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The government challenged it in the top court on the ground that the ban was necessary in public interest, prompting the top court to stay the Delhi HC’s order.

The Supreme Court on Wednesday said the central government need not consult the statutory board on drugs before banning any fixed-drug combinations, an observation that goes against a major legal plank of companies battling against a ban on 344 such products. Fixed-dose combinations (FDCs) are cocktail drugs of two or more therapeutic ingredients packed in a single dose.
The government had banned these 344 FDCs in 2016 in public interest, claiming they were unsafe and "irrational". The action had hit several popular brands like Corex, Saridon, D’Cold Total and Vicks Action 500 Extra, prompting pharma companies to submit over 500 petitions at around 10 high courts, with Delhi receiving a sizeable chunk.in last December, the Delhi HC set aside the central government notification. The government challenged it in the top court on the ground that the ban was necessary in public interest, prompting the top court to stay the Delhi HC’s order.
Pharma companies such as Glenmark, Pfizer and Procter & Gamble contended that the principle of natural justice required some kind of hearing from stakeholders before the government can take a call on a technical subject like this one.
Before prohibiting fixed-dose combination drugs, the government must consult the statutory bodies provided for in the Drugs and Cosmetics Act, the companies argued before a bench of Justices RF Nariman and Sanjay Kishan Kaul. “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 argued.

Justice Nariman, however, 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.” Justice Kaul said the arguments would have been appealing had the subject matter been anything but drugs.
The court said it was with the government on this legal point. The companies will now likely argue the other legal points against the ban at the next hearing, scheduled for December 6.“Arguments on December 6 will look at how many FDCs can be excluded from the ban and how many we are not able to justify entirely," a lawyer involved in the case told ET, speaking on the condition of anonymity. The industry is positive about the court's decision to allow further arguments in this case.
“The judge is open to hearing a little bit from our side as well, which is positive," said RK Sanghavi of lobby group Indian Drug Manufacturers Association. The association on Wednesday submitted a list of 175 FDCs out of the original 344 that it had determined were not only safe for consumption but needed for specific patients.