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BDCDA directs traders to identify Chlorpheniramine & Phenylephrine stock to ensure regulatory compliance
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Nandita Vijayasimha, Bengaluru
September 02 , 2026
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The Bangalore District Chemists & Druggists Association (BDCDA) has asked the pharmacy wholesalers and retailers to identify chlorpheniramine maleate and phenylephrine hydrochloride in their inventory to ensure regulatory compliance.
This follows after an advisory from the Karnataka Food Safety and Drugs Control Administration (FSDA) regarding fixed dose combination (FDC) formulations containing chlorpheniramine maleate and phenylephrine hydrochloride, with reference to the Government of India, ministry of health and family welfare Notification S.O. 4595(E) dated 18.08.2026, issued under Section 26A of the Drugs and Cosmetics Act, 1940.
The Central government has restricted the manufacture, sale or distribution of FDC formulations containing chlorpheniramine maleate and phenylephrine hydrochloride, with the mandatory warning: “Fixed dose combination chlorpheniramine maleate + phenylephrine hydrochloride shall not be used in children below four years of age.”
We have now advised our wholesalers, distributors and retailers to stock and sell only duly licensed and compliant products. There is also a need to verify the prescribed warning on labels and package inserts, ensure promotional material does not contradict the statutory warning, exercise particular caution regarding children below four years of age and maintain proper purchase and sale records and cooperate with regulatory authorities, said B. Thirunavukkarasu, president, BDCDA.
In view of the recent seizure of spurious and allegedly relabelled medicines and related materials valued at approximately Rs. 4.91 crore at an unlicensed facility near Bidadi, BDCDA strongly reiterates the importance of traceability and authorised sourcing. Authorities reported that lower-cost medicines were allegedly repackaged and relabelled to resemble established pharmaceutical brands. Hence our direction to all pharmacies is to purchase medicines only from authorised, company-appointed, jurisdiction-based stockists/distributors, and to maintain proper invoices and batch-wise traceability, he added.
We have categorically stated that all our pharmacy outlets should avoid unauthorised, unverifiable or grey-market sources, irrespective of commercial offers or discounts. This is because in medicines, a low price can never justify compromising authenticity, traceability and patient safety, Thirunavukkarasu noted.
Simultaneously 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. Even the parents and caregivers are specifically advised not to use chlorpheniramine maleate + phenylephrine hydrochloride FDC in children below four years of age and to consult a qualified medical practitioner rather than self-medicate young children.
Thirunavukkarasu said that now BDCDA is issuing this advisory in a time-bound manner to ensure that the regulatory direction reaches every level of the pharmaceutical supply chain and the general public. The recent spurious and re-labelled medicine seizure is a serious reminder that every medicine must be traceable from its authorised source to the patient. “We insist that our members should strictly follow the Karnataka Drugs Control Authority's directions and procure medicines only through authorised, company-appointed and jurisdiction-based channels.”
Patient safety, authenticity of medicines and regulatory compliance must remain the foremost responsibility of every stakeholder in the pharmaceutical supply chain. Here BDCDA remains committed to strengthening responsible pharmaceutical distribution, regulatory compliance and public health protection, said Thirunavukkarasu.
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