Nigeria seals company producing unregistered drugs
The National Agency of Food and Drug Administration and Control (NAFDAC) has sealed Gentle Hills Limited, a pharmaceutical company suspected of producing and storing unregistered products.
Nigeria’s drug regulatory agency sealed the company during a routine facility visit to pharmaceutical companies in Port Harcourt, Rivers State.
The company is producing some products without NAFDAC registered numbers
“The practice is not in line with NAFDAC Good Manufacturing Practice (GMP) regulations,”Mr Naeche John, a Deputy Director in NAFDAC said.
“The agency has once visited the company on a facility check to ensure it is operating in line with GMP, but was refused access, until it brought in its regulatory force agents.
“GMP is a controlled system to ensure that products are consistently produced and controlled in quality standard expected of a particular product.
“We saw that the company has some packaging materials and finished products which were not registered by NAFDAC, while about twelve product packages and labels had the same NAFDAC number, which is not supposed to be.
“The Managing Director of the company, Mr Nnamdi Anyanwu, claimed he had yet to start production at the company’s new site.
“But we saw some finished products and evidence of production in the factory without evidence of approved registered numbers of the agency.
“We saw different brands of cough syrup packages, such as quinykid syrup, pundy suspension, Mist Alba, flush quick action, chestalyn, sprilyn, spirex, containers for production, biological test tubes, among others,” he said.
The official said although the company has claimed to have contract with a manufacturing company that produced for them, but the said company’s name was not on the labels and packages of any of the products.
“Rather it’s Gentle Hills Ltd that is on the packaging as the manufacturer.
“The managing director also claimed to have reported to NAFDAC about the errors made on the labels and packages of the manufacturer’s address by the printer.
“We urge him to bring a copy of the letter he submitted notifying NAFDAC of the errors to our office.
“All these abnormalities speak volume about the standard of the products manufactured in the company not in line with the GMP regulations.
“We have invited the management of the company to our office for sanction,” the NAFDAC official said.
However, the managing director of the company said their products were fully registered by the regulator, adding, “we do not intend to make any product without NAFDAC registration number and we have never made any without approval.
“We are still waiting for the registration numbers after proper documentation at NAFDAC.”
Nnamdi Anyanwu insisted that the company had notified NAFDAC about the errors on the address on the labels and advised by the agency to correct the errors.
