SC Seeks Centre, DCGI Response on Micro Labs' Plea Against Anti-Diabetic FDC Ban

New Delhi: The Supreme Court sought responses from the Union government and the Drug Controller General of India regarding an appeal filed by Micro Labs against the prohibition of two fixed-dose combination (FDC) formulations used in managing Type II diabetes mellitus.

The Supreme Court of India on 23 February 2026 issued notice in a Special Leave Petition (SLP) filed by Mirco Labs Limited, challenging a judgment of the High Court of Delhi.

The matter concerns Mirco Labs Limited’s appeal before the Supreme Court against an impugned final judgment and order dated 9 January 2026 passed by the High Court of Delhi in LPA No. 106/2020. Mirco Labs Limited approached the Supreme Court by filing Petition(s) for Special Leave to Appeal (Civil) No. 6591/2026.

As per a recent media report in The Economic Times, on January 9, a Division Bench of the Delhi High Court restored the Centre’s ban on certain fixed-dose combination (FDC) medicines, setting aside an earlier order by a Single Judge that had provided relief to pharmaceutical companies, including Lupin and Intas Pharmaceuticals.

The Single Judge, in February 2019, had quashed two government notifications issued in 2018 that prohibited the manufacture and sale of specific anti-diabetic FDC formulations.

The affected combinations included formulations containing glimepiride, pioglitazone, and metformin, namely “Glimepiride 1 mg/2 mg + Pioglitazone 15 mg/15 mg + Metformin 850 mg/850 mg” and “Glimepiride 1 mg/2 mg/3 mg + Pioglitazone 15 mg/15 mg/15 mg + Metformin 1000 mg/1000 mg," ET reported.

The case was taken up for hearing before a bench comprising Justice Vikram Nath and Justice Sandeep Mehta. Senior Advocate Mukul Rohatgi appeared on behalf of Mirco Labs Limited, along with Archana Sahadeva (AOR) and other counsel.

Upon hearing the petitioner’s counsel, the Supreme Court passed a brief order:

“Issue notice, returnable within four weeks.”

To view the order, click the link below: