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Stricter Regulations Sought for Drug Trials
Health officials said Monday that they wanted to introduce tougher rules for clinical drug trials after a scandal involving vaccine tests by GlaxoSmithKline earlier this year.
Doctors warned that the change would put drug research at risk. But the Health and Social Development Ministry, which helped draft the bill, noted that the legislation would also for the first time allow any clinic to participate in trials.
The bill, which is expected to be submitted for reading to the State Duma shortly, would give any clinic the right to carry out a trial as along as it secures permission first, said Maxim Lakomkin, a spokesman for the Federal Health and Social Development Inspection Service, which drafted the bill with the Health and Social Development Ministry. Currently, only specially accredited clinics can participate in trials.
Volgograd prosecutors opened a criminal investigation into a clinic in February, accusing it, among other things, of not being on the list of accredited clinics. Parents had complained that the clinic was administering a chicken pox, measles and rubella vaccine made by British pharmaceuticals giant GlaxoSmithKline on their babies without telling them it was part of a clinical trial.