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FOPE said that the manufactures follow the rules as laid down in the DPCO, 2013. At the same time, manufacturers look to NPPA to fix the price expeditiously and as per the NPPA’s defined timelines for various provisions under DPCO including disposal of Form-1 application.
“However, our members have brought to our notice that many Form 1 applications get delayed beyond the timeline of 60 days,” it said.
The lobby group has said that aunching a new product requires meticulous planning so that reached both patients and doctors well on time.
“If it gets stuck at NPPA for want of Pricing, the manufacturers may incur huge losses including possibilities of losing the business opportunity to be the first to launch a new product,” it said.
It further said that sometimes the manufacturers are forced to launch the product after the expiration of the time limit prescribed by the regulator. “In such cases, we may request the NPPA that it should not be construed as a violation of the provisions where the manufacturer had submitted the Form 1 application for price fixation of the new drug and has waited for the NPPA to notify the price as per timeline outlined”. The NPPA had earlier observed that in some cases, the applicants (manufacturers/marketers) are launching new drugs immediately upon filing of Form-I application with NPPA without waiting for the fixation and notification of the retail price. The NPPA said launching new drugs before notification of retail prices is in violation of Paragraph 15 of DPCO, 2013.
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