Cancer drug without registration: NMRA claims correct procedure followed

The National Medicines Regulatory Authority Chairman, Dr Rasitha Wijewantha, has drawn our attention to last week's news item headlined “Cancer drug to be imported without registration.”

The NMRA Chairman said: “Trastuzumab Powder for injection, Brand Name Herzuma, manufactured by Celltrion INC Republic of South Korea, and Marketed by George Steuart’s Health ( Pvt) Ltd was given registration/ marketing authorization by the NMRA on the 10th of November 2021, following the correct procedure after a careful evaluation and approval of the medicines evaluation committee and price negotiation.

"Hence the news item, which stated that the medicine was given a waiver of registration to import the product is totally incorrect and misleading. Also there is no requirement of waiver for importing registered medicines."

Reporter’s /News Editor's note: The confirmation that the above drug had been provided a waiver of registration was given by the NMRA Chairman himself and was quoted accordingly in the news item published.