DPCO 1995.pptx

Pharmaceutical Jurisprudence(PJ)

1. DRUG (PRICE CONTROL) ORDER 1995 Prepared by : Priya D. Yannawar

2. Content: Introduction Objective Schedule Definitions retail price of formulation Power to fix retail price of scheduled formulations penalties

3. Introduction This order is governed under Central Government Regulated by Essential Commodities Act, 1955 under section 3. Amendment: Display of price order-1962 Control of price-1963 DPCO-1966 DPCO-1970 DPCO-1979 DPCO-1987 DPCO-1995 DPCO-2013

4. Objective: To achieve adequate production To secure or regulate the equitable distribution To maintain and increase the supplies of bulk drug and formulations To make this available at fair prices.

5. Schedule: There are total three schedule Schedule 1: List of 76 bulk drugs Schedule 2: Form of approval or revision of prices of schedule formulation( form 1 to form 6 ) Schedule 3: Pre tax returns on sale turnover of manufactured importer of formulation as A,B,C category.

6. Definition's: Bulk drugs: Any pharmaceutical, chemical, biological or plant product including its salts and derivatives which conforming to pharmacopoeial standard Ceiling price: price fixed by government for scheduled formulation. Dealer: Person carrying out business of purchase or sale of drugs whether as wholesaler or retailer Distributor: Distributor of drugs or his agents appointed by manufacturer Formulation: Medicine processed out of, or containing one or more drugs with or without pharmaceutical excipients to treat diseases.

7. Continue.. Import: Bringing into India from place outside India Net worth: It means paid up share capital of a company plus free reserve Retail price: It means the retail price of drug fixed in accordance with the provisions of drugs (price control) order Retailer : Means a dealer carrying on the retail business of sale of drugs to customer Scheduled bulk drugs: Bulk drug specified in the first schedule Scheduled formulation: Formulation containing any bulk drug specified in the first schedule either individually or in the combination

8. Retail price of formulation : By applying following formula, retail price of the formulation is calculated by the government: RP = (MC+ CC+ PM+ PC) * ( 1+ MAPE/100) + ED RP = Retail price MC = Material cost CC = conversion cost PM = Cost of packing material PC = packing charges MAPE = maximum allowable post manufacturing expenses ED = excise duty

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10. Power to exempt: Government has power to exempt any manufacturer from the operation of all or any of this order on consideration of all or any of the following factor: Number of worker employed Amount of capital invested Type of product manufactured Sales turnover Production of new drug which has not been produced

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