News
Cancer drug to be imported without registration
View(s):The Health Ministry has given permission to a private company to import without registration a drug required for cancer on the grounds that no supplier had come forward to import it.
Accordingly, a ‘Waiver of Registration’ has been granted by the National Medicines Regulatory Authority to George Steuart Health (Pvt) Ltd for the import of the drug known as Trastuzumab from South Korea.
NMRA Chairman Dr Rasitha Wijewantha told the Sunday Times that since the Health Ministry had given the approval the waiver had been granted.
He said that in view of the urgent requirement the usual process where the samples were checked and the side effects looked into would not be followed and instead the importer should take responsibility for the drug.
Dr Wijewantha said usually they did not encourage the process, but in view of the government requirement the approval had been granted.
The particular drug is used in the treatment of breast and stomach cancer and is to be supplied only to state hospitals.
The maximum retail price of the drug has been fixed at Rs 90,250 a vial.
NMRA Right of Reply The National Medicines Regulatory Authority Chairman Dr Rasitha Wijewantha has drawn attention to a news items published in the Sunday Times last week under the heading "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 Chairman of the NMRA himself and was quoted accordingly in the news item published. |
|---|
The best way to say that you found the home of your dreams is by finding it on Hitad.lk. We have listings for apartments for sale or rent in Sri Lanka, no matter what locale you're looking for! Whether you live in Colombo, Galle, Kandy, Matara, Jaffna and more - we've got them all!