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IPA seeks clarification from DCGI on notification restricting use of FDC for common cold in infants below 4 years
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Peethaambaran Kunnathoor, Chennai
April 22 , 2025
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The Community Pharmacy Division (CPD) of the Indian Pharmaceutical Association (IPA) has demanded that the Drug Controller General of India (DCGI) should come out with a clarification on certain concerns of the community pharmacists in the country with regard to the notification on restriction of the FDC, chlorpheniramine maleate and phenylephrine hydrochloride, a drug used for common cold among infants below four years.
The Union government came out with a restriction on the FDC on April 15, 2025 after a thorough contemplation of the risk factors that affect children below four years with the use of this drug, but suggested safer alternatives in place of the FDC.
However, the decision of the union government did not satisfy the Indian Pharmaceutical Association which represents the community pharmacists engaged in the business of wholesale and retail of pharmaceuticals in the country. The association perused the notification issued on April 15 by the ministry of health and family welfare and the subject matter was discussed among the members. Accordingly, they are now faced with the dilemma of stocking and sale of the FDC and related other combinations.
Raj Vaidya, the head of community pharmacy division of the IPA has written a letter to the DCGI seeking clarifications on the concerns now being raised by the community pharmacists in the country, following the imposition of restriction on the particular FDC.
Vaidya wanted the national drug regulator to answer the query whether a community pharmacist can dispense the FDC provided a person approaches the pharmacy with a prescription for the medicine by a doctor. In the notification of the government, there is no mention about any ban on the medicine, but only restrictions on use for children below four years, and on manufacture, sale and distribution. This confuses the pharmacists about whether it is a complete ban or not.
Secondly, the Raj Vaidya asks the DCGI to explain if the retail and wholesale pharmacists can sell the already stocked batches on the shelves of the pharmacies till the end of the stock without requisite warning. Also, advice has been sought on whether the stock needs to be sent back to the manufacturer.
Thirdly, the community pharmacist leader wanted the drug regulator to clarify whether the restriction and labelling requirements are applicable to the FDC, paracetamol and chlorpheniramine maleate and phenylephrine hydrochloride.
Raj Vaidya said he is waiting for the reply of the DCGI to take a final decision on the matters. He said he is also confused by the notification which is not self-explanatory.
Meanwhile, Pharmabiz has sent some queries to the WhatsApp number of Dr Rajeev Singh Reghuvanshi, DCGI, requesting clarifications on the same queries, but he did not respond to them.
The notification dated April 15, 2025 mandating restriction of the FDC drug says that a subject expert committee (SEC) appointed by the union government recommended that all formulations of fixed dose combination of chlorpheniramine maleate IP and phenylephrine hydrochloride should not be used in children below four years of age and accordingly manufacturers should mention a warning on the label and in the promotional literature that “fixed dose combination shall not be used in children below four years of age. "Similarly, the drugs technical advisory board (DTAB) also examined the particular FDC and recommended that all formulations of the drug combination should be prohibited for use in children below four years under Section 26 A of the D&C Act 1940, and for manufacture, sale and distribution there is one condition that the manufacturers should mention a warning on the label that the FDC should not be used in children below 4 years of age.
Commenting on the notification, the Joint Drug Controller in Jharkhand, SK Tiwari, said it is actually a ban on the FDC by the central government, and it is applicable all over India. He said the manufacturers must recall the product lacking the warning and issue circulars to wholesalers and retailers asking them not to sell it. He said the retail pharmacists are prohibited from dispensing the drugs in order to ensure compliance with the government order.
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