(Published in Part II, Section 3, Sub-section (ii) of the Gazette of India, Extraordinary)
Ministry of Chemicals and Fertilizers
Department of Pharmaceuticals
S.O. 3156(E)-In implementation of directions given in review order passed by the Department of Pharmaceuticals on 7.7.2014 vide letter no. 31015/11/2014/PI.I on review application filed by M/s. Nitin Life Sciences Ltd. in respect of S.O. No. 945(E) dated 27.03.2014 for fixation of Retail Price of Superspas-RF Injection under DPCO, 2013 and, in exercise of the powers, conferred by paragraphs 5, 11 and 15 of the Drugs (Prices Control) Order, 2013, read with S.O. No. 1394(E) dated the 30th May, 2013 issued by the Government of India in the Ministry of Chemicals and Fertilizers, and in supersession of the above same Order i.e. S.O. 945(E), dated 27th March, 2014, the Government of India in the Ministry of Chemicals and Fertilizers, National Pharmaceutical Pricing Authority (hereby referred as the NPPA), hereby fixes, the price as specified in column (5) of the table hereto annexed as the retail price, exclusive of local taxes, if any, in relation to each of the formulation specified in the corresponding entry in column (2) of the said Table with the strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof; manufactured and marketed by M/s Nitin Life Sciences Ltd. and M/s Seagull Pharmaceuticals Pvt. Ltd. respectively.
(1) (2) (3) (4) (5)
Each ml contains
1. Dicyclomine HCl+ Dicyclomine HCl-10 mg 1 Ampoule 8.06
Diclofenac Sodium+ Diclofenac Sodium - 25 mg (2ml)
Benzalkonium Chloride Benzalkonium Chloride Solution - 0.05% w/v
Injection (as preservative)
(Superspas –RF) Water for Injections – q.s.
(a) The manufacturer of above mentioned formulation i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (5) of the table hereinabove.
(b) The manufacturer may add local taxes only if they have paid actually or it is payable to the Government on the retail price mentioned in the column (5) of the above 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 (5) 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 as per the paragraph 24 (2) of the DPCO, 2013.
(d) Where concerned manufacturer of aforesaid formulation with dosage or strength or both as specified in the above table, launches a new drug as per paragraph 2 (u) of DPCO,2013 then he 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.
(e) The above mentioned retail price is applicable only to the individual manufacturers/marketer as mentioned above i.e. who has applied for the same by submitting Form-I for price fixation / revision as stipulated under DPCO, 2013 and subject to fulfillment of all the applicable statutory requirements as laid down by the Government 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 manufacturers/marketing companies.
(f) In case the retail price of aforesaid formulation is not complied as per instant price notification and notes specified hereinabove in this notification, then the concerned manufacturer/marketing company shall be liable to deposit 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 retail price of the aforesaid formulation as specified in column (2) of the above mentioned table in this notification, the price order(s) if any, issued for concerned manufacturer / marketer prior to the above said date of notification, stand withdrawn.
PN/151/19/2014/F F. No. 8(19)/2014/D.P./NPPA-Div.-II