Home India Ministry of Chemicals and Fertilizers issued by the Government of India in the Ministry of Chemica...
Date: 2019-07-03 Category: Extra Ordinary State: Union Government Country: India

issued by the Government of India in the Ministry of Chemicals and Fertilizers the National Pharmaceutical Pricing Authority

Issued by Ministry of Chemicals and Fertilizers · Department of Pharmaceuticals

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Executive Summary & Key Takeaways

Executive Summary: This order, issued by the National Pharmaceutical Pricing Authority, fixes the retail prices of specified drug formulations as listed in the attached table, effective July 3, 2019. Manufacturers must adhere to these prices and issue price lists in Form V to the NPPA, State Drug Controllers, and dealers. Retailers and dealers must display these price lists conspicuously. Key Points / Main Content: Pricing Fixation: * Retail prices for specified formulations are fixed as per column 6 of the table, excluding goods and services tax. * These prices apply to manufacturers who have submitted Form I for price fixation/revision under DPCO, 2013. * Manufacturers of new drugs under paragraph 2(u) of DPCO, 2013, must adhere to the retail prices specified. Tax and Price Calculation: * Manufacturers may add goods and services tax if it is actually paid or payable to the government on the retail price. * Retail prices for packs of formulations must be calculated according to paragraph 11 of DPCO, 2013, using the specified retail price in column 6. Price List and Display: * Manufacturers must issue a price list in Form V to the NPPA through IPDMS, State Drug Controllers, and dealers, as per paragraph 24 of DPCO, 2013. * Retailers and dealers must display the price list and supplementary list in a conspicuous location as per para 24(4) of DPCO 2013. Compliance and Penalties: * Manufacturers/marketing companies must comply with statutory requirements and have the necessary manufacturing licenses. * Non-compliance will result in liability to deposit the overcharged amount with interest under the Essential Commodities Act, 1955, read with DPCO, 2013. Supersession: * This order supersedes any prior orders fixing ceiling or retail prices for the formulations specified in the table. Impact Analysis: Manufacturers: * Impact: Must adhere to the fixed retail prices, calculate pack prices correctly, and issue price lists. Liable for penalties for non-compliance. * Action Required: Fix prices accordingly, issue price lists in Form V, ensure compliance with DPCO 2013 and Essential Commodities Act, 1955. Retailers and Dealers: * Impact: Must display price lists conspicuously for easy access to customers. * Action Required: Display updated price lists and supplementary lists in a prominent location. National Pharmaceutical Pricing Authority (NPPA): * Impact: Responsible for enforcing the order and ensuring compliance. * Action Required: Receive and review price lists, monitor compliance, and take action against non-compliant manufacturers. Consumers: * Impact: Benefit from fixed retail prices for essential medicines. * Action Required: Be aware of the fixed prices and report any discrepancies.

