New Delhi: In a relief to pharma companies, including Glenmark Pharmaceuticals and Zuventus Healthcare, the Delhi High Court on Thursday held that the government’s April 15 notification that prohibited the manufacture, sale, and distribution of all fixed-dose combinations (certain cough syrup brands) for those below four years of age will apply prospectively.
The notification issued by the M inistry of Health and Welfare, which came into effect immediately on the said date, mandated a manufacturer to include a warning stating ‘fixed-dose combination shall not be used in children below four years of age’ on the label and package insert or promotional literature of the drug.
A Division Bench led by Chief Justice DK Upadhaya accepted the concerns of the manufacturers that the notification cannot applied retrospectively as some stocks have been manufactured and were in the market before the ban came into effect on April 15.
However, the court asked the companies to issue an advisory to doctors, chemists and retailers that fixed dose combination of drugs shall not in “any circumstances” be prescribed/administered to children below four years of age.
Additionally, the judges asked the manufacturers to publish an “unambiguously worded notice” in two national newspapers—one in English and one in Hindi— having nationwide circulation. The size of the notices must be designed to attract the attention of readers, the court said.
The notice and advisory shall be published within a week, the court said.
However, the manufacturers have been directed to “compulsorily comply” with the notification by mentioning the warning on all their labels and packaging of all stocks manufactured and circulated after April 15.
The pharma companies must file an affidavit furnishing details of the stocks manufactured, sold or have been in circulation before April 15, the court said.
However, the court clarified that any such public notice published by the pharma companies should not be construed as an advertisement and would not amount to any breach of their drug license conditions.
If the pharma companies abide by the conditions regarding the notice, advisory, and undertakings, irrespective of the manufacture and sale of the drug in question, no coercive measures against them will be taken, the court. The court will hear the case for compliance on May 15.
Senior counsel Amit Sibal and counsel Ajay Bhargava alleged that the drug manufacturers and other stakeholders were not given any opportunity of hearing before the notification was issued.
The directions came on a couple of appeals filed by Glenmark and Zuventus challenging the validity of the April 15 notification issued by the Department of Health and Welfare that prohibited the use of all formulations of the fixed dose combination of chlorpheniramine maleate plus phenylephrine hydrochloride in children below four years of age.
The restrictions issued under Section 26A of the Drugs and Cosmetics Act, 1940 were imposed on the recommendations of the Drugs Technical Advisory, citing safety concerns.
The prohibited fixed drug combination is a commonly used formulation found in various over-the-counter drugs used to treat colds and allergies. The drugs, widely prescribed and sold under various brand names, include Ascoril Flu Drops and some variants of Alex by Glenmark Pharma.
