(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. 3019(E)- In exercise of the powers, conferred by sub-paragraph (1)/(2)/(4) of paragraph 8 of the Drugs (Prices Control) Order, 1995, read with No. S.O. 637 (E) dated the 4th September, 1997 issued by the Government of India in the Ministry of Chemicals and Fertilizers, the National Pharmaceutical Pricing Authority, hereby fixes/revises the prices as specified in column (5) of the table hereto annexed as the retail price/revised retail price, exclusive of excise duty, Sales Taxes/VAT and local taxes, if any, and in column (6) as equivalent MRP inclusive of excise duty, education cess, Sales Tax/VAT in relation to each of the formulation specified in the corresponding entry in column (2) of the said table with the pack size specified in the corresponding entries in column (3) thereof; manufactured/imported by M/s Allergan India Pvt. Ltd.
NPPA in its 128th Authority Meeting held on 21.12.2012 duly considered the aforesaid price fixation order and approved the prices of imported formulations having domestic / indigenous substitute as per the guidelines approved in 121st Authority Meeting held on 22.7.2011 for such imported formulations. Accordingly, prices for concerned imported formulations were approved in public interest under various provisions of the DPCO, 1995, in order to ensure fair and reasonable price to consumer public.
without Excise Duty Excise Duty inclusive
Sales Tax /VAT Sales Tax /VAT of all
and Local Tax, if any and Local Tax, if any taxes
(Rs.) (Rs.) (Rs.)
(1) (2) (3) (4) (5) (6)
“1. Ozurdex/Retina 1 Injectable 52136.18 52136.18 54221.63”
(Dexamethasone intravitreal injection)
Each 0.7mg contains in the
Novadur solid polymer drug delivery
system containing ply (D,L-Lactide-co-glycolide)
PLGA biodegradable plymer matrix
*Subject to actual payment of Government levies/taxes, as applicable.
(a) The prices fixed are the maximum retail prices in column no. (6) (inclusive of excise duty, sales tax/VAT and local taxes if any) for the specified pack and packs of similar strength, and companies cannot claim exemption on any ground there from, unless specifically permitted by the Government/NPPA through an order.
(b) The companies / manufacturers may added taxes only if they have paid actually to the Government on the price mentioned in the column (5). If there is any variation in the MRP (inclusive of the taxes), the same may be intimated to the NPPA in the Form-V of DPCO, 1995.
(c) For different packing material used or, different drug delivery systems or any other special features/forms claimed, the retail prices, as specified in Column No. 5 above, shall be applicable unless the companies approaches NPPA for specific price approvals for its formulations.
(d) The manufacturer and marketing company for the above said formulation shall be required to take the requisite prior approval from the competent Authority for any change in the composition of the above said formulation with written prior intimation to the National Pharmaceutical Pricing Authority.
(e) These prices/revised prices shall be made effective within 15 days of receipt of this order as required under sub para 14(1) of DPCO, 1995. The necessary price-list should also be issued as required under sub-paragraph (3) of paragraph 14 of the Drugs (Prices Control) Order, 1995.
(f) These prices fixed/notified hereinabove under the provisions of DPCO, 1995 have to be mandatorily implemented by the manufacturing/marketing company notwithstanding its status of compliance of conditions for such formulation pack under the Drugs and Cosmetics Act, 1940.
(g) The manufacturer or marketing company not complying with the ceiling prices and conditions specified in notes hereinabove within 15 days from the date of above said notification, shall be liable to deposit overcharged amount along with the interest under the provisions of the DPCO, 1995 read with the EC Act, 1955.
PN/128/2012/F F. No. 8(37)/2012/D.P./NPPA-Div.-II