New Guidelines Proposed for OTC Drugs in India

The committee emphasizes the importance of clear and comprehensive labeling for all OTC drugs.

1252
OTC Drugs Medicines Self medication
OTC

Last Updated on May 15, 2024 by The Health Master

OTC Drugs

India’s healthcare landscape is set for a significant transformation with a sub-committee’s recommendations to the Union Health Ministry regarding Over-the-Counter drugs (OTC drugs).

This article explores the proposed two-tier classification system and its potential impact on patient care.

The Need for Defined OTC Regulations

Currently, India lacks a distinct category for OTC drugs.

All allopathic medicines, including those considered safe for self-medication, fall under Schedule H and H1, requiring a doctor’s prescription.

This forces patients, even with minor ailments, to consult physicians, leading to unnecessary healthcare costs.

Proposed Two-Tier Classification System

The committee proposes a new system categorizing OTC drugs:

  • OTC-1: This category would encompass medications with a strong safety profile, readily available to patients, and suitable for self-care. These drugs could be sold at retail outlets like pharmacies and potentially even grocery stores (depending on final regulations).
  • OTC-2: This category would include medications with a slightly lower safety profile or requiring a pharmacist’s supervision for dispensing. These would be sold exclusively at registered pharmacies.

Benefits of the Proposed System

  • Improved Accessibility: Patients with common ailments (cough, cold, fever) could easily access OTC-1 medications without a doctor’s visit, especially in remote areas with limited access to physicians.
  • Reduced Treatment Costs: Eliminating the need for doctor consultations for minor ailments will significantly reduce healthcare expenses for a large section of the population.
  • Combating Misuse: The proposed “unit dose packaging” for OTC-1 drugs will minimize the risk of misuse or overdose, particularly in areas with high illiteracy rates.
  • Empowering Pharmacists: Pharmacists will be authorized to dispense OTC-2 medications under the new system, enhancing their role in primary healthcare.

Clear Labeling: A Crucial Aspect

The committee emphasizes the importance of clear and comprehensive labeling for all OTC drugs. This will empower consumers to:

  • Self-diagnose minor ailments.
  • Choose the appropriate OTC medication.
  • Understand proper dosage and administration.
  • Identify potential side effects and know when to seek medical attention.

A Robust Regulatory Framework for OTC Drugs

The committee recommends incorporating a dedicated schedule for OTC drugs within the Drugs and Cosmetics Act.

This will create a robust regulatory framework for safe and responsible use of OTC medications.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon

For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:

YouTube Icon

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos on consumer awareness, click on the below YouTube icon:

YouTube Icon
Telegram
WhatsApp
Facebook
LinkedIn
YouTube Icon
Google-news