No relief for Fixed Dose Combinations in Type 2 Diabetes: HC rejects pharma plea

The Centre had banned the FDCs of the formulation of Metformin, Pioglitazone and Glimepiride of varying compositions.

New Delhi: The Delhi High Court has rejected a batch of pleas challenging the Centre's notification banning manufacture and sale of fixed dose combination (FDC) drugs used for the treatment of Type-II diabetes. Justice Vibhu Bakhru said there was no ground to interfere with the central government's September 7, 2018, notification and dismissed the petitions filed by eight pharma companies.

The Centre had banned the FDCs of the formulation of Metformin, Pioglitazone and Glimepiride of varying compositions.

These FDCs are used for the treatment of Type-II diabetes mellitus and to improve the glycemic control as an adjunct to diet and exercise.

The pharma firms had challenged the Centre's September 7, 2018 notification banning the manufacture, sale and distribution of 328 FDC drugs. FDCs are two or more drugs combined in a fixed ratio into a single dosage form.

The firms on whose pleas the order was passed are Unison Pharmaceuticals Pvt Ltd, Alkem Laboratories Ltd, East West Pharma, Intas Pharmaceuticals Ltd, Lupin Ltd, Micro Labs Ltd, Eris Lifesciences Ltd and Franco Indian Pharmaceuticals.

Franco Indian Pharmaceuticals was represented through advocate Arunabh Chowdhury.

The court noted that manufacture, sale and distribution of the FDCs have been prescribed on account of the inclusion of the formulation Pioglitazone 7.5 mg.

It noted the sub-committee constituted to examine the matter of prescribing/restricting the FDCs had found that the evidence for the efficacy of 7.5 mg of Pioglitazone is insufficient and, therefore, had recommended prohibition of the said FDCs.

While recommending a prohibition on manufacture and sale of these FDCs, the sub-committee had said there was no therapeutic justification for this FDC and it may involve risk to human beings.

"Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26A of Drugs and Cosmetics Act, 1940," it had said.

The court, in its verdict, said it was unable to accept that the report submitted by the sub-committee is unreasoned.

"The reasons indicated are brief but there is no ambiguity as to why the sub-committee has recommended prohibiting the FDCs in question.

"This is also not a case where the parties had presented any material, which has not been considered by the sub-committee. The articles relied upon by the petitioners were duly considered and reference to the same is found in the bibliography of the report of the sub-committee," it said.

"In view of the above, this court finds no ground to interference with the impugned notifications. The petitions are, accordingly, dismissed," the judge said.

On January 7, the court had set aside the Centre's notification banning the manufacturing and sale of Wockhardt's anti-inflammatory medicine 'Ace Proxyvon', used in painful rheumatic conditions.

Ace Proxyvon, sold by Wockhardt in a tablet form, is a mixture of three salts -- aceclofenac, paracetamol and rabeprazole -- a combination which was banned.

Various pleas on the same issue are pending before the court.

Other pharma firms including Glenmark, Obsurge Biotech, Coral Laboratories, Mankind Pharma, Koye Pharmaceuticals, Macleods and Laborate have also moved the high court against the ban on their FDCs ranging from anti-inflammatory and painkillers to antibiotics and drugs for treating bacterial infections.

The firms had claimed that the notification was passed without following the earlier directives of the Supreme Court and the FDC has a sound therapeutic justification and poses no risk to human beings.

The Centre had contended that "exercise of power under Section 26A of the Drugs and Cosmetics Act is legislative in nature and principles of natural justice have no application" and there was no requirement for the sub-committee to indicate any elaborate reasons.

The Health Ministry had, through notification of March 10, 2016, prohibited 349 FDCs for manufacture, sale and distribution under Section 26A of the Drugs and Cosmetics Act, 1940. The notification was then contested by the pharma companies in the Delhi High Court and the Supreme Court.

The high court in December 2016 had quashed the ban on the FDCs, which was challenged by the Centre in the apex court.

The top court had in December 2017 set aside the high court order and referred the banned FDCs to DTAB for re-examination.

Complying with the apex court direction, an expert panel set up by DTAB, in its report to the Centre, had stated there was no therapeutic justification for the ingredients contained in 328 of the 349 FDCs, which may also involve risk to humans.

The board had recommended that it was necessary to prohibit the manufacture, sale or distribution of these FDCs under the Drugs and Cosmetics Act, 1940 in the larger public interest.

Also Read: FDC Ban: Avoid These Combinations of Paracetamol