CDSCO Committee to Revise Rule 64 for drug sales in India

The CDSCO has formed a committee comprising state drug regulators to re-evaluate Rule 64 of the Drugs and Cosmetics Rules, 1945

CDSCO Central Drug Standard Control Organisation

Last Updated on May 29, 2024 by The Health Master


Ensuring the quality and integrity of medicines throughout the distribution chain remains a crucial concern. To address this, the Central Drugs Standard Control Organisation (CDSCO) has taken a significant step.

Revisiting Rule 64

The CDSCO has formed a committee comprising state drug regulators to re-evaluate Rule 64 of the Drugs and Cosmetics Rules, 1945.

This move aligns with the Drugs Consultative Committee’s (DCC) recommendation to integrate Good Distribution Practices (GDP) into the regulations.

The aim is to revamp drug selling practices in India, specifically focusing on Rule 64 within Part VI, which governs the sale of non-homeopathic medicines “with regards to the present scenario,” as stated by the CDSCO.

This committee, led by the Deputy Drugs Controller (enforcement cell) at CDSCO headquarters, will have Drugs Controllers from Odisha, Madhya Pradesh, Punjab, and Telangana as members.

They are tasked with submitting a report within two months.

Must read article: Good storage practice of medicines at Medical Store

Enforcing Good Distribution Practices

The DCC, during its recent meeting, emphasized the importance of including revised Good Distribution Practices (GDP) guidelines for pharmaceutical products within the Drugs Rules, 1945.

This move aims to ensure proper implementation across the entire supply chain.

Currently, these guidelines are voluntary, and their non-mandatory nature has led to lapses in maintaining proper storage conditions for drugs during transportation and at wholesale and retail levels.

The Committee, comprising drug regulatory experts from across the country, observed that due to the voluntary nature of the current guidelines, manufacturers haven’t been strictly adhering to proper storage conditions throughout the distribution chain.

Recognizing this issue, the DCC agreed that the revised GDP guidelines should be circulated to all states and union territories before finalization.

Once finalized, these guidelines will be incorporated into the Drugs Rules, providing legal backing for their enforcement.

The Importance of a Robust Distribution System

The Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945, establish regulations for selling, stocking, exhibiting, offering for sale, and distributing drugs (Rules 64 and 65).

All stakeholders involved in pharmaceutical product distribution have a responsibility to ensure the quality and integrity of these products throughout the entire chain, from manufacturing to the final dispensing or provision to patients.

Maintaining a robust distribution system is crucial for safeguarding the quality of medicines.

Aligning with WHO Standards

The DCC acknowledged that the CDSCO had already published draft guidelines on Good Distribution Practices for biological products, implementing them in 2012 after stakeholder consultations and adhering to World Health Organization (WHO) guidelines.

The 54th DCC meeting, held in July 2018, further emphasized the significance of implementing good distribution/storage practices.

It was suggested to include necessary provisions to legally enforce these guidelines as a Schedule to the Drugs & Cosmetics Act, 1945.

Following this, the CDSCO drafted revised GDP guidelines in 2018, seeking stakeholder feedback.

These draft guidelines are currently undergoing further revision to align them with the updated WHO guidelines of 2020.

Industry Seeking Action on Storage and Transportation

The pharmaceutical industry has consistently urged the government to address issues related to the transportation and storage of medicines.

These factors can significantly impact the quality of medicines, ultimately posing a challenge for manufacturers.

The revised regulations and focus on Good Distribution Practices present a positive step towards ensuring the quality and safety of medicines reaching patients throughout India.

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.

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