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.
A central government notification banning the 344 fixed-dose combinations in 2016 was set aside by the Delhi High Court in December. The government had banned these combinations in public interest, claiming they were unsafe and “irrational”.
The ban 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.
The government challenged these in the top court on the ground that the ban was necessary in public interest, prompting the top court to stay the order.
Pharma companies such as Glenmark NSE -0.60 %, Pfizer NSE -1.79 % and Procter & Gamble had 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 had argued before a bench of Justices RF Nariman and Sanjay Kishan Kaul.
“Otherwise the power would be unfettered, unlimited,” senior advocate Abhishek Manu Singhvi had 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 had 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,” Nariman said. Justice Kaul also 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 Dec 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 pharmaceutical lobby group Indian Drug Manufacturers Association.
The association on Wednesday submitted a list of around 175 FDCs out of the original list of 344 that it had determined were not only safe for consumption but needed for specific patients, he said.
This list excluded the FDCs approved before 1988 and those already approved by the Drug Controller General of India, he added.
“The judgment will definitely have an impact depending on how much commercials are at stake and more importantly on the patients’ dependency on such FDCs, especially in cases of chronic diseases,” said Ashish Prasad, partner at Economic Laws Practice.
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