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Industry Specific- Pharma Central Ministry of Chemicals and Fertilizers Drug (Price Control) Order, 2013

National Pharmaceutical Pricing Authority (NPPA) has issued an Office memorandum regarding the launch of new drugs before the notification of retail prices in violation of Paragraph 15 of the Drug Price Control Order (DPCO), 2013

01-Feb-2024 | File No. 36(09)/2023/Div-III/NPPA

National Pharmaceutical Pricing Authority (NPPA) has issued an Office memorandum addressing the launch of new drugs before the notification of retail prices, violating Paragraph 15 of the Drug Price Control Order (DPCO), 2013. The memorandum highlights the existing manufactures need prior price approval from the government when launching new drugs and NPPA ensures timely processing and disposal of Form I. By virtue of the Office memorandum, it has been observed that some manufacturers or marketers are launching new drugs immediately upon filing Form I applications with NPPA, without waiting for the fixation and notification of retail prices. Pharmaceutical manufacturers are strongly advised to refrain from this practice and ensure strict compliance with the extant provisions of the law. Failure to comply may lead to penal actions, including measures under DPCO, 2013 and Essential Commodities Act, 1955. Please refer to the attached document for more details.

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