Regulation of Pharmaceutical Manufacturers Against Premature Launch of New Drugs 

LegalitySimplified

The  National Pharmaceutical Pricing Authority (NPPA) issued an office memorandum, on 01st February, 2024,  addressing the issue of launching new drugs before the notification of retail prices in violation of Paragraph 15 of the Drugs (Prices Control) Order, 2013 (DPCO)

The DPCO under Paragraph 15  states that manufacturers who are intending to launch a new drug by combining a scheduled drug with another drug or by altering its strength or dosages must apply for prior price approval from the government. The NPPA is responsible for examining these applications and fixing retail prices in accordance with the law and the applications are disposed of in a timely manner. 

However, the memorandum highlights instances where manufacturers are launching new drugs immediately upon filing the Form-I application with the NPPA, before the retail prices are fixed and notified. Such actions are deemed as a blatant violation of the law, and the memorandum advises all pharmaceutical manufacturers to refrain from this practice and ensure strict compliance with the existing provisions. Non-compliance may result in penal action.

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