Delhi HC quashes ban on anti-inflammatory drug Ace Proxyvon, faults Centre

The Delhi High Court on Monday set aside the central government’s ban on anti-inflammatory medicine Ace Proxyvon, saying the Centre should have taken the decision of banning the drug only after “due application of mind”. Ace Proxyvon is used for painful rheumatic therapy of ailments such as osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

In September last year, the government had banned around 328 Fixed Dose Combination (FDC) drugs citing lack of therapeutic justification. FDCs are two or more drugs combined in a fixed ratio into a single dosage form. 

These included painkillers, respiratory and other gastro-intestinal medicines. Following the ban in September, Wockhardt had moved the court challenging the ban on its drug, Ace Proxyvon. The medicine is a combination of three salts namely aceclofenac, paracetamol, and rabeprazol. The government had banned this combination. 

Wockhardt, however, contented that it had not been provided with the Drugs Technical Advisory Board (DTAB) report, which had formed the basis of the ban by the government. It had also said that its FDC had a sound therapeutic justification and posed no risk to humans. The market affected by the ban of these 300-odd FDCs is estimated to be around Rs 1,040 crore. The total market size of the domestic pharma industry is about Rs 1.2 trillion. 

In March 2016, the health ministry had banned sale and manufacture of nearly 349 FDC medicines. Following an appeal by the pharmaceutical companies, the ban was overturned by the Delhi High Court. However, the Centre appealed against the ban in the Supreme Court (SC), which asked the DTAB to re-examine the case and give its findings by on whether it is then necessary or expedient, in the larger public interest, to regulate, restrict or prohibit the manufacture, sale or distribution of such FDCs. DTAB had later concluded that there was no therapeutic justification for the ingredients contained in 328 of the 349 FDCs, following which they were banned.

Earlier, in September last year, the Delhi High Court had said that no coercive steps to be taken against a handful of pharma companies who had filed a writ petition before the court for the existing stock already in circulation. 

The SC had in September granted interim relief to some brands (Piramal Healthcare’s Saridon, GlaxoSmithKline’s Piriton etc) and allowed their sale. The apex court is yet to take a final decision on the matter. 

The SC, however, did not grant any relief to the other medicines in the list of 328 FDC drugs, which were banned by the health ministry by its September 7 notification.