DRAP Guidelines on Recalls of Defective Products: Procedure | Pakistan

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The Drug Regulatory Authority of Pakistan (DRAP), the country’s regulatory agency in healthcare products, has published a guidance document dedicated to recall procedures to be followed concerning healthcare products placed on the country’s market.

The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved to ensure compliance with them.

The authority also reserves the right to make changes to the document and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation. 

In particular, the document provides a comprehensive overview of a recall procedure to be followed by the parties responsible for medical devices once a defective product is identified. 

Recall Procedure Overview

First of all, the authority emphasizes that recall procedures are critical mechanisms designed to safeguard patients and consumers from the potential dangers associated with defective therapeutic goods.
These goods may be harmful under regular usage conditions, fail to meet their marketing authorization specifications, lack therapeutic efficacy, or are not being produced in line with the Good Manufacturing Practice standards.

The primary responsibility for initiating a complete recall, whether voluntary or mandated by regulations, lies with the product’s licensee as the main party responsible for the product allowed for marketing and use in the country.

This action reflects the legal obligations of manufacturers, wholesalers, and retailers to protect public health from products posing health risks or defects.

Stages of a Product Recall

The document further outlines the critical stages of recalls. A product recall is typically comprised of the five key stages:

1. Receipt of Information on Defective Product: The process begins when a licensee receives complaints or reports concerning a product’s quality, safety, or efficacy, prompting them to inform the DRAP about the recall specifics, including the nature of the problem, product details, and initial actions taken.
   
2. Submission of Information for Recall Assessment: The licensee must submit detailed information about the recall for DRAP’s evaluation, including the problem’s nature, product specifics, and a risk assessment along with proposed actions.
   
3. Recall Assessment: DRAP and the Action Group on Risk Assessment and Recall of SF Products assess the provided information to finalize the recall’s classification, level, and strategy.
   
4. Recall Communication: Effective communication strategies are implemented to ensure that defective products are removed from the market.
   
5. Monitoring and Evaluation of Recall: The recall’s effectiveness is monitored, and follow-up actions are recommended to prevent future incidents.

Action Group on Risk Assessment and Recall

According to the document, the Action Group, comprising representatives from DRAP, provincial health departments, and quality control laboratories, is crucial in receiving and evaluating reports of defective therapeutic goods.

They determine the recall’s classification and level, devise a strategy for effective recall, and monitor the implementation of necessary actions by licensees.

Classification and Levels of Recall

By the applicable regulatory requirements, recalls are classified into three main categories based on the health risks they pose:

• Class I: Represents a significant risk of severe health consequences.
  
• Class II: May cause temporary or medically reversible adverse health consequences but are not life-threatening.
  
• Class III: Unlikely to cause harm but are recalled for other reasons, such as non-compliance with marketing authorizations.

The level of recall is determined by the extent of the product’s distribution, with specific protocols for the consumer/user level, distributor/wholesale level, and further details on the depth of recall necessary.

Recall Strategy Implementation

The recall strategy will be developed based on gathered information and in consultation with the Action Group.

It should cover the recall’s scope, notification methods, communication of the recall message, customer instructions, and logistics for returning the product.
The strategy also considers the impact of the recall on market supply and consumer health.

Conclusion

In summary, by the virtue of this guidance, the authority emphasizes the importance of swift action and thorough communication to mitigate risks associated with defective therapeutic goods. By following these guidelines and the underlying legislation they are based on, regulatory bodies, manufacturers, and distributors can effectively manage recalls, ensuring patient and consumer safety while maintaining trust in the healthcare system.

Source

https://www.dra.gov.pk/wp-content/uploads/2024/02/Draft-Recall-Guidelines-Edition-2-V1-.pdf

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