BLISS GVS Pharma Limited, the Indian company at the centre of the Gsunate Plus Suppository saga, has described as unfortunate a statement by the Food and Drugs Authority (FDA) that the company’s products are fake.
“We would like to state emphatically that all our products have been subjected to stringent quality standards and meet the required accreditations in India,” it said.
In a statement signed by Mr Vipul B. Thakar of Bliss GVS Pharma, India, the company said it complied with all the norms laid down by the Food and Drugs Administration of India for the manufacture of its products and maintained high international GMP standards.
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“Bliss has been supplying high quality medicines to Ghana for the past 13 years which meet the stringent quality standards as prescribed by the FDA. We have been extending our helping hand to the FDA on all issues bordering on compliance with regulatory requirements,” it stated.
It said the company had made payments for the renewal of its product registrations and the renewal process was on, saying that “given us a chance and time by the FDA to comply with points they had raised about our products, we would have been in a position to explain them better. We would also like to emphasise that till date our product has not been failed in quality aspects”.
The statement said Bliss was committed to ensuring public health and safety and had never and would never compromise on that, adding that the company had, in the past decade, created an organisation which adhered to the highest standards of ethics, while making quality medicines available to society.
“We assure the Ghanaian public that we will take all the necessary steps to assist the FDA in its quest to protect public safety and continue to provide the quality assured and affordable medicines in Ghana,” it said.
It said Bliss GVS Pharma had more than 28 years’ experience in manufacturing, marketing and exporting more than 250 formulations in various dosage forms to more than 50 countries across the globe and in the past 13 years to Ghana.