SOME drugs from a manufacturer, whose six medications have been pulled off Bahrain’s shelves after failing to meet GCC standards, are still available in the country, it has emerged.
However, authorities have expressed their inability to unilaterally withdraw all Julphar products which entered the local market before a temporary ban was imposed on its drugs in September 2018.
The ban came after Saudi Food and Drug Authority (SFDA) inspected the UAE-based manufacturer’s factory in Ras Al Khaimah and found it fell short of complying with GCC regulatory standards.
Gulf Pharmaceutical Industries (Julphar) is one of the largest pharmaceutical manufacturers in the Middle East and Africa.
“Julphar products are still in the country but they have been imported before September, after which no shipment (of Julphar products) was allowed even for the governmental hospitals,” National Health Regulatory Authority (NHRA) drugs control department chief pharmacist Nawal Alshaaboon told the GDN.
“However, we cannot withdraw any pharmaceutical product unless there is proof of its failure, which is difficult to prove with limited facilities.
“Therefore, we are depending on other authorities with better facilities, such as the SFDA and Gulf Health Council for Drug Registration.”
The GDN reported last month that the NHRA followed the UAE and Oman in banning the sale and prescription of Zordyl Mouthwash as it contained “harmful impurities”.
This followed the withdrawal of aspirin medication Jusprin 81mg earlier in the week.
Other Julphar drugs withdrawn in September included all concentrations of Enoxirt, select operating numbers of Narapril 5mg, 10mg and 20mg and two variants of the Julmentin injection, while in July the Glynase 5mg tablet, a common drug in the treatment of diabetes, was withdrawn from the market due to concerns about its effectiveness.
Recall
“Recall standard is divided into high, medium and low risk,” explained Ms Alshaaboon.
“Only in high-risk cases, when we know patients are using the medication at home, do we need to approach the patients and make public announcements advising a halt to using the medication.
“Otherwise, the recall will be at the level of agent store and pharmacies and will not be announced to the public.”
Banned medicines once withdrawn are either returned to the country of origin or safely destroyed with the NHRA’s approval.
The agents importing the medicines are responsible to do this and are accountable to submit proof of action to the authority, said Ms Alshaaboon.
“We are in contact with both the Gulf Health Council for Drug Registration and the SFDA, along with other GCC countries in all matters related to medicine safety.
“If we find any product being recalled by any other (relevant) authority we follow similar action, after ensuring the same batches are being sold in the country.
“Public recall announcements are made through hospitals, NHRA website, Bahrain TV and newspapers.
“In the cases of Jusprin 81 and Zordyl Mouthwash, public and patients were asked to stop using them and urged to immediately return the products to the hospital pharmacy or private pharmacy.”
Meanwhile, Julphar reiterated its commitment to “patient safety” without commenting on the reasons for its products failing “standards”.
Julphar manager Jerome Carle reiterated it was “working very closely with the authorities to ensure a quick resolution”, adding that the UAE Ministry of Health and Prevention (MOHAP) issued the company a new Good Manufacturing Practice (GMP) certification in December.
“We withdrew both Jusprin and Zordyl on the recommendations of MOHAP and the SFDA respectively,” he told the GDN in an email.
“Our stringent policies and procedures ensure we are in full compliance with regulatory requirements and we routinely welcome inspections from the world’s leading regulatory authorities.
“We were granted a new GMP certification from MOHAP last month (December) which is a clear indication that our products meet all the necessary regulations and standards.
“We have also carried out various upgrades to our plants to increase productivity and ensure we continue to meet the necessary requirements.”
raji@gdn.com.bh
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