NMRA reports pharma company for import procedure violations

• NMRA claims Isolez Biotech Pharma had not obtained necessary approvals to import batch of antibodies from India 
• Accuses company of forging a Waiver of Registration for customs clearance 
• Says forged WOR was on a NMRA letterhead and featured signature of a senior official 
• Use of drug in Sri Lanka suspended pending further investigations

The National Medicines Regulatory Authority (NMRA) lodged a complaint with the Criminal Investigations Department (CID) yesterday against Isolez Biotech Pharma Ag. Ltd. for importing a batch of human immunoglobulin IV manufactured by Livealth Biopharma Ltd. India, in violation of the due procedure. 

Releasing a statement the NMRA said the drug had been imported and used in the country without obtaining necessary approvals.

According to the NMRA, the company had submitted forged documents to Sri Lanka Customs for clearance purposes when importing the drug which had later failed the quality tests. 

The NMRA revealed that the company had failed to register the drug with the authority prior to importation.

It said Isolez Biotech Pharma had also not obtained a Waiver of Registration (WOR) from the NMRA as required and instead submitted a forged WOR document featuring the NMRA letterhead and the signature of a senior official. 

The company’s alleged deception was revealed following reports of allergic reactions among patients who received the drug at the Colombo National Hospital on 22 August and the Matale District Hospital on 16 September. 

The use of the contentious batch of human immunoglobulin has now been suspended pending ongoing investigations.