(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 24^th February, 2016

ORDER

S.O. 580(E) –  In implementation of directions given in review order passed by the Department of Pharmaceuticals in respect of M/s Bharat Serums and Vaccines Limited vide letter no. 31015/82/2013/PI.I dated 28.10.2015 in respect of Antitetanus Human Immunoglobulin Injection 250 IU/pack and 500 IU/pack.

Therefore, in exercise of the powers, conferred by paragraph 4, 6, 10, 11 and 14 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, (National Pharmaceutical Pricing Authority) S.O. 3371(E) & 3372(E) dated 5^thNovember, 2013, S.O1156(E) dated 28^th April, 2014 and S.O. 619(E) dated 26^th February, 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

Note :

1. 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.
2. 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.
3. 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 paragraph 24 (2) of the DPCO, 2013.
4. 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.
5. 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.
6. 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 (Price Control) Order, 2013 read with the Essential Commodities Act, 1955.
7. 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/158/26/2016/F

F. No. 8(26)/2016/D.P./NPPA-Div.-II
(BALJIT SINGH)
Assistant Director