Drug Pricing and Competition Issues in India Through Dpco and Cdcso Activites

Introduction medicine price is a tortuous phenomena. Different countries have distinct methodologies of pricing such as Germany has consultation found pring. Canada has system of fixing pricing of patented drugs. India fix the prices of prescription(prenominal) drugs on the basis of cost of the drug. salute is the main phemomena iin the pricing policies of the drugs. set is important aspect of competition law also. But competition delegating is not a price control agency. However price ground anti-competitive practices be important ara in competition law. DRUG restrictive 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, capability and quality of drugs, cosmetics, diagnostics and devices in the country regulates the market authorization of immature drugs and clinical trials standards supervis es 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 deoxyribonucleic acid technology.The issues relating to patent are dealt by Department of Industrial form _or_ system of government and Promotion. The Drugs restrainer General of India (DCGI), who heads the Central Drugs Standards obtain 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 sets Control Order (DPCO) 1995 and various other policies instituted by the Department of Chemicals and Petrochemicals. price REGULATION IN INDIA The drug prices are regulated under demand Commodities Act 1955.It is administered by Department of Chemicals and Petrochemicals , Ministry of Chemicals and Fertilizers. The prices of drugs are fixed under the segment 3 of Essential Commodities Act 1955. National rock of essential medicines is on the watch under this Act. The prices are controlled according to Drug Price Order 1995. It employs Cost Based formula of drug pricing. In India Drug manufacturing, standards and marketing is through under Drug and Cosmetics Act 1940. There are Drug and cosmetics overshadow 1945 to assist and provide procedure for the assisiting the Act. NPPA has been reguaslting the drug pricing since 1997.It fixes the prices of essential drugs. The angle of essential medicines is updated at regular intervals. As mentioned earlier, pricing policy and persistence ordination constitutes one of the key responsibilities of the NPPA. Price control on medicines was number 1 introduced in India in 1962 and has subsequently persisted through the Drug Price Control Order (DPCO). As per the directive of NPPA, the criterion for price reg ulation is based on the nature of the drug in terms of whether it enjoys mass use and in terms of whether there is lack of adequate competition for the drug.The yr 1978 witnessed selective price controls based on disease burden and prevalence. The list of prices under DPCO subsequently witnessed a gradual decrease over a period of time. Around 80% of the market, with 342 drugs, was under price control in 1979. The number of drugs under DPCO decreased from 142 drugs in 1987 to 74 in 1995. Drugs with mettle rough sales and a market share of more than 50% are subjected to price regulation. These drugs are referred to as scheduled drugs. The NPPA also regulates the prices of bulk drugs. The MRP call off on medicines was levied by the Finance ministry in 2005.The objective was to increase gross and lower prices of medicines by using fiscal deterrent on MRP. This form may have had some impact in terms of magnifying the return to industries located in the excise free zones. This also succeeded in attracting some small pharmaceutical firms to these zones. (Gehl Sampath 2008, Srivastava 2008). General objective and scope of price regulation in India the general objective of price regulation India is to regulate the good distribution and increasing supply of bulk drugs and formulations in india and making it easy in india. Consequences of excessive pricingImpact of price regualation on indian drug pricing Coverage of drugs in India Prices of formulations based on scheduled bulk drugs are fixed in two ways (i) based on applications of the shapers and (ii) 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 compulsory to apply for fixation of price of formulation within 30 age of fixation of price of such bulk drug (s). Applications received in NPPA from manufacturers in Form III and importers in Form IV of DPCO are considered for price fixation.As per para 8(4), the ti me frame for granting price approval on formulation is 2 months from the date of receipt of the complete information from the company. 2. determine and Competition Issues 3. NPPA pricing methodology a. DPCO 1995 b. National Drug Pricing Policy 2002 c. National Drug Pricing Policy 2006 theatre director General (Investigation and Registration) Vs. Fulford India Ltd. Ishaan Labs (P) Ltd v Union of India Director General (Investigation And Registration) Vs. Parke Davis India Ltd. And Ors. MANU/MR/0039/2003, I(2004)CPJ15(MRTP) Director General (Investigation And Registration) Vs.Pfizer Ltd. MANU/MR/0008/1999 (2000)1complj405(MRTPC) Director-General (Investigation And Registration) Vs. Zandu Pharmaceutical works Ltd. MANU/MR/0012/1994, 199481compcas377(NULL). Director General (Investigation And Registration) Vs Biddle Sawyer Ltd. On 11/7/2001 Director General (Investigation And Registration) Vs Infar (India) Limited On 24/8/1999 Director-General (I & R) Vs only India Organisation O f Chemists And Druggists And Ors. On 1/7/1996 Director-General (Investigation And Registration) Vs Indian Drugs Manufacturers Association And Anr.On 16/8/1991 Director-General (Investigation And Registration) Vs Indian Drugs Manufacturers Association And Anr. On 16/8/1991 1992 73 Compcas 663 NULL Mars cures & Chemicals Ltd. V. The Union Of India & Anr W. P. (C) 10277/2009 & Cm Appl 8853/2009 Ranbaxy Laboratories Limited V. Union Of India Union Of India & Anr. Vs. Cynamide India Ltd. & Anr. 1987 Air 1802, 1987 Scr (2) 841 4. Canadian Patented Medicine Prices survey Board Legal Framework Policies Guidelines and Procedures Submissions by Patentees on Level of Therapeutic Improvement Comparable Dosage Forms Therapeutic Class Comparison TestReasonable Relationship Test Median multinational Price Comparison Test Highest International Price Comparison Test International Therapeutic Class Comparison Test Application of Price Tests for tender Drug Products CPI-Adjustment M ethodology DIP Methodology Criteria for Commencing an Investigation Any foodstuff Price Reviews Offset of Excess Revenues Updates to the Compendium of Policies, Guidelines and Procedures ICN Pharmaceuticals Inc. v. Canada (Patented Medicine Price Review Board) 1996 F. C. J. No. 1065 Shire Biochem Inc. v. Canada (Attorney General 2007 F. C. J. No. 1688 Conclusion