ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) has introduced a comprehensive draft guideline addressing the storage and disposal of substandard-falsified (SF) and recalled therapeutic goods, including medicines, medical devices, and health products that fail to meet quality standards or are intentionally misrepresented.
The main aim of this guideline is to establish a systematic approach to effectively manage such products, covering their identification, reporting, proper disposal, and documentation.
The draft guideline covers several key components. These include clarifying the roles and responsibilities of various stakeholders, such as manufacturers, importers, distributors, healthcare professionals, and regulatory bodies, in handling substandard, falsified, and recalled therapeutic goods.
Additionally, it outlines criteria for selecting appropriate storage facilities and methods for managing defective therapeutic goods. The guideline also prescribes methods for environmentally responsible disposal and sets out requirements for maintaining and submitting records and reports.
DRAP has extended an invitation to all stakeholders, including the pharmaceutical industry, healthcare practitioners, civil society organizations, and the general public, to provide their comments and feedback on this draft guideline.
Stakeholders are encouraged to submit their input and suggestions within a 15-day window from the document's release date, using the provided format. Detailed instructions for submitting comments can be found on the DRAP website.
DRAP has expressed gratitude for the cooperation and active involvement of all stakeholders in ensuring the quality, safety, and efficacy of therapeutic goods in Pakistan.
