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Licenses of Manufacturers of Liposomal Amphotericin B Suspended

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

 

Source: with inputs of TOI
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