Authority Bans Almeda's Mask from Pharmacy Shelves

Apr 12 , 2020. By HAGOS GEBREAMLAK ( FORTUNE STAFF WRITER )

The Federal Food & Drug Authority (FDA) has banned Almeda Textiles Factory from  selling its masks to pharmacies and health centres for not complying with the international standards set for medical masks.

The Authority revoked the certificate of competence it gave to the company on March 25, 2020, stating that the products are not up to the standards of the World Health Organization (WHO).

Almeda Textiles has been preparing to make face masks since the first Novel Coronavirus (COVID-19) case was reported in Ethiopia on March 13, 2020. It started making 50,000 masks a day on March 15, 2020, and got the certificate of competence for the product from the Authority after eight days. However, two days later, the Authority revoked Almeda's certificate, stating that the company was awarded it by mistake.

The Authority does not give permission or a certificate of competence for garment products, according to Gezahegn Endale, coordinator of branch offices at FDA.

“Anyone can produce masks and distribute them without permission from the Authority," said Gezahegn, "but these masks can’t be used for surgical or medical purposes at health centres unless the Authority gives a certificate of competence.”

Kinfe Haile, director of the Authority's Tigray regional branch, argues that the office gave a certificate of competence to the company considering the quality of its garment products and its production capacity, not for the masks.

The certificate was revoked, since Almeda could not present the documents that verify the standard and quality of the masks, according to Kinfe.

"The company didn't come up with evidence from certified institutions that show the masks prevent viral and bacterial penetration," Kinfe said. "If we find out that the company is selling the masks to hospitals and pharmacies, we'll take the necessary action."

Teklemariam Tesfu, general manager of Almeda Textiles, argues that the company did not ask for a certificate to produce medical masks but instead applied to produce fabric or civilian masks and that it does not sell masks to hospitals and pharmacies.

"We're producing not mainly for business purposes but for social responsibility," he told Fortune.

Teklemariam argues that the masks are double layer and 160 GSM (gram a square metre), unlike other masks that are single layer and between 15 and 20 GSM, and are capable of preventing viral particle penetration.

The company has partnered with Guna Trading Plc, one of the founding members of the Endowment Fund for the Rehabilitation of Tigray (EFFORT), to distribute the masks. Almeda, which operates with 6,000 permanent employees and two billion Birr of investment capital, provides the masks to Guna for 13 Br a unit, while Guna sells them for 15 Br to the public, as of March 24, 2020.

Before starting to sell the products to the public, Almeda donated the washable masks to prisoners and police officers in Tigray Regional State. The management also planned to supply the masks for free to prisons, hospitals and people who cannot afford them.

To satisfy the demand for masks, Almeda, which produces 120,000 to 150,000 medical garments monthly and exports to the United States, is planning to increase its production to 100,000 masks a day in the coming weeks.

The factory is producing masks by stopping production of other garments that have been ordered.

Owned by EFFORT, Almeda started operations in 2000 by producing woven and knitted fabrics and until recently it was producing military items for the Ethiopian Defense Force.

The masks have to be made to the proper standards to prevent micro viral penetration, according to Abera Kumie, an associate professor of preventive medicine at Addis Abeba University.

Using masks that are not made for the purpose may increase the spread of the virus, because people might misunderstand them to be preventive and thus neglect the other precautionary advice announced by the government, according to Abera.

"Besides, hospitals and other treatment centres should make sure they use standard and quality N95 masks to prevent the pandemic," urges Abera.

PUBLISHED ON Apr 12,2020 [ VOL 21 , NO 1041]