New Delhi: The Delhi High Court on Friday set aside a Central government notification restricting manufacture, sale and distribution of an anti-diabetic medicine by pharmaceutical company Lupin Ltd.
Gluconorm P 30, a medicine manufactured by Lupin Ltd, was part of the 328 Fixed Dose Combination (FDC) drugs whose manufacture, distribution and sale was banned by the Ministry of Health and Family Welfare in September last year.
Gluconorm P 30 is used to control high blood sugar levels in patients with Type-2 diabetes.
The Centre, in March 2016, had prohibited the manufacture for sale and distribution of 349 FDCs, but it was contested by the affected manufacturers in high courts and the Supreme Court.
Complying with the December 2017 Supreme Court judgment, the Drugs Technical Advisory Board (DTAB) examined the matter and, in its report to the Centre, recommended prohibiting the FDCs on the ground that there was no therapeutic justification for their ingredients and that these FDCs could involve risks to humans.
Earlier, an expert committee appointed by the Centre had also made similar observations.
Considering the recommendations of the DTAB and the expert committee, the Health Ministry had, through a gazette notification, prohibited 328 of the 349 FDCs.