Drap advises hospitals to procure prescription drugs only from authorized dealers

• DRAP CEO urges healthcare facilities to adhere to guidelines.
• The NOC can be received within 24 to 48 hours, says Asim Rauf.
• The advisory comes amid a flurry of counterfeit cancer drugs.
  

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 authorized distributors and authorized sellers, The News reported on Sunday.

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

Stressing the need to comply with national healthcare regulations, the regulator has warned that unregistered or inappropriate medical products pose serious risks to patients’ health and may cause significant harm.

Speaking on the issue, DRAP CEO Asim Rauf said, “DRAP has created an online mechanism for issuing NOC for import of therapeutic products that are not registered and available in the country. Healthcare facilities must ensure compliance with DRAP guidelines for the supply of 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 import essential drugs, vaccines and biological products as they were not registered in the country but were required by health facilities for their patients, he observed.

DRAP’s Director of Quality Assurance, Dr Obaidullah, emphasized the importance of procuring medicines and medical devices exclusively from approved and authorized dealers.

“To assist healthcare providers in procuring critical medicines that are not readily available or registered in Pakistan, DRAP offers an improved approval process,” said Obaidullah.

Hospitals, healthcare facilities and even individuals can submit e-applications for essential therapeutic products through the DRAP regulatory portal. Institutions can request DRAP’s expedited approval to import unregistered drugs prescribed by health professionals, he added.

“The Quality Assurance Department at DRAP is equipped to expedite the process of entry of unregistered drugs, which can be facilitated in a short time through the online application process,” said the DRAP official, adding that the provision was helpful for patients who they need medicines for their treatment, which were not available domestically.

Individual patients can seek DRAP’s permission to directly import life-saving prescription drugs as long as they are necessary for treatment and prescribed by a licensed physician, the official noted.

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

The advisory was prompted in part by a recent incident involving Avastin, an anticancer drug, that was given as an off-label treatment for eye conditions such as diabetic retinopathy. While Avastin is mainly indicated for colon, lung and kidney cancers, ophthalmologists in Pakistan have used it as a cost-effective solution for diabetic retinopathy.

However, following reports of serious side effects, including cases of blindness linked to spurious Avastin injections, DRAP has temporarily suspended the use of Avastin in ophthalmology. Subsequent investigations by DRAP, in collaboration with Roche Pakistan Limited, confirmed the adulterated nature of Avastin injections, highlighting the need for strict regulatory oversight.

Dr. Obaidullah emphasized that compliance with these guidelines is essential to mitigate public health risks associated with unregistered or improperly supplied drugs.