The Kerala branch of the Federation of Indian Pharmacist Organizations (FIPO) has formally opposed the Drugs Technical Advisory Board’s (DTAB) recommendation to allow the sale of certain over-the-counter (OTC) medicines through unlicensed establishments. In a letter to the Union Health Ministry, FIPO emphasized that all drugs including OTC must be dispensed only under a valid drug license and by a registered pharmacist.

Key highlights

Strict opposition to unregulated drug sales

• FIPO has requested the Union Ministry of Health and Family Welfare to reject DTAB’s proposal that allows non-licensed outlets to sell OTC drugs.

• The association believes this move could compromise patient safety and violate provisions of the Drugs and Cosmetics Act, 1940.

Concerns over accountability

• Licensed pharmacies maintain detailed dispensing records, including patient and doctor details.

• Such monitoring is not feasible in unlicensed shops, increasing the risk of drug misuse and self-medication hazards.

DTAB’s draft proposal explained

• DTAB proposed adding 16 common OTC drugs (e.g., paracetamol 500mg, clotrimazole cream, diclofenac ointment) to Schedule K, exempting them from prescription requirements.

• FIPO supports their OTC sale only through licensed pharmacies, not general stores or unregulated outlets.

Legal & ethical standpoint

• FIPO argues the DTAB recommendation violates the spirit of the D&C Act by bypassing legal mandates for pharmacist oversight.

• The letter asserts that loosening licensing norms would be unconstitutional and erode established safeguards on medicine quality and storage.

Pharmacists as pillars of public health

• FIPO has also suggested that pharmacists be allowed to refill prescriptions for chronic diseases (like diabetes and hypertension) for a limited period, based on the original prescription.

• This would improve access to continuity of care, especially in rural and underserved regions.

FIPO’s appeal marks a critical moment in India’s pharmacy regulation debate. While the government seeks to increase medicine accessibility, pharmacists urge caution against compromising safety and standards. The ball now lies with the Union Health Ministry to find a balance between ease of access and regulatory discipline in India's evolving pharma retail space.