How WHO regulations forced FDA to suspend Tobinco’s Entrance Pharmaceutical from production

The seeming feud between the Food and Drugs Authority (FDA) and Tobinco Pharmaceuticals Ltd. continues as a new document sighted by GhanaWeb shows that the authority directed a subsidiary of the company to shut down its operations this year, 2024.

A letter addressed to the Managing Director of Entrance Pharmaceutical and Research Centre, a subsidiary of Tobinco, which was issued by the Chief Executive Officer, Dr. Delese Darko, shows that the authority directed the closure of the company, citing violations of World Health Organization (WHO) guidelines for Good Manufacturing Practices.

The letter indicated that the violations by Tobinco’s subsidiary were very serious and involved "39 major" and "5 other" deficiencies of WHO guidelines at the manufacturing plant of Entrance Pharmaceutical, which were sighted during an inspection by officials of the FDA.

“Following the routine inspection of your facility located at 16 Okpoi Gonno Light Industrial Area, Accra, by the Food and Drugs Authority from June 24 to June 26, 2024, to ascertain the level of compliance with Good Manufacturing Practices (GMP), certain deficiencies were observed.

“The deficiencies, which have been categorised into 5 "critical," 39 "major," and 5 "other" deficiencies, have rendered the facility non-compliant with the WHO guidelines for good manufacturing practices. In view of this, the safety, quality, and efficacy of the general and beta-lactam pharmaceutical products manufactured at your facility are a threat to public health and safety. Find attached the deficiencies and their categorisation,” part of the letter, which is dated July 1, 2024, reads.

It added, “You are, by this letter, directed to suspend all production activities and submit a Corrective and Preventive Action Report (CAPA) within fifteen (15) days upon receipt of this letter.”

Some of the products produced by the company include Foligrow blood tonic and multivitamin, Entracin, Entradol, Zinvite, Lufart, Artenate, Tobin’s Baby Grip water, Entrance Antacid, Tobvital Multivitamin, Lonart, Coldrilif, Tobcee Syrup, and Antralyn Baby, among others.

The 10-page letter from the FDA pointed to issues of quality control in the production of drugs by the Tobinco subsidiary, documentation (including incomplete files and a lack of audit trails), qualification and validation of production and laboratory activities, as well as issues with the "pharmaceutical quality system of the company."

A report by The Herald indicated that the officials of the FDA were at Entrance Pharmaceutical last week to ensure that its direction for the company to suspend production is in force.

It added that the authority is now expected to update the WHO on its latest findings at the company.

The latest revelation comes on the back of the CEO of the FDA, Dr Delese Darko, being accused of not fighting a good fight in the suit filed against the authority by Tobinco Pharmaceuticals Ltd.

Tobinco, in 2019, sued the FDA, accusing the authority of unlawfully seizing and destroying their drugs. The High Court in Accra, which has been hearing the case, has now ruled in favour of the pharmaceutical company and ordered the FDA to pay it about GH¢94m in judgment debt.

A 2017 letter by Dr Delese Darko, addressed to lawyers of Tobinco, Akufo-Addo, Prempeh & Co, has now gone viral.

In the letter, the FDA boss, responding to a letter from the lawyers, said that the authority did nothing wrong with its actions against the pharmaceutical company.

Darko insisted that Tobinco not only violated the laws of the country but also put the lives of Ghanaians at risk with its decision to import fake drugs into the country.

Read the full letter from the FDA to Tobinco’s Entrance Pharmaceutical below:

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