The National Pharmaceutical Pricing Authority after being satisfied that it is necessary in the public interest so to do, hereby direct that all the concerned manufacturers importers shall comply with the requirements contained in para 21(1) and provide the month-wise production and sale figures for the last 12 months under para 29 of the said Order immediately to the NPPA.

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L.-33004/99 vlk/kj.k EXTRAORDINARY Hkkx II—[k.M 3—mi&[k.M (ii) PART II—Section 3—Sub-section (ii) izkf/dkj ls izdkf'kr PUBLISHED BY AUTHORITY la- 1801] ubZ fnYyh] eaxyokj] flrEcj 9] 2014@Hkkæ 18] 1936 No. 1801] NEW DELHI, TUESDAY, SEPTEMBER 9, 2014/BHADRA 18, 1936 jlk;u vkSj moZjd ea=kky; (vkS"k/ foHkkx) (jk"Vªh; vkS"k/ ewY; fu/kZj.k izkf/dj.k) vkns'k ubZ fnYyh] 9 flrEcj] 2014 dk- vk- 2292¼v½-&tcfd Hkkjr ljdkj ds jlk;u vkSj moZjd ea=kky; ds fnukad 29 vxLr] 1997 ds ladYi l-a 33@7@97&ih vkb&Z I }kjk jk"Vªh; vk"Sk/k eYw ; fu/kkjZ .k ikzf/kdj.k dh LFkkiuk] vU; ckrk as d s lkFk iiz taq vk"Skf/k;k as rFkk fofufefZr;kas d s eYw ; fu/kkZfjr dju s vkSj mue as ifjorZu ;fn dkbs Z gk]as dk s vf/klfwpr dju]s vfu;fa=r vkS"k/kk as vkSj fofufeZfr;k as d s eYw ;k as ij utj j[kus vkSj vkS"k/k ¼ewY; fu;a=.k½ vkns'k ¼Mhihlhvks½ ds izko/kkuksa dk dk;kZUo;u djus ds fy, dh xbZ FkhA 2- tcfd] Mhihlhvks ds mís'; vko';d nokvksa lLrh dherksa ij lHkh ds fy, miyC/k gSa fd ;g lqfuf'pr djus ds fy, gS] vkSj Hkkjr ds ekuuh; mPpre U;k;ky; ds vius fnukafdr 12&11&2002 ds vkns'k esa ,l,yih la[;k 3688@2003 ¼Hkkjr la?k cuke ds- ,l- xksihukFk vkSj vU;½ esa vko';d vkSj thou j{kd nokbZ;ka tks dkuwu dh 'kfDr gS vkSj ewY; fu;a=.k ls ckgj ugha gks ljdkj us ;g lqfuf'pr djus ds fy, funsZ'k fn;s gSa vkSj 3- rFkk tcfd jlk;u ,oa moZjd ea=kky; ds dk-vk la- 1394¼v½] fnukad 30 ebZ] 2013] vko';d oLrq vf/kfu;e] 1955 dh /kkjk 3 vkSj 5 }kjk inz Ùk 'kfDr;k as dk i;z kxs djr s g,q iSjk 21¼1½ vkSj iSjk 29 lfgr Mhihlhvk]s 2013 d s fufn"ZV iSjkxzkQksa ds laca/k esa 'kfDr;ka mDr vkns'k esa dsUnzh; ljdkj dh vksj ls ,uihih, ds ikl lkSi fn;k gSA 4- rFkk Mhihlhvks] 2013 ds iSjk 21¼1½ e sa vU; ckrk sa ds lkFk vf/kd`r gS] tcfd ljdkj vuqlfwpr fofufeZfr;k sa vkSj vulq fwpr fofufefZr;k as e as vra fo"ZV lfØ; Hk"skftd vo;ok as dk mRiknu vkSj miyC/krk dk s ekuhVj djxs h vkSj vulq fwpr fofufefZr;kas vkjS vulq fwpr fofufefZr;k as e as vra fo"ZV lfØ; Hk"skftd vo;ok as d s fofuekrZ k bl vkn's k d s i:z i&III e as ;Fkk foojf.kr frekgh lpw uk nxs kA 5- rFkk tcfd Mhihlhvks] 2013 ds iSjk 29 e sa izko/kku gS fd izR;sd fofuekZrk lfØ; Hks"kftd vo;ok sa ds O;fDrxr foØ; ;k mld s }kjk fofufeZr ;k vk;kfrr vkSj mld s }kjk foif.kr vkS"kf/k;k as dk iziqta ] tk s Hkh ekeyk gk]s dk vfHky[s k j[kxs k vkSj fofufeZfr;k as d s ;fwuVk as vkSj iSdk as vkSj ljdkj }kjk le;≤ ij ;FkkfunZsf'kr ,ls s vU; vfHky[s k Hkh j[kxs k vkSj ljdkj dk s fdlh vfHkys[k dh ekax djus vkSj fofuekZrk ds ifjlj ij ,sls vfHkys[k ds fujh{k.k djus dh 'kfDr gksxhA 6- rFkk tcfd bl laca/k esa ljdkj us 'kfDr;ka tks ,uihih, dks lkSi nh gS] vkSj ,uihih, ;g Hkh ns[ksxk fd gj fuekZrk mRiknu Lrj vkSj nokvksa dh i;kZIr vkiwfrZ cuk, j[kus ds fy, vkSj ;g Hkh lqfuf'pr djsxk fd oks Mhihlhvks] 2013 ds 3590 GI/2014 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] vUrxZr vuqlwph&II ds QkWeZ&III esa frekgh lwpuk