Licenses of Manufacturers of Liposomal Amphotericin B Suspended
New Delhi,: An expert committee of The Ministry of Health has sounded an alert to all pharmaceutical companies by recommending for suspension of licenses of 10 companies manufacturing the generic version of a life saving drug-Liposomal Amphotericin B. The drug is used to treat fungal infections in critically ill patients.
Confirming its action in the Lok Sabha, the ministry stated that show cause notices had been issued to 10 companies manufacturing this injectable drug and were expected to have come up with replies within a three week period as to why the suspension order should not be carried out against them for the drug.. The ministry revealed that of the ten, seven companies had responded and prima facie, their responses were not found satisfactory enough to conclude that the products were ' safe and efficacious.'
As informed by TOI the Medanta Medicity, Chief liver transplant Surgeon, Dr A S Soin had called the Ministry's decision crucial saying that many of the generic drugs in the market were not tested for safety and efficacy.
"While the government is pushing generic drugs as they are cheaper, there is inadequate attention on following quality protocol. This action will make the manufacturers more attentive towards quality control," he further added.
Dr Soin heeded manufacturers of generic drugs to follow basic safety testing and trial on patients. "In transplant patients, generic drugs use is huge given not all can afford branded medicines. So we do our own trials, approved by relevant authorities," he stated.
Costing 80-85% less, generic drugs are a copy of the original drug whose patent has ended. The Delhi Government has ordered doctors at state run hospitals to prescribe only generic drugs.
According to a Lok Nayak hospital doctor while theoretically the plan works well, there were problems in its application
Confirming its action in the Lok Sabha, the ministry stated that show cause notices had been issued to 10 companies manufacturing this injectable drug and were expected to have come up with replies within a three week period as to why the suspension order should not be carried out against them for the drug.. The ministry revealed that of the ten, seven companies had responded and prima facie, their responses were not found satisfactory enough to conclude that the products were ' safe and efficacious.'
As informed by TOI the Medanta Medicity, Chief liver transplant Surgeon, Dr A S Soin had called the Ministry's decision crucial saying that many of the generic drugs in the market were not tested for safety and efficacy.
"While the government is pushing generic drugs as they are cheaper, there is inadequate attention on following quality protocol. This action will make the manufacturers more attentive towards quality control," he further added.
Dr Soin heeded manufacturers of generic drugs to follow basic safety testing and trial on patients. "In transplant patients, generic drugs use is huge given not all can afford branded medicines. So we do our own trials, approved by relevant authorities," he stated.
Costing 80-85% less, generic drugs are a copy of the original drug whose patent has ended. The Delhi Government has ordered doctors at state run hospitals to prescribe only generic drugs.
According to a Lok Nayak hospital doctor while theoretically the plan works well, there were problems in its application
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd