VISAKHAPATNAM: Three officials, including the chief executive officer, of Actimus Biosciences Private Ltd here were arrested on Tuesday in connection with the bio-equivalence tests conducted on some boys recently.
The arrested were CEO Gangadhar, general manager (operations) YK Naidu and assistant manager Ananda Rao, said sub-inspector of police Raghava Rao.
Earlier, a team of officials from the Andhra Pradesh Drug Control Authority inspected the company and found that Lamotrigine, an anticonvulsant drug used in the treatment of epilepsy and bipolar disorder, had been administered to the boys and collected blood samples after every 30 or 40 minutes to test the drug’s efficacy.
Acting swiftly, the III Town police registered a case under Section 342 CrPC (forcibly taking individuals) against Actimus Biosciences. AP Drug Control Authority officials found that the company’s tests lacked transparency and it conducted bio-equivalence tests without informing the volunteers before a test is done to study how a drug is being sold at a lesser price would work.
They also found that after interacting with M Naresh Reddy that the representatives of the Actimus Biosciences Private Limited forced on the students conduct the bio-equivalence tests.
Since the Drug Control Authority has no powers to take any action against Actimus Biosciences Private Limited it will submit a interim report to the Central Drugs Standard Control Organisation and the representatives of the Central Drugs Standard Control Organisation likely to inspect the Actimus Biosciences Private Limited within a short period.
Assistant director of AP Drug Control Authority R Uday Bhaskar told Express they inspected the Actimus Biosciences and found some lapses in conducting the bio-equivalence tests on US-based Lamotrigine, an anticonvulsant drug.