Drug and price controle order

The drug price control order (DPCO) is an order issued by
the government under the Essential Commodities Act which
enables it to fix the prices of some essential bulk drugs and
their formulations
 The origin of this control dates back to 1970 when for the
first time the government placed limits on profitability of
pharmaceutical companies.

1. DRUG AND PRICE CONTROL ORDER MR.SHUBHAM SHARMA DEPARTMENT OF PHARMACEUTICS M.PHARM IIMT UNIVERSITY MEERUT

2. INTRODUCTION  The drug price control order (DPCO) is an order issued by the government under the Essential Commodities Act which enables it to fix the prices of some essential bulk drugs and their formulations  The origin of this control dates back to 1970 when for the first time the government placed limits on profitability of pharmaceutical companies.

3. OBJECTIVES  To achieve adequate production  To regulate equal distribution  To maintain and increase supply of bulk drugs and formulations  To make these available at fair prices.

4. DEFINATION  BULK DRUGS :- It means any pharmaceutical, chemical and biological or plant product conforming to pharmacopoeia standards specified in D & C Act, 1940.  CEILING PRICE :- Price fixed by government for scheduled formulation.  FORMULATION :- Medicine processed out or containing one or more bulk drugs with/without pharmaceutical aid for internal/external use for/in diagnosis, treatment, mitigation or p rev e nti o n of d i se a se in h u ma n /a n im a ls.(n o t i n cl u de a y urv e d i c, si d h h a , unan i , tibbi and homeopathic system of medicine.)

5.  DRUGS :- Substance intended to be used for or in the diagnosis, treatment, or prevention of any disease or disorder in human or animal.  RETAIL PRICE :- Retail price of drugs fixed in accordance with previsions of DPCO 1995 and include celling price.  SCHDULED/NOSCHEDULED BULK DRUGS :- It means bulk drugs specified/not specified in first schedule. Distributor, dealer, retailer, wholesaler, pre tax return, sale turnover.

6. PRICE OF BLUCK DRUGS  Government has power to fix the maximum sale price.  While fixing the sale price government shall take into following considerations:- Post-tax return of 14% on net worth. Return of 22%on capital employed.  On the basic stage of production, post tax return of 18% on net worth or26% on capital employed.  15 days for new bulk drug production  Manufacturer fill detail in from-1 for revision of sale price and government will respond within 4 months.  Manufacture will submit information in form I and II with in 30 days`

7. INFORMATION REQUIRED FROM MANUFACTURER TO THE GOVERNMENT  For the both scheduled and non-scheduled bulk drugs  List of drugs produced with cost in form 1 and 2 respectively.  But for scheduled bulk drugs it should given by 30 th September every year

8. RETAIL PRICE OF FORMULATION  Formula for calculation:--  R.P= (M.C+C.C+P.M+P.C.) x (1+ MAPE/100)+ED.  Wh er e , R.P= Retail price M.C= material cost C.C= conversion cost P.M= packaging material cost P.C= packing charges E.D= excise duty MAPE= maximum allowable post manufacturing expenses

9. WITHOUT APROVAL OF GOVERNMENT  Manufacturer should not increased retail price of drug.  Manufacturer should not marketed new formulation.  No person shall sell imported scheduled formulation.

10. CONTROL OF SALE PRICES OF BULK DRUG AND FORMULATION  No person or retailer shall sale the drug / formulation to any customer at increasing price specified In current price list indicated on container label.

11. SALE OF SPLIT QUANTITY OF FORMULATION  No dealer shall sell the loose quantity of formulation  At price exceeding pro –rata prices of formulation plus 5%.

12. OFFENCES OF PENALTIES  Shall be punishable with imprisonment for one year and also liable to find  In the case of any other order with imprisonment for not less than three months but which may extend to seven years and also liable to fine.  Retail price not to exceed or local taxes extra

13. REFENCES  A text book of Forensic Pharmacy , B.M. Mithal, Vallabh Prakashan, page no 172 to 176.  Forensic Pharmacy, B.S Kuchekar, A.M Khadatare, S.C Itkar, Nirali Prakashan 3.1 to 3.18  http:/ /seednet.go v .in/m aterial/E s senta i l _ C o m m od i ty_Act_19 55 .

14. THANK YOU