The Delhi High Court on Friday allowed Indian pharma major Wockhardt Ltd to sell its anti-inflammatory medicine that are already in the distribution channel, which is among the 328 fixed dose combination (FDC) drugs banned by the Centre a week ago.
“Considering that it is not disputed that the drug in question has been in the market for the past 11 years and that stock of the drugs would already be in the distribution work, this court does consider it apposite to direct that no coercive steps be taken against the petitioners subject to the petitioners stopping the production of the drug forthwith,” Justice Vibhu Bakhru said.
The court allowed the company to sell its drug — Ace Proxyvon — and also asked the Health Ministry to place before it all relevant reports on basis of which it had arrived at the decision to ban the medicine.
“The respondents may also produce any material or report, which indicates or establishes that the drug in question is harmful at large,” the court said, adding that it is not inclined to grant interim stay on the government’s notification at this stage. 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 court also issued notice to the ministry concern and listed the matter for further consideration on September 18. Additional Solicitor General Maninder Acharya and Central government standing counsel Anil Soni opposed interim relief.
The matter came up for hearing after Wockhardt mentioned before a bench of Justices S Ravindra Bhat and A K Chawla, for urgent listing of their matter. It was allowed it to be listed before an appropriate bench. 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. 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.