The sale of hundreds of medicines for which authorization was given on the basis of clinical studies conducted at GVK Biosciences in Hyderabad was recommended suspension by the European Medicines Agency (EMA).
The French medicines agency (ANSM) carried out an inspection, which revealed data manipulations of electrocardiograms (ECGs) during the conduct of some studies of generic medicines.
Clinical Trials
Clinical trials are experiments that yield useful information to clinicians if a particular treatment is of any value to a patient.
Advertisement
"These manipulations appeared to have taken place over a period of at least five years. Their systematic nature, the extended period of time during which they took place and the number of members of staff involved cast doubt on the integrity of the way trials were performed at the site generally and on the reliability of data generated at that site," said a statement issued by EMA.
EMA's Committee for Medicinal Products for Human Use (CHMP) looked at over 1,000 pharmaceutical forms and strengths of medicines studied at the GVK site.
![How Safe are Your Drugs? Q&A with Drug Safety Expert]( "How Safe are Your Drugs? Q&A with Drug Safety Expert")
Jim Tizzard, CEO, TAKE Life Sciences discusses pharmacovigilance, of monitoring pharma products, identifying possible risks and side effects, informing the public and medical professionals of updates.
For over 300 of them, sufficient supporting data from other sources were available; these will therefore remain on the market in the EU as EMA is satisfied with the available data.
The list of medicines for which the CHMP recommends suspension is available on the EMA website. The EMA statement said that the agency and the national authorities worked closely with international partners to ensure that studies underpinning marketing authorisations in the EU were carried out to the highest standards and that the companies involved comply fully with all aspects of Good Clinical Practice (GCP).
There is no evidence of harm or lack of effectiveness linked to the conduct of studies by GVK Biosciences, it added. The EMA said that some medicines, for which insufficient alternatives are available to meet patients' needs would remain on the market in some countries as new data were being awaited.
The EMA awaits new data to make final decisions on whether to suspend or allow continued availability of medicines and the national authorities in the EU would consider the availability of individual medicines in their countries.
Source: Medindia
How Safe are Your Drugs? Q&A with Drug Safety Expert
Jim Tizzard, CEO, TAKE Life Sciences discusses pharmacovigilance, of monitoring pharma products, identifying possible risks and side effects, informing the public and medical professionals of updates.
Advertisement
For over 300 of them, sufficient supporting data from other sources were available; these will therefore remain on the market in the EU as EMA is satisfied with the available data.
The list of medicines for which the CHMP recommends suspension is available on the EMA website. The EMA statement said that the agency and the national authorities worked closely with international partners to ensure that studies underpinning marketing authorisations in the EU were carried out to the highest standards and that the companies involved comply fully with all aspects of Good Clinical Practice (GCP).
There is no evidence of harm or lack of effectiveness linked to the conduct of studies by GVK Biosciences, it added. The EMA said that some medicines, for which insufficient alternatives are available to meet patients' needs would remain on the market in some countries as new data were being awaited.
The EMA awaits new data to make final decisions on whether to suspend or allow continued availability of medicines and the national authorities in the EU would consider the availability of individual medicines in their countries.
Source: Medindia
Clinical Trials in India - Boon or Bane?
Do the recent controversies associated with clinical trials imply that we are being regarded as Guinea pigs by the West?
Advertisement
Advertisement
|
Advertisement
Recommended Readings
Latest Drug News
The CDSCO has approved the intravenous administration of AstraZeneca Pharma India's liver cancer drug, Tremelimumab Concentrate.
The FDA advises consumers not to use compounded medications as an alternative to known diabetic and weight reduction medications Ozempic, Rybelsus, and Wegovy.
Addressing the unmet needs of Parkinson's Disease by providing disease-modifying therapies could bring about a major shift in the way that patients are treated.
Microrobots could swirl through a person's blood stream, search for targeted areas to treat for various ailments.
Supplementation with multivitamins is an inexpensive way for older adults to slow down memory loss.