F. NO. 8 (7)/2007/DP/NPPA-Div.II

GOVERNMENT OF INDIA
MINISTRY OF CHEMICALS AND FERTILIZERS
NATIONAL PHARMACEUTICAL PRICING AUTHORITY

NEW DELHI, DATED THE 05/02/2007

ORDER

In exercise of the powers, conferred by sub-paragraph (1)/ (2) /(4) of paragraph 8 of the Drugs (Price Control) Order 1995 read with No. S.O. No. 637(E) dated 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 here to annexed as the retail price, exclusive of excise duty, Sales Tax/ VAT and local taxes, if any in relation to each of the formulations specified in the corresponding entry in Column 2 of the said table with pack size specified in the corresponding entries in Column (3) thereof.

This order is hereby issued in compliance of the directions contained therein Order No. 5/46/2006-PI.I. dated 22/23.01.2007 of Department of Chemicals & Petro-Chemicals in the Review Application of Hindustan Antibiotics Ltd. (HAL), Pimpri, Pune passed by the Department of Chemicals & Petro-Chemicals against the notification No. S.O.513(E) dated 19.05.2006 of NPPA notifying the price of bulk drug Benzathine Penicillin G, the price of the related formulations based on the said bulk drug are hereby revised with immediate effect.

TABLE

3. This order shall be applicable if the manufacturer of the formulation specified in column (2)of the Table above has complied with the requirements, if any, of

(a)         the Drugs and Cosmetics Act, 1940 (23 of 1940) and the rules made thereunder; and

(b)         the Industries (Development and Regulation) Act, 1951 (65 of 1951) as amended from time to time.

4.(a)     Excise Duty, sales taxes/VAT and local taxes, if any, shall be worked out by the company concerned as per the rate applicable and added in the retail price / revised retail price specified in column no (5) of the above table to arrive at the MRP inclusive of all taxes.

(b)     The prices fixed/revised is the Maximum Retail Prices (excluding of excise duty, sales taxes/VAT and of local taxes, if any) for the specified pack and packs of similar strength. Companies cannot claim exemption on any ground therefrom, unless specifically permitted by the Government/NPPA through an order.

(c)        For different packing material used or any special feature claimed, companies are required to approach NPPA for approval/fixation of specific prices.

5. These prices/revised prices shall be made effective immediately. The necessary price-list should also be issued as required under sub-paragraph (3) of paragraph 14 of the Drugs (Prices Control) Order, 1995.
6. The ceiling price(s) fixed under para 9 of Drugs (Prices Control) Order, 1995 for Benzathine Pencillin G based formulation will not be applicable in this case until this order is revised/or rescinded.
7. The company is required to submit quarterly report on production, captive consumption of bulk drug for the production of formulation as per proforma by 10th January, April, July and October of its preceding quarter to the Government / NPPA in respect of Benzathine Pencillin G.
8. The manufacturers using the bulk drug Benzathine Pencillin G produced by M/s HAL Ltd. in their derivative formulations would also be allowed the price mentioned in the table given under Para 2 above in Column(5) subject to condition that the respective formulators submit the documentary evidence regarding its procurements of the said bulk drug from M/s HAL to the Govt./NPPA

(A. K. PAL)
Dy. Director

N/91/2007/F
M/s. HAL, Pimpri, Pune for information and further necessary action.

Copy to :
Sh. Gurdeep Singh, Director (PI)in compliance of the order contained in letter No. 5/46/2006-PI-I dated 22/23.01.2007 of the Deptt. of C&PC in the review application of Hindustan Antibiotics Ltd. (HAL), Pimpri, Pune against notification No. S.O.513 (E) dated 19.5.206 of NPPA fixing the price of Bulk Drug Benzathine Penicillin G.