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Informist, Thursday, Apr. 24, 2025

 

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--Glenmark moves HC vs govt banning select cough syrups for kids below 4 yrs 
--CONTEXT: Govt on Apr 15 notified ban on select cough syrups for kids 
--Zuventus, other pharma cos also move HC against cough syrup notification 
--HC: Govt notification to ban select cough syrups to apply prospectively 
--HC to pharma cos:Put notice in newspaper on cough syrup combination safety 
--HC to cos: Must advise doctors, retailers on cough syrup combination safety 
--HC to cos:Give detail of cough syrup made and in circulation before Apr 15 
--HC: No coercive action against pharma cos if cough syrup advisory followed

 

NEW DELHI – In a relief to Glenmark Pharmaceuticals Ltd. and other pharmaceutical companies, the Delhi High Court on Thursday ruled that the government's restriction on the manufacture, sale, and distribution of all fixed-dose combinations of chlorpheniramine maleate and phenylephrine hydrochloride for children under four years of age will apply prospectively. The notification, issued by the government on Apr. 15, requires manufacturers to include a warning stating "fixed-dose combination shall not be used in children below four years of age" on the drug's label, package insert, and promotional materials.

The "banned" fixed drug combination is a commonly used formulation found in many over-the-counter medicines and syrups 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 Pharmaceuticals.

 

The high court directed pharmaceutical companies to "compulsorily comply" with the Apr. 15 notification by including the warning--"fixed dose combination shall not be used in children below four years of age"—-on the label and packaging of all stocks manufactured, circulated, or set to be manufactured after Apr. 15. 

 

The petitioners, Glenmark, Zuventus Healthcare Ltd. and others, had moved the high court against the government's notification. The petitioners said that before the notification was issued, an opportunity of hearing was not provided to manufacturers and other stakeholders, which was necessary according to law laid down by the courts. Irrespective of the validity of the notification, it cannot be made applicable retrospectively, the petitioners had argued.  

 

The pharma companies shall put an "unambiguously worded notice" in national newspapers having nationwide circulation, and give advisories to doctors, retailers, and chemists that fixed-dose combinations of drugs, as per the notification, shall not, in any circumstance, be prescribed to be administered to children below four years of age, the court said. The notice and advisory shall be published within a week, the high court said. Moreover, the pharma companies shall file an affidavit furnishing details of the stocks manufactured and that have been in circulation before Apr. 15.

 

If the pharma companies abide by the conditions regarding the notice, advisory, and also filing of the affidavit, irrespective of the manufacture and sale of the drug in question, no coercive measures against them will be taken, said the court. The high court clarified that any such notice on the issue published by the pharma companies should not be construed as an advertisement and would not amount to a breach of licence conditions. The court will hear the case for compliance on May 15.  

 

At 1320 IST, the shares of Glenmark Pharmaceuticals Ltd. were up 0.8% at INR 1,423.90 on the National Stock Exchange.  End

 

IST, or Indian Standard Time, is five-and-a-half hours ahead of GMT

 

Reported by Surya Tripathi
Edited by Subhojit Sarkar

 

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