Drug Regulators evaluates list of OTC Medicines

These requests advocated for the reclassification of specific formulations from prescription to OTC medicines

May 13, 2024

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OTC Drugs Medicines Self medication — OTC

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Last Updated on May 20, 2024 by The Health Master

OTC Medicines

India’s drug regulators landscape is poised for a shift with the formation of an expert panel to evaluate list of OTC Medicines.

This committee, tasked with evaluating specific prescription drugs for potential over-the-counter medicines (OTC Medicines) sales, comes in response to growing patient demand and lobbying efforts by pharmaceutical companies.

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Expert Panel Composition and Objectives

The newly formed sub-committee boasts a diverse membership.

Renowned doctors from leading government hospitals, representatives from the Indian Council of Medical Research (ICMR), and drug controllers from various states will collaborate to develop a framework for transitioning select OTC medicines.

This framework will be informed by established international regulations and best practices.

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Time-Bound Evaluation and Potential OTC Candidates

The sub-committee, established last week, has a strict deadline.

Their report outlining recommendations and the chosen path forward is due within three months.

This expedited timeframe reflects the urgency associated with this policy change.

Previously, Indian drug regulators received numerous requests from pharmaceutical companies.

These requests advocated for the reclassification of specific formulations from prescription to OTC medicines.

Some of the most commonly mentioned medications include:

Diclofenac Patches:

These pain-relieving patches are particularly helpful for managing discomfort caused by osteoarthritis and sprains.

Transdermal Diclofenac:

This topical medication offers short-term pain relief for minor injuries like strains, sprains, and bruises, both in adults and children aged 6 and above.

Notably, Diclofenac belongs to the nonsteroidal anti-inflammatory drug (NSAID) class.

Acetylsalicylic Acid Effervescent 500mg Tablets:

These effervescent tablets are known for their analgesic (pain-relieving), antipyretic (fever-reducing), and anti-inflammatory properties.

Dextromethorphan:

This cough suppressant is a potential candidate for OTC sales, offering temporary relief from cough symptoms.

Potential Benefits and Considerations

Transitioning certain medications to OTC status holds promise for increased patient access and potentially reduced healthcare costs.

However, the sub-committee must carefully consider potential safety concerns associated with unsupervised medication use.

This policy shift has the potential to significantly impact both patients and the pharmaceutical industry in India.

The coming months will be crucial as the expert panel deliberates and finalizes its recommendations.

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