The National Pharmaceutical Pricing Authority (NPPA) on February 01, 2024, issued a notification regarding the Launch of New Drugs before the notification of Retail Prices by NPPA in violation of Paragraph 15 of DPCO, 2013.
The following has been stated:
• It has been observed by this office that in some cases, the applicants (manufacturers/marketers) are launching new drugs immediately upon filing of Form-I application with NPPA without waiting for fixation and notification of the retail price. It may be noted that such launch of new drugs before notification of retail price is a blatant and deliberate violation of the extant provisions of law.
• It has advised all the pharmaceutical manufacturers to refrain from such practice and to ensure strict compliance with the extant provisions of law. Otherwise, NPPA would be constrained to initiate penal action against the defaulting manufacturers under the provisions of DPCO, 2013 and Section 7 of the Essential Commodities Act, 1955.
[Notification No 36(09)/2023/Div-III/NPPA]
