The Drugs Technical Advisory Board (DTAB) will consider a crucial proposal for the regulation of sales of over-the-counter (OTC) medicines in India, after a report by a sub-committee suggested curbs on a number of widely prescribed drugs. The suggestion has been made to avoid the misuse of freely available drugs by restricting their sale without a prescription.

Key Highlights

Prescription Mandatory for Common Medicines

• Drugs such as antipyretics, analgesics, antacids, cough preparations, oral contraceptive pills, antiseptics, laxatives, nasal sprays, domperidone, and iron/folic acid tablets have been left out of the list of OTC medicines.

• These would be subject to a physician's sanction to be sold in case the suggestion is approved.

Pack Size Limitations Advised

• The panel advises even approved OTC medicines to be sold only in limited pack sizes appropriate to a maximum five-day course of treatment.

• Recommendations such as restricting pack sizes to 2, 3, or 5 doses based on the toxicity and danger of abuse remain.

Sub-Committee Report Submitted

• An eight-membered committee was convened by the Central Drugs Standard Control Organisation (CDSCO) in order to conceptualize India's first OTC drug framework.

• Chairman Dr. Anupam Prakash assured that the report had indeed been submitted and that safety besides accessibility were foremost on their priorities.

Lack of Definition for OTC in India

• In contrast to nations such as the US and UK, India does not have a legal definition of 'OTC' drugs under the Drugs and Cosmetics Act, 1945.

• This bill aims to provide clarity and establish structured regulation to avoid abuse and self-medication.

Quotations of Officials or Leaders
Dr. Anupam Prakash, Chairman, OTC Sub-Committee
“The aim was to increase the accessibility of commonly used medicines and at the same time ensure patient safety. We have included SOS medicines but dropped several that should not be freely dispensed.”If sanctioned, this policy change would fundamentally change the sale of medicines in India, being a step toward stricter control on access to drugs while maintaining patient safety. This week's DTAB meeting will be a watershed moment for India's regulatory policy towards non-prescription medicines.