Ban on Ace Proxyvon cancelled, Delhi High Court says Centre didn’t apply mind
“Ace Proxyvon” was one of the 328 fixed dose combination (FDC) drugs banned by the Centre in September last year. This is the first challenge to the centre’s ban order to be decided by the high court.
The Delhi High Court on Monday set aside the ban on anti-inflammatory medicine “Ace Proxyvon”, used for painful rheumatic therapy, ruling that the centre’s decision to ban the drug had been taken without application of mind. Justice Vibhu Bhakru also said the ban order was passed without following certain procedures.
Justice Vibhu Bakhru said that the sub-committee was required to give sufficient reason for its recommendation, as its report was required to be considered by the Centre for determining the question whether to proscribe or restrict a Fixed Drug Combination (FDC).
“……this Court is of the view that the impugned notification cannot be sustained. The same is set aside. The matter is remanded to DTAB/Subcommittee constituted by it to examine the issue regarding the said FDC in accordance with the directions issued by the Supreme Court…,” the judge said.
“Ace Proxyvon” was one of the 328 fixed dose combination (FDC) drugs banned by the Centre in September last year. The health ministry’s ban on FDCs included painkillers, anti-diabetic, respiratory and gastro-intestinal medicines, covering 6,000 brands.
FDCs are two or more drugs combined in a fixed ratio into a single dosage form.
This is the one of the first petitions against the centre’s ban order to be decided by the high court.
The court was hearing a petition by Wockhardt Limited, which had challenged the Centre’s notification of September 7 banning Ace Proxyvon, which is prescribed for people with painful rheumatic conditions such as osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
Ace Proxyvon, sold in a tablet form, is a mixture of three salts -- aceclofenac, paracetamol and rabeprazol -- a combination which is banned.
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The pharma major had argued that it had not been provided with the report of the Drugs Technical Advisory Board, or DTAB, that formed the basis of the decision to ban the medicine.
The health ministry had banned manufacture and sale of 349 fixed dose combination medicines in March 2016. Pharma companies had then appealed in the high court, which cancelled the ban. The Centre appealed against the ban in the Supreme Court which asked DTAB to re-examine the case. The expert panel had concluded that there was no therapeutic justification for the ingredients contained in 328 of the 349 FDCs and may also involve risk to humans.