In a significant change that has the potential to redefine access to prevalent drugs, a government-nominated panel has suggested permiting over-the-counter (OTC) sale of 27 prescription medicines—like paracetamol, ibuprofen, and levocetirizine—through pharmacies and general stores alike.

Key Highlights27 Prescription Medicines Suggested for Sale OTC

• The sub-committee has suggested making available over-the-counter 27 popular generic formulations such as paracetamol (antipyretic), ibuprofen (pain reliever), and levocetirizine (anti-allergy).

• Certain dosage strengths will be established to avoid misuse or over-dosing.

No Indian OTC Framework Yet

• India does not have an overall OTC drug regulation system at present.

• The Central Drugs Standard Control Organisation (CDSCO) set up a sub-committee in May 2024 to prepare required amendments under the Drugs Rules, 1945.

Controlled Doses for Public Safety

• The panel stressed that sale of only mild to moderate doses of painkillers and antipyretics be considered without prescription.

• The aim is to increase access in a manner that ensures safe use and limited side effects.

Recommendations Submitted to DTAB
The eight-member committee submitted its report to the Drugs Technical Advisory Board (DTAB).

Recommendations are:

• Legal provisions for declaring drugs as OTC.

• A distinct Schedule under the Drugs Rules, 1945 for OTC classification.

• Clear labelling and packaging rules.

• Next Steps in Policy Implementation

• The DTAB will discuss the suggestions in a future meeting.

• Phased implementation is likely, as the central government draws up a complete plan to facilitate OTC access.

Quotes from Officials or Leaders
Senior Health Ministry Official:
"Levocetirizine for allergies, ibuprofen for pain, and paracetamol for fever. These are safe drugs. The idea is to make them available, but in a controlled environment."If cleared, India may witness ordinary OTC drugs being available at general stores, a major public health achievement. Though the initiative is to make drugs more affordable and convenient, experts warn that proper education, labelling, and control over dosage will be essential to avoid abuse.