izLrqr dj jgk gS] blds vykok ljdkj@vkSj fujh{k.k djus ls igys fuekZrk rRlaca/kh mRiknu ls lacaf/kr fjdkMZ rS;kj j[kuk gksxkA 7- rFkk tcfd dqN vko';d nokbZ;ka vFkkZr~ ,aVh Lusd osue] jscht+ bE;quksXykscqfyu] ,yC;wfeu bUtsD'ku vkSj ,aVh eysfj;y ds dEchus'ku ds lYiQkMksDlhu$ik;fjfeFkkekbu xksfy;ksa dh eysfj;k vkSj jks/h la;kstu dh deh Mhihlhvks] 2013 ds rgr vHkko esa ,uihih, ds ikl fu;fer fjiksfV±x esa crk;k x;k gS vkSj ,slk izrhr gksrk gS fd blls lacaf/r fuekZrkvksa ns'kh cktkj vkSj@;k laLFkkvksa esa bu nokvksa dh lkekU; vkiwfrZ ugha cuk, j[k jgs gS] blfy, bl rjg ds egRoiw.kZ vkSj vko';d nokvksa dh miyC/r ns'k ds dbZ fgLlksa dks izHkkfor dj jgh gSA 8- blfy, vc dk-vk la- 1394(v)] fnukad 30 ebZ] 2013 dks jlk;u ,oa moZjd ea=kky;] Hkkjr ljdkj }kjk tkjh vkS"kf/ (ewY; fu;a=k.k) vkns'k] 2013 ds ,uihih, us vko';d oLrq vf/kfu;e] 1955 dh /kjk 3 vkSj 5 }kjk iSjk 21(1) vkSj iSjk 29 lfgr Mhihlhvks] 2013 ds fufnZ"V iSjkxzkQksa ds laca/k esa iznÙk 'kfDr;ksa dk iz;ksx djrs gq,] tufgr esa tkjh djrs gq, larq"V gS fd ,slk djuk vko';d gS fd blds }kjk lHkh lacaf/r i{kksa ds fuekZrkvksa@vk;rdksa iSjk 21(1) esa fufgr vko';drkvksa ds lkFk vuqikyu djrs gq, Mhihlhvks] 2013 ds iSjk 29 ds vUrxZr mDr vkns'k ds rgr vfUre 12 eghuksa dh mRikn vkSj fcØh vkadM+s izfr ekg ds miyC/ djk;sxkA lHkh fuekZrkvksa@vk;krdksa dks rqjUr mi;ZqDr iSjk 7 esa fufnZ"V vko';d nokvksa ls lacaf/kr deh ds lek/ku ds fy, ,d vuqikyu fjiksVZ ,uihih dh bl vf/lwpuk ds tkjh gksus ds 96 ?kaVksa ds vUnj izLrqr djsxkA 9- mi;qZDr iSjk 8 dh vlQyrk@vuqikyu u gksus dh fLFkfr esa fuekZrk@foi.ku dEiuh@vk;rd vko';d oLrq vf/fu;e] 1955 ds izklafxd izko/kuksa ds rgr naMkRed dkjZokbZ ds fy, mÙkjnk;h gksaxsA 10- mDr fofufeZfr;ksa ds fy, fuekZrk@foi.ku dEiuh bl vkns'k vkSj blesa mYysf[kr 'krks± ds izfr la;qDr ,oa xaHkhj :i ls mÙkjnk;h gksaxsA [dk-al-a@150@18@2014@fo@iQk- l-a 15(3)@2014@fMoh--III@,uihih,] bUtsVh Jhfuokl] v/;{k MINISTRY OF CHEMICALS AND FERTILIZERS (Department of Pharmaceuticals) (NATIONAL PHARMACEUTICALS PRICING AUTHORITY) ORDER New Delhi, the 9th September, 2014 S.O. 2292(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 revisions, if any, of drugs, monitor the prices and availability of scheduled and non-scheduled drugs and oversee the implementation of the provisions of the Drugs (Price Control) Order (DPCO); and 2. Whereas the aim of the DPCO is to ensure that essential drugs are available to all at affordable prices, and the Hon’ble Supreme Court of India vide their Order dated 12.11.2002 in SLP no. 3668/2003 (Union of India vs K.S. Gopinath & others) have directed the Government to ensure that essential and life saving drugs do not fall out of the price control, which has the force of law; and 3. And whereas the Ministry of Chemicals and Fertilizers vide S.O.1394(E), dated the 30th May, 2013, in exercise of the powered 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 21(1) and para 29 of the said order to be exercised by the NPPA on behalf of the Central Government. 4. And whereas para 21(1) of DPCO inter alia authorises that the Government, shall monitor the production and availability of scheduled formulations and the active pharmaceutical ingredients contained in the scheduled formulation and the manufacturer of scheduled formulations and the active pharmaceutical ingredients¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 3 contained in the scheduled formulation shall furnish the information as stated in Form-III of schedule-II of this Order quarterly. 