In what could be a major decision, the Indian government is looking to tweak an existing provision that allows new medicines developed by foreign companies to be exempt from price control for five years. The move comes in the wake of sharp criticism of the government's amendment in January 2019 which allowed for the price control exemption, with health organizations arguing it discourages local drug manufacturing, reports The Pharma Letter’s India correspondent.
Executives of the Department of Pharmaceuticals (DoP) and the National Pharmaceuticals Pricing Authority are said to be revisiting paragraph 32 of the Drugs (Price Control) Order (DPCO), which lists out certain exemptions.
Paragraph 32 states the provisions of the DPCO shall not apply to a manufacturer producing a new drug patented under the Indian Patent Act, and not produced elsewhere, for a period of five years from the date of commencement of its commercial production in the country.
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