(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 Pharmaceutical Pricing Authority

New Delhi, the 9^th November, 2015

ORDER

S.O. 3021(E)- In implementation of directions given in line with review order passed by the Department of Pharmaceuticals in respect of M/s. Abbott Healthcare Pvt. Ltd. vide letter no. 31015/23/2015-PI.I dated 09.9.2015 in respect of Chloroquine Phosphate Injection.

Therefore, in respect of above mentioned price fixation and, in exercise of the powers, conferred by paragraph 4, 10, 11, 14 and 16 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated the 30^th May, 2013 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) S.O. 3790(E) dated 20^th December, 2013 and S.O. 834(E) dated 25^th March, 2015, in so far as it relates to formulation packs mentioned in the table below, except in respect of things done or omitted to be done before such supersession, the National Pharmaceutical Pricing Authority, hereby fixes the prices as specified in column (5) of the table herein below as ceiling prices 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 specified respectively in the corresponding entries in columns (3) and (4) thereof:

Table

(a)        All the existing manufacturers of above mentioned scheduled formulations having MRP lower than the ceiling price specified in column (5) in the above table plus local taxes as applicable, if any, shall continue to maintain the existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013.

(b)        All the manufacturers are required to follow and ensure to revise their Maximum Retail price (MRP) (inclusive of excise duty and all taxes) of all formulation packs downward, pursuant to Ministry of Finance (Department of Revenue), vide Notification No. 14/2015 and 15/2015 –Central Excise dated 1st March, 2015 read with the NPPA notification S.O. 776(E) dated 17.3.2015.

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

(d)        The ceiling price for a pack of the scheduled formulation shall be arrived at by the concerned manufacturer in accordance with the ceiling price specified in column (5) of the above table as per provisions contained in paragraph 11 of the Drugs (Prices Control) Order, 2013. The manufacturer shall issue a price list in Form–V as per the paragraph 24 (2) of the DPCO, 2013.

(e)        The manufacturer availing of the revised ceiling price as per WPI shall report to the Government in Form II of Schedule II to Drugs (Price Control) Order, 2013 within a period of 15 days of such revision.  Non submission of Form II in this regard shall be construed as non-revision in MRP as per WPI and the concerned manufacturers shall be liable to deposit the amount charged over and above the pre-revised MRP along with interest thereon from the date of overcharging.

(f)         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 then 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.

(g)        The manufacturers of above said scheduled formulation shall furnish quarterly return to the NPPA, in respect of production / import and sale of scheduled formulation in Form-III of Schedule-II of the DPCO, 2013. Any manufacturer intending to discontinue 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.

(h)        The manufacturer not complying with the ceiling price and notes specified hereinabove shall be liable to deposit the overcharged amount along with the interest thereon under the provisions of the Drugs (Prices Control) Order, 2013 read with the Essential Commodities Act, 1955.

(i)         Consequent to the issue of ceiling price of the scheduled formulation as specified in column (2) of the above table in this notification, the price order(s) if any, issued prior to the above said date of notification, stand superseded.

PN/157/25/2015/F

F. No. 8(25)/2015/D.P./NPPA-Div.-II

      (ANAND PRAKASH)

                                                                                                                     Deputy Director