- DRAP CEO urged healthcare facilities to adhere to the guidelines.
- Asim Rauf said the NOC will be obtained within 24-48 hours.
- The advisory comes amid a wave of counterfeit cancer drugs in circulation.
ISLAMABAD: In a move aimed at enhancing patient safety, the Drug Regulatory Authority of Pakistan (DRAP) has issued a directive to healthcare facilities across the country to purchase registered therapeutic drugs from licensed distributors and authorized sellers. It was recommended to procure only news It was reported on Sunday.
The advisory, issued by DRAP’s Quality Assurance Department, comes amid reports of adverse reactions caused by administration of counterfeit Avastin injections at health facilities in Punjab.
The regulator stressed the need to comply with national medical regulations and warned that unregistered or improperly sourced medical products pose serious health risks to patients and can cause serious harm.
Commenting on the issue, DRAP CEO Asim Rauf said, “DRAP has established an online mechanism for issuing NOCs for the import of therapeutic drugs that are not registered and available in the country. Facilities must ensure compliance with DRAP guidelines in the procurement of therapeutic drugs.” . ”
The official pointed out that through an online mechanism, medical institutions and even individuals can obtain a no-objection certificate (NOC) from DRAP within 24-48 hours.
The mechanism helped import essential medicines, vaccines and biological products that were not registered in the country but were needed by health facilities for patients, he said.
Dr. Obaidullah, Director of Quality Assurance at DRAP, emphasized the importance of obtaining medicines and medical devices only from approved and certified distributors.
“DRAP provides a streamlined approval process to help healthcare providers procure critical medicines that are not readily available or registered within Pakistan,” Obaidullah said. Ta.
Hospitals, healthcare facilities, and even individuals can submit online applications for essential therapeutic products through DRAP’s regulatory portal. He added that medical institutions can seek expedited permission from DRAP for the import of unregistered medicines prescribed by medical professionals.
“DRAP’s Quality Assurance Department is well equipped to expedite the import process of unregistered medicines, which can be expedited within a short period of time through an online application process,” DRAP officials said, adding that this provision will help patients in need. However, it was not available domestically.
Individual patients can seek DRAP permission to directly import lifesaving prescription drugs as long as they are essential to their treatment and prescribed by a qualified physician, officials said.
Healthcare professionals and institutions are also encouraged to report adverse reactions to therapeutic drugs to DRAP’s National Pharmacovigilance Center (NPC). Adverse events may be reported using the Adverse Event Reporting Form, which can be accessed from the DRAP website.
The recommendation was prompted in part by recent incidents involving the cancer drug Avastin, which was given as an off-label treatment for eye diseases such as diabetic retinopathy. Although Avastin is primarily indicated for colorectal, lung and kidney cancers, ophthalmologists in Pakistan are using it as a cost-effective solution to diabetic retinopathy.
However, following reports of serious side effects, including cases of blindness, associated with counterfeit Avastin injections, DRAP temporarily suspended the use of Avastin in ophthalmology. A subsequent investigation by DRAP, conducted in collaboration with Roche Pakistan Limited, confirmed that the properties of Avastin injection were falsified and highlighted the need for strict regulatory oversight.
Dr. Obaidullah emphasized that compliance with these guidelines is essential to reduce the public health risks associated with unregistered or improperly sourced medicines.
