DRAP invited Stakeholders Comments on revision of Guidelines on Recall of Defective Therapeutic Goods

The Drug Regulatory Authority of Pakistan (DRAP) is revising the Guidelines on Recalls and Rapid Alerts of Defective Therapeutic Goods, which were first published in 2021. The revision is based on the feedback from stakeholders and the recommendations from the World Health Organization (WHO).

The guidelines provide a comprehensive framework for reporting, investigating, and recalling suspected defective therapeutic goods products and applies to the therapeutic goods industry and supply chain, healthcare professionals, patients, sponsors of clinical trials, and regulatory staff. The guidelines aim to provide recommendations and explain the procedures to be adopted by the DRAP and the Pharmaceutical Industry for the effective removal of defective therapeutic goods from the market that may cause harm to the consumer and to safeguard public health.

By adhering to these guidelines, the licensees and the DRAP can ensure a timely, coordinated, and transparent response to any defective therapeutic goods incidents, and thus protect the health and safety of the public and the animals.

The main objectives of the revision are to:

  • Update the procedures for recalls and related actions for defective therapeutic goods
  • Adopt a uniform and consistent approach to conducting recalls in Pakistan
  • Incorporate the best practices and lessons learned from the consultative workshop on recalls and rapid alerts held by DRAP
  • Enhance the communication and coordination among the manufacturers, importers, suppliers, and DRAP in conducting recalls
  • Strengthen the monitoring and evaluation of the recall outcomes and follow-up actions

We invite all stakeholders to review the draft revised guidelines and provide us with your comments and suggestions . This draft guideline is available for comments from 21-02-2024. Stakeholders can submit their comments and suggestions within 15 days of uploading this document using prescribed format, (further information on comments submission can access on this link. Comments and suggestions can be forwarded via email to sanaullah.babardra.gov.pk with copy to mahvash.ansaridra.gov.pk or can be posted at following mailing address: Deputy Director, Quality Assurance & Laboratory Testing, Drug Regulatory Authority of Pakistan, 3rd floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad.