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

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1. Introduction 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 …show more content…

Consequences of excessive pricing Impact 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 manufacturers 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 required to apply for fixation of price of formulation within 30 days 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 time frame for granting price approval on formulation is 2 months from the date of receipt of the complete information from the company. 2.Pricing and Competition Issues 3. NPPA pricing methodology a. DPCO 1995 b. National Drug Pricing Policy 2002 c. National Drug Pricing Policy 2006 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

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