Key Entities Referenced

National Pharmaceutical Pricing Authority: A government regulatory agency in India that fixes and revises prices of pharmaceutical products. Abbreviated as NPPA. Drugs Prices Control Order, 2013: A legal order issued by the Government of India to regulate the prices of drugs. Ministry of Chemicals and Fertilizers: A ministry in the Government of India responsible for the formulation and implementation of policies related to the chemical and fertilizer industries. Department of Pharmaceuticals: A department under the Ministry of Chemicals and Fertilizers, Government of India, that deals with policies and regulations related to the pharmaceutical sector. New Delhi: The capital city of India, where the order was issued. Essential Commodities Act, 1955: An act of the Parliament of India that ensures the supply of certain commodities, including drugs, and empowers the government to control their production, supply, and distribution. Ms Cris Pharma India Ltd.: A manufacturer and marketing company of pharmaceutical formulations. Ms Zuventus Healthcare Limited: A manufacturer and marketing company of pharmaceutical formulations.
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Hkkx ij dher lpw h vkSj iwjd lpw h] ;fn dkbs Z gk]s dks lia nz f“kZr djxs kA ¼M-½ mi;DqZ r xSj vf/kdre dher ¼[knq jk eYw ;½ dsoy mi;DqZ r fuekZrk@foi.ku d s fy, ykx w gS tSlk fd mUgkusa s vkS"k/k ¼ewY; fu;a=.k½ vkn's k] 2013 d s rgr vucq ) eYw ; fu/kkZj.k@l'a kks/ku d s fy, QkWe Z I ij tek fd;k x;k Fkk vkSj ljdkj }kjk fu/kkfZjr lHkh ykx w oS/kkfud vko';drkvks a dh ifwr Z d s v/khu izklfaxd fof/k;k@sa fu;eks a d s vUrxZr tSlk fd dUsnzh;@jkT; ykblfslxa vkWFkksfjVh d s l{ke izkf/kdkjh }kjk eUs;Qw sDpfjxa ykblsal eta jw h d s rgr lca fa/kr fofufeZr fuekZrk@foi.ku dEifu;k a tk s vuiq kyu djrh gSA ¼p½ fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ks a vkSj fofufn"ZV 'krks± dk ikyu ugh a djrh gS a rk s o s vko';d oLrq,¡ vf/kfu;e] 1955 d s lkFk ifBr Mhihlhvk]s 2013 d s izko/kkuk sa d s v/khu C;kt lfgr vf/kiHz kkfjr jkf'k dk s tek dju s d s fy, nk;h gkxsa As ¼N½ bl vkn's k es a mijksDr lkj.kh d s LrHa k ¼2½ e sa dh rRLFkkuh ifzof"V e sa fofufn"ZV 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 iow Z tkjh gq, g]S Lor% gh fujLr gk s tk;saxsA [dk-al-a@200@68@2019@,Q@Qk- l-a 8¼68½@2019@Mhih@,uihih,&fMoh-&II] izlus thr nkl] lgk;d fun's kd¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 3 MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (NATIONAL PHARMACEUTICAL PRICING AUTHORITY) ORDER New Delhi, the 3rd July, 2019 S.O.2300(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 / Marketing Company Price Brand Name (Rs.) (1) (2) (3) (4) (5) (6) 1. Mefenamic acid + Each tablet contains: M/s Cris Pharma (India) 2.76 Paracetamol tablet Mefenamic acid IP 500mg, 1 Tablet Ltd. / M/s Seagull Paracetamol IP 325mg Pharmaceuticals Pvt. Ltd. 2. Mefenamic acid + Each 5ml Suspension contains: M/s Cris Pharma (India) 0.63 Paracetamol Mefenamic acid IP 100mg, 1 ML Ltd. / M/s Seagull Suspension Paracetamol IP 250mg Pharmaceuticals Pvt. Ltd. 3. Glimepiride + Each uncoated bilayered tablet 8.75 Metformin Tablet contains: M/s Windlas Biotech Pvt. Glimepiride IP 2mg 1 Tablet Ltd. / M/s Zuventus Metformin Hydrochloride IP Healthcare Limited 1000mg (in prolonged release form) 4. Glimepiride + Each uncoated bilayered tablet 5.46 Metformin tablet contains: M/s Swiss Garnier Glimepiride IP 1mg 1 Tablet Biotech / M/s Zuventus Metformin Hydrochloride IP 500mg Healthcare Limited (in Sustain Release) 5. Glimepiride + Each uncoated bilayered tablet 7.96 Metformin tablet contains: M/s Swiss Garnier Glimepiride IP 2mg 1 Tablet Biotech / M/s Zuventus Metformin Hydrochloride IP 500mg Healthcare Limited (in Sustain Release) 6. Escitalopram + Each film coated tablet contains: 6.24 Clonazepam tablet Escitalopram Oxalate IP eq. to 1 Tablet M/s Eris Lifesciences Ltd. Escitalopram 5mg, Clonazepam IP 0.5mg 7. Telmisartan + Each film coated tablet contains: M/s Sun Pharma 8.21 Chlorthalidone tablet Telmisartan IP 40mg, Laboratories Limited / 1 Tablet Chlorthalidone IP 12.5mg M/s Sun Pharmaceuticals Industries Limited 8. Glimepiride + Each uncoated bilayered tablet 6.57 Metformin Tablet contains: M/s Windlas Biotech Pvt. Glimepiride IP 1mg 1 Tablet Ltd. / M/s Zuventus Metformin Hydrochloride IP Healthcare Limited 1000mg (in prolonged release form) 9. Gliclazide + Each un coated tablet contains: 6.65 M/s Anphar Organics Pvt. Metformin Tablet Gliclazide IP 80mg 1 Tablet Ltd. / M/s Lupin Limited Metformin Hydrochloride IP 500mg 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.4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] (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/200/68/2019/F/F. No. 8(68)/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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