GSA And FDA Clash Over Right To Register Food And Drugs

The Ghana Standards Authority (GSA) and the Food and Drugs Authority (FDA) have once again clashed over which regulatory body has the mandate to regulate food and drugs in the country.

While the GSA claims to have the mandate to regulate and inspect all high risk products in the country, which include food and drugs, the FDA on the other hand has vehemently refuted that claim, explaining that there are 17 high risk products in the country but the GSA has the mandate to regulate 15 of them, minus food and drugs.

The argument over which authority has the mandate to regulate food and drugs in the country reared its head at a meeting at the instance of the Association of Ghanaian Industries (AGI) in Accra on April 29, 2014.

The meeting was aimed at getting the regulatory bodies, as well as the Accra Metropolitan Assembly (AMA), to explain their operations to industry players in the country.

Although it was not immediately stated, it was clear that the meeting was to get the regulatory bodies and the assembly to clarify which of them had the clear mandate to undertake specific actions on products produced or imported by industry in the country.

It has often been problematic for manufacturers to get authorisation for their products because of the conflict between the GSA and the FDA over which organisation has the right to register their products before they hit the market.

There have been many instances where industry players have had to bypass the two regulators because of the unnecessary time wasting tactics that come about as a result of the misunderstanding between them over which one has the right to register food and drugs in particular.

This turf war has been raging for many years but the government seems not to have found any solution to the problem, thereby creating confusion in the minds of industry players.

The arguments
The Director for the Certification Division of the GSA, Mr Mustapha Tawiah Kumah, stated that the GSA was mandated to regulate and inspect all high risk products in the country, which include food and drugs.
He said the GSA was also mandated to inspect and certify all those products to ensure that they were up to the standards required.

Mr Kumah said the certification of products, which was formerly optional, was set to be made mandatory within the next few months.
He said that was necessary because many of the products being produced and imported daily.

According to him, the destination inspection companies alone could not inspect all those products effectively. He said the mandatory certification would, however, ensure that all the products were inspected properly before being certified.

The Deputy Chief Executive Officer (CEO) of FDA, Mr John Odame Darkwa, however, rebutted the assertion of Mr Kumah over which organisation had the right to register food and drugs by pointing out that the GSA had the mandate to regulate 15 of 17 high risk products, minus food and drugs.

He wondered why after the GSA and the FDA had reached a Memorandum of Understanding (MoU) on two separate occasions to iron out the issues, the GSA would still carry itself as the regulator of food and drugs in the country.

He warned that nobody could sell any food or drugs unless it had been duly registered by the FDA. Mr Odame Darkwa said registration of products was mandatory but certification was optional and, therefore, the producer or importer could choose to certify his product or not.
He, therefore, asked the GSA to concentrate on the other 15 products and leave out food and drugs in order to take the burden off the industry players.

Industry pleads
Some members of the industry also pleaded with the two bodies to come to a consensus to avoid duplication of their mandate as far as the registration of the same products are concerned.

They maintained that with the mandatory certification, which is set to implemented by the GSA, it will mean producers and importers will have to pay for registration and also pay for the certification of the same product at a two different institutions, a situation they said could negatively impact cost of operations and profit eventually.

AGI demands collaboration
Meanwhile, the Association of Ghanaian Industries (AGI) has called for greater collaboration between the two regulators, industry, as well as the Accra Metropolitan Assembly (AMA), to ensure greater partnership that will lead to the development of the country.

Consequently, it urged members of the association to fully cooperate with state agencies to avoid falling foul of the rules and regulations governing their operations.

The President of AGI, Mr James Asare Adjei, said the regulatory bodies and the assembly had to be seen as partners in the development of the economy.

He called on industry to understand the regulators and urged the players to ensure that their products met their standard.
The AGI President also asked the regulators to understand industry and its businesses to enable them to handle their issues with dispatch.

Source: Graphic Business