NPPA show-cause notices to Sun Pharma, Glenmark, Abbott, Lupin for self-exemption from price cap for anti-diabetic drugs

New Delhi: The National Pharmaceutical Pricing Authority (NPPA) has called for action and issued show-cause notices to drug giants including Sun Pharma, Glenmark, Abbott and Lupin for launching anti-diabetic medicines in the market without seeking exemption under Para 32 of Drug Price Control Orders (DPCO), thereby, excluding products from the price control regime.

The provisions of DPCO, 2013 is not applicable for formulations developed via indigenous research and development for up to five years. This means they are exempted from any price regulation for the period. However, to get this exemption, companies have to show approval of such new drugs from Drugs Controller General India(DCGI)0 to the Government.

"The provisions of para 32 of DPCO 2013 stipulates that the exemption under para 32 of DPCO 2013 would be applicable only when the companies seeking exemption under para 32 of DPCO 2013 produce requisite documents before the Government, " NPPA noted.

However, during the authority meeting held on December 9 under the Chairmanship of Shubhra Singh, it found self-invocation of para 32 of DPCO 2013 by Sun Pharma, Abbott, Lupin, Glenmark, Boehringer and AstraZeneca, that launched their anti-diabetic drugs in violation of DPCO 2013.

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“RemoM” and “RemoZenM” tablets containing Remogliflozin Etabonate 100 mg + Metformin Hydrochloride 500 mg which was withdrawn by the company before retail price was fixed. Later, the company had 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

NPPA was further informed that Lupin and Boehringer Ingelheim had launched ‘Empagliflozin + Metformin’ combination tablets and Sun Pharma Laboratories 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 Healthcare had also launched Dapagliflozin + Metformin’ combination tablet without obtaining approval from NPPA.

Accordingly, NPPA issued a show-cause notice to Glenmark, Lupin, Sun Pharma, Abbott Healthcare.

"The Authority took a serious view of this issue as this amounts to self-invocation of para 32 of DPCO 2013 by the companies which are a willful violation of DPCO 2013," NPPA said.

"The due procedure for grant of such exemption requires the submission of all documents by the company for a considered view to be taken by the Authority after due diligence has been done on the submissions made, " it added.

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 are therefore exempted from applicability of provisions of DPCO, 2013.

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