Drug pricing is a complex phenomena. Different countries have different methodologies of pricing such as Germany has reference based pring. Canada has system of fixing pricing of patented drugs. India fix the prices of prescription drugs on the basis of cost of the drug. Cost is the main phemomena iin the pricing policies of the drugs. Pricing is important aspect of competition law also. But competition commission is not a price control agency. However price based anti-competitive practices are important area in competition law. DRUG REGULATORY REGIME IN INDIA
Indian drug regulatory regime is devided in two branches. Drug standards and marketing is dealt by CDCSO and drug pricing is controlled by NPPA. The CDSCO prescribes standards and measures for ensuring the safety, efficacy and quality of drugs, cosmetics, diagnostics and devices in the country; regulates the market authorization of new drugs and clinical trials standards; supervises drug imports and approves licences to manufacture the drugs. The process for drug approval entails the coordination of different departments, in addition to the DCGI, depending on whether the application in question is for a biological drug or one based on recombinant DNA technology. The issues relating to patent are dealt by Department of Industrial Policy and Promotion. The Drugs Controller General of India (DCGI), who heads the Central Drugs Standards Control Organization (CDSCO), assumes responsibility for the amendments to the Acts and Rules. Other major related Acts and Rules include the Pharmacy Act of 1948, The Drugs and Magic Remedies Act of 1954 and Drug Prices Control Order (DPCO) 1995 and various other policies instituted by the Department of Chemicals and Petrochemicals. PRICING REGULATION IN INDIA
The drug prices are regulated under Essential Commodities Act 1955. It is administered by Department of Chemicals and Petrochemicals, Ministry of Chemicals and Fertilizers. The prices of drugs...
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