India's drug price regulator, National Pharmaceutical Pricing Authority (NPPA), issued show-cause notices to five companies for launching anti-diabetic formulations in the market without seeking exemption from the government under para 32 of DPCO 2013, according to minutes of NPPA meeting held on December 9.
The provisions of the drug price control order (DPCO), 2013 do not apply to drugs developed through indigenous research and development for up to five years. This means they are exempted from any price regulation for the period.
To get this exemption, para 32 of DPCO 2013 stipulates that companies will have to show approval of such new drugs from Drugs Controller General (India) to the government.
NPPA issued show-cause notices to Glenmark, Lupin, Sun Pharma, Abbott and Boehringer Ingelheim for alleged violation of Para 32 of DPCO.
The Authority noted that Glenmark Pharmaceuticals had earlier applied for retail price fixation for the products RemoM and RemoZenM tablets containing Remogliflozin Etabonate 100 mg + Metformin Hydrochloride 500 mg which was withdrawn by the company before the retail price was fixed.
Later, Glenmark Pharmaceuticals launched the products RemoM and RemoZenM tablets containing Remogliflozin Etabonate 100 mg + Metformin Hydrochloride 500 mg in the market without seeking exemption from NPPA under para 32 of DPCO 2013
Glenmark informed NPPA that Lupin and Boehringer Ingelheim had launched Empagliflozin, Metformin combination tablets, and Sun Pharma and AstraZeneca had also launched Dapagliflozin, Metformin combination tablets without seeking prior approval of NPPA.
Based on the representation of Glenmark, NPPA analysed Pharmatrac data and it was observed that Abbott had also launched Dapagliflozin, Metformin combination tablet without obtaining approval from NPPA.
Accordingly, NPPA issued show-cause notices to all the companies.
In response to the show-cause notices, the companies stated that the formulations are patented products which are within the purview of Para 32 of DPCO, 2013 and therefore, exempted from applicability of provisions of DPCO, 2013.
NPPA said it took a "serious view of this issue as this amounts to the self invocation of para 32 of DPCO, 2013 by the companies which is a willful violation of DPCO 2013," NPPA said.
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