5. And whereas para 29 of DPCO provides that every manufacturer shall maintain records relating to the sales of individual active pharmaceutical ingredients or bulk drugs manufactured or imported and marketed by him, as the case may be, and the sales of formulations units and packs and also such other records as may be directed from time to time by the Government and the Government shall have the power to call for any record and to inspect such records at the premises of the manufacturer. 6. And whereas the NPPA, which has been delegated with the powers of the Government in this regard, is of the considered view that every manufacturer shall maintain the production level and adequate supply of the medicines and also ensure submission of the information in Form-III of the Schedule–II of the DPCO, 2013 quarterly. Further the manufacturer shall keep the records ready for producing before the Government and / or inspection thereof. 7. And whereas the scarcity of certain essential medicines, namely, Anti-Snake Venom, Rabies vaccine, Rabies Immunoglobulin, Albumin Injection and Anti-malarial combination of Sulfadoxine + Pyrimethamine Tablets has been reported to the NPPA and in absence of regular reporting under DPCO, 2013 by the manufacturers it appears that the concerned manufacturers are not maintaining normal supplies of these medicines in domestic market and/or Institutions. Hence, the availability of such vital and essential drugs has been affected many parts of the country. 8. Now, therefore, in exercise of the powers delegated under para 21(1) and para 29 of the Drugs (Prices Control) Order, 2013 vide S.O. No. 1394(E) dated 30th May, 2013 issued by the Government of India in the Ministry of Chemicals and Fertilizers, in exercise of powers conferred by section 3 and 5 of the Essential Commodities Act, 1955, the National Pharmaceutical Pricing Authority after being satisfied that it is necessary in the public interest so to do, hereby direct that all the concerned manufacturers / importers shall comply with the requirements contained in para 21(1) and provide the month-wise production and sale figures for the last 12 months under para 29 of the said Order immediately to the NPPA. All the manufacturers / importers of the essential medicines specified in para 7 above shall also submit a compliance report of resolving the shortage of these drugs in the country immediately but not later than 96 hours from the date of issuance of this notification to NPPA. 9. In case of failure / non-compliance of para 8 above, the manufacturer/marketer/importer shall be liable for penal action under the relevant provisions of Essential Commodities Act, 1955. 10 The manufacturer/importer/marketing company for the above said formulation(s) shall be jointly and severally responsible to comply with this order and conditions mentioned hereinabove. [PN/150/18/2014/F./F. No. 15(3)/2014/Div-III/NPPA] INJETI SRINIVAS, Chairman Printed by the Manager, Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.