Companies challenge ban on fixed-dose combination drugs

Drug companies have contested the government’s power to regulate, restrict and prohibit the manufacture of widely sold fixed-dose combinations such as Corex, D’cold and Saridon without consulting the technical advisory board.

Companies including Glenmark, Pfizer and Procter & Gamble contended before Supreme Court Justices RF Nariman and Sanjay Kishan Kaul on Wednesday that the principle of natural justice required some kind of hearing from stakeholders before the government can take a call.

A Central government notification banning 344 such fixed-dose combinations in 2016 was set aside by the Delhi High Court in December. The Central government has challenged it on the ground that the ban was necessary in public interest. Before prohibiting fixed-dose combination drugs, the government must consult the statutory bodies provided for in the Drugs and Cosmetics Act, 1940, the companies argued.

“Otherwise the power would be unfettered, unlimited,” senior advocate Abhishek Manu Singhvi said. “This cannot be done without consulting the stakeholders. Public safety, public risk can only be assessed on the basis of expert inputs.” In the absence of an emergency, such a consultation should be made mandatory, he said.

Justice Nariman said such consultations were not specified in Section 26A of the act, which defines the power of the Central government to regulate the manufacture and sale of drugs and cosmetics in public interest. “If we hold otherwise, we will neither be reading the law up or down but reading in, which is legislating,” Nariman said. Justice Kaul said the arguments would have been appealing had the subject matter been anything but drugs.