Cough Syrup Warning Will Not Affect Existing Stock: HC Relief to Glenmark, Zuventus
Delhi High Court
New Delhi: In a major relief to pharma companies Glenmark Pharmaceuticals Ltd. and Zuventus Healthcare Ltd., the Delhi High Court has ruled that the government's recent notification requiring a new warning label on cough syrups containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride will apply prospectively and not impact stocks manufactured before April 15, 2025.
The order was passed by a bench comprising Chief Justice Devendra Kumar Upadhyaya and Justice Tushar Rao Gedela while hearing two writ petitions filed by Glenmark Pharmaceuticals and Zuventus Healthcare.
The Delhi High Court made it clear;
"Any statutory provision or a piece of subordinate legislation or even a statutory notification under some statute will operate prospectively unless the statute or the notification itself provides for its retrospective application."
Accordingly, the court ruled that the notification dated April 15, 2025, issued by the Ministry of Health and Family Welfare under Section 26A of the Drugs and Cosmetics Act, 1940, would not apply to stocks manufactured before April 15, 2025.
The controversy arose after the Centre issued a notification requiring that formulations containing Chlorpheniramine Maleate + Phenylephrine Hydrochloride must carry a specific warning on their labels, package inserts, and promotional materials stating:
"fixed dose combination shall not be used in children below four years of age."
The banned fixed drug combination is commonly used in many over-the-counter medicines for treating colds and allergies. These medicines are sold under different brand names include Ascoril Flu Drops and certain variants of Alex, both marketed by Glenmark Pharma, reports ET.
Glenmark Pharmaceuticals and Zuventus Healthcare challenged this notification in the Delhi High Court, arguing that it could not affect stock already manufactured and circulated in the market prior to the notification date.
The pharma companies argued that they had no objection to the notification being applied prospectively but raised concerns about its retrospective application. Their counsel submitted that , "so far as the prospective application of the Impugned Notification is concerned, the petitioners do not have any objection and, accordingly, they undertake that all the stock which may be manufactured after 15.04.2025 shall necessarily contain the label as per the requirement of the Impugned Notification."
They further contended that imposing new labeling obligations on already manufactured and legally approved stocks would be unfair, particularly when no hearing was provided before the issuance of the notification, as mandated by the Supreme Court in Union of India v. Pfizer Limited (2018) 2 SCC 39.
On the other hand, the government defended the notification by stating that it was issued after due consultation with the Subject Expert Committee and the Drugs Technical Advisory Board (DTAB) considering the health risks to children.
However, during the hearing, government counsel clarified that "the Impugned Notification will have no retrospective application."
This assurance from the Centre played a crucial role in shaping the court's final decision.
The High Court was of the opinion that;
"The Impugned Notification cannot apply retrospectively for the simple reason that the Impugned Notification does not provide for its retrospective application. It is also to be noticed that the Impugned Notification requires that manufacturers “shall” mention the warning as given in the Impugned Notification and further that it shall come into force on the date of its publication in the Official Gazette."
"It is trite in law that any statutory provision or a piece of subordinate legislation or even a statutory notification under some statute will operate prospectively unless the statute or the notification itself provides for its retrospective application. A perusal of the Impugned Notification does not indicate that it provides for its application retrospectively."
subsequently, the Court noted that;
"The petitioners, as undertaken by them, shall compulsorily comply with the requirement of the terms of the Impugned Notification by mentioning the wording 'fixed dose combination shall not be used in children below four years of age' on the label and package insert and the promotional literature of the drug, on all stocks manufactured and circulated after 15.04.2025."
"The petitioners shall put an unambiguously worded notice in two national newspapers, one in English and the other in Hindi, having nation-wide circulation in all their editions."
"The petitioners shall also issue advisory to the doctors, retailers and also to the chemists clearly indicating therein that the fixed dose combination of the drugs as per the Impugned Notification shall not, in any circumstance, be prescribed for administration to the children below the age of four years."
"The notice and the advisory as aforesaid shall be published/ issued within a week from today."
The Court further added that,
"The petitioners shall file an affidavit before this Court giving details of their stocks which were manufactured upto 15.04.2025 along with copies of the advertisement and the advisory as aforesaid, within two weeks."
Crucially, the court also held that no coercive action under Section 28B of the Drugs and Cosmetics Act would be taken against the companies concerning already manufactured stock, provided these conditions are met.
The matter has been listed for compliance on May 19, 2025.
To view the original order, click on the link below:
