Centre’s FDC ban: P&G, Glenmark, Reckitt get HC stay

Five healthcare majors, including Procter and Gamble, Glenmark and Reckitt Benckiser on Wednesday got interim relief from the Delhi High Court which stayed till March 21 the ban imposed by the government on sale of some of their fixed dose combination (FDC) medicines.

Justice Rajiv Sahai Endlaw said "same orders" would be passed in respect of the five companies which also included Alembic Pharmaceuticals and Piramal Enterprises Ltd as was passed yesterday and day before in the case of pharma majors Pfizer, Abbott Healthcare and Macleods Pharmaceuticals.

As a result of the court's order, the ban on sale of P&G's Vicks Action 500 extra, Reckitt's D'Cold and Piramal's Saridon have been lifted till March 21. A similar relief has been extended to various cough syrups as well as cold medication sold by Glenmark and Alembic. Alembic has got the relief with respect to its Zeet and Glycodin cough syrups and Wikoryl cold tablet.

For Glenmark, the drugs which would benefit from the order are its Ascoril and Alex cough syrups, Candid ear drops, Candidbiotic, Candid total antifungal cream and Trigulin anti diabetic medicine. The court asked the counsel for the companies to give the number of years their products have been in the market and listed the matter for further hearing on March 21 when the pleas of Pfizer, Abbott and Macleods would also be taken up.

The Health Ministry, through a gazette notification, has banned over 300 fixed dose combination drugs, including cough syrups compositions, saying they involve "risk" to humans and safer alternatives were available.

The companies have sought quashing of the notification on the ground that no show cause notice or hearing was granted to them prior to issuing of the notification. They have alleged that the notification is silent on the aspect as to which expert committee was appointed by Health Ministry to examine the safety and deficiency of the FDCs.

As per the notification,"On the basis of recommendations of an expert committee, the Central government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition of manufacture for sale, sale and distribution for human use of said drugs in the country."