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Health News of Tuesday, 24 December 2013

Source: Graphic Online

Committee identifies lapses at FDA following Tobinco saga

The committee to review the governance process of drug regulation has identified regulatory and administrative lapses on the part of the Food and Drugs Authority (FDA).

It said for instance, the Drug Registration Committee of the authority met only once in four years.

The committee said the process of drug registration was also found to be fraught with many challenges including lack of transparency where applicants were not given enough information about the status of their applications for registration of products.

“It was realised that some applications for registration of pharmaceutical products can take up to two years despite the fact that all documents have been submitted and the requisite fees paid up front,” the Chairman of the committee, Dr Alfred Tia Sugri, has said.

He was addressing some journalists in Accra yesterday during the handover of the committee’s findings to the Ministry of Health.

The committee was set up in October this year, to review governance and leadership processes in the regulation of imports, as well as stakeholder issues on importers and local producers of medicines in the country.

Dr Sugri said Tobinco also acted illegally for releasing the medicines onto the market for sale without waiting for proper registration and analysis on the drugs by the FDA.

Other Findings

It was also found out that although the medicines and other consumables of the company entered the country without certification from the FDA, the authority gave the company a written permit to clear the drugs from the harbour under a “Release and Detention” arrangement.

Dr Sugri said after the medicines were released under the permit, there were no follow-ups by the FDA to be sure that Tobinco kept the drugs in known and secure warehouses without distributing them.

“Food and Drugs Authority never placed their own locks on the doors of those warehouses along with the locks of Tobinco Limited,” he said.

Additionally, Dr Sugri said, the committee found out that the acting Head of the Pharmaceutical Industrial Support Department of the FDA, Mr Samuel Asante Boateng, acted as a consultant of Entrance Industries and Research Centre, a subsidiary of Tobinco, which was clearly a conflict of interest.

“His action also violates Article 284 of the 1992 Constitution and the Public Service Regulations,” Dr Sugri said.

Recommendations

It was recommended that the dormant Drug Registration Committee of the FDA should be made to work and time limits set for drug registration applications.

It urged the Ministry of Health to have a monitoring system and a robust pharmaceutical desk at its headquarters to forestall arbitrariness and curb disturbances in the pharmaceutical regulatory environment.

The Minister’s Remarks

Madam Aryittey said all drugs that did not have permit from the FDA would be exported back to their countries of origin to await certification from the FDA before importing them into the country.

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