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The Tamil Nadu Pharmaceutical Traders Association (TN PTA) has urged the Drugs Technical Advisory Board (DTAB) under the CDSCO not to support the proposal for allowing sale of over-the-counter (OTC) medicines in non-pharmaceutical shops like super markets and general stores without prescription.
The general stores or supermarket stores do not have any pharmacist support, hence the OTC drugs should not be allowed to dispense by unqualified people or sold through any unlicensed entity, the association wanted the advisory board.
The letter signed by Chola Mahendran and MS Saravanan, the president and the secretary of the association, wants that OTC drugs, whether they are scheduled or non-scheduled, should be sold through licensed pharmacies.
The leaders of the trade body disagree with the proposal now under consideration of the DTAB that a few selected over-the-counter drugs can be permitted to sell through super markets and general retail shops without prescription. “While we understand that the proposal aims to increase accessibility of common medications, we believe that such a move will pose serious risks to public health. Easy and unsupervised availability of medications such as painkillers, antipyretics, cough syrups, and certain scheduled and non-scheduled drugs, can result in misuse, overuse, underuse, dependency and dangerous self-medication practices. In the absence of professional pharmaceutical guidance, these risks can be magnified”, they warned.
The leaders said in the letter that they registered their objection to the proposal being considered by the highest statutory body which is responsible to give advice to the government on matters related to administration of the drug act in the country. TN PTA finds that sale of OTC drugs through general stores would increase the chances for the entry of spurious or counterfeit drugs into the market, and on reaching the public they will lead to harmful consequences. The association apprised the advisory board that even the commonly used medicines like paracetamol and Ibuprofen have severe side effects and should only be used under the guidance of a qualified pharmacist.
According to Mannargudi Ramachandran, the patron of the association, all OTC medicines, whether they are used with the prescription of a registered medical practitioner (RMP) or not, must be sold only through licensed pharmacies operating under the provisions of the Drugs and Cosmetics Act. Allowing non-pharmaceutical outlets to sell these medicines will severely compromise the current safeguards provided by licensed pharmacies. Unlike trained pharmacists, staff in general stores and supermarkets may not be equipped to counsel the customers on correct dosage, contraindications, and potential side effects.
He suggested that proper packaging, restricted dosage limits, and treatment duration guidelines must be strictly enforced to prevent drug abuse and ensure patient safety. Unrestricted sale of medicines will lead to self-medication which will create health hazards.
Last year, when the proposal was made by the government to allow traditional grocery shops (Kirana stores) to sell OTC drugs without licenses, the national pharma trade body, AIOCD, had given a memorandum to the government informing the authorities about the adverse effects of selling medicines to the common man by unqualified persons. The national trade body’s observation was that the drug trade is a regulated area, and all the common medicines need to be regulated by authorized officials as per drug rules and monitored by qualified pharmacists.
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