Drugs Panel Proposes Curbs on OTC Medicines to Prevent Misuse

India's premier drug advisory panel is in the process of weighing a proposal to limit the over-the-counter sale of frequently used self-medication drugs in a bid to curb abuse and guarantee patient safety, sources familiar with the issue revealed. Only 27 drugs would be sold without prescription, subject to dosage limitations and quantity controls, according to proposed guidelines.

The list comprises antipyretics, analgesics, antacids, cough mixtures, oral contraceptives, antiseptics, laxatives, nasal sprays, domperidone (an anti-emetic), iron and folic acid tablets, and SOS drugs.

A number of drugs that are now available over the counter have been left out of the list, as the sub-committee feels that they must be dispensed only with a doctor's prescription. The Drugs Technical Advisory Board will meet this week to finalize the recommendation.

Dr Anupam Prakash, the OTC sub-committee chairman, confirmed that the report had been submitted. "The aim was to increase the accessibility of commonly used medicines and at the same time ensure safety of the patient," he said. "All SOS medicines have been included on the list. We have dropped many medicines which are available at pharmacists and should only be dispensed with prescriptions," said Prakash.

Last year, the CDSCO constituted an eight-member sub-committee to work out a framework for OTC drugs. The committee was asked to draw up guidelines for deciding which medicines can be dispensed without a prescription, taking into account clinician feedback. Under the proposal, OTC medicines would be sold without a prescription only if their use period does not extend beyond five days.

In contrast to nations such as the US and UK, where 'over the counter' is well defined in their respective drug legislations, India's Drugs and Cosmetics Act, 1945, lacks a definition for OTC drugs.