CDSCO Guidelines on Drug Recall

These Guidelines on Drug Recall encompasses drugs prohibited under the Provisions of Drugs & Cosmetics Act and those with suspended/cancelled product licenses.

Rakesh Dahiya

Last Updated on March 6, 2024 by The Health Master

Guidelines on Drug Recall

The Guidelines on Drug Recall issued by Central Drugs Standard Control Organisation (CDSCO) covers all types of Drug Recall and Rapid Alert System for Drugs Including Biologicals & Vaccines.

Here is the gist of the guidelines:


Drug Recall refers to the action of withdrawing or removing drugs from distribution or use, including corrective measures for reported deficiencies in quality, efficacy, or safety.

Defective products can include those of Not of Standard Quality (NSQ), Adulterated or Spurious drugs.

Safety and efficacy-related Drug recalls involve serious adverse reactions and deaths.

The Drug recall process also encompasses drugs prohibited under the Provisions of Drugs & Cosmetics Act and those with suspended/cancelled product licenses.

The Rapid Alert System is designed to transmit urgent alerts without delay.

The seriousness of the defect, its potential harm to patients, animals (in the case of veterinary products), consumers, operators, and the environment must be assessed.


While the Drugs & Cosmetics Act & Rules make references to product recalls, complaints, and adverse reactions, there is a need for an effective and uniform drug recall procedure with established timelines at every level of the supply chain.

Current auditing and accountability measures are lacking, leading to instances where drugs are declared substandard, serious adverse effects or deaths are reported, or banned drugs voluntarily withdrawn from the market.


These guidelines apply to all quality-defective product reports and reported incidents of safety and efficacy for all drugs, including vaccines and biologicals.

Licensees (manufacturers, importers, stockists, distributors, retailers) are expected to follow these guidelines for both voluntary and statutory recalls.

Drug Control Authorities at the central or state level may also use these procedures when urgent action is needed to protect public or animal health.


  • Drug Recall: Removal or correction of marketed products due to deficiencies in quality, safety, or efficacy.
  • Batch Recall: Removal of specific batches found to be defective and posing a health risk.
  • Voluntary Recall: Initiated by the licensee based on abnormal observations, market complaints, or other failures.
  • Statutory Recall: Directed by Drug Control Authorities after violations of laws are identified.

Drug Recall Classification:

Drug Recall classification (Class I, II, or III) indicates the degree of health hazard.

Class I poses a reasonable probability of serious health consequences or death, while Class II and III pose varying levels of risk.

Drug Recall Procedures:

  • Voluntary Recall: Voluntary recalls can be triggered by various incidents affecting the quality, safety, and efficacy of the batch/product.
  • Statutory Recall: Statutory recalls are directed by Drug Control Authorities in response to violations of laws.

Levels of Recall:

There are four levels: consumer/user, retail, wholesale and manufacturers. The level is determined by recall classification and the extent of distribution.

Time Lines for Effective Drug Recall System & Rapid Alert:

Timeframes for Class I, II, and III recalls are set based on the category of risks involved, ranging from 24 hours to 30 days.

Procedure for Drug Recall System & Rapid Alert:

Once a product/batch to be recalled is identified, the licensee must make a decision within 24-72 hours for Class I recall.

Communication is sent within 24 hours of the decision, and regulatory authorities are informed immediately.

Overview of Process Flow Drug Recall System & Rapid Alert:

The process involves risk assessment, communication, information dissemination, and compliance with recall classifications.

Stepwise Drug Recall Procedure:

This involves notifying stakeholders, blocking distribution, recalling stock, and maintaining records.

Follow-Up Action of Recalled Goods:

Follow-up actions include monitoring the recall process, investigating the reason for the recall, and taking remedial actions to prevent recurrence.

Mock Recall:

Mock recalls are conducted to test the effectiveness of recall arrangements.

Traceability and evaluation of the real recall are essential components.

These guidelines provide a comprehensive framework for the recall and rapid alert system for drugs, ensuring timely and effective responses to quality, safety, and efficacy issues.

Compliance with these guidelines is crucial for maintaining public health and safety.

NSQ Drug: Route cause analysis and CAPA

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