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The Karnataka Pharma Retailers & Distributors Organization (KPRDO) has issued a stern reminder to all pharmacy outlets asking to strictly adhere to the Union and state government’s directive regarding the sale of cough syrups. In view of the recent fatalities following adverse drug reactions and the regulatory orders that have come forth from both CDSCO and state government’s health and family welfare department, the KPRDO emphasized that over-the-counter (OTC) sales of these medications are prohibited and urged pharmacies to ensure full compliance in order to safeguard public health and prevent misuse of these products.
C Jayaram, president and VV Kapparshettar, secretary, KPRDO in a communication to the pharmacy outlets in the state has said that it is imperative that all registered pharmacists and pharmacy outlets need to strictly refrain from dispensing cold & cough syrups for children under 2 years of age under any circumstances. In case where a medical practitioner inadvertently prescribes cough syrups for children under 2 years, it is the responsibility of the registered pharmacist to bring it to the notice of the prescriber about the recent government's guidelines.
Dispensing for children above 5 years, if required, must be used only after clinical evaluation with close supervision and strict adherence to appropriate dosage and also multi drug combinations/irrational combinations must be avoided. Under no circumstances OTC sales should be entertained for cough syrups and should be dispensed only against a valid and authentic prescription issued by a registered medical practitioner, in the supervision of registered pharmacist, they added.
Pharmacists should also counsel patients on the potential risks associated with such medicines in infants/children and suggest safe non-medical alternatives such as adequate hydration, saline nasal drops, rest, etc and nutritious diet measures should be encouraged, pointed out Jayaram and Kapparshettar.
Besides, KPRDO said that chemists must ensure procurement of medicines are only from authorised stockists adhering to good distribution practices (GDP) and keep a close watch on the pharma companies’ good manufacturing practice (GMP) to make certain the compliance of these licenced manufacturers. Any violations of these compliances, including irrational prescription, over-the-counter-sales and the use of unapproved fixed dose combinations will attract statutory action under the Drugs & Cosmetics Act 1940 And Rules 1945, they warned.
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