F.NO. 8 (48)/2003/DP/NPPA-Div.II

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

NEW DELHI, DATED THE 9/7/2003

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. 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 (7) of the Table hereto annexed as the retail price/revised retail price, exclusive of local tax 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;

TABLE

2. 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.

3.(a)     The prices fixed/revised are the maximum retail prices (inclusive of excise duty and exclusive of local taxes, if any) for the specified pack and packs of similar strength, and companies cannot claim exemption on any ground therefrom, unless specifically permitted by the Government/NPPA through an order.

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

4. 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.
5. The Ceiling Prices fixed for Prednisolone based formulation packs (Sl. No. 1 to 5) will not be applicable in this case.

6.(a)     The prices given in column 7 of the above table (Sl. No. 1 to 5) will remain valid subject to the condition that the company will captively consume the bulk drug Prednisolone produced by it. Thereafter in a year it shall maintain atleast the following ratio of production of formulations between indigenously produced and imported bulk drug :

(i)     Indigenous 80%

(i)     Import based 20%

(b)     For any deviation from the above ratio the company will be required to deposit the differential accrued and deposit the same to the Central Government as may be determined by the NPPA based on the cost of imported bulk drug in a year.

(c)     The company is required to submit quarterly report on production/consumption of bulk drug / formulation as per proforma by 10th January, Arpil, July and October of its preceeding quarter to the Government/NPPA in respect of use of domestic as well as imported bulk drug in their formulations.

(S. K. BHATT)
Dy. Director

PN/70/2003/F
M/s WYETH LEDERLE LTD.