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Ensure Safety of Medicines – FDA to Drug Companies

The Chief Executive Officer (CEO) of the Food and Drugs Authority (FDA), Mrs Delese Darko, has asked managers of local pharmaceutical companies to put in place robust vigilance systems that will ensure the safety of their products.

She said the pharmaceutical industry was a sensitive sector of the economy for which reason there was the need for its players to adhere strictly to quality standards to promote access to safe medicines for local consumption.

“Generic medicines are similar to branded ones but differences may also arise based on excipients, formulation or commercial presentation and container closure systems which could affect the quality, efficacy and safety of the medicine.”

“There is, therefore, the need for a robust pharmacovigilance system for both branded and generic drugs irrespective of the age of the molecule,” she stressed.


Mrs Darko made the call at a national symposium on pharmacovigilance and patient safety organised by the FDA for managers of the pharmaceutical industry in Accra last Friday.

The symposium, which was attended by 39 CEOs and managers of entities in the pharmaceutical industry, was meant to provide them with relevant information on enhancing vigilance in their operations to ensure the safety of their products.

It was also a platform to build the capacity of industry players on the requirements for the establishment of pharmacovigilance system in their industries.


Pharmacovigilance is the process and science of monitoring the safety of medicines and taking action to reduce risks and maintaining a favourable befitting risk balance.

Ghana became the first country in sub-Saharan Africa to become a member of the World Health Organisation (WHO) Programme for International Drug Monitoring in November 2001. The country is also the first in the world to start a formal training programme for Qualified Persons for Pharmacovigilance (QPPVs).

Mrs Darko explained that the initiative, which had so far seen the training of 57 QPPVs since 2015, was meant to support the pharmaceutical companies with the right human resource to establish their monitoring systems.


She said there would be a mechanism in place for the local pharmaceutical companies to sign contracts with the QPPVs to support their operations as a measure to guard against sub-standard medicines in the country.

“The FDA believes that the requirements in Section 125 of the Public Health Act cannot be realised without dialogue, cooperation and collaboration with the key stakeholders in the pharmaceutical industry.”

“This capacity building initiative should, therefore, be a means to reinforce the need to set up vigilance systems in companies to benefit patients and customers,” she said.

The Director of Vigilance Risk Management of Medicines Division in the United Kingdom (UK), Dr June Raine, said the wealth of a country had a link with the health of its people so it was important to ensure that medicines were of high quality.

She said the major health threats posed to countries of late was the increase in sub-standard medicines, stressing that the way forward was for the vigilance systems to be established.

Source: Graphic


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