Gluconorm-PG is a triple combination of diabetes drugs Glimepiride, Metformin, Pioglitazone, with sales of around Rs 50 crore.
In a major relief to drug maker Lupin, the Delhi High Court on February 13 set aside the ban imposed by Central government on the manufacture and sale of its fixed dose combinations (FDC) Gluconorm-PG 1 Forte and Gluconorm-PG 2 Forte, which is used in the treatment of diabetes.
Gluconorm-PG 1 Forte and Gluconorm-PG 2 Forte were part of 344 FDCs banned by the government on September 7, 2018, which exercised its powers under Section 26A of the Drugs and Cosmetics Act.
Gluconorm-PG is a triple combination of Glimepiride, Metformin, Pioglitazone, with sales of around Rs 50 crore.
The ban by the Central government was based on the report submitted by a sub-committee of the Drug Technical Advisory Board (DTAB) on July 31, 2018.
Lupin had immediately moved to the Delhi High Court against the ban, alleging it as arbitrary and contrary to material that supports the efficacy of the FDC.
Lupin had argued that the FDCs reduce the individual dose requirement and have a rapid action on the blood glucose levels.The triple drug can effectively reduce the use of insulin in patients suffering from type- 2 diabetes, additionally, the patients also benefit from the improved cardiovascular outcomes because of improved glycemic control, Lupin claimed.