertilizers · Department of Pharmaceuticals

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Executive Summary & Key Takeaways

Executive Summary: The National Pharmaceutical Pricing Authority (NPPA) issues an order fixing the retail prices of specified drugs, effective November 14, 2019. This order, under the Drugs Prices Control Order (DPCO) 2013, read with specified Government of India notifications, sets maximum retail prices for various formulations, exclusive of GST. Manufacturers must adhere to these prices and related regulations. Key Points / Main Content: * **Price Fixation:** * Retail prices for specific drug formulations are fixed as per column 6 of the provided table, excluding GST. * The specified prices apply to the manufacturers and marketers who submitted Form I for price fixation/revision under DPCO, 2013. * **Manufacturer Responsibilities:** * Manufacturers can add GST if actually paid or payable to the government on the specified retail price. * Retail prices for packs must align with column 6 of the table, according to DPCO 2013, paragraph 11. * A price list in Form V must be issued to NPPA via IPDMS, State Drug Controllers, and dealers, as per paragraph 24 of DPCO 2013. * **Retailer and Dealer Obligations:** * Retailers and dealers must display the price list and any supplementary list provided by the manufacturer conspicuously, ensuring easy access for customers (DPCO 2013, para 24(4)). * **Compliance and Penalties:** * Manufacturers/marketers not complying with the price notification and specified conditions will be liable to deposit overcharged amounts with interest, as per the Essential Commodities Act, 1955, read with DPCO 2013. * **Supersession of Previous Orders:** * This order supersedes any prior orders fixing ceiling or retail prices for the formulations specified in column 2 of the table. Impact Analysis: * **Manufacturers:** * Impact: Must adhere to the retail prices fixed by the NPPA for the specified formulations and comply with all associated regulations. * Action Required: Adjust pricing to align with the NPPA's fixed retail prices, issue a price list in Form V, and ensure compliance with DPCO 2013 and the Essential Commodities Act, 1955. * **Retailers and Dealers:** * Impact: Must sell the specified formulations at or below the fixed retail prices and display pricing information transparently. * Action Required: Display the price list and supplementary lists provided by manufacturers in a conspicuous location accessible to customers. * **Consumers:** * Impact: Will have access to the specified drugs at the regulated retail prices. * Action Required: Be aware of the fixed prices and report any discrepancies to the appropriate authorities. * **National Pharmaceutical Pricing Authority (NPPA):** * Impact: Responsible for enforcing the price regulations and ensuring compliance among manufacturers, retailers, and dealers. * Action Required: Monitor the market for compliance, address any violations, and update price regulations as necessary.

