A six-member expert panel set up by the Government of India is taking a re-look at the allegations of manipulations of clinical trials data by GVK Biosciences Pvt Ltd.
“We have visited the facility of GVK Bio yesterday and found no evidence of manipulation of data,’’ Sudhanshu Pandey, Joint Secretary, Department of Commerce told newspersons on the sidelines of the 11the annual general meeting of the Pharmaceutical Exports Promotion Council (Pharmexcil) here on Wednesday.
Pandey, who is one of the members of the panel, however, hastened to add that the panel will not come to a ‘pre-judgment’ on the issue and will submit its report to the Government as soon as possible.
In July, the European Union had announced a ban on marketing of 700 generics on the charge that GVK Biosciences, which had carried out the clinical trials and manipulated the results. The ban came into effect on August 21.
Citing that an earlier report submitted by the Central Drug Standards Control Organisation which also did not find any discrepancy in the EGC reports as has been alleged by a French inspector earlier, the official said many other European regulators and the USFDA which conducted similar inspections in the same period on GVK Bio also did not find any fault with the procedures.
“We are, however, not to support anybody. We want to find out what is the truth in the allegations,’’ the official added.
Referring to other initiatives, he said the Government was working on reducing multiple inspections by different global regulators on a single facility. “This is adding up to the cost of drugs. If this can be brought down, the prices of drugs can be reduced,’’ he said.