Recalls and Rapid Alerts

Last Updated on February 22, 2022

Drug Regulatory Authority of Pakistan (DRAP) is ensuring that therapeutic goods available in market shall meet the prescribed standards of quality, safety, and efficacy. When a therapeutic good is suspected of being potentially harmful to consumers due to its defective quality, safety, or efficacy, a recall is issued to re remove the defective products market. It is the responsibility of marketing authorization (registration/enlistment) holder to ensure that every level of supply chain ( manufacturer, importer, distributor, and retail outlets) is well aware of the recall procedures.

Division of Quality Assurance and Laboratory Testing is performing the post marketing surveillance of therapeutic goods under DRAP Act, 2012 and is responsible for evaluation, coordination and monitoring of safety, efficacy and quality of drugs, and regulatory oversight of drug recalls and withdrawals.

Decision to make a recall

Recalls could be voluntary or statutory, both are effective methods for removing or correcting a defective therapeutic goods. Voluntary recalls are initiated by the company (i.e. Registration holders, manufacturers ) as a result of defect in any product quality during periodic review (Internal / External) or investigation of a market complaint or any other failure that present a risk of injury. Statutory recall are regulatory recall are directed by the Drug Regulatory Authority of Pakistan (DRAP) or Provincial Health Department/Provincial Government after notifying that the product is considered to be in violation of the laws, the DRAP Act, 2012, the Drugs Act, 1976 and the rules framed thereunder.

Recall Classification

Class I

Class I Recall is a situation in which there is a reasonable probability that the use of, or exposure to, a violative / defective product will cause serious or permanent adverse health consequences or death.

Class II

Class II Recall is a situation in which use of, or exposure to, a violative / defective product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Class III

Class III Recall is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequence.

The level (or depth) of recall of a product/batch shall be determined based on recall classification and level to which distribution has taken place. There are three levels of recall such as consumer/user, retail and wholesale

Recall Communication to stakeholder

Whenever a product recall is initiated, a recall alert is generated for effective communication to all stakeholder and target audience. DRAP also issued a recall alert through its website for rapid transmission of information to regulatory field force.

Contact details for product recalls

Telephone:+ 92 51 910 73 17
Email: gsms@dra.gov.pk
Postal address:Action Group on Health Hazard Evaluation of Defective Therapeutic Goods
3rd Floor, Drug Regulatory Authority of Pakistan, TF Complex, G-9/4, Islamabad