Key Entities Referenced

National Pharmaceutical Pricing Authority: A government regulatory agency in India that fixes and regulates drug prices. Abbreviated as NPPA. Drugs Prices Control Order, 2013: A legal order in India that empowers the NPPA to control the prices of essential medicines. Ministry of Chemicals and Fertilizers: A ministry of the Government of India responsible for the development and regulation of the chemical and fertilizer industries. Department of Pharmaceuticals: A department within the Ministry of Chemicals and Fertilizers focused on the pharmaceutical sector. Fluconazole: An antifungal medication, retail price fixed by this notification. Atorvastatin: A statin medication used to lower cholesterol, retail price fixed by this notification. Vildagliptin: An anti-diabetic medication, retail price fixed by this notification. New Delhi: The location where the order was issued.
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fu/kkZfjr djsaxsA ¼[k½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (6) esa of.kZr vf/kdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS ;k ;g ns; gS rks os oLrq ,oa lsok dj dks tksM+ ldrs gSaA ¼x½ vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LraHk ¼6½ esa fofufnZ"V [kqnjk ewY; ds vk/kkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fu/kkZfjr djsaA fuekZrk vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds iSjkxzkQ 24 ds rgr QkWeZ V esa vf/klwpuk dh rkjh[k ls ,d ewY; lwph ,uihih, dks vkbZihMh,e,l ds ek/;e ls tkjh djsa rFkk mldh dkiWh jkT; vkS"kf/k fu;a=dksa vkSj fofuekZrk forjdksa dks tkjh djsaA ¼?k½ vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds 24 (4) ds mica/kksa ds vuqlkj izR;sd QqVdj fodzsrk vkSj forjd fofuekZrk }kjk fn, x, :i esa ,sls ifjlj] tgka dkjckj dks bl izdkj fd;k tk jgk gS fd mlls ijke’kZ ds bPNqd fdlh O;fDr ds fy, igqap vklku gks] ogka mlds fdlh lgtn`’; Hkkx ij dher lwph vkSj iwjd lwph] ;fn dksbZ gks] dks laiznf’kZr djsxkA¹Hkkx IIµ[k.M 3(ii)] Hkkjr dk jkti=k % vlk/kj.k 3 ¼M-½ mi;qZDr xSj vf/kdre dher ¼[kqnjk ewY;½ dsoy mi;qZDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgksaus vkS"k/k ¼ewY; fu;a=.k½ vkns'k] 2013 ds rgr vuqc) ewY; fu/kkZj.k@la'kks/ku ds fy, QkWeZ I ij tek fd;k x;k Fkk vkSj ljdkj }kjk fu/kkZfjr lHkh ykxw oS/kkfud vko';drkvksa dh iwfrZ ds v/khu izklafxd fof/k;ksa@fu;eksa ds vUrxZr tSlk fd dsUnzh;@jkT; ykblsflax vkWFkksfjVh ds l{ke izkf/kdkjh }kjk esU;wQsDpfjax ykblsal eatwjh ds rgr lacaf/kr fofufeZr fuekZrk@foi.ku dEifu;ka tks vuqikyu djrh gSA ¼p½ fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa vkSj fofufnZ"V 'krks± dk ikyu ugha djrh gSa rks os vko';d oLrq,¡ vf/kfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izko/kkuksa ds v/khu C;kt lfgr vf/kizHkkfjr jkf'k dks tek djus ds fy, nk;h gksaxsA ¼N½ bl vkns'k esa mijksDr lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V fofufeZfr;ksa ds iSdksa dh [kqnjk ewY; fu;r gksus ds ifj.kkeLo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA [dka-la-@202@70/2019@,Q@Qk- la- 8¼70½@2019@Mhih@,uihih,&fMoh--II] izlsuthr nkl] lgk;d funs'kd MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (NATIONAL PHARMACEUTICAL PRICING AUTHORITY) ORDER New Delhi, the 14th November, 2019 S.O. 4103(E).—In exercise of the powers conferred by paragraphs 5, 11 and 15 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated the 30th May, 2013 and S.O.701(E) dated 10th March, 2016 issued by the Government of India in the Ministry of Chemicals and Fertilizers, the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA), hereby fixes, the price as specified in column (6) of the table herein below as the retail price, exclusive of goods and services tax, if any, in relation to the formulation specified in the corresponding entry in column (2) of the said Table with the strength, unit and name of manufacturer & marketing company, as specified in the corresponding entries in columns (3), (4) and (5) thereof; TABLE Sl. Name of the Strength Unit Manufacturer & Retail No. Formulation / Brand Marketing Company Price Name (Rs.) (1) (2) (3) (4) (5) (6) 1. Fluconazole Tablet Each uncoated tablet contains: M/s Skymap 16.16 1 Tablet Fluconazole IP 300mg Pharmaceuticals Pvt. Ltd. 2. Atorvastatin + Aspirin Each hard gelatine capsule contains: 5.27 + Clopidogrel Capsule Atorvastatin Calcium IP eq. to Atorvastatin 20mg (As two white coloured film coated tablets, each containing 10mg Atorvastatin Tablets IP), M/s Windlas Biotech Pvt. Aspirin IP 75mg (As enteric coated white 1 Capsule Ltd. / M/s Mankind coloured pellets) Pharma Limited Clopidogrel Bisulphate IP eq. to Clopidogrel 75mg (As two brown coloured film coated tablets, Each containing 37.5mg Clopidogrel tablet IP) 3. Atorvastatin + Aspirin Each hard gelatine capsule contains: 3.80 + Clopidogrel Capsule Atorvastatin Calcium IP eq. to Atorvastatin M/s Synokem 10mg (As Pellets), Pharmaceuticals Ltd. / 1 Capsule Clopidogrel Bisulphate IP eq. to Clopidogrel M/s Emcure 75mg (As Pellets) Pharmaceuticals Limited Aspirin IP 75mg (As enteric coated pellets)4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] 4. Atorvastatin + Aspirin Each hard gelatine capsule contains: 5.27 + Clopidogrel Capsule Atorvastatin Calcium IP eq. to Atorvastatin M/s Synokem 20mg (As Pellets), Pharmaceuticals Ltd. / 1 Capsule Clopidogrel Bisulphate IP eq. to Clopidogrel M/s Emcure 75mg (As Pellets) Pharmaceuticals Limited Aspirin IP 75mg (As enteric coated pellets) 5. Atorvastatin + Aspirin Each hard gelatine capsule contains: 3.80 + Clopidogrel Capsule Atorvastatin Calcium IP eq. to Atorvastatin M/s Synokem 10mg (As Pellets), 1 Capsule Pharmaceuticals Ltd. / Clopidogrel Bisulphate IP eq. to Clopidogrel M/s Cipla Limited 75mg (As Pellets) Aspirin IP 75mg (As enteric coated pellets) 6. Atorvastatin + Aspirin Each hard gelatine capsule contains: 5.27 + Clopidogrel Capsule Atorvastatin Calcium IP eq. to Atorvastatin M/s Synokem 20mg (As Pellets), 1 Capsule Pharmaceuticals Ltd. / Clopidogrel Bisulphate IP eq. to Clopidogrel M/s Cipla Limited 75mg (As Pellets) Aspirin IP 75mg (As enteric coated pellets) 7. Vildagliptin + Each film coated Tablet contains: M/s Mediforce Healthcare 22.77 Metformin Tablet Vildagliptin 50mg, 1 Tablet Pvt. Ltd. / M/s Mankind Metformin Hydrochloride IP 500mg, Pharma Limited 8. Vildagliptin + Each film coated Tablet contains: M/s Exemed 12.26 Metformin Tablet Vildagliptin 50mg, 1 Tablet Pharmaceuticals / M/s (Vidalog M 500) Metformin Hydrochloride IP 500mg, Wockhardt Limited 9. Vildagliptin + Each film coated Tablet contains: M/s Mediforce Healthcare 22.75 Metformin Tablet Vildagliptin 50mg, 1 Tablet Pvt. Ltd. / M/s Mankind Metformin Hydrochloride IP 850mg, Pharma Limited 10. Vildagliptin + Each film coated Tablet contains: M/s Exemed 12.26 Metformin Tablet Vildagliptin 50mg, 1 Tablet Pharmaceuticals / M/s (Vidalog M 850) Metformin Hydrochloride IP 850mg, Wockhardt Limited 11. Vildagliptin + Each film coated Tablet contains: M/s Mediforce Healthcare 23.40 Metformin Tablet Vildagliptin 50mg, 1 Tablet Pvt. Ltd. / M/s Mankind Metformin Hydrochloride IP 1000mg, Pharma Limited 12. Vildagliptin + Each film coated Tablet contains: M/s Exemed 12.53 Metformin Tablet Vildagliptin 50mg, 1 Tablet Pharmaceuticals / M/s (Vidalog M 1000) Metformin Hydrochloride IP 1000mg, Wockhardt Limited 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 deposit¹Hkkx IIµ[k.M 3(ii)] Hkkjr dk jkti=k % vlk/kj.k 5 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/202/70/2019/F/ F. No. 8(70)/2019/D.P./NPPA-Div.-II ] PRASENJIT DAS, Assistant Director Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.

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