Cipla, Glenmark get NPPA nod for inhaler pricing over 'innovative' quotient

The drug pricing regulator has allowed two Mumbai-based pharma majors — Cipla and Glenmark — to have an enhanced pricing for two of their respiratory (inhaler) products on grounds that these were ‘innovative’ from the other similar products available in the market. 

In a meeting in December, the National Pharmaceutical Pricing Authority’s (NPPA) expert committee decided to allow Cipla’s Synchrobreathe Inhaler Device a separate price other than the ceiling price already recommended  by the regulator. Similarly, for Glenmark’s digital dose counter (sold under brand name Digihaler) the NPPA agreed to allow a different price. 

According to a source, the NPPA has raised the price cap on the Digihaler by about 5-8 per cent or so. “The cost of medicine, however, remains same. The device is allowed in the separate or increased price cap. When a patient refills the inhaler with medicine, the cost remains same,” the source said. 

Glenmark had appealed to the pricing regulator in 2016 asking for a differential price for its Digihaler on grounds that it was different from the other metered dose inhalers (MDIs) available in the market and was easier and safer for the patients to use. The matter was eventually placed before an expert committee, which came back with its report on the same in December. The NPPA can grant a differential price for certain dosages or drug delivery forms of formulations that are under price control under paragraph 11 of the Drug Price Control Order, 2013. 

Cipla and Glenmark did not respond to queries immediately. In 2015, Cipla had launched its inhaler device Synchrobreathe, which is a novel, breath-actuated inhaler, with a dose counter. It is used to manage obstructive airway disease. The device is simple to use and eliminates coordination challenges in patients, which is a major issue faced when using conventional pressurised MDIs. Cipla had thus approached the NPPA to allow a separate ceiling price for the innovative delivery method. 

Earlier in December, the NPPA had issued show-cause notices to five firms for launching anti-diabetic formulations in the market without seeking exemption from the government under para 32 of the DPCO, 2013. For drugs developed through indigenous research and development, the provisions of DPCO do not apply for up to five years, which means they are exempted from price regulation for the period.

Companies need to apply and get approval for this exemption under para 32 of the DPCO, 2013. NPPA issued show -cause notices to Glenmark, Lupin, Sun Pharma, Abbott and Boehringer Ingelheim for alleged violation of para 32 of DPCO.