Revised Schedule M: The Role of Pharmaceutical Waste Management

The DCC has called for the strict implementation of waste disposal provisions outlined in the revised Schedule M

March 27, 2024

342

Table of Contents

Last Updated on April 8, 2024 by The Health Master

Revised Schedule M

The Drugs Consultative Committee (DCC), an advisory body established by the Central government, has emphasized the importance of implementing provisions for waste disposal outlined in the revised Schedule M to combat AMR effectively.

Follow us on WhtasApp Channel

Understanding the Scope of AMR

Antimicrobial resistance (AMR) occurs when microorganisms such as bacteria, viruses, fungi, and parasites develop resistance to antimicrobial drugs, rendering them ineffective.

This phenomenon poses a serious threat to public health, as it limits the effectiveness of treatments for various infectious diseases.

The Role of Pharmaceutical Waste

Pharmaceutical waste, which includes expired or unused medications, plays a significant role in contributing to AMR.

Improper disposal of pharmaceuticals can lead to the contamination of water bodies and soil, facilitating the spread of resistant microorganisms.

Click for more articles on Schedule M

The Initiatives by Drugs Consultative Committee

Implementation of Schedule M Provisions

The DCC has called for the strict implementation of waste disposal provisions outlined in the revised Schedule M.

These provisions mandate safe storage, handling, and disposal of pharmaceutical waste to prevent environmental contamination and mitigate AMR.

Establishment of Nodal Cells

To address the complexities of pharmaceutical waste management and AMR, the DCC has proposed the creation of dedicated nodal cells in each state.

These cells would be responsible for coordinating efforts to manage pharmaceutical waste effectively and develop strategies for combating AMR at the local level.

Click for more on GMP

Recommendations and Proposals

Stakeholder Interactions for GMP Implementation

The DCC advocates for regular interactions with stakeholders to promote the adoption of Good Manufacturing Practices (GMP).

By monitoring antimicrobial waste in industrial effluents, stakeholders can identify and address potential sources of AMR.

Compliance with Pharmaceutical Manufacturers’ Recommendations

Pharmaceutical manufacturers play a crucial role in waste management and AMR prevention.

The DCC emphasizes the importance of implementing manufacturers’ recommendations to mitigate the risks associated with pharmaceutical waste.

Guidance for State Drugs Controllers

To enhance enforcement activities and regulatory oversight, the DCC proposes developing guidance for State Drugs Controllers, particularly regarding the management of waste from antimicrobial production.

By providing clear directives, regulators can ensure compliance with waste disposal protocols.

Read and Download minutes of all meetings of DCC

Regulatory Framework and Compliance

Provisions of Revised Schedule M

The revised Schedule M under the Drugs Rules, 1945, outlines specific provisions for the safe storage, handling, and disposal of pharmaceutical waste.

Compliance with these regulations is essential to prevent environmental contamination and minimize the risk of AMR.

Bio-Medical Waste Management Rules

In addition to Schedule M, the Bio-Medical Waste (Management and Handling) Rules, 2016, mandate the proper disposal of biomedical waste, including pharmaceuticals.

Adherence to these rules is crucial for safeguarding public health and mitigating the spread of AMR.

Addressing Concerns and Challenges

Findings of the NCDC Survey

A study conducted by the National Centre for Disease Control (NCDC) revealed alarming trends in antibiotic use in India, with over half of prescribed antibiotics posing a high risk of AMR.

These findings underscore the urgent need for comprehensive measures to address AMR.

Prevalence of Antibiotic Misuse

The survey also highlighted the prevalence of antibiotic misuse, with a significant percentage of patients receiving multiple antibiotics simultaneously.

Such practices contribute to the development of antimicrobial resistance and necessitate stringent regulatory interventions.

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.