Bangalore District Chemists & Druggists Association (BDCDA) has directed pharmacy wholesalers and retailers to identify chlorpheniramine maleate and phenylephrine hydrochloride in their inventory to ensure regulatory compliance. This follows an advisory from the Karnataka Food Safety and Drugs Control Administration (FSDA) referencing a Government of India notification under Section 26A of the Drugs and Cosmetics Act, 1940. The central government has restricted the manufacture, sale, or distribution of fixed dose combination (FDC) formulations containing these specific ingredients.
New restrictions on children
The notification mandates a specific warning: “Fixed dose combination chlorpheniramine maleate + phenylephrine hydrochloride shall not be used in children below four years of age.” BDCDA President B. Thirunavukkarasu stated that members must now stock and sell only duly licensed and compliant products. He emphasized the need to verify the prescribed warning on labels and package inserts, ensuring promotional materials do not contradict the statutory warning.
Thirunavukkarasu also noted that the association is issuing this advisory in a time‑bound manner to ensure the regulatory direction reaches every level of the pharmaceutical supply chain and the general public.
In addition to checking the warning, pharmacies are urged to examine batch numbers, manufacturing dates, and expiry information for each unit of the combination product. This granular verification helps confirm that the medicine originates from an authorized manufacturer and has not been subjected to unauthorized repackaging. By cross‑referencing these details with the records supplied by the appointed distributors, retailers can quickly flag any discrepancy before the product reaches the consumer.
The association further advises that any deviation from the mandated warning—such as omission, alteration, or ambiguous phrasing—should be reported immediately to the Karnataka Drugs Control Authority. Prompt reporting enables regulators to intervene, retrieve non‑conforming stock, and prevent inadvertent exposure of vulnerable patients.
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Stopping grey‑market sales
In view of a recent seizure of spurious and allegedly relabelled medicines valued at approximately Rs. 4.91 crore at an unlicensed facility near Bidadi, BDCDA is reinforcing the importance of traceability and authorized sourcing. Authorities reported that lower‑cost medicines were allegedly repackaged and relabelled to resemble established pharmaceutical brands. Consequently, the association has categorically stated that all pharmacy outlets should avoid unauthorised, unverifiable, or grey‑market sources, regardless of commercial offers or discounts.
Pharmacists are advised to purchase medicines only from authorized, company‑appointed, jurisdiction‑based stockists or distributors. This is to maintain proper invoices and batch‑wise traceability. Thirunavukkarasu added that in medicines, a low price can never justify compromising authenticity, traceability, and patient safety. The BDCDA has also urged the public to purchase medicines only from licensed pharmacies, retain purchase bills, and avoid medicines obtained through unknown or unauthorised channels.
Beyond the procurement process, the association stresses that every transaction should be documented with a clear paper trail linking the product back to its original manufacturer. Such documentation includes supplier certificates, transport manifests, and receipt of goods signed by a qualified pharmacist. Maintaining these records not only satisfies regulatory audits but also creates a rapid response pathway if a future recall is required.
Even parents and caregivers are specifically advised not to use chlorpheniramine maleate + phenylephrine hydrochloride FDC in children below four years of age. They are encouraged to consult a qualified medical practitioner rather than self‑medicating young children. The association remains committed to strengthening responsible pharmaceutical distribution, regulatory compliance, and public health protection.
