MCDA clarifies, seeks Drug Controller's attention
Source: The Sangai Express
Imphal, August 08, 2013:
Clarifying that the reported detection of fungus in Eldex-P manufactured by Inven Pharmaceuticals is not due to lack of quality maintenance, Manipur Chemists and Druggists Association (MCDA) has stated that the presence of fungus in one or two bottle(s) out of 300/400 IV Fluid bottles is a common occurence.
A press release issued by Dr RK Ratan Kumar Singh, General Secretary MCDA said, if the fungus was caused by lack of quality maintenance by the company then the defect would be found in all the bottles of the batch number.
The certificate of analysis of the bottle found with fungus with the batch number G13C008 and documents of Good Manufacturing Practices (GMP) of company's revise schedule-M have been sent to the Medical Directorate and MCDA by the company.
There are many reasons for the presence of fungus in one or two bottles, like heavy exposure during transporation, too much of shaking, faulty storage and invisible leakage in the bottle.
As there is possibilty of the air penetrating through the vacuum bottle somehow, every IV Fluid bottles are inscribed upon with a statutory warning which reads "This product is thoroughly examined for clarity and strength.
Check visually.
And do not use if, container is found leaking or solution hazy/Having particulate matter/Fungus/Microbial contamination due to even invisible damage to bottle, in transit or storage.", the release added.
It also stated, for these reasons, doctors and nurses examine the bottles before injecting the IV Fluid.
On the other hand, in such a time when the State is facing transportation problem and subsequently worried if IV Fluid used by most patients, would fall short, it is very surprising for medical professionals and persons related with medicine and unfortunate for the patients that Inven Pharmaceuticals medicines have been banned in the State, without having discussed with concerned authority and individuals.
Drug Controller Manipur is appealed to look into the matter and publicise the real thing, the release added.