Formal approval required for drug trials now

In view of the reported cases of clandestine drug trials by doctors in many parts of the country and in league with the pharmaceutical industries, the Ethical Committee (EC) of the Patna Medical College Hospital has alerted heads of all its departments and asked them not to permit any such exercise without the approval of the committee.

The committee has also made it mandatory for them to take formal consent from the patients before subjecting them to clinical trials to check the efficacy of newer medicines. "Not only the drug trials but also all sort of researches, either by post graduate students or senior doctors, will be allowed only after obtaining prior permission from the eight-member ethical committee," said chairman of the committee Dr NP Yadav.

Dr Yadav, who is also principal of the Patna Medical College, said directives had been issued to HODs not to permit evaluation of drugs nor allow their launching on the hospital campus without the approval of the EC. Member secretary of the committee, Dr Amar Kant Jha 'Amar', said all PG students would have to approach the EC for permission to take up any research project they intend to carry out as part of their course.

He said, before giving approval to any such exercise, the EC would deliberate on the subject matter among members and only after that would it either approve or disapprove it. "We have recently given permission to 120 such proposals only after properly evaluating them," he added.

Amar said, the EC was also trying to locate any such ongoing projects, which were being carried out by the hospital doctors clandestinely and which had no approval from the committee. "We have alerted the HODs also on this count," he said. State drug controller SN Sahu said, the drug control administration was also on the alert for any drug trial being conducted by private doctors or clinics in the private sector.