The Delhi High Court on Friday allowed Indian pharmaceutical major Wockhardt to sell till Tuesday its anti-inflammatory medicine that is among the 328 fixed dose combination drugs banned by the Union Health Ministry, PTI reported.
Justice Vibhu Bakhru, in an interim order, allowed the company to sell its drug, Ace Proxyvon, till September 18, the next date of hearing, and asked the health ministry to submit records based on which it had arrived at the decision to ban the medicine.
The government on Thursday announced the ban with immediate effect, and also placed certain conditions on six other fixed dose combination drugs. Popularly known as FDCs, these medicines are a cocktail of two or more drugs sold by the Indian pharmaceutical industry.
Wockhardt moved the Delhi High Court on Friday against the Union Health Ministry’s decision. A bench of Justice S Ravindra Bhat and AK Chawla listed the matter for hearing on Friday, but the registry was unable to send the petition file ahead to the designated bench by the time the court closed at 5 pm. The matter was taken up for hearing after 6 pm.
Ace Proxyvon is sold in a tablet form and is a mixture of three salts – aceclofenac, paracetamol and rabeprazol – now a banned combination. It is used to treat patients with rheumatic conditions such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.
In its petition, Wockhardt alleged it was not provided the report of the Drugs Technical Advisory Board, based on which the ban was implemented. The company said it has been manufacturing and selling the drug for 11 years and the only reason put forth for banning Ace Proxyvon was that the combination offered no therapeutic value.
The ban is likely to affect around 6,000 brands, including painkiller Saridon, skin cream Panderm, combination diabetes drug Gluconorm PG, antibiotic Lupidiclox and antibacterial Taxim AZ. They are expected to have a combined market size of between Rs 2,000 crore and Rs 2,500 crore.
On March 10, 2016, the Central Drugs Standard Control Organisation, or CDSCO as it commonly known, issued a notification prohibiting the manufacture, sale and distribution of 344 FDCs, later adding five more to the list.
The ban was poised to hit the profits of the pharmaceutical industry since there are thousands of FDCs in the market. The pharmaceutical industry challenged the ban on the grounds that the central government had not consulted the Drugs Technical Advisory Board.
In December 2016, the Delhi High Court set aside the orders banning the FDCs. Later, this judgement was appealed against by the central government and the Supreme Court overruled the High Court’s ruling, concluding that Section 26A of the Drugs and Cosmetics Act, 1940, does not require the Central government to consult the advisory board. It then ordered the Drugs Technical Advisory Board to examine these drugs and submit a report to the Centre.
Based on the board’s recommendations, the government banned the FDCs in a gazette notification dated September 7.