ISLAMABAD: The Drug Regulatory Authority of Pakistan (DRAP) following detection of serious adverse implications owing to the use of unregistered/unavailable drugs in the country over the past few months has advised all the healthcare facilities to only import registered/enlisted drugs.
In an advisory released here on Monday, the DRAP said, “recently, adverse drug reactions (DARs) have been reported in a healthcare facility following the use of Avastin injections. Investigations have confirmed that these injections were falsified, and same has been endorsed by the maker authorization holder of the product i.e. M/S Roche Pakistan Limited”.
In September 2023, the DRAP launched an investigation after reports surged regarding the loss of vision in diabetic patients after using the aforementioned drug.
Now after over a year, DRAP completed the probe and keeping in view the findings of the investigation it said all the hospitals/healthcare facilities are required to procure registered/enlisted therapeutic goods exclusively through authorised distributors or sellers of the product.
DRAP said in case any therapeutic good is either unregistered or unavailable due to any reason, hospitals or health institutions can import such products by attaining permission of DRAP as per SRO 134 (I) 2021 dated 9 February 2021. Moreover, DRAP said that additional detailed guidance on the importation of unregistered or unavailable drugs for hospitals or institutional patients use can be found on official website of DRAP.
Furthermore, all adverse reactions experienced with the use of any product should be reported to the National Pharmacovigilance Centre (CPC) of DRAP, using adverse event reporting form which is also available on official DRAP website.
Copyright Business Recorder, 2024
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