DUBAI, 21st January, 2019 (WAM) — The Ministry of Health and Prevention, MoHAP, has issued a circular to the directors of medical districts, government and private hospitals, doctors, pharmacists and assistant pharmacists to withdraw the Jusprin 81mg Tablet, which is manufactured by Gulf Pharmaceutical Industries (Julphar).
The Ministry revealed that the decision to withdraw and suspend the registration of this product comes after stability results showed that the product registered with the Ministry is not identical. The decision was also made due to the manufacturer’s failure to comply with the GCC Guidelines for Stability Testing of Drug Substances and Pharmaceutical Products.
The circular also comes after inspectors from the Ministry of Health and Prevention visited Julphar’s factory, where it was discovered that the product is not bioequivalent with the reference drug. The Ministry also received another report from the Saudi Food and Drug Authority, SFDA, indicating the product’s failure for the same reason.
Commenting on the new circular, Dr. Amin Hussein Al Amiri, Assistant Under-Secretary for Public Health Policy and Licensing Sector, stated that the circular to withdraw the product was issued because the product violates the Federal Law No. 04 of 1983 concerning pharmaceuticals and related companies, and the Ministerial Resolution No. 366 of 2010 governing the withdrawal, suspension, or prevention of circulation of pharmaceutical and medical products.
Dr. Al Amiri clarified that the circular called on the supplier to withdraw the above-mentioned product from the public and private health sectors, and it requested all health care practitioners not to use the product if they have it. The circular also requested that all pharmacies stop dispensing the product and return it to the supplier. Individuals suffering from any drug related side effects caused by using this product can get in touch with the Ministry by phone: 04-2301448, or by fax: 04-2301947, or by e-mail: email@example.com.
The circulars issued by the Ministry can also be viewed on the Ministry’s website.
Dr. Al Amiri emphasised that the Ministry is in regular contact with the Food and Drug Administration and the medicine authorities of Europe and Australia. He added that if any warning is issued regarding any drug, the Ministry immediately takes action and issues a circular to all concerned health authorities to remove these products and destroy them, ensuring the health and safety of the community.
He also appealed to the members of the community not to use the product mentioned, and to get rid of this drug if it is available. He also stressed the need to consult with a doctor to find alternatives to this medicine.