The Federation of Pharma Entrepreneurs (FOPE) has sought clarification and a reasonable transition period for implementing the Ministry of Health & Family Welfare’s Notification S.O. 4595(E), dated August 18, 2026, concerning fixed-dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride.
In its representation to the government, FOPE said the industry supports the notification’s objective of ensuring patient safety and rational use of medicines, particularly among children below four years of age. However, it highlighted several practical and regulatory concerns that could affect manufacturers and stakeholders across the supply chain.
A key concern raised by FOPE is the implementation of the new warning requirement on existing stocks. The notification requires the warning, “Fixed dose combination shall not be used in children below four years of age,” to be included on labels, package inserts or promotional literature.
FOPE pointed out that products manufactured before the notification may already be held by carrying and forwarding agents, distributors, stockists, retail pharmacies, hospitals and institutions. It has therefore sought an adequate transition period to allow depletion or appropriate modification of existing stocks.
The federation has also urged the government to clarify that the new requirements will apply prospectively and that products manufactured, distributed and marketed in compliance with regulations applicable at the time should not face retrospective action solely because they do not carry the newly mandated warning.
FOPE has further sought clarity on the scope of Notification S.O. 4595(E) in relation to the earlier Notification S.O. 1717(E), dated April 15, 2025. It said the term FDC is broad and could encompass different dosage forms, including eye drops and injectables, which may not be relevant to the intended warning requirement.
The federation has also called for greater emphasis on rational prescribing and guidance to registered medical practitioners, noting that several such formulations are prescription medicines and that healthcare professionals are already subject to applicable obligations relating to rational prescribing and patient safety.
To facilitate implementation without disrupting existing inventory, FOPE has proposed a mechanism under Rule 104A of the Drugs and Cosmetics Rules, 1945, including permitting stakeholders to affix warning stickers or stamps on existing stocks and modify package inserts, wherever applicable.
FOPE has cited the precedent of regulatory permissions allowing stickers or stamps for compliance with ceiling prices under the DPCO and has sought a similar mechanism for the FDC warning.
The federation has urged the government to:
- clarify that Notification S.O. 4595(E) will operate prospectively;
- provide a reasonable transition period for existing stocks;
- ensure that compliant pre-notification stocks are not subjected to coercive action solely due to the absence of the new warning;
- permit an appropriate compliance mechanism for existing inventory;
- issue uniform implementation guidance to all stakeholders; and
- clarify the precise formulations and dosage forms covered by the notification.
FOPE reiterated its commitment to working with the government on regulatory compliance while ensuring patient safety and minimising avoidable disruption to the pharmaceutical supply chain.