The Administrative Prosecution refers 5 leaders in the Egyptian Medicines Authority to urgent trial

Written by Muhammad Abu Deif

Wednesday, November 22, 2023 02:56 PM

The defendants are:

1) Director General of the General Administration for Market Control in the Central Administration for Pharmaceutical Affairs of the Egyptian Medicines Authority.

2) Former Director of the Pharmaceutical Factories Inspection Department.

3) Deputy Director General of Pharmaceutical Factories Inspection Affairs at the Egyptian Pharmaceutical Authority.

4) Director of the Pharmaceutical Inspection Department at the Ministry of Health and Population.

5) Head of the Central Operations Department of the Egyptian Medicines Authority.

The charges brought against the defendants were as follows:

The first accused:

He failed to issue publications to control and investigate the counterfeit nutritional supplement preparations revealed by the investigations during the period from 8/12/202 to 7/14/2021, and he neglected to mention tracking the production hotspots for the counterfeit preparations for which Circular No. 16 of 2021 was issued, which led to a lack of inspection and a failure to take action. The necessary measures regarding factories producing the preparations mentioned in this circular, and failure to direct Circular No. 21 of 2021 issued regarding violating preparations to the relevant authorities, which are health directorates, pharmaceutical factories, and distribution companies; Which resulted in its continued trading in the markets.

The second accused:

She signed the “GMP Certificate” for the Good Manufacturing Practices system in a pharmaceutical factory, for shipments intended for export outside the country, which included a statement stating that the inspection of the factory was in 2014, contrary to the truth, and that the inspection of the aforementioned factory was conducted within the years 2019-2020. .

The third accused:

It failed to present the periodic inspection report on a pharmaceutical factory issued in July 2019 to the Authority’s Supreme Inspection Committee, from that date until November 2020, despite the report containing serious violations in the factory, and it failed to take the prescribed measures immediately after receiving the periodic inspection report on a pharmaceutical factory in the month of October 2019 until August 2020, and if the report included the presence of expired raw materials used in manufacturing, and failed to form a committee to track those expired raw materials; Which prevented the discovery of its use in the production of pharmaceutical preparations.

It also signed 7 “GMP” certificates for the Good Manufacturing Practices system for four pharmaceutical factories, for shipments intended for export outside the country, which included data that contradicted the truth, including the availability of good production and manufacturing conditions in those factories and the conduct of periodic inspection of them, which contradicted the truth.

The fourth accused:

He failed to take the legally prescribed measures regarding the issuance of seizure and seizure circulars for 61 pharmaceutical preparations, which are detailed in the report of the committee formed by the decision of the head of the sector of the Office of the Minister of Health and Population No. 8 of 2020.

The fifth accused:

He was not careful when issuing Circular No. 16 of 2021 issued by the Egyptian Medicines Authority, by not including the necessity of tracking production hotspots. Which led to a lack of inspection and failure to take the necessary legal measures against factories producing nutritional supplements and preparations mentioned in the aforementioned circular, and neglect in supervising and following up on the Authority’s inspection and market control departments. Which led to their neglect of Directive Circular No. 21 of 2021 issued to seize and seize the products described therein to health directorates, pharmaceutical factories, distribution companies, and relevant parties.

The technical office of the head of the Authority for Investigations, headed by Counselor Abdullah Qandil, had received a number of complaints filed by a group of pharmacists in the Nutritional Supplements Inspection Department at the Egyptian Medicine Authority, regarding the circulation of nutritional supplement preparations in pharmacies and major companies, including adulterated, unregistered, and violating their registration data, which included 24 preparations. It is adulterated and not registered at all with the body whose registration number is recorded on the packages of these preparations, such as the National Institute for Nutrition, the General Authority for Standardization, and the Food Safety Authority, and not registered with the body entrusted with registering these pharmaceutical preparations, which is the Egyptian Drug Authority. There are also 31 preparations that have been registered with the National Institute for Nutrition as nutritional preparations. (Candy – syrup powder – toffee) and are traded in the markets as preparations in pharmaceutical forms that have therapeutic effects written on their packaging, in violation of what was registered, and they are manufactured with raw materials of unknown origin and in unlicensed places.

