FDA engages pharmaceutical industry players over essential drugs

The Food and Drugs Authority (FDA) has met with stakeholders of the Pharmaceutical Industry and assured them of fast tracking the approval for the production of essential drugs, including chloroquine, which are needed for the case management of COVID-19.

The stakeholders, however, gave the assurance that the industry had the capacity to produce the selected drugs and that the current stocks of locally manufactured and imported medicines were adequate to cater for the COVID-19 pandemic for the next three months.

In an interview with the Ghana News Agency on Thursday, Mr James Lartey, the Head of Communications Department, said the Authority would, however, not compromise the quality, safety and efficacy of any drug, as seen in the approval for hand sanitisers.

The proposed drugs for treatment for COVID-19 include hydroxychloroquine and chloroquine; and Remdesivir.

Hydroxychloroquine and chloroquine are oral prescription drugs that have been used for treatment of malaria and certain inflammatory conditions.

Chloroquine has also been used for malaria treatment and chemoprophylaxis; while hydroxychloroquine is used for treatment of rheumatoid arthritis, systemic lupus erythematosus and porphyria cutanea tarda.

“Remdesivir is an investigational intravenous drug with broad antiviral activity that inhibits viral replication through the premature termination of RNA transcription and has in-vitro activity against SARS-CoV-2 and in-vitro and in-vivo activity against related beta coronaviruses,” the FDA explained.

“It is necessary to establish the current stocks of essential medicines, both finished products and raw materials, the capacity of the local manufacturers to meet the needs of the country to help the Ministry of Health in planning to avert any shortages and stock outs.

The meeting was also used to solicit support from the industry to fight the pandemic.

Mrs Delese Darko, the Chief Executive Officer (CEO), led a team of FDA Officers during the engagement.

The stakeholders included the Chamber of Pharmacy, Pharmaceutical Manufacturers Association of Ghana (PMAG), Pharmaceutical Importers and Wholesalers Association (PIWA), Community Practice Pharmacists Association (CPPA), and Small Scale Pharmaceuticals Manufacturers Association.

Part of the FDA's function is to advise the Minister of Health on measures for the protection of consumer wellbeing.

The industry players, however, urged the Government to supply the requisite guarantees to enable them to secure financial support from the banks to produce the needed essentials drugs.

It should also consider making provision for Personal Protective Equipment (PPE) to Community Pharmacists and Over-the-Counter Medicine Sellers who were the first-line of call for most consumers.