Delhi HC refuses to stay ban on fixed dose drug

NEWDELHI: The Delhi high court on Friday refused to stay the ban on anti-inflammatory medicine “Ace Proxyvon”, one of the 328 fixed dose combination (FDC) drugs banned by the Centre, but allowed its manufacturer Wockhardt to sell it till Tuesday to sell till September 18, the next date of hearing.

Justice Vibhu Bakhru, in an interim order, asked the health ministry to place before it all relevant records based on which it had arrived at the decision to ban the medicine. “This court is not passing any interim order and there is no stay on the ban. However, some stock is already there in the distribution network. This court considers it to be apposite that no coercive action be taken against the petitioners (company) subject to the stopping of the production,” the court said.

The court was hearing a plea by Wockhardt Limited, which had challenged the Centre’s notification of September 7 banning Ace Proxyvon, an FDC drug prescribed for people with painful rheumatic conditions such as osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. FDCs are two or more drugs combined in a fixed ratio into a single dosage form.

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, which claims to have been manufacturing and selling the drug for over 11 years, contended that it has not been provided with the Drugs Technical Advisory Board (DTAB) report, based on which the decision to ban it was taken.

Appearing for the Centre, Additional Solicitor General (ASG) Maninder Kaur Acharya submitted that hearings have been given to the petitioner in compliance to the orders of the Supreme Court. RICHA BANKA