This document is a Corrigendum Order (S.O. 2062E) issued by the National Pharmaceutical Pricing Authority (NPPA), Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India, dated June 9, 2016. It amends the NPPA's earlier notification S.O. 1993E, dated June 3, 2016, regarding ceiling prices for pharmaceutical formulations in Non-PVC packaging.
The amendment specifies that manufacturers intending to avail the ceiling prices for Non-PVC packaging must apply to the NPPA with supporting documentation to demonstrate that their packaging meets specific criteria: (i) self-collapsible, (ii) without air vents, and (iii) with no chance of contamination at manufacturing and admixing levels. Manufacturers must seek and obtain approval for admissibility of prices for Non-PVC packaging by approaching NPPA and demonstrating such features. If these conditions are not met and prior approval not taken, the ceiling price applicable to PVC packaging will also apply to the Non-PVC packaging.
The order number is PN164322016/F. No. 8322016/D.P.NPPA/Div. II and is issued by Baljit Singh, Assistant Director.
Key Entities Referenced
National Pharmaceutical Pricing Authority: A department under the Ministry of Chemicals and Fertilizers, responsible for pharmaceutical price regulation in India.
Ministry of Chemicals and Fertilizers: The Indian government ministry responsible for the formulation and implementation of policies related to the chemical and fertilizer industries.
Department of Pharmaceuticals: A department within the Ministry of Chemicals and Fertilizers that deals with policy related to pharmaceuticals.
New Delhi: The location of the National Pharmaceutical Pricing Authority and the place where the corrigendum order was issued.
Gazette of India: The official journal of the government of India, publishing official notifications and legal announcements.
NonPVC packaging: A type of packaging material used for pharmaceutical formulations, different from PVC packaging, and subject to specific pricing regulations.
PVC packs: Polyvinyl chloride packaging, a type of packaging for which pricing is regulated in the pharmaceutical industry.
Baljit Singh: Assistant Director at D.P. NPPA, signatory of the order.
jftLVªh laö Mhö ,yö&33004@99 REGD. NO. D. 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- 1459] ubZ fnYyh] 'kqØokj] twu 10] 2016@T;s"B 20] 1938
No. 1459] NEW DELHI, FRIDAY, JUNE 10, 2016/JYAISTHA 20, 1938
jlk;u vkSj moZjd ea=ky;
¼vkS"k/k foHkkx½
¼jk"Vªh; vkS’k/k ewY; fu/kkZj.k izkf/kdj.k½
”kqf)i= vkns”k
ubZ fnYyh] 9 tuw ] 2016
dk-vk- 2062¼v+½-&jk’Vªh; vk’Sk/k eYw ; fu/kkZj.k izkf/kdj.k d s dk-vk- l-a 1993¼v½ fnukda 3 tuw ] 2016 vlk/kkj.k
jkti= d s ukVs ¼M½+ e sa fuEu izfrLFkkiu fd;k tkrk g S %
^^ukWu ihohlh idS ftxa gsrq fu/kkfZjr eYw ; dk ykHk izkIr dju s gsrq vkS’kf/k fuEkkZrkvk sa dk s fu/kkZfjr fof”kf’V;k sa d s leFkZu
e sa vko”;d vfHky[s kk sa d s lkFk ,u-ih-ih-, dk s vkons u izLrqr djuk gkxs kA^^
bl izdkj ukVs % ¼M½+ fuEUk :Ik e sa i<+k tk;xs k %
¼M½+ ukWu ihohlh iSdftxa ds fy, mi;qZDr lkj.kh d s LrHa k 5 esa fofufnZ’V vf/kdre dher d s fy, fuEu fof”kf’V;k a
vko”;d gkxsa h (i) Lo; a fleVu s (ii) ,;j oVsa ugh a gkus s (iii) fuekZ.k ,o a ,MfefDlxa Lrjk sa ij lna ’wk.k dh lHa kkouk u gkus s
oky s iSdA ukWu ihohlh idS ftxa gsrq fu/kkZfjr eYw ; dk ykHk izkIr dju s gsrq vkS’kf/k fuEkkZrkvk sa dk s fu/kkZfjr fof”kf’V;k sa d s
leFkZu e sa vko”;d vfHky[s kk sa d s lkFk ,u-ih-ih-, dk s vkons u izLrqr djuk gkxs k vU;Fkk ihohlh idS d s fy, vf/kdre dher
bl rjg d s ukWu&ihohlh idS fstxa d s fy, Hkh ykx w gkxs hA
[ih,u@164@32@2016@,Q@Qk- l-a 8¼32½@2016@Mh-ih@,uihih,&fMoh-& II]
cythr flga ] mi fun”s kd
2964 GI/2016 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals)
(NATIONAL PHARMACEUTICALS PRICING AUTHORITY)
New Delhi, the 9th June, 2016
CORRIGENDUM ORDER
S.O. 2062(E).—In the National Pharmaceutical Pricing Authority's notification S.O. 1993(E),
dated 3rd June, 2016, published in the Gazette of India, Extraordinary, following shall be inserted in
Note (e):
“The manufacturer intending to avail the ceiling prices for such Non-PVC packaging shall
approach NPPA alongwith documents supporting such features, demonstrate and take approval for
admissibility of prices for Non-PVC packaging.”
Therefore the Note (e) shall be read as follows:
“(e) For formulation in Non-PVC packaging, ceiling price mentioned in column (5) of the
above said table shall be admissible provided such packs are (i) self collapsible; (ii) not having air-
vent; and (iii) there is no chance of contamination at manufacturing as well as admixing levels. The
manufacturer intending to avail the ceiling prices for such Non-PVC packaging shall approach
NPPA alongwith documents supporting such features, demonstrate and take approval for
admissibility of prices for Non-PVC packaging. Otherwise the ceiling price for PVC packs shall be
applicable for such Non-PVC packaging also.”
[PN/164/32/2016/F/F. No. 8(32)/2016/D.P./NPPA-Div. II]
BALJIT SINGH, Assistant Director
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.