Wockhardt Moves HC Against Ban On Its Fixed Dose Combination Drug

New Delhi, 15 Sept 2018: The Delhi High Court said Friday no coercive steps be taken against Indian pharma major Wockhardt for sale of stocks of its banned anti-inflammatory medicine which is already in the market, subject to the company stopping production of the drug.

Justice Vibhu Bakhru, in an interim order, said the medicine, one of 328 fixed dose combination (FDC) drugs banned by the Centre a week ago, has been in the market for past 11 years and its stocks would already be in the distribution network.

The court made it clear that it was not at this stage going to stay the notification which banned Wockhardt's product and added the company would not be proceeded against only in respect of the stock already in the distribution channels.

With the direction, the court listed Wockhardt's plea for further hearing on September 18 when the Centre, represented by Additional Solicitor General Maninder Acharya and central government standing counsel Anil Soni, has to produce the relevant records based on which the notification of September 7 was issued.

The Health Ministry also has to produce material which indicates or establishes that the drug -- Ace Proxyvon -- was harmful to public at large, the order said.

The petition by Wockhardt was mentioned before a bench of justices S Ravindra Bhat and A K Chawla, which allowed it to be listed before an appropriate bench for hearing Friday itself.

However when the court rose at 5 pm, the petition file had not reached the designated bench from the high court's registry which is entrusted with the task of listing of the matters. The matter was taken up for hearing after 6 pm.

The ministry by its September 7 notification had banned the manufacture, sale and distribution of 328 FDC drugs. FDCs are two or more drugs combined in a fixed ratio into a single dosage form.

Ace Proxyvon, which is sold by the company in a tablet form, is a mixture of three salts -- aceclofenac, paracetamol and rabeprazol -- a combination which is banned.

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

It claimed the only reason given in the September 7 notification was that the combination had no therapeutic value.

The medicine is reportedly prescribed for people with painful rheumatic conditions, such as osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

The Health Ministry had, through a notification of March 10, 2016, prohibited 349 FDCs for manufacture, sale and distribution under Section 26 A of the Drugs and Cosmetics Act, 1940. The notification was then contested by the pharma companies in the Delhi High Court and the Supreme Court.

The high court in December 2016 had quashed the ban on the FDCs, which was challenged by the Centre in the apex court.

The top court had in December last year set aside the high court order and referred the banned FDCs to DTAB for re-examination.

Complying with the apex court direction, an expert panel set up by DTAB, in its report to the Centre, had stated there was no therapeutic justification for the ingredients contained in 328 of the 349 FDCs, which may also involve risk to humans.

The board had recommended that it was necessary to prohibit the manufacture, sale or distribution of these FDCs under the Drugs and Cosmetics Act, 1940 in larger public interest.Business Standard