The German drug regulator has banned the sale of 80 generic medicines with immediate effect on the grounds that their clinical trials conducted by GVK Biosciences were “insufficient”. The Federal Institute for Drugs and Medical Devices has ordered drug manufacturers, wholesale dealers, medical stores, and other outlets not to sell or use these medicines any longer. The list includes drugs from 16 generic manufacturers including Mylan, Panacea Biotec, Lupin and Dr Reddy’s.

The regulator also suspended the marketing authorisation to the drugs concerned, based on the data of clinical trials supplied by GVK Bio. The regulator said it had informed the drug manufacturers of its decision on Monday and the ban on the sales of the medicines came into effect on Tuesday. Among the medicines affected by the ban are those for treating high blood pressure, depression, migraine, epilepsy and Parkinson’s disease from 16-odd pharmaceutical companies.

In a statement, the regulator said it did not expect the ban to cause any shortage of supplies as similar generic versions of these medicines as well as their original branded versions are available in the market. So far, it has no information about any health risks for patients who have been using the banned medicines.

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 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 GVK Bio, 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 added.

Among the 80 drugs banned by the watchdog, marketing authorisations were already withdrawn for 17 medicines by five companies as the authorisation holders either asked for that, or did not seek an extension, the statement said.