In a recent development, the Drugs Consultative Committee (DCC) of the Union health ministry has underscored the necessity for a unified system for drug safety in the country to facilitate swift actions related to the dissemination of information and the suspension or cancellation of licenses for the sale of spurious drugs.
The committee observed that the current system of drug alerts through the central drug regulator’s website falls short of its intended purpose.
1. Ineffectiveness of Website Alerts
The DCC highlighted a significant loophole in the existing system, noting that website alerts featuring only the manufacturer’s name in the case of spurious drugs are inadequate for creating awareness among stakeholders, healthcare professionals, and patients.
The committee emphasizes the need for a more robust and informative system.
2. Circulation of Spurious drugs
Despite isolated cases of spurious drugs reported from various parts of the country, wholesale and retail outlets continue to allow the circulation of these drugs for additional profit, bypassing authorized distribution channels.
This poses a serious threat to public health.
3. Uniform Standard Operating Procedure (SOP)
To address the shortcomings, the DCC has decided to establish a sub-committee tasked with formulating a uniform Standard Operating Procedure (SOP) for administrative actions taken by State Licensing Authorities (SLAs) on critical, major, and minor violations under the Drugs and Cosmetics Act and Rules.
4. Data Sharing Among States
This collaborative effort aims to enhance information flow and improve the effectiveness of regulatory actions.
5. Timely Action and Information Dissemination
The committee stresses the urgency of implementing a system that ensures quick actions, including the prompt circulation of information on NSQ and spurious results, uploading on websites, and the suspension or cancellation of licenses for the sale of spurious drugs.
6. Varied Sampling Procedures
The sampling process, conducted by Drugs Inspectors of Central and State drugs control, varies across states.
Standardizing sampling procedures is crucial for uniformity in drug quality surveillance.
7. Manufacturer Response
Manufacturers are currently requested to initiate drugs recalls based on test reports.
A comprehensive system to address such discrepancies is needed.
8. Sub-Committee for SOP Examination
- Madhya Pradesh,
- CDSCO, and
- Two representatives from consuming states.
This sub-committee is tasked with examining proposals for uniform implementation and action taken by SLAs for violations under the Drugs and Cosmetics Act and Rules.
9. Addressing Enforcement Challenges
CDSCO has received representations regarding enforcement activities, highlighting the lack of standard operating procedures in some states.
In conclusion, the Drugs Consultative Committee recognizes the pressing need for a cohesive and effective system to address challenges in drug safety.
The proposed measures, including a uniform SOP, collaborative data sharing, and prompt regulatory actions, aim to create a more secure pharmaceutical landscape in the country.
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.
Q1: Why is a uniform SOP crucial for drug safety?
A1: A uniform SOP ensures consistent regulatory actions across states, preventing variations influenced by external pressures.
Q2: How will data sharing among states improve drug safety?
A2: Collaborative data sharing enhances information flow, allowing timely regulatory actions and increased awareness about NSQ and spurious drugs.
Q3: What challenges do manufacturers face in responding to NSQ reports?
A3: Manufacturers sometimes deny responsibility for NSQ drugs, claiming them to be spurious. Addressing such discrepancies is essential for effective regulatory measures.
Q4: Why is the current system of website alerts deemed ineffective?
A4: Website alerts featuring only the manufacturer’s name lack the necessary information for stakeholders, healthcare professionals, and patients to make informed decisions.
Q5: What role does the sub-committee play in addressing enforcement challenges?
A5: The sub-committee, formed by the DCC, is tasked with examining proposals for uniform implementation and action by State Licensing Authorities, aiming to address enforcement challenges under the Drugs and Cosmetics Act and Rules.
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