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India Today
25-04-2025
- Health
- India Today
India bans select cough syrups for children under 4 amid safety concerns
On April 15, 2025, the government of India released an order restricting the manufacture, distribution, and sale of fixed-dose combination (FDC) cough syrups for children under the age of four that contain chlorpheniramine maleate and phenylephrine hydrocholoride. This came after the recommendation from DTAB and the Subject Expert Commmittee, which emphasised the issues relating to the safety and effectiveness of these products in young previously mentioned medicines include popular brands such as Ascoril Flu Drops and some of Alex by Glenmark, T-Minic by Haleon (previously GlaxoSmithKline), and Maxtra by Zuventus Healthcare. These manufacturers are now required to add label and package insert warnings that say: 'Combination of FDC shall not be given to children below four years of age.'Glenmark and Zuventus Healthcare contested the government's notification claiming that it was illegal to apply it retrospectively. On April 24, 2025, the ruling of the Delhi High Court delegated that this ban will be implemented as sequential meaning it will not include stocks that were made before April fifteen as they were exempted. Nonetheless, the court required these companies to inform all medical professionals through formal advisories and public notices in widely circulated newspapers stating that these FDC cough syrups must never be given to children under four years regardless of the the manufacturers were ordered by the court to submit sworn statements regarding the produced and distributed stocks prior to the new guidelines coming into effect so as to maintain compliance and around the nation have raised issues pertaining to the management of remaining stock of the banned cough syrups post the ban. The IPA or the Indian Pharmaceutical Association has consulted the DCGI or the Drugs Controller General of India inquiring whether the remaining supply is meant to be returned or can be sold until there is zero stock left. Moreover, there is a need for clarification on the dispensing of prescriptions meant for toddlers during this period of shifting stakeholders include the manufacturers, pharmacists, and health care service providers, along with other stakeholders. As such, they have also been suggested alongside more time in the adaptation period to ensure the new regulations are seamlessly measures imposed by the government highlight the necessity of safeguarding children's medicines. The restrictions placed on using selected FDC cough syrups in very young children are intended to avoid certain negative outcomes and safeguard the interests of this sensitive age public notices, along with the warnings, are directed towards ensuring that as a professional, one pays more attention to the targeted health care services and therapeutics as they relate to monitoring changes within the processes of these healthcare sectors, it is crucial that the guardians, pharmaceutical practitioners, and the rest involved in the regulation work closely together to protect the young children's wellbeing while being fully responsible for adapting to the new instruction policies.
Time of India
24-04-2025
- Health
- Time of India
Relief for pharma cos as Delhi HC says cough syrup ban applies prospectively
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 Ministry 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. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Play War Thunder now for free War Thunder Play Now Undo 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. Live Events 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.
