Sun Pharmaceutical Industries must secure formal permission from the Delhi High Court before launching any generic semaglutide tablets in India, according to a directive issued by Justice Anup Jairam Bhambhani, as reported by The Economic Times.
Delhi High Court Mandate and Legal Arguments
Under the court’s directive, Sun Pharma Laboratories—a subsidiary of Sun Pharmaceutical Industries—is required to immediately inform and seek approval from the bench if it receives a commercial manufacturing licence for semaglutide tablets, before taking any steps to bring the product to market, according to LiveMint. Novo Nordisk argued in its petition that the approval Sun Pharma recently secured from the Subject Expert Committee (SEC) of India’s drug regulator for 3-milligram, 7-milligram, and 14-milligram tablet strengths infringes upon its valid intellectual property.
Novo Nordisk pressed for an immediate restraint order. According to the Danish drugmaker, Sun Pharma was poised to launch the tablets commercially the moment marketing approval cleared, creating a situation where the product would be exceedingly difficult to recall once distributed, as detailed by The Economic Times. In its defense, Sun Pharma challenged the territorial jurisdiction of the Delhi High Court, noting that the Indian generic firm is headquartered in Maharashtra.
Market Stakes and Regulatory Landscape in India
Countering the jurisdictional argument, Novo Nordisk maintained that Sun Pharma Laboratories actively operates through a Delhi address and conducts business within the union territory. The Danish firm pointed out that Sun Pharma sells its products both online and offline in Delhi and would inevitably distribute the semaglutide tablets there upon final approval, according to The Economic Times.
