CDSCO Forms Committee to Review OTC Drugs in India

The aim is to establish clear guidelines for selling specific medications as OTC drugs, thereby eliminating the need for a doctor's prescription for purchase

The Health Master

May 15, 2024

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OTC Drugs Medicines Self medication — OTC

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Last Updated on May 22, 2024 by The Health Master

OTC Drugs

The Central Drugs Standard Control Organisation (CDSCO), India’s leading drug regulatory body, has taken a significant step towards improving access to safe and effective self-care medications for Over-The-Counter drugs (OTC drugs).

In line with a recommendation from the Drugs Technical Advisory Board (DTAB), the CDSCO has formed an eight-member sub-committee to review and amend the Drugs Rules for the designation of specific medications as Over-The-Counter drugs (OTC drugs).

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Proposed Changes to Schedule K for Easier Access

The Department of Health and Family Welfare previously issued a draft notification in May 2022.

This notification proposed modifications to Schedule K of the Drugs Rules, 1945.

The aim is to establish clear guidelines for selling specific medications as OTC drugs, thereby eliminating the need for a doctor’s prescription for purchase.

Expert Committee to Lead the Review

The newly formed sub-committee, led by Dr. Anupam Prakash (Director and Professor of Medicine at Lady Hardinge Medical College, Delhi), comprises leading medical professionals from various fields.

Here’s a breakdown of the committee’s esteemed members:

Internal Medicine: Dr. Anupam Prakash (Chair), Dr. Umesh D Suranagi (Associate Professor), Dr. Ratan Kumar Gupta (Department of Paediatrics)
Pharmacology: Dr. Bikash Medhi (Professor)
General Medicine: Dr. Abhishek Agarwal (Professor)
Regulatory Bodies: Drug Controllers of Jharkhand and Karnataka
Research: Representative from Indian Council of Medical Research (ICMR)

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Transparency and Timeliness

The sub-committee is expected to complete its review and submit a report within three months.

Members will uphold strict confidentiality, and the CDSCO has ensured no member has any conflict of interest. Additionally, the committee can enlist subject-matter experts when necessary.

Industry Input and International Considerations

The CDSCO’s decision follows representations from pharmaceutical companies seeking OTC status for specific formulations.

Some examples include diclofenac diethylamine transdermal patches (200mg), acetylsalicylic acid effervescent tablets (500mg), dextromethorphan HBr lozenges (50mg), and mometasone furoate nasal spray (50mcg).

As part of the comprehensive review process, the committee will consider international guidelines for designating OTC drugs.

This ensures India aligns with global best practices for safe and effective self-care options.

Building on Existing Efforts

The DGHS (Directorate General of Health Services) has already established various clinical committees to examine the OTC issue.

These committees will provide valuable input to the sub-committee for its deliberations.

The CDSCO’s initiative marks a positive step towards simplifying access to essential medications in India.

By establishing clear guidelines for OTC drugs, this move empowers individuals to manage minor ailments effectively while optimizing healthcare resources for more complex medical needs.

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