National drug authority to probe distribution of EU-banned drugs
National Drug Authority will review its inventory to ensure none of the banned drugs have been stccked for use
A European ban on 700 drugs from the Indian company GVK Biosciences is raising concerns over the usage of these medicines in Uganda.
According to Mr Zaid Mwondha, central regional inspector of drugs at the National Drug Authority, the drug authority is investigating whether any medicine developed by GVK Biosciences (GVK BIO) was distributed in the country.
GVK BIO is a research and development organisation that creates generic drugs. Generic drugs are non-brand versions of drugs — such as ibuprofen and its original patent Advil — that carry the same chemicals and strength but are more affordable.
The European Medicines Agency (EMA) suspended the distribution of 700 drugs — including varying dosages of the same type — by GVK BIO, on July 16.
Why the drugs have been banned
The ban is the result of a series of inspections by the French medicines agency ANSM and by a European committee of the company’s site in Hyderabad, India.
The inspections found that clinical studies of some generic medicines conducted by GVK BIO over a period of at least five years included manipulated data from electrocardiograms (ECGs) used during testing.
According to a release by the EMA, the results of the ANSM inspections “cast doubt on the integrity of the conduct of trials at this site.”
“There are no products registered by GVK BIO listed under the NDA’s current drug register, according to Mwondha. However, there is a possibility that drugs distributed by donor groups or other organisations were developed by GVK BIO,” he added.
The NDA investigation will check the sources of medicinal products through projects or donors.
The drug authority will also review its inventory to ensure any imported drugs that have not yet been registered are not linked to GVK BIO, Mr Mwondha said.
“In case there is any product found on the market from the said manufacturer, then it is illegal,” states Fredrick Ssekyana, head of public relations for the NDA, in an email.
The list of GVK BIO drugs banned by the EU include painkillers such as ibuprofen, the antibiotic ciprofloxacin, and other medications for high blood pressure, allergies and depression.
Despite the suspended distribution of these drugs in Europe, they are still considered safe.
The European agency stated in a media release that “there is no evidence of harm or lack of effectiveness with any of the medicines linked to studies conducted by (GVK BIO).”
Not all GVK BIO medicines are raising concerns either.
Three hundred additional drugs are still approved for distribution by EU member nations because independent studies of these drugs have confirmed their efficacy.
