Germany bans 80 generic drugs for insufficient clinical trials by GVK Biosciences

As many as 80 generic medicines have been banned by Germany's drug regulator with immediate effect on the grounds that their clinical trials conducted by GVK Biosciences, the home-grown pharmaceutical research company, were insufficient.

Medicines of 16 pharmaceutical companies have been affected by the ban. The drugs include those for treating high blood pressure, depression, migraine, epilepsy and Parkinson's disease.

The Federal Institute for Drugs and Medical Devices said on Wednesday it had ordered drug manufacturers, wholesale dealers, medical stores and other outlets not to sell or use these medicines any longer.

Patients still using these banned medicines have been advised to consult their doctors, even though the regulator has no information about any health risks for such patients.

The German watchdog said it had informed the drugs manufacturers about its decision on Monday and the ban on the sales of medicines came into effect on Wednesday.

The regulator also suspended the marketing authorisation given to the drugs concerned based on the data of clinical trials supplied by GVK Biosciences, the Hyderabad-based contract research company.

In a press statement, the Federal Institute said it did not expect its ban to cause any shortage of supplies as similar generic versions of these medicines by other drug makers as well as their original branded versions are available in the market.

The regulator investigated the marketing authorisation of 176 medicines by 28 pharmaceutical companies after an inspection of GVK Biosciences' facility in Hyderabad revealed substantial deficiencies in carrying out the clinical trials of the generic medicines and in the validity of its data to support marketing authorisation applications, the statement said.

In view of these serious and systematic deficiencies, the bio-equivalence studies carried by the domestic drug firm to establish that the generic versions have the same effect on the human body as the original branded versions, cannot be accepted as a basis for marketing approval, the statement said.

Among the 80 drugs banned by the watchdog, marketing authorisations were already withdrawn in the case of 17 medicines by five companies because the authorisation holders either asked for that or did not seek an extension, the statement said.

However, marketing authorisation of these drugs and the remaining 63 medicines by 11 companies will remain suspended until the authorisation holder submits the results of a new bio-equivalence study. Marketing approval given to 96 medicines will remain valid, the regulator said.

Media reports said earlier that the European Union's drug regulator the European Medicines Agency (EMA) believes that GVK Biosciences has been systematically manipulating its studies carried out on behalf of European drug manufacturers.

EMA had raised concern over the reliability of the studies conducted at the company's facility between 2008 and 2013 and ordered a review of the marketing approvals based on the data provided by GVK Biosciences.

(PTI)