Supreme Court exempts Saridon, Piriton from government's FDC ban list

The Supreme Court has allowed the sale of Saridon, Piriton expectorant and Dart tablets, three combination drugs among more than 300 that the government banned recently for being risky for patients, according to a report in the Economic Times newspaper.

While hearing a plea by GlaxoSmith-Kline, Piramal and Jagdale Industries, the court allowed them to continue selling the drugs because they were being manufactured before 1988, the report quoted a lawyer present at the proceedings as saying. “The Union of India disputed this position, saying that these fixed dose combinations are not pre-1988 combinations,” a second lawyer said. The court had earlier said the health ministry could not rely on its technical committee’s report to ban 15 combination drugs that were manufactured since before 1988, another lawyer said. The apex court directed the government to reply within two weeks to a separate application by the Federation of Pharma Entrepreneurs seeking a stay on the ban against all 328 combination drugs. The federation contended the government did not follow due process, one of the lawyers said.

Several popular cough syrups, painkillers and cold medicines are combination drugs, containing two or more therapeutic ingredients in a single dose. Saridon is marketed by Piramal to treat headaches. GSK’s Piriton is a cough syrup. “The court has passed an interim order permitting us (and other pre-1988 manufacturers who were excluded from the exempt list) to continue manufacturing and sale of the product subject to its final decision on our application,” a GSK spokesperson was quoted as saying in the report. Wockhardt, Lupin, Alkem, Mankind and MacLeods Pharmaceuticals are among the drug companies that have approached the Delhi High Court for relief from the ban.