Delhi HC sets aside govt ban on Lupin's anti-diabetic drug Gluconorm-30

The Delhi High Court on Friday set aside a government notification in which it had banned Lupin’s fixed dose combination (FDC) drug, Gluconorm-30, used to control diabetes.  The FDC is a combination of Pioglitazone 30 and Metformin 500, and is used to reduce the individual dose requirement of diabetes patients. A detailed copy of the judgement is awaited.

“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,” the counsel for the company, Ajay Bhargava said.

This is the second anti-diabetes drug, manufactured by Lupin, which has been taken out of the banned FDC list.  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.

The drug, used for treatment of patients suffering from Type 2 diabetes, was also banned by the central government vide a notification issued on September 7, 2018. Exercising its powers under Section 26A of the Drugs and Cosmetics Act, 1940 (Drugs Act), the government had prohibited the manufacture, sale and distribution of 344 FDC drugs. The ban, the government had then said, was based on the recommendations of a report submitted by a committee of the DTAB On July 31.

The government had then also said that these drugs were being banned as they had “no therapeutic justification” and that the ingredients of the banned FDC drugs "may involve risk to human beings”.

Many companies had subsequently moved the high court, challenging the ban as arbitrary and unjustified. Earlier, the Health Ministry,  had in March 2016 prohibited the manufacture, sale and distribution of 349 FDCs. The ban was challenged in high court and Supreme Court, which subsequently overturned it.

The courts had then asked the ministry to form an expert panel which would relook into the FDCs. The Drug Technical Advisory Board (DTAB) reiterated the claims made by the Centre and said that nearly 328 of the total 349 had no therapeutic justification. Based on these suggestions, the government had in September 2018 again banned these FDCs.

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