Clinical Trials Should Be Conducted Only After Approval: Goa Medical College And Hospital

Goa Medical College and Hospital (GMC) directed all its departments to get approval- administrative and financial- from the competent authority before conducting clinical trials. Dr Pradeep Naik, Dean of GMC, issued circular to all heads of the departments saying that necessary approvals from the competent authority are required to undertake research or clinical trial and that there is need of approval from the Ethics Committee.

“Undertaking such projects/trial without approval of competent authority attracts the provisions of CCS (Conduct) Rules, 1964,” the circular mentioned.

The circular was issued, after it came to light that clinical trials were conducted without prior approval of the competent authority and funds received from pharmaceutical companies, which ran into lakhs of rupees, went directly into bank accounts of doctors conducting the clinical trials.

Certain departments received approval from the hospital’s ethics committee but did not receive approval from the government, said an official.

Two doctors were suspended after an inquiry by the Vigilance Department into the alleged unauthorized clinical trials. The duo, Dr A M Mesquita, Professor and Head of Pulmonary Medicine Department and Assistant Professor Dr Lalita Fernandes of the GMC were accused of financial misconduct running into lakhs of rupees while conducting the trials. They have also been accused of conducting over a dozen of such trials for a couple of years.

Source-Medindia