Drap advises hospitals to procure registered drugs from authorised dealers only

• DRAP CEO urges healthcare facilities to adhere to guidelines.
• NOC can be obtained within 24 to 48 hours, says Asim Rauf.
• Advisory comes amid circulation of falsified cancer medication.
  

ISLAMABAD: In a move aimed at ensuring increased patient safety, the Drug Regulatory Authority of Pakistan (DRAP) has advised healthcare facilities across the country to procure only registered therapeutic products from authorised distributors and licensed sellers, The News reported on Sunday.

The advisory issued by DRAP's Quality Assurance Division comes amid reports of adverse reactions due to the administration of falsified Avastin injections at a healthcare facility in Punjab.

Stressing the need to adhere to national healthcare regulations, the regulatory authority has warned that unregistered or improperly sourced medical products pose serious health risks to patients and could result in significant harm.

Speaking on the issue, DRAP's Chief Executive Officer Asim Rauf said: "DRAP has established an online mechanism for issuing NOCs for import of therapeutic goods that are not registered and available in the country. Healthcare facilities must ensure compliance with DRAP guidelines in procuring therapeutic goods."

The official noted that through the online mechanism, healthcare facilities, and even individuals, could get a no-objection certificate (NOC) from DRAP within 24 to 48 hours.

This mechanism helped in importing essential medicines, vaccines and biological products, as they were not registered in the country, but were required by health facilities for their patients, he remarked.

DRAP's Director Quality Assurance Dr Obaidullah underscored the importance of acquiring drugs and medical devices solely from approved and authorised dealers.

"To assist healthcare providers in procuring critical drugs not readily available or registered within Pakistan, DRAP offers a streamlined approval process," said Obaidullah.

Hospitals, healthcare facilities and even individuals can submit online applications for essential therapeutic products through DRAP's regulatory portal. Institutions can seek DRAP’s expedited clearance for importing unregistered drugs prescribed by healthcare professionals, he added.

"Quality Assurance Division at DRAP is equipped to fast-track import process for unregistered drugs, which can be facilitated within a short span of time through the online application process," the DRAP official said, adding that the provision was helpful for patients in need of drugs for their treatment, but which were not available domestically.

Individual patients can seek DRAP's authorisation to import prescribed, life-saving medicines directly, as long as they are essential to treatment and prescribed by a licensed physician, the official noted.

Healthcare professionals and institutions are also encouraged to report adverse reactions to any therapeutic products to DRAP’s National Pharmacovigilance Centre (NPC). Adverse events can be reported using the Adverse Event Reporting Form which is accessible on DRAP's website.

The advisory was partly prompted by a recent incident involving Avastin, a cancer medication, administered as an off-label treatment for eye conditions such as diabetic retinopathy. While Avastin is primarily indicated for colorectal, lung and kidney cancers, ophthalmologists in Pakistan have used it as a cost-effective solution for diabetic retinopathy.

However, following reports of severe adverse reactions, including cases of blindness linked to falsified Avastin injections, DRAP temporarily suspended Avastin's use in ophthalmology. Subsequent investigations by DRAP, in collaboration with Roche Pakistan Limited, confirmed the falsified nature of Avastin injections, underscoring the need for stringent regulatory oversight.

Dr Obaidullah emphasised compliance with these guidelines is essential in mitigating public health risks associated with unregistered or improperly procured medicines.