The Delhi High Court on Thursday directed pharmaceutical companies to issue advisories to doctors, chemists, and retailers stating that fixed-dose combination (FDC) cough syrups must not, under any circumstances, be administered to children below the age of four.
The directive came in response to a petition filed by drug manufacturers Glenmark and Zuventus Healthcare, who had challenged the Centre’s April 15 notification. The government order had prohibited the use of certain cough syrup brands for children under four, citing safety concerns.
A Bench headed by Chief Justice DK Upadhaya acknowledged the companies' objection that the order should not apply retrospectively. However, the court made it clear that the firms must strictly comply with the government’s notification for all drugs manufactured after April 15. It instructed the companies to include a warning on packaging labels and promotional material that reads: "fixed combination not to be used for children below four years."
Additionally, the court ordered the manufacturers to publish clear and prominent notices in two national newspapers—one in English and one in Hindi—with nationwide circulation. The notices must be designed to attract the attention of readers.
The High Court also clarified that these public notices should not be considered advertisements and would not constitute a violation of drug license conditions.
The government's April directive was based on safety evaluations that prompted the drug regulator to ban the use of certain FDC cough syrups in young children. Manufacturers have also been instructed to include explicit warnings on labels and package inserts going forward.
(With inputs from Indu Bhan)
The directive came in response to a petition filed by drug manufacturers Glenmark and Zuventus Healthcare, who had challenged the Centre’s April 15 notification. The government order had prohibited the use of certain cough syrup brands for children under four, citing safety concerns.
A Bench headed by Chief Justice DK Upadhaya acknowledged the companies' objection that the order should not apply retrospectively. However, the court made it clear that the firms must strictly comply with the government’s notification for all drugs manufactured after April 15. It instructed the companies to include a warning on packaging labels and promotional material that reads: "fixed combination not to be used for children below four years."
Additionally, the court ordered the manufacturers to publish clear and prominent notices in two national newspapers—one in English and one in Hindi—with nationwide circulation. The notices must be designed to attract the attention of readers.
The High Court also clarified that these public notices should not be considered advertisements and would not constitute a violation of drug license conditions.
The government's April directive was based on safety evaluations that prompted the drug regulator to ban the use of certain FDC cough syrups in young children. Manufacturers have also been instructed to include explicit warnings on labels and package inserts going forward.
(With inputs from Indu Bhan)
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