HEALTH
Pharmacy Chamber Appeals To FDA To Reduce Registration Fee For Pharmaceutical Products
The Chief Executive Officer (CEO) of the Chamber of Pharmacy Ghana, Mr Anthony Ameka, has called on the Food and Drugs Authority (FDA) to reduce the registration fees for locally made pharmaceutical products.
According to him, the registration fees for some medicines were as high as $3,600, while inspection fees sometimes cost $20,000, making Ghana one of the most expensive countries in Africa to operate a pharmaceutical business.
Mr. Anthony Ameka made this revelation in Kumasi on Wednesday, February 20, 2019 during Chamber of Pharmacy in collaboration with Star Ghana stakeholders Consultative Forum aimed at promoting discussions and debate for the review of Food and Drugs Authority fees and charges for GMP factory inspection.
He noted that only one thousand two hundred (1, 200) pharmaceutical products in the country have been registered by Food and Drugs Authority (FDA).
Mr Ameka explained that the effects of the high registration fees were the inability to present new products for registration and evading re-registration when the product’s permit periods expired.
“The high costs of registration fees of pharmaceutical products make it extremely difficult for the industry to meet their regulatory obligations. Some companies are unable to present new products for registration, inability to re-register products when same expires, and this might cause shortage of drugs on the market as well as unsolicited products such as un-registered, fake or sub-standard entering the market via the porous borders and low compliance by industry in general” he stated.
He said, in 2017, the Research and Advocacy Committee was commissioned by National Executive Council (NEC), of the Chamber to conduct a research into the fee charged by other regulatory within the sub region and they noted that.
Comparing the registration and re-registration fees for allopathic medicines in Ghana and some selected countries, Mr Ameka pointed out that while the industry paid $3,600 for three years, Nigeria charged $750 for five years, Kenyans paid $1,000 for a lifetime with $300 as retention fee, Uganda $1,250 for a lifetime and $500 for retention fee.
He said stakeholders consultations would be made for proposal of Legislative Instrument (LI) through the Ministry of Health to the Parliament for the amendment of FDA fees and charges.
Mr Ameka appealed to the FDA to extend the duration upon which the charges were made, recommending that all fees should be charged in the local currency.
“This will ensure stability in the fees and the prices of medicines on the market, thus increasing access to medicines by the ordinary Ghanaian,” he said.
For his part, the Head of Herbal and Food supplement of the Food and Drugs Authority (FDA), Emmanuel Yaw Kwarteng, said un-registered, fake or sub-standard products in the market is dangerous for the country since it posses hazard to the health of the citizenry.
He called on the government to beef up security in the various borders to control authorize products from entering into the country.
Source: Thepressradio.com/Anokye Elvis
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