WHO alerts DRAP to counterfeit blood cancer medicines

Islamabad: The World Health Organization (WHO) has alerted the Drug Regulatory Authority of Pakistan (DRAP) about counterfeit blood cancer medicines circulating in the market, prompting the regulator to issue rapid medical product alerts and ban the sale and use of affected batches.

According to DRAP, the WHO shared Medical Product Alerts identifying counterfeit versions of two widely used blood cancer medicines, Jakavi tablets and Darzalex injections.

Acting on the WHO's recommendation, DRAP issued rapid alerts to healthcare providers, distributors and provincial drug authorities.

DRAP said the affected medicines are counterfeit products manufactured under the names of well-known pharmaceutical brands.

The regulator has prohibited the sale, distribution and use of the identified batches due to serious concerns over their authenticity and safety.

The counterfeit batches include Darzalex 400mg (Batch STV01) and Darzalex 100mg (Batch MYS7381), which were traced in the Maldives and Mexico. The counterfeit packaging bears the address of Janssen Cilag Belgium, while the company has confirmed that the affected batches are fake.

DRAP also identified counterfeit batches of Jakavi tablets, including 20mg (Batch AVT50), 15mg (Batch FNR06) and 10mg (Batch SGL04). The counterfeit packaging carries the address of Novartis Switzerland, which has also confirmed that the affected batches are not genuine.

The regulator said laboratory testing found that the counterfeit medicines failed to meet quality standards. Verification of the active pharmaceutical ingredients could not be established, while unrelated particles were detected in samples of the counterfeit Darzalex injections.

DRAP warned that the safety and effectiveness of these counterfeit medicines cannot be guaranteed and that their use could pose a serious, potentially life-threatening risk to patients.

The authority has directed regulatory enforcement teams and provincial drug control directorates to strengthen market surveillance. It has also urged distributors, pharmacies and medical stores to immediately report any suspected counterfeit batches to the relevant authorities.