Cancer drug shortage: Bureaucrats fight over file while patients suffer



By Don Asoka Wijewardena   


Lives of more than 1,000 cancer patients awaiting highly expensive cancer injection ‘Albumin Bound Paclitaxel’ are in danger due to the Health Ministry’s long delay in furnishing the required information to the Sri Lanka Oncological Association (SLOA) for final approval.


SLOA President Consultant Oncologist Dr. Mahendra Perera, contacted for comment, said that many cancer patients in dire need of albumin bound paclitaxel injection were at higher risk because of the health ministry’s inability to furnish the required information to him for approval for importing it from India.


He said that the original albumin bound paclitaxel had been imported from the US. The price of one injection phial was Rs. 78,000. But, a local agent had called for a tender to supply the same phial at Rs. 38,000. The original US injection had quality, efficacy and effectiveness and it was fully quality assured.


Dr. Perera added that he had asked the Health Ministry to furnish information about the local agent, but so far he had not received any response from the Ministry. The dossier he had asked for should include the registration procedure, bio-similar status of the drug, the quality, efficacy and safety in comparison to the original drug, the complete details of the trial period in which the drug had been used to treat cancer patients, the manufacturing process of the Indian company and pending six months trail period.


He said that if the albumin bound paclitaxel injection imported from India met all the standards mentioned above, he would approve it. "I am expecting the complete dossier of the injection phial from the Health Ministry. I am not concerned about the price at all. What I want to know is whether the Indian manufactured paclitaxel injection conform to the guidelines issued by us. If the Indian imported drugs do so, I have no objection to approving the drug to be imported from India.


Medical Supplies Division (MSD) Director Dr. Kamal Jayasinghe, contacted for comment, said that the file on the local agent and the relevant details of the drug had been given to Cosmetic Devices and Drug Regulatory Authority (CDDRA) Director Dr. Hemantha Beneragama and it was he who must furnish it to Dr. Mahendra Perera.


Dr. Beneragama was not available for comment.


 
 
 
 
 
 
 
 
 
 
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