Delhi HC sets aside govt ban on Lupin FDC, refers matter back to Drug Board

Govt had in September 2018 banned 344 FDC drugs, including Lupin's combo for diabetics, citing lack of therapeutic justification

The Delhi High Court on Wednesday set aside the central government’s ban on Lupin’s fixed dose combination drug (FDC) Gluconorm-PG 1 Forte and Gluconorm-PG 2 Forte and remanded the matter back to Drug Technical Advisory Board (DTAB) for further consideration on the issue. A detailed copy of the order is awaited.

The drug, used for treatment of patients suffering from Type 2 diabetes, was 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”.

In its arguments before the high court, Lupin said that its diabetes drug Gluconorm-PG 1 Forte and Gluconorm-PG 2 Forte helped reduce dose requirement of patients and had a rapid action on the blood glucose levels. Patients also benefit from improved cardiovascular outcome because of improved glycaemic control. It is therefore wrong to say that the drug had no therapeutic justification, Lupin lawyer Ajay Bhargava said.