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Delhi HC Quashes Centre’s Ban On Wockhardt’s ‘Ace Proxyvon’
Both the High Court and Supreme Court flooded with the petitions against the Ministry of Health which issued a Notification on manufacture, sale and distribution of 328 FDC drugs. FDC implies Fixed Dosage Drugs and Ace proxyvon manufactured and sold by Wockhardt is one such medicine, which is a combination of three salts—aceclofenac, paracetamol and rabeprazole, was banned by the Union Health Ministry Notification.
Not only Wockhardt, but a host of firms such as Glenmark, Alkem Laboratories, Obsurge Biotech, Coral Laboratories, Lupin, Mankind Pharma, Koye Pharmaceuticals, Macleods and Labourite also approached the Hon’ble bench of the High Court seeking lift of the ban on their FDCs which include painkillers, antibiotics, and medicines for bacterial infections.
However, it is to be noted that the first petition against the Union Health Ministry has been disposed of through quashing the ban on Ace Proxyvon. The petitioner had filed the petition on September 15, and the Court in its order stated that the pharma company could not be coerced to restrict the sale of its banned anti-inflammatory medicine which has been in the market for 11 years and entered the vast distribution network already.
The Pharmaceutical Company raised two prime contentions. It contended that no report of the Drugs Technical Advisory Board, based on which the said notification came into effect, was provided to the company. The second contention was regarding the Union Health Ministry's claim about the absence of therapeutic value in the dispute medicine.
In fact, medicine is formulated to deal with issues such as painful rheumatic conditions, such as osteoarthritis, rheumatoidarthritis and ankylosing spondylitis. Previously, a similar notification by the Union Health Ministry in 2016 prohibited the sale and manufacture of about 349 Fixed Drug Combinations under section 26 A of the Drugs and Cosmetics Act, 1940.
After quashing the ban on the number of FDCs by the High Court, the centre was constrained to resort to the Apex Court of India which set aside the High Court order and subjected the banned FDCs to scrutiny again. In accordance with this order of the apex court, the DTAB set up an expert panel and stated in its report that there was no therapeutic value in the ingredients used for the formulation of 328 of the 349 FDCs, which may cause harm to the humans. In light of this, the board sought to ban the list of FDCs to save the public interests.
