07 Oct 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Indian pharmaceutical company, Bliss Pharmaceuticals, denied the allegations made by the US FDA terming the malaria drugs manufactured and distributed by the company in Ghana as ‘fake'.
Dismissing the classification of the FDA that products of the company, which are distributed locally by Tobinco Pharmaceuticals in Ghana are fake, the company issued a statement.
"We will like to state emphatically that all our products have been subjected to stringent quality standards and meet the required accreditations in India. It is unfortunate that the FDA released a statement classifying our products as fake," the statement said.
The statement further added that the claim by the US FDA led to the blacklisting of the company manufactured medicinal products for the Ghanaian market. It said that Bliss complies with all norms laid down by the US FDA for manufacture of its products and maintains high international GMP standards.
The statement also clarified that the company has been working along with FDA authorities on all issues pertaining to compliance of regulatory requirements.
"We have made payments for renewal of our product registrations and the renewal process is on."
The statement added that it has maintained high levels of compliance owing to strict implementation of GMP, GLP, ICH guidelines. "We would also like to emphasize that until date our product has not been failed in quality aspects. We are committed to ensure public health and safety and have never and would not compromise on this," the statement further said.
It added, "We assure the Ghanaian public that we will take all necessary steps to assist the US FDA in its quest to protect public safety and to continue to provide the quality assured and affordable medicines in Ghana."