Counselor Helmy Hussein Al-Omda, a member of the technical office of the Chairman of the Authority, began investigation procedures into the incident, beginning his investigations by forming several examination committees, which included:

A committee decided by the Ministry of Health and Population headed by the head of the Central Administration for Pharmaceutical Affairs at the Ministry of Health, and a committee decided by the Presidency of the Council of Ministers and headed by the Secretariat of Medical Affairs. The work of the two committees ended and they submitted their reports to the prosecution on all the violations that were revealed to them and those responsible for them.

The Public Prosecution also formed a committee headed by the Head of the Complaints Department of the Central Administration for Inspection of Pharmaceutical Factories, to undertake inspections of the work of two pharmaceutical manufacturers whose unsafe products were raised in the investigations. The committee concluded its report submitted to the Public Prosecution by recommending the withdrawal and seizure of all orders related to the manufacturers under investigation. This is because the conditions for safe production are not available, with the exception of batches for which conformities have been issued by the Egyptian Medicines Authority, due to the unsafe and unsafe conditions in which these batches were produced.

During the investigations, the prosecution was directed to quickly issue the necessary decisions regarding these preparations, and accordingly; Circular No. 16/2021 was issued, which included the speedy seizure, withdrawal, and seizure of 68 “dietary supplement” products from all pharmacies.

Circular No. 21/2021 was also issued to stop the circulation, withdrawal and seizure of pharmaceutical preparations produced by the two pharmaceutical manufacturers that were inspected and it was proven that there were serious violations in each of them due to the lack of conditions for the safe production of medical preparations.

During extensive investigations, the prosecution heard members of the committees formed for the examination, and the testimony of a number of specialists and technicians in the relevant authorities, in addition to the testimony of a member of the Central Auditing Organization regarding the financial violations that resulted from the examination of the Authority’s work in this regard, and who submitted to the prosecution the Central Auditing Organization’s report on the result of this examination. The prosecution also confronted all those accused of the violations revealed by the investigations.

After presenting the results of the investigations to the head of the commission, he ordered that all the accused be referred to urgent trial.

The prosecution also ordered that the Prime Minister be notified regarding what was raised in the investigations before the head of the Egyptian Medicines Authority, regarding his issuance of several decisions assigning him to head the public and central departments of the aforementioned authority, from the year 2020 to date, in violation of the provisions of the law.

Notifying the original delegated authorities of the Head of the Central Administration of the General Secretariat of the Egyptian Medicines Authority, the Director of the Human Resources Department of the Authority, and the Legal Advisor of the Authority, regarding the violations revealed by the investigations conducted by them; This is because those mentioned are affiliated with entities subject to a special investigation and disciplinary system.

An independent investigation was conducted into a number of violations revealed by the investigations, which are:

1) Fabricating an incorrect graduation certificate attributed to the Faculty of Commerce at Cairo University, and presenting it as part of the justifications for appointing a worker at the National Authority for Research and Control of Biological Preparations.

2) A pharmacist managing the inspection of pharmaceutical factories at the Egyptian Pharmaceutical Authority, in the presence of the Engineering Drawings Review Committee – in her capacity as a representative of a private pharmaceutical company – in violation of the law and constituting a conflict of interest.

3) It was discovered that some samples were not suitable for one of the serums designed to prevent some epidemic diseases.

4) A number of administrative violations included in many complaints from employees of the Egyptian Medicines Authority.

5) Circulating a number of illegal and unlicensed preparations and supplying them to medical facilities affiliated with the Ministry of Health.

The prosecution also charged the Egyptian Tax Authority, the Egyptian Medicine Authority, and the bodies and entities that were replaced by the Egyptian Medicine Authority, to quickly implement the provisions of the Value Added Tax Law and its executive regulations on the jurisdictions and areas of work of the Egyptian Medicine Authority that are subject to its provisions.