New Delhi: The National Pharmaceutical Pricing Authority (NPPA), India’s drug price watchdog, has decided to issue show-cause notices to two pharmaceutical firms — Mankind Pharma and Intas Pharmaceuticals — for selling anti-diabetic medicine in the market without seeking price approval.
The NPPA, which prevents drugmakers from overcharging the consumers, is an autonomous body to regulate prices of medicines under the National List of Essential Medicines (NLEM), and also monitors the prices of drugs outside the list.
In a meeting conducted by the price regulator on 23 December, the authority discussed the 22 new drug formulations for fixing their retail price.
The NPPA has received requests from Glenmark Pharmaceuticals and Torrent Pharmaceuticals for fixing the price of a Type 2 diabetes drug that is a combination of two anti-diabetic medicines — Remogliflozin etabonate and Metformin hydrochloride.
But during the process of fixing the prices, the regulator noted that the drug has been launched by two other drug firms — New Delhi-based Intas Pharmaceuticals and Ahmedabad-based Mankind Pharma — without seeking price approval.
When Remogliflozin is combined with Metformin, a regulated drug, its price needs to be fixed by the NPPA.
According to the minutes of the meeting, uploaded on the NPPA’s website, an “explanation has been issued for non-compliance” from both the companies.
“The authority deliberated upon the matter in detail and decided to issue Show Cause Notice (SCN) to M/s Intas Pharmaceuticals Ltd and M/s Mankind Pharma Ltd for the same,” read the minutes.
Arjun Juneja, chief operating officer, Mankind Pharma, told ThePrint he would not offer any comments on the NPPA’s move.
ThePrint reached Intas via email for a comment, but there was no response till the publication of this report.
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How does the drug work?
The Type 2 diabetes drug works by removing excess sugar from the body via urine. It helps reduce the sugar by lowering the glucose production in the liver. Additionally, it delays sugar absorption from the intestines.
In April 2019, Mumbai-based Glenmark had received the approval from the Central Drugs Standard Control Organisation to sell the combination of Remogliflozin etabonate and Metformin hydrochloride in India.
Remogliflozin etabonate is Glenmark’s patent drug and it became the first company in the world to launch it. With this, India also became the first country to get access to this drug.
Remogliflozin, according to a press release issued by Glenmark, is an innovative, patent-protected sodium glucose co-transporter-2 (SGLT2) inhibitor indicated in treatment of type-2 diabetes mellitus in adults.
Also read: Danish firm gets FDA approval for oral diabetes pill, no word yet on India launch
Very interesting topic