National pharmaceutical pricing athourity (nppa)
Published on: Mar 3, 2016
Transcripts - National pharmaceutical pricing athourity (nppa)
National Pharmaceutical Pricing Authority ( NPPA ) Submitted to:- Submitted by:- Dr. Arun Nanda Hari Om Dept. of P’ceuticals DRA 1st sem sciences, Roll No.-1454 M.D.U, Rohtak M.D.U, Rohtak
INTRODUCTIONNPPA is an organization of the Government ofIndia to fix/ revise the prices of controlledbulk drugs and formulations and to enforceprices and availability of the medicines in thecountry, under the Drugs (Prices Control)Order, 1995.
The Gazette of India - Extraordinary PART II - Section 3 - Sub-Section (ii) Ministry of Chemicals and Fertilizers Department of Chemicals and Petrochemicals New Delhi, dated the 6th January, 1995 ORDER S.O. 18 (E). : In exercise of the powers conferred by section 3 of the Essential Commodities Act, 1955 (10 of 1955), the Central Government hereby makes the following Order, namely:- This Order may be called the Drugs (Prices Control) Order, 1995. It shall come into force on the date of its publication in the Official Gazette
ORGANIZATION Chairman Member SecretaryAdvisor (pricing) Director (Admin. Director Division) (monitoring Bulk &enforcement Director division) drugs (Formulation division) Director (legal division)
Functions of National PharmaceuticalPricing Authority To implement and enforce the provisions of the Drugs (Prices Control) Order. To deal with all legal matters arising out of the decisions of the Authority. To undertake and/ or sponsor relevant studies in respect of pricing of drugs/ pharmaceuticals. To render advice to the Central Government on changes/ revisions in the drug policy. To render assistance to the Central Government in the parliamentary matters relating to the drug pricing.
PROCEDURE FOR PRICEFIXATION / REVISION OF BULK DRUGS As per par 3 of DPCO, 1995 prices of scheduled bulk drugs are fixed by the NPPA.Following steps are involved in fixation/revision of bulk drug prices :-Step1: Identification of bulk drugsDrug taken up for study on the basis of:-- validity period- concerned manufacturer/company- Drug produced in the country for which no price has been notified under DPCO,1995
Step 2:Collection of data Data is collected by issuing questionnaire/Form I of DPCO, 1995/cost-audit report etc. and verification by plant visits, if required.Step 3 : Preparation of actual cost statement Prepare on basis of data submitted / collected & verified during plant visit.Step 4 : Preparation of Technical Parameters Technical parameters are prepared based on data submitted and collected. Plant capacity is assessed considering 330 working days for normal operation of plant leaving 35 days for scheduled maintenance of plant. The achievable production level is considered at 90% utilisation of assessed capacity allowing 10% production loss on account of unforseen break down.
Step 5 : Preparation of Estimated Cost The estimated cost for the pricing period are then prepared based on actual cost & the technical parameters. While projecting the future cost, an increment is recognized at 5% per annum in respect of salaries & wages. The customs duty and other taxes as per the current budget are considered.Step 6 : Calculation of Fair price of bulk drug Fair price is calculated by providing returns as specified in sub para (2), para 3 of DPCO, 1995.
Step 7 : Fixation of maximum sale price of the drug When the number of manufacturers of the said drug is more than one, the maximum sale price is fixed at 2/3rd cut off level or weighted average price, depending upon the situation.Step 8 : Notification of bulk drug price in official Gazette
Procedure for Pricing ofFormulations Prices of formulations based on scheduled bulk drugs are fixed in two ways:- (A) Based on applications of the manufacturers and (B) On suo-motu basis. As per para 8 (2) of Drug (Prices Control) Order (DPCO), 1995, a manufacturer using scheduled bulk drug in his formulation is required to apply for fixation of price of formulation within 30 days of fixation of price of such bulk drug (s). The time frame for granting price approval on formulation is 2 months from the date of receipt of the complete information from the company.
Procedure :A.(a) Examination of Technical Parameters Checking the Quantity of Bulk Drug as per label claim. The overage claim is allowed as per batch production record or norms fixed by Govt. (b) Examination of Prices of Bulk Drug When notified price of bulk drug exists, the notified price or actual price is considered. In the case of imported bulk drug used in the formulation, weighted average import price is considered vis-à-vis the price submitted by the applicant
(c) Examination of Excipient claims(d) Examination of PL, CC, PC and PM cost Are considered as per the norms notified in the Gazette vide S.O. 578(E) dated 13.07.99.(e) Application of MAPE Maximum allowable post manufacturing expenses (MAPE) is given at 100% on the ex-factory cost for indigenous formulation, while MAPE up to 50% of the landed cost is allowed for imported formulation.
(f) Working out the retail price The retail price of formulations are worked out as formula given in para 7 of DPCO, 1995 "R.P. = [M.C. +C.C.+P.M.+P.C.] x [1+MAPE/100] +E.D.", (B). Suo - Motu Cases If the manufacturers or companies do not apply for revision of formulation prices as required under Para 8(2) of DPCO, 1995 within a period of 30 days of price reduction of bulk drug or fall in other statutory levies, steps are taken for suo-motu revision. Broadly the procedure given above is followed.