NPPA brings Remoglifozin, Metformin combination under price control, pulls up Mankind, Intas Pharma for unapproved launch

Earlier in April 2019, Glenmark received regulatory approval for Remogliflozin etabonate 100 mg tablets, twice daily, after successfully completing Phase-3 clinical trials in which Remogliflozin demonstrated good efficacy and safety profile in a head-to-head comparison against Dapagliflozin. With this approval, Glenmark became the first company to launch the novel SGLT2 inhibitor Remogliflozin in India under the brand names 'Remo' and 'Remozen'.

Later, it received Central Drugs Standard Control Organisation (CDSCO) approval to market a combination of its novel, patent protected and globally-researched sodium glucose co-transporter-2 (SGLT2) inhibitor Remogliflozin etabonate (Remogliflozin) and Metformin Hydrochloride (Metformin) film-coated tablets in India under the brand names 'Remo-M' and Remozen-M'. The approved dosage strengths were 100 mg of Remogliflozin combined with either 500 mg or 1,000 mg of Metformin.

This combination is indicated as an adjunct to diet and exercise to improve glycemic control in type-2 diabetes mellitus patients (for full indication, it is advisable to refer the package insert).

Glenmark had launched Remogliflozin as a mono-therapy, at a price that was over 50% lower than the existing SGLT2 inhibitors available in India. Prior to the launch of Remogliflozin, the average per day therapy cost of SGLT2 inhibitors in India was about Rs. 55.

In July, 2019, Glenmark entered into a licensing agreement with Torrent Pharma to co-market diabetes drug Remogliflozin Etabonate in India. Under the terms of the agreement, Glenmark received an upfront payment, license fees and royalties for the non-exclusive sub-license rights from Torrent.

"Glenmark will manufacture and supply Remogliflozin while Torrent will market the drug under its own trademark 'Zucator' in India," Glenmark Pharma had clarified in a filing.

Soon after, Torrent Pharma moved an application with the apex price regulator for exemption under Para 32(i) of DPCO 2013 for the said formulation. Para. 32 of DPCO 2013 creates an exemption from price control for new drugs patented under the India Patents Act, 1970, thereby creating an unprecedented link between the Patents Act and drug prices.

However, apart from noting that the new drug application for the said drug has been granted to Glenmark, the authority also noted the manufacturing license for these formulations has been granted by the State Licensing Authority to Glenmark.

It further observed that Torrent Pharma does not have new drug approval for the formulations (a) Remoglifozin Etabonate 100 mg + Metformin Hydrochloride 500 mg tablet and (b) Remoglifozin Etabonate 100 mg + Metformin Hydrochloride 1000 mg tablet from Central Drugs Standard Control Organisation (CDSCO).

"Torrent Pharmaceuticals Ltd has only entered into an agreement with M/s Glenmark Pharmaceuticals Ltd as a sub-license partner for marketing the formulation in India. Torrent Pharmaceuticals Ltd also does not hold the patent in its name," NPPA said in its meeting.

The Authority deliberated upon the matter in detail and observed;

"Provisions of para 32 of DPCO 2013 do not provide for exemption to sub-license partners and hence Torrent Pharmaceuticals Ltd has no locus standi to apply for exemption under para 32 of DPCO 2013. Accordingly, the Authority decided to reject the applications of M/s Torrent Pharmaceuticals Ltd for exemption under para 32 of DPCO 2013 for the formulations Remoglifozin Etabonate 100 mg + Metformin Hydrochloride 500 mg tablet and Remoglifozin Etabonate 100 mg + Metformin Hydrochloride 1000 mg tablet."