(Published in Part II, Section 3, Sub Section (ii) of the 
Gazette of India Extraordinary)

Government of India
Ministry of Chemicals and Fertilizers
Department of Pharmaceuticals
(National Pharmaceuticals Pricing Authority)

                                                                New Delhi, the 24^th June, 2016

ORDER

S.O.2210(E)  – Whereas in line with the directions given in the review order issued vide letter no. 31015/9/2013/PI.I dated 5th June .2016 passed by the Department of Pharmaceuticals in application of review from various pharmaceutical companies against S.O. No. 3127(E) dated 10th December, 2014, ceiling prices of Glucose 5% Injection, Sodium Chloride 0.9% Injection and Glucose 5% + Sodium Chloride 0.9% Injection were fixed by National Pharmaceutical Pricing Authority (i.e. NPPA) vide notification S.O 1993(E) dated 3rd Jun, 2016 and Corrigendum Order 2062(E) dated 09th Jun, 2016.

Whereas the manufacturers have made representations about existing unit volume based pricing system because of which manufacturing of aforesaid formulations in all kind of packaging for few pack sizes has become non remunerative affecting the availability, which may become detrimental to the public interest.

Whereas, the NPPA had convened a meeting for demonstration by the manufacturers claiming entitlement for separate ceiling prices as notified by S.O. 1993(E) dated 3rd Jun, 2016 and Corrigendum Order 2062(E) dated 09th Jun, 2016.

Whereas based on the representation and feedback of various glass and non glass manufactures, and its own examination, NPPA modified the previous categorisation of different types of packaging as (a) glass (b) non glass and (c) non glass with special features.

Whereas NPPA in its a Authority meeting held on 23rd Jun, 2016 has decided to re-fix ceiling price of aforesaid formulations under modfied categories i.e. glass , non glass and separate ceiling prices for specific manufacturers of non glass with special features.

Whereas the Non-PVC (with special features) category packaging have been re-examined taking into consideration more comprehensive features such as: (i) self collapsibility and self-sealability (ii) not having air-vent; and (iii) having no chance of contamination during manufacture/ infusion/ admixing levels alongwith supporting documentation and demonstration.

In exercise of powers, conferred by sub paragraph (3) and (4) of paragraph 11 and paragraph 14 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated the 30th May, 2013, S.O. 1192(E) dated 22nd March, 2016 issued by the Government of India in the Ministry of Chemicals and Fertilizers and in supersession of the order of the Government of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority) No. S.O. 3127(E) dated 10th December, 2014, S.O. 619(E) dated 26th February, 2015 , S.O. 644(E) dated 2nd March, 2016 and S.O 1993(E) dated 3rd Jun, 2016 read with Corrigendum order S.O 2062 dated 9th Jun, 2016 in so far as it relates to formulation packs of Non-PVC with special feature packaging which hereinafter modified as Non-Glass with special features mentioned in the table herein below manufactured by the manufacturers specified in Table B for specified products and packsize, except in respect of things done or omitted to be done before such supersession, the National Pharmaceutical Pricing Authority, hereby fixes the price as specified in column (5) of the table herein below as separate ceiling price exclusive of local tax applicable, if any in respect of the scheduled formulations specified in the corresponding entry in column (2) of the said Table with the strength and unit/packaging specified respectively in the corresponding entries in columns (3) and (4) thereof:

Table ‘A’

Table ‘B’

NOTE :

(a)        All the existing manufacturers of scheduled formulations, selling the branded or generic or both the versions of scheduled formulations at a price higher than the ceiling price (plus local taxes as applicable) so fixed and notified by the Government, shall revise their prices of all such formulations downward not exceeding the ceiling price specified in column (5) in the above table plus local taxes as applicable, if any.

(b)       The manufacturers may add local taxes only if they have paid actually or if it is payable to the Government on the ceiling price mentioned in column (5) of the above said table.

(c)     The manufacturer shall issue a price list in Form-V in compliance from date of this notification as per paragraph 24 of the DPCO, 2013.

(d)       The ceiling prices fixed herein above will remain valid until revised as per provisions of paragraph 16 and 18 of DPCO 2013, as the case may be.

(e)      Any other manufacturer claiming separate ceiling price for Non-Glass with special feature shall apply to NPPA for separatel ceiling price approval with details and demonstrate, that such pack has all of the features as (i) self collapsibility and self-sealability (ii) not having air-vent; and (iii) there is no chance of contamination during manufacture/ infusion/ admixing levels alongwith documentation and demonstration.

(f)    For other special features claimed or any other pack size manufactured, the manufacturer shall approach the NPPA for specific price approval for its formulations.

(g)     Where an existing manufacturer of scheduled formulation with dosage or strength or both as specified in the above table, launches a new drug as per paragraph 2 (u) of the DPCO, 2013 such existing manufacturer shall apply for prior price approval of such new drug to the NPPA in Form I as specified under Schedule-II of the DPCO, 2013.

(h)        The manufacturers of above said scheduled formulations shall furnish quarterly return to the NPPA, in respect of production / import and sale of scheduled formulations in Form-III of Schedule-II of the DPCO, 2013. Any manufacturer intending to discontinue production of above said scheduled formulation shall furnish information to the NPPA, in respect of discontinuation of the 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)        The manufacturers not complying with the ceiling price and notes specified hereinabove shall be liable to deposit the overcharged amount along with interest thereon under the provisions of the Drugs (Price Control) Order, 2013 read with Essential Commodities Act, 1955.

(j)        Consequent to the issue of ceiling prices of such formulations for specified in column (2) of the above Table A 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/165/33/2016/F

F.No. 8(33)/2016/D.P./NPPA-Div.II

(BALJIT SINGH)
Assistant Director
National Pharmaceutical Pricing Authority