Ban on pain killer containing ‘Ace Proxyvon’ cancelled by High Court


NATIONAL | January 7, 2019:

On Monday, the Delhi High Court set aside the anti-inflammatory medicine "Ace Proxyvon" ban which is used for painful rheumatic therapy, ruling that the centre's decision to ban the drug had been taken with application of mind.

Justice Vibhu Bhakru also said the ban order was passed without following certain procedures.

"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.

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.

Source: HT