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FIPO urges health ministry to reject DTAB's proposal to allow unlicensed establishments to sell OTC drugs
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Peethaambaran Kunnathoor, Chennai
June 19 , 2025
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The Kerala branch of the Federation of Indian Pharmacist Organizations (FIPO) is strongly opposing the Drugs Technical Advisory Board's (DTAB) recommendation to exempt certain drugs from sales licensing and allow unlicensed establishments to sell these medicines. The association has now urged the Union health ministry to reject the proposal.
Maintaining its position, FIPO insists that all medicines, including over-the-counter (OTC) drugs, must continue to be dispensed under a valid drug license and by a registered pharmacist.
The association argues that qualified pharmacists directly oversee licensed medical stores, ensuring full compliance with the Drugs and Cosmetics Act and the Rules. They are responsible for maintaining dispensing registers that record vital information such as the patient's name and address, the prescriber's name, the name and quantity of the dispensed drug, and a reference number to verify the course of treatment. Such rigorous record-keeping and accountability are simply not feasible in establishments without a valid drug license. Allowing OTC drugs through these outlets would compromise public health and create avenues for misuse.
While they express support for the government's initiative to amend the Drugs and Cosmetics Rules 1945, which would permit 16 specific drugs to be sold OTC through licensed medical stores, the members of the FIPO strongly oppose any measure that would allow the sale of these drugs through unlicensed establishments.
Writing to the union health secretary, MK Premanandan, secretary of the Kerala branch of the FIPO highlighted the DTAB’s draft proposal. According to him, this proposal suggests adding 16 specific drugs, such as paracetamol 500mg, clotrimazole cream, and diclofenac ointment, to Schedule K for OTC sale, subject to certain stipulations. The primary objective of this amendment is to expand the availability of drugs for OTC sale without a prescription from a registered medical practitioner. FIPO expresses concern that this also implies dispensing without a registered pharmacist, and therefore urges the government to adhere to the statutory requirements of a valid license and a registered pharmacist for all medicine dispensing.
According to the letter, the sale and distribution of drugs are strictly governed by the Drugs and Cosmetics Act of 1940 and its 1945 Rules. These legislations empower pharmacies and other entities to sell drugs, with a core emphasis on guaranteeing the quality, safety, and efficacy of medicines through mandatory compliance with storage conditions and the essential supervision of registered pharmacists. FIPO, therefore, considers the DTAB's recommendation to permit the sale of OTC drugs without both a drug license and pharmacist supervision to be unconstitutional, advocating strongly for its rejection.
The letter says, "The existing licensing framework appropriately mandates compliance with minimum storage conditions and the essential supervision of registered pharmacists, a legal requirement that is neither permissible nor advisable to dilute." It argues that given the DTAB's own formation under the D&C Act, its recommendations are bound to operate strictly within the Act's established legal and constitutional parameters.
FIPO has also urged the union health ministry to allow pharmacists to refill prescriptions for non-communicable diseases (NCDs) and lifestyle diseases for a limited period. This, they argue, would depend on the original prescription's nature and validity, ensuring patients receive uninterrupted treatment and greater convenience.
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