Relief to Lupin: High court removes ban its diabetes drug Gluconorm P 30

The high court has now ruled in favour of Lupin and quashed the apex court's decision to ban Lupin's anti-diabetic drug- Gluconorm P 30.

New Delhi: In a major relief to the Mumbai-based drugmaker, Lupin Limited, the Delhi high court has set aside a central government notification in which it had banned the manufacture, sale and distribution of the company's fixed-dose combination (FDC) Gluconorm P 30, an anti-diabetic drug.

Gluconorm P 30, is a combination of Pioglitazone 30 and Metformin 500. The combo drug is used to minimize the individual dose requirement of diabetes sufferer. It is used to regulate high blood sugar levels in patients with type-2 diabetes.

Medical Dialogues had earlier reported that the Ministry of Health and Family Welfare had prohibited the manufacture for sale, sale or distribution for human use of 328 Fixed Dose Combinations (FDCs).

The move came after the DTAB recommended that there was no therapeutic justification for the ingredients contained in 328 FDCs and that these FDCs might involve risk to human beings. Earlier, an expert committee appointed by the Centre had also made similar observations.

Also Read: Health Minsitry bans 328 FDC Banned Drugs, check out the complete list

The move was challenged by the affected manufacturers including Unison Pharmaceuticals Pvt Ltd, Alkem Laboratories Ltd, East West Pharma, Intas Pharmaceuticals Ltd, Lupin Ltd, Micro Labs Ltd, Eris Lifesciences Ltd and Franco Indian Pharmaceuticals.

However, the Delhi High Court had rejected a batch of pleas challenging the Centre's notification banning manufacture and sale of fixed dose combination (FDC) drugs used for the treatment of Type-II diabetes.

Justice Vibhu Bakhru said there was no ground to interfere with the central government's September 7, 2018, notification and dismissed the petitions filed by eight pharma companies.

Also Read: No relief for Fixed Dose Combinations in Type 2 Diabetes: HC rejects pharma plea

The High court has now ruled in favour of Lupin and quashed the apex court's decision to ban Lupin's anti-diabetic drug- Gluconorm P 30.

Diabetes mellitus type 2 (or adult-onset diabetes) is a metabolic disorder where high levels of blood sugar occur. Left untreated, it can cause heart attacks, strokes, blindness and kidney failure.

Commenting on the matter the counsel for the company, Ajay Bhargava told Business Standard, "In addition to lowering blood sugar, the dual drug can effectively reduce the use of insulin in patients suffering from type 2 diabetes. Thus, Lupin had challenged the ban imposed by the central government."

Gluconorm P 30 is the second anti-diabetes drug, manufactured by Lupin, which has been taken out of the banned FDC list adds BS. The high court had on January 13 set aside another notification vide which the government had banned Lupin's anti-diabetic drug Gluconorm -PG 1 Forte and Gluconorm -PG 2 Forte.