FORMAT FOR STATE DRUG CONTROLLER FOR SEEKING INFORMATION FROM THE DRUG COMPANY IN RESPECT OF PRICE APPROVAL FOR THE SCHEDULED FORMULATION

F.No.……………………

State Drug Controller

……………………..

……………………..

To,

            M/s. (Name of the Company & Address)

……………………..

……..……………………..

Sub: –  DPCO’95 Manufacturing & Marketing of Scheduled Formulation without obtaining price approval under Para 8 of DPCO’95.

Sir,

With reference to the scheduled formulation having brand name …………………………..manufactured/ marketed by your company, it is stated that composition of the said formulation are found to contain one or more Scheduled Bulk Drugs specified in first schedule of DPCO’95.

In this connection it is stated that under the provisions of Para 8 of DPCO’95, it is mandatory on the part of the manufacturer/ Importer of the Scheduled Formulations to seek prior approval for the retail price from NPPA. Further, under the provisions of Para 8 of DPCO’95, the manufacturers or importers are required –

(i)         To make an application in form III within 30 days for the price fixation or revision of the scheduled formulation which consist of scheduled bulk drug for which price has been fixed or revised by NPPA/ Government.

(ii)        To obtain price approval from NPPA/ Government of India in case of the new pack of formulation or New Dosage Form of his existing Scheduled Formulation which is not covered under sub paragraph 3 of Para 9 of DPCO’95.

(iii)       To obtain prior price approval from the NPPA/ Government to sell or dispose of any imported Scheduled Formulation.

In view of the above your company is hereby directed to furnish the following information –

1. Copy of the price approval obtained from NPPA/ Government of India in respect of scheduled formulation manufacturered / marketed by your company.
2. In case your company is manufacturing/ marketing a scheduled formulation without prior price approval then reasons for not obtaining the necessary price approval shall be furnished.
3. Copy of the Drug manufacturing License obtained by you for the manufacture and marketing of the above said scheduled formulation.
4. The date from which the above said scheduled formulation has been manufactured by the company with the complete details of the quantity manufactured, sold and the price charged in the sale of the said formulation in the relevant period.

The above said details should be furnished within fifteen days of the receipt of the letter.

Yours faithfully,
Drug Controller

Copy to:    The Director (Monitoring & Enforcement). National Pharmaceutical Pricing Authority, 5^th and 3^rd Floor, YMCA Cultural Centre Building, 1 Jai Singh Road, N. Delhi